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BACKGROUND The main rationale for the use of lithium in the long-term treatment of unipolar affective disorder is its efficacy in treating bipolar affective disorder and resistant depression . However , there is considerable uncertainty about which pharmacological intervention is most effective in the long-term treatment of recurrent unipolar affective disorder . OBJECTIVES To assess the effects of lithium versus antidepressants for the long-term treatment of recurrent affective disorder . SEARCH STRATEGY We search ed the Cochrane Collaboration Depression , Anxiety and Neurosis Controlled Trials Registers ( CCDANCTR- Studies and CCDANCTR-References ) on 2/9/2005 . Reference lists of relevant papers and major textbooks of affective disorder were checked . Experts in the field and pharmaceutical companies were contacted regarding unpublished material . SELECTION CRITERIA R and omised controlled trials comparing lithium against antidepressant medication for the long-term treatment of patients with a diagnosis of affective disorder . DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data . We contacted study authors for additional information . We collected adverse effects information from the trials . MAIN RESULTS Eight trials involving 475 people were included . Two of the studies included a mixed group of participants with either bipolar or unipolar disorder . Relapse was defined as admission to hospital and when all kinds of relapses were considered ( both depressive and manic ) , there was a statistically significant difference in favour of lithium ( relative risk ( RR ) fixed effect 0.34 , 95 % CI 0.14 to 0.82 ) . The results did not exclude the point of no effect , when the r and om-effects model was used ( RR r and om effects 0.40 , 95 % CI 0.14 to 1.18 ) . There were no other statistically significant differences between lithium and antidepressants according to all other outcomes considered . Manic or depressive relapse was defined as prescription of non- study medication for mood disorder , manic or depressive relapse ( as defined by the study authors ) , quality of life , social functioning , occupational functioning , overall drop-out rate , drop-out rate due to side-effects , troublesome side-effects , mortality due to all causes and specifically suicides . AUTHORS ' CONCLUSIONS There was adequate efficacy evidence for lithium or antidepressants preventing relapse in unipolar affective disorder , however their relative efficacy was unknown . When considering lithium or antidepressant long-term therapy , patients and clinicians should take into account the patient 's clinical history , the side-effects and the individual 's likely adherence to the recommended treatment regime . Large-scale , long-term r and omised trials in unselected groups of subjects with unipolar affective disorder are needed | [
"Prolactin ( PRL ) and Cortisol ( CORT ) responses to d , l-fenfluramine ( FEN ) challenge ( 60 mg ) were examined in patients with affective disorders on two occasions under euthymic conditions : drug-free before admission to prophylactic treatment and after about 9 months of medication with lithium or carbamazepine . Response to treatment was assessed by a complex algorithm using continuous ratings in outpatient clinic over a period of 2 years . In general , treatment result ed in a delayed and diminished CORT release ( n.s . ) ; subgroup analysis revealed an attenuated CORT response ( P CORT baseline value ( P CORT stimulation in nonresponders . This result was not affected by FEN/NorFEN or lithium/carbamazepine serum levels , baseline CORT values , age , sex , diagnostic distribution , number of appointments to the outpatient clinic or duration of medication at the time of FEN test session . Before onset of prophylactic medication responders and nonresponders could not be discriminated significantly regarding stimulated hormone release , probably due to the small sample size ( n = 17 ) . CORT response to FEN was increased in drugfree unipolar patients compared to bipolar ( P lithium medication result ed in a significantly greater increase in CORT release than carbamazepine ( P PRL stimulation showed patterns of secretion quite similar to those of CORT , without reaching statistical significance in most cases . Perhaps due to method ological differences in assessing treatment response , these data do not confirm former results , which supposed an enhanced 5-HT net activity in long-term prophylactic lithium treatment . Because of high interindividual variances of hormone parameters , the FEN-test procedure is not a useful tool for the prediction of therapeutical outcome in terms of clinical routine use . Relations of stimulated hormone response as a marker of central serotoninergic activity and clinical outcome are discussed",
" Relapse rates of the first 35 unipolar and bipolar II manic-depressive patients who entered the controlled phase of a continuing evaluation of the prophylactic value of lithium alone or in combination with imipramine were analyzed . Lithium had a prophylactic effect in unipolar patients and possibly in bipolar II patients . Imipramine did not have a prophylactic effect in either group of patients",
" In two r and omized double-blind controlled trials on 63 depressed female in- patients subject to recurrent affective disorder ( bipolar and unipolar manic-depressive psychosis ) lithium was shown to have major acute antidepressant effects . At the end of three weeks lithium produced more uniform improvement than did imipramine ; lithium in combination with tryptophan ( in the form of Optimax ) was superior to tryptophan alone -- the latter drug having no discernible antidepressant activity in this group of patients . Lithium did not produce an antidepressant effect until the second and third week of both trials",
"Abstract The prophylactic effect of lithium was studied in a group of sixty-five patients with recurrent affective disorders in four centres . Patients were r and omly allocated to lithium or identical-looking placebo tablets for periods of up to 112 weeks . In addition , patients received any further medication or treatment which the psychiatrist in charge of the case thought was necessary . Patients receiving lithium had very significantly less affective illness than patients receiving placebo tablets , whether this was measured by time spent as an inpatient or by the duration of outpatient episodes . The amount of antidepressant or of antimanic medication prescribed was also significantly less in the lithium group . No patient on lithium was given electroconvulsive therapy ( E.C.T. ) , whereas 43 % of the placebo group received one or more courses of E.C.T. A global rating was made independently by two assessors who did not know whether the patient was in the lithium or in the placebo group . These assessors , the psychiatrist in charge of the case and a psychiatric social worker , showed a very high concordance in their ratings . 86 % of patients on lithium were rated as showing little or no affective disorders ( global rating 1 and 2 ) during the trial , as compared to only 8 % of the placebo group . Only 11 % of the lithium group was rated as unchanged or worse than during the 2 years previous to the trial , as compared with 75 % of the placebo group . Lithium seemed to be as effective in patients with unipolar recurrent depressive illness as in patients with both mania and depression",
"Depressed out patients ( n = 51 ) resistant to treatment with maprotiline were treated in a blind , r and omized , single-centre study , for 6 weeks with either the reversible and selective monoamine oxidase A-inhibitor ( MAO-A-I ) , brofaromine or lithium addition to maprotiline . The Hamilton Rating Scale for Depression was scored by an independent rater before and after the 6 week treatment period . No significant differences in efficacy were found between the two treatment regimes . In the patients who completed the trial , brofaromine was well tolerated with the exception of insomnia . Anticholinergic effects as well as thyroid dysfunctions ( 17 out of 20 ) were more frequent in the maprotiline/lithium group",
"The authors compared rates of new episodes in a sample of 64 unipolar subjects treated with fluvoxamine ( n = 32 ) and lithium ( n = 32 ) during a follow-up period of 24 months . Unipolar patients on lithium treatment had a worse outcome with a higher frequency of new recurrences compared with of new recurrences compared with patients on fluvoxamine during the course of preventive treatment",
"The paper reports on the process of patient recruitment for a controlled clinical multicenter study on the treatment of affective disorders . Two thirds of the patients screened did not participate because prophylactic treatment was either unnecessary or not justified for medical reasons . Further , a number of patients equal to that eventually allocated to the trial refused to participate for personal , idiosyncratic reasons . In spite of this , the patients in the trial were very similar to those not participating with respect to relevant variables such as age , sex , number of and intervals between previous episodes or severity of the present episode",
"Mixed mania ( i.e. , a manic syndrome accompanied by depressive symptoms ) and its response to long-term preventive drug treatment was studied as part of a larger NIMH collaborative study . Following recovery from a manic episode , patients received either lithium , imipramine , or the combination of lithium and imipramine for a 2-year period . It was found that patients who had recovered from a mixed manic state were at significantly higher risk for recurrences than patients who had recovered from a pure ( non-mixed ) manic state . Lithium and the combination of lithium and imipramine were highly effective preventive treatments for the pure manic group and poor treatments for the mixed group . Imipramine was ineffective for both the pure and mixed groups . The need for identifying mixed mania in therapeutic trials and in evaluating alternative treatments for lithium with this subgroup is discussed",
" Forty-one out- patients with a history of at least three attacks of depressive illness were r and omly allocated to treatment on a double-blind basis for one year with either mianserin 20 mg three times daily plus placebo lithium tablets , or to lithium tablets once daily plus placebo mianserin tablets . After one year , the dosage of mianserin was increased to 30 mg t.d.s . for a further six months . All but three of the patients had previously been stabilized on prophylactic lithium therapy . Lithium was found to be significantly superior to mianserin in avoiding admission to hospital or ECT . The overall affective morbidity index , calculated from global rating , showed no significant difference between drugs , but the index of the mianserin group was higher in the second six months than in the first . The lithium group showed no such change . Lithium remains the choice for the prophylaxis of unipolar recurrent depressive illness",
"In an 18 hospital study , 205 patients hospitalized with a diagnosis of manic-depressive illness , manic type , were treated upon discharge with lithium carbonate or placebo for a two-year period . Lithium carbonate was significantly more effective than placebo in preventing relapses ( ie , affective episodes severe enough to require hospitalization or use of non study drugs ) . The difference in treatment outcome between lithium carbonate and placebo was due mainly to the lower incidence of manic relapses on lithium carbonate . Patients on lithium carbonate also had a lower incidence of depressive relapses than patients on placebo but the limited incidence of severe depression in this sample makes it difficult to draw any conclusions regarding the prophylactic efficacy of lithium carbonate in depressive illness . The results from this trial coupled with those from other studies indicate that lithium carbonate combined with regular clinical appraisal s is a safe and effective treatment for preventing relapse in manic-depressive illness",
"Early morning sleep deprivation ( patient awake from 0200 to 2200 hours ) produces a same-day antidepressant effect in approximately one-half of patients with major depression . Unfortunately , these antidepressant effects are short-lived and patients usually relapse to baseline depression levels within 48 hours . Recent work suggests , however , that the use of lithium with early morning sleep deprivation sustains this rapid antidepressant effect and makes it clinical ly useful . In a 30-day study , we compared the abilities of four different treatments ( lithium plus early morning sleep deprivation , lithium plus a control sleep deprivation procedure , and desipramine with either of the two sleep manipulations ) to induce a rapid ( next-day ) and sustained antidepressant response in 16 depressed patients . Lithium plus early morning sleep deprivation produced a quicker response than lithium with the control sleep deprivation , and the response was sustained for at least 30 days . In this design , however , lithium/early morning sleep deprivation was no faster than either of the two desipramine/sleep deprivation conditions in inducing remission . These results support the results of previous studies and suggest further investigation of this novel sleep/pharmacologic intervention is warranted",
"OBJECTIVES To compare the relapse rate of elderly depressed patients taking low dose lithium as an additional therapy with antidepressant medication to those receiving antidepressant medication alone . METHODS Fifty elderly subjects recovering from a major depressive illness taking continuation antidepressants were r and omised , in a double blind study , to receive additional lithium carbonate or placebo and followed up over a two year period for evidence of relapse . RESULTS Relapse rate was significantly greater in those subjects taking antidepressant medication alone compared to subjects taking additional lithium therapy . After six months four ( 17 % ) subjects taking antidepressant medication alone had relapsed , whereas none of the subjects taking additional lithium had relapsed . After two years eight ( 33 % ) subjects taking antidepressant medication alone had relapsed , whereas only one ( 4 % ) of the subjects taking additional lithium had relapsed . CONCLUSION This preliminary study suggests that long-term low dose lithium therapy is well tolerated and protects elderly patients from a relapse of depressive illness",
"A double-blind prospect i ve study was carried out comparing the prophylactic effect of maprotiline and lithium carbonate over a period of one year in patients suffering from recurrent affective disorders . The average Affective Morbidity Index was lower , but not significantly so , in patients treated with lithium . A further analysis , based on dividing patients into those with no affective morbidity and those who showed some affective morbidity during the study , demonstrated lithium carbonate to be significantly superior to maprotiline both in the group as a whole and in unipolar depressives . A correlation between high plasma maprotiline concentration and low morbidity was observed and was in line with an earlier report . A highly significant negative correlation ( r=-0 - 97 ; p less than 0 - 001 ) was found between plasma maprotiline concentration and body weight . Although the results showed lithium carbonate to be superior to maprotiline in the study , it should be emphasized that the plasma levels of lithium were constantly monitored and maintained at what is considered to be its optimum concentration , whereas the maprotiline treated patients were kept on a fixed dosage regime irrespective of plasma levels",
"OBJECTIVE Use of lithium to augment antidepressant medication has been shown to be beneficial in the acute treatment of depression . The authors examined the efficacy of lithium augmentation in the continuation treatment of unipolar major depressive disorder . METHOD Thirty patients with a refractory major depressive episode who had responded to acute lithium augmentation during an open 6-week study participated in a r and omized , parallel-group , double-blind , placebo-controlled trial of lithium augmentation during continuation treatment . After a 2 - 4-week stabilization period following remission , patients were r and omly assigned to receive either lithium or placebo for a 4-month period . Antidepressant medication was continued throughout the study . RESULTS Relapses ( including one suicide ) occurred in seven ( 47 % ) of the 15 patients who received placebo in addition to antidepressants . None ( 0 % ) of the 14 patients who received lithium augmentation with antidepressants suffered a relapse during the double-blind phase of the study . Five of the seven relapsing patients in the placebo group developed a depressive episode , and the other two experienced a manic episode . CONCLUSIONS Lithium augmentation in the continuation phase of treatment of unipolar major depressive disorder effectively protects patients against a relapse . Patients who respond to lithium augmentation should be maintained on lithium augmentation for a minimum of 6 months or even longer",
"As reported by Prien ( see p 847 ) , two United States committees concluded in 1975 that lithium is prophylactically efficacious , ie , significantly better than placebo , in recurrent bipolar affective illness . The committees felt , however , that they could not recommend the prophylactic use of lithium in recurrent unipolar affective illness ( 1 ) because there is uncertainty as to what a unipolar disorder represents and ( 2 ) because the evidence for the efficacy of lithium in this disease type is based on a relatively small number of patients . With the first reason given , the committees more or less acknowledge that lack of trust in the psychiatrists ' ability to diagnose recurrent unipolar affective illness played a role in their decision . I have no comment to offer on this . As regards the second reason : It might be worth comparing the evidence now available for prophylactic efficacy of lithium and of cyclic antidepressants in unipolar affective illness .",
"In a double-blind , long-term follow-up study , 117 bipolar patients received lithium carbonate , imipramine hydrochloride , or both and 150 unipolar patients received lithium carbonate , imipramine , both lithium carbonate and imipramine , or placebo . With bipolar patients , lithium carbonate and the combination treatment were superior to imipramine in preventing manic recurrences and were as effective as imipramine in preventing manic recurrences and were as effective as imipramine in preventing depressive episodes . The combination treatment provided no advantage over lithium carbonate alone . With unipolar patients , imipramine and the combination treatment were more effective than lithium carbonate and placebo in preventing depressive recurrences . The combination treatment provided no advantage over imipramine alone . The lithium carbonate-treated group had fewer manic episodes than the other groups . Treatment outcome , which was evaluated primarily in terms of the occurrence of major depression or manic episodes , was significantly related to characteristics of the index episode , ie , the episode that brought the patient into the study",
"A detailed analysis of the results of a multi-centre clinical trial shows that , while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo , there was no clinical ly significant difference between the prophylactic efficacy of the 2 antidepressants . An account is given of the relative adverse effects of the treatments , and the implication s of the findings are discussed",
"In the early 1980s , the National Institute of Mental Health supported a multicenter , r and omized , controlled , clinical trial on unipolar and bipolar disorder to evaluate the comparative efficacies of lithium carbonate , imipramine hydrochloride , a lithium-imipramine combination , and placebo in preventing the recurrence of affective disorders . The objective of this report is to present a re analysis of the relative efficacies of these treatments in patients with unipolar disorder to focus attention on general issues related to the design and conduct of maintenance therapy trials . We show that the earlier conclusions of that study that imipramine and the combination therapy are more effective than lithium and placebo in preventing the recurrence of depression in unipolar patients can be accounted for by alternative explanations that are a consequence of the design of the study . Our findings have important implication s for the design , conduct , and interpretation of results of maintenance therapy clinical trials in general",
"In a double‐blind study on 22 patients with major depressive disorder the effects of lithium and clomipramine on signs and symptoms and on calcium and magnesium in plasma were compared . Ratings of antidepressant and side effects were performed by 2 psychiatrists at the end of a placebo period of 5–7 days and after treatment for 2 and 4 weeks . Psychopathology was rated by 15 reported and 4 observed items from the Comprehensive Psycho pat ho logical Rating Scale ( CPRS ) . Eleven items present in 72–100 % of the patients were used to evaluate the effect of the two drugs . After 2 weeks of treatment the rated scores dropped for more than half of the CPRS items . After 4 weeks the scores for all but one item were reduced in both groups . The sums of scores were significantly reduced after 2 weeks in both groups and after 4 weeks global scores were reduced as well . The drugs had notable and similar antidepressant effects . Lithium treatment was associated with fluctuations in calcium and magnesium levels in plasma not seen during clomipramine treatment . Serum prolactin increased during clomipramine treatment but was unaffected by lithium treatment . No correlations were found between the sum of rating scores and blood levels of drugs , prolactin , calcium or magnesium",
"Recent findings have indicated that lithium treatment markedly reduces suicide risk in major affective disorders . To compare the effect of lithium with carbamazepine and amitriptyline , suicidal behavior was analyzed during the r and omized prospect i ve long-term MAP study ( N = 378 ; duration 2.5 years ) . Of the nine suicides and five attempted suicides , none took place during lithium treatment . The findings support the view that lithium has a specific antisuicidal effect over and above its prophylactic benefit",
" Forty‐five endogenously depressed patients in nine different hospitals were given , r and omly , tricyclic antidepressants plus placebo , or tricyclic antidepressants plus lithium carbonate , for a minimum of 4 weeks . At the hospital with the largest single material , the six patients in the lithium group showed significantly greater improvement after 1 and 4 weeks than the seven patients in the placebo group . At the other hospitals , a total of 14 patients received lithium and 18 placebo , with no significant difference in outcome . However , the heterogeneity of this part of the material might easily have obscured any real difference in treatment outcome . Treatment response in the total material did not correlate significantly with diagnosis ( e.g. , whether unipolar or bipolar affective illness ) , age or sex . No significant side effects were reported",
"Most previous studies of long-term maintenance therapy for bipolar illness simply compared proportions of patients experiencing recurrences . This method is inadequate because the length of time until a recurrence is not taken into account and because data from patients who withdraw prematurely from the study without a recurrence are either ignored or analyzed improperly . More appropriate survival analytic techniques were applied to the data from the National Institute of Mental Health Collaborative Study of bipolar patients treated with lithium carbonate , imipramine hydrochloride , or both . An interaction between treatment and the nature of the index episode ( the episode that brought the patients into the study ) was found . In patients with manic index episodes , both lithium and the combination were superior to imipramine . In patients with depressive index episodes , the combination was significantly superior to imipramine , whereas lithium was indistinguishable from imipramine . The latter finding differs from the original analysis , which found the combination to be no different from the other two treatments for patients with a depressive index episode",
"The authors report on two recent two-year studies that attempted to determine the effectiveness of lithium carbonate in treating recurrent affective illness . In study I , 205 bipolar ( manic-depressive ) patients were r and omly assigned to lithium or placebo ; in study 2 , 44 bipolar and 78 unipolar ( depressive ) patients were r and omly assigned lithium , imipramine , or placebo . The results showed lithium to be effective in treating both manic and depressive episodes and imipramine to be effective in treating depressive episodes . The findings emphasize the importance of considering the patient 's previous course of illness in selecting a program of maintenance treatment",
"The criteria required for the inclusion of patients into the group studied are described . The 29 patients suffered from recurrent affective disorders . No patient satisfying the criteria for selection was excluded . Reasons why 11 of the 29 patients could not be included in the double-blind trial are given . The double-blind trial was performed on the remaining 18 patients . The significance of the difference between the lengths of remissions achieved by the lithium group and the dummy group was measured by the Mann-Whitney U-test . The superiority of lithium over the dummy just failed to be significant at the 5 per cent level , 0.10>p>0.05 . One case of serious toxicity occurred . The patient recovered rapidly and completely . The design and result of the trial is discussed",
" Patients with recurrent affective illness ( N-122 ) were r and omly assigned to lithium carbonate , imipramine , or placebo therapy for two years following discharge from hospitalization for acute depression . Patients were classified as bipolar or unipolar based on the presence or absence of a history of mania . With bipolar patients lithium carbonate was significantly more effective than imipramine or placebo in preventing affective episodes ( ie , manic or depressive attacks severe enough to require hospitalization or use of non study drugs ) . There was a relatively high incidence of manic episodes on imipramine . Unipolar patients responded equally well to lithium carbonate or imipramine . Both treatments were significantly more effective than placebo . The difference between treatments was due primarily to depressive episodes ; manic episodes occurred infrequently and were evenly distributed across treatment groups . There was no significant difference between lithium carbonate and imipramine among unipolar patients",
"The 24-hour urinary serotonin ( 5-HT ) and 5-hydroxyindoleacetic acid ( 5-HIAA ) outputs were repeatedly measured in 21 patients with major affective disorders after a minimum of three weeks free of drug treatments and at steady state during subsequent antidepressant treatments or during the second week after a series of electroconvulsive treatments ( ECTs ) . The 5-HIAA outputs were more variable over time than the outputs of major catecholamine metabolites , previously studied by us . Patients with rapid mood cycles excreted large amounts of 5-HT . Lithium carbonate and ECTs reduced the outputs of 5-HT and 5-HIAA , respectively . Lithium carbonate also stabilized the output of 5-HT . No common effect of different antidepressant treatments on indole outputs was found",
"In a longitudinal outpatient study , the authors found that lithium produced a mild decrease in depth of depression scores among patients who had been on the drug for more than seven months , as compared with patients who had been receiving lithium less than seven months . They assess the factors contributing to reported positive clinical results of maintenance lithium treatment in recurrent affective disorder",
"The hypothesis that flupenthixol decanoate may serve as an alter‐native to prophylactically administered lithium in recurrent manicdepressive illness , bipolar and unipolar type , was tested in two groups of patients . In Group I the patients were allocated r and omly to maintenance treatment with either lithium or flupenthixol decanoate . The patients in Group II had previously been given lithium and were switched to flupenthixol decanoate because of unsatisfactory prophylactic effect of lithium , doubtful tablet compliance , troublesome side effects , or fear of later harmful effects . The flupenthixol decanoate dosage was 20 mg every 2–3 weeks . The study was not blind",
"The present study , including 81 depressive patients , compares the prophylactic efficacy of lithium and amitriptyline in recurrent unipolar depression over a treatment period of 2.5 years in a r and omised multicentre design . Hospitalisation , re-emergence of depressive or subdepressive recurrences , unwanted side-effects and need of concomitant psychotropic medication were considered to indicate treatment failures . Average dosage for amitriptyline was 98 + /- 37 mg/day , average lithium blood level was 0.59 + /- 0.12 mmol/l . Survival analyses demonstrated a significant superiority of lithium ( P = 0.015 ) regarding the outcome criteria ' recurrences and /or sub clinical recurrences ' and non-significantly better results of lithium compared to amitriptyline concerning ' recurrence ' ( P = 0.059 ) or ' recurrence and /or concomitant medication ' ( P = 0.066 )",
"Recently , the therapeutic benefit of lithium augmentation in old age has come into question . These data , in light of the documented high incidence of side effects after lithium use in elderly patients , result ed in the design of a prospect i ve , placebo-controlled lithium augmentation withdrawal study in elderly patients with unipolar depression . Twelve eligible geriatric patients ( 10 women and 2 men ; mean [ + /-SD ] age , 76.2 + /- 5.7 years ) with DSM-III-R unipolar depression receiving adjunct lithium therapy were r and omized to receive continued lithium augmentation or matching placebo ( withdrawal rate 150 mg/day/wk ) . At each clinic visit , patients were assessed for depression ( Montgomery-Asberg Depression Rating Scale and Geriatric Depression Rating Scale ) and lithium-induced toxicities ( a 21-item side-effect checklist , renal and thyroid biochemistry ) . Over the 2-year observation period , the placebo group reported a decrease in composite 21-item side-effect score and specific lithium toxicities ( e.g. , urinary urgency , h and tremor , and renal/thyroid abnormalities ) . Two patients in the lithium maintenance group had a recurrence of depression at 61 and 96 weeks , respectively , immediately after a stressful life event ( cerebrovascular accident [ CVA ] or death of spouse ) , and two patients had a recurrence in the placebo group at 7 and 92 weeks , respectively , without any apparent changes in life stresses . No other prognostic risk factors for recurrence were identified . Depression that recurred in patients who were receiving placebo was relatively resistant to reinstitution of lithium augmentation therapy . In otherwise stable geriatric patients with unipolar depression , the documented benefits of reduced side effects should be weighed against the risk of recurrence and subsequent lithium resistance before withdrawal of lithium augmentation",
"The authors studied 52 manic-depressive patients who were assigned to either lithium or placebo during their normal interval phases for periods up to 28 months . Patients receiving lithium had fewer manic and depressive episodes per patient-year than placebo patients . However , this difference may have been due to a sample bias produced by a large dropout rate among patients who had manic episodes . The findings also suggest a relationship between response to lithium and family history of bipolar illness",
" Twenty-seven patients with recurrent unipolar depression and 22 with bipolar II illness in remission for at least six months were r and omly assigned on a double-blind basis to treatment regimens using lithium carbonate , imipramine hydrochloride , lithium carbonate plus imipramine , or placebo . Lithium carbonate was found to help prevent depressive relapse among patients with unipolar disease , and relapse of any type among those with bipolar II disease . No effect or interaction of imipramine was found in either group . These results add to a growing body of data that suggest the usefulness of lithium carbonate in the prophylaxis of unipolar depressive illness . The relative usefulness of lithium carbonate and imipramine requires further study",
"The effect of lithium carbonate therapy on patients with depression is still unconfirmed . Our past studies have shown a favorable response to the drug in patients with depression of mild or moderate severity . Therefore , we performed a controlled double-blind study of lithium carbonate and imipramine hydrochloride in 64 patients with depression . No significant differences were noted in the overall therapeutic response , depression scale scores , or clinical effects between the two drug groups",
"In a double-blind crossover study comparing lithium carbonate with desimipramine in the treatment of selected depressed patients , there was considerable improvement in both groups of patients , with no statistically significant difference between the effectiveness of the two drugs . This finding , together with other reports , raises the question of whether lithium carbonate might be effective in the treatment of selected depressed patients . Consideration is also given to the implication s of our observations and findings for the bipolar concept of mania and depression . Evidence is considered for an alternative model which highlights some of the similarities between these two clinical states",
"A major problem for the practitioner is the lack of satisfactory guidelines as to how long continuation drug treatment of depressive episodes must be maintained to ensure that the episode is over . This often leads to either premature withdrawal of the drug and subsequent relapse or unnecessarily prolonged treatment . Results from a collaborative project of the National Institute of Mental Health provide the first study -derived guidelines on the length of continuation therapy . Findings indicate that withdrawal of such therapy is safe only after the patient has been free of significant symptoms for 16 to 20 weeks and that focusing on mild as well as severe symptoms is critical in this decision",
" Abstract Fifty manic-depressive patients and thirty-four patients with recurrent endogenous depression who had been on open lithium treatment for at least a year took part in double-blind discontinuance studies to compare lithium carbonate and placebo . Within each diagnostic group matched pairs were allocated at r and om to lithium carbonate or placebo . Relapses occurring first in the lithium partners constituted placebo preferences and those occurring first in the placebo parners lithium preferences . Relapses were recorded when requiring hospital admission or supervision with additional therapy at home . Serum-lithium levels were monitored . The trials terminated in significant preference for lithium both in manic-depressive and in recurrent-depressive disorder ; this happened when nine patients in each group had relapsed on placebo and none on lithium . During the whole trial , which lasted five months , twenty-one placebo patients relapsed and none of the lithium patients . Before the trials , patients had been on lithium for up to 7 years ; even after this long period there was still risk of relapse on withdrawal of the drug"
] | 4116588a-06ff-11f0-808a-c43d1ab1c353 |
We have prepared the Japanese Breast Cancer Society clinical practice guidelines ( CPGs ) for surgical treatment of breast cancer , 2018 up date after a systematic review ( SR ) of the literature based upon the Medical Information Network Distribution Service ( Minds ) procedure . The CPG committee for surgical treatment of breast cancer , composed of breast surgeons and plastic surgeons treating breast cancer , has developed the CPGs . Eight clinical questions ( CQs ) were selected and divided roughly into the following five categories : ( 1 ) breast surgery in initial therapy ( CQs 1 - 3 ) ; ( 2 ) axillary surgery in initial therapy ( CQs 4 - 5 ) ; ( 3 ) breast reconstruction in initial therapy ( CQ 6 ) ; ( 4 ) surgical treatment for recurrent and metastatic breast cancer ( CQs 7 - 8 ) ; and ( 5 ) others . Recommendations for these CQs were decided by the GRADE grid method . In addition , 4 outlines , 14 background questions ( BQs ) , and 12 future research questions ( FQs ) were also selected . Statements for these BQs and FQs are provided . We developed the up date d CPGs for surgical treatment of breast cancer , 2018 , which include 8 CQs and recommendations . As a decision-making tool for the underst and ing and treatment of breast cancer , these guidelines will help surgical oncologists dealing with breast cancer , medical staff , and patients , along with their family members | [
"BACKGROUND The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures . METHODS We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assay of 21 prospect ively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative , tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14 . The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospect ively defined algorithm to calculate a recurrence score and to determine a risk group ( low , intermediate , or high ) for each patient . RESULTS Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks . The proportions of patients categorized as having a low , intermediate , or high risk by the RT-PCR assay were 51 , 22 , and 27 percent , respectively . The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk , intermediate-risk , and high-risk groups were 6.8 percent ( 95 percent confidence interval , 4.0 to 9.6 ) , 14.3 percent ( 95 percent confidence interval , 8.3 to 20.3 ) , and 30.5 percent ( 95 percent confidence interval , 23.6 to 37.4 ) . The rate in the low-risk group was significantly lower than that in the high-risk group ( P overall survival ( P distant recurrence in individual patients . CONCLUSIONS The recurrence score has been vali date d as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative , estrogen-receptor-positive breast cancer",
"BACKGROUND Adjuvant systemic treatment for patients with isolated locoregional recurrence ( ILRR ) of breast cancer is based on a single reported r and omized trial . The trial , conducted by the Swiss Group for Clinical Cancer Research , compared tamoxifen ( TAM ) with observation after complete excision of the ILRR and proper radiotherapy . We performed a definitive analysis of treatment outcome at > 11 years of follow-up , after the majority of the patients had a subsequent event of interest . Patient and methods One hundred and sixty-seven patients with ' good-risk ' characteristics of disease were r and omized . ' Good-risk ' was defined as estrogen receptor expression in the ILRR , or having a disease-free interval of > 12 months and a recurrence consisting of three or less tumor nodules , each Seventy-nine percent of the patients were postmenopausal at r and omization . RESULTS The median follow-up time of the surviving patients was 11.6 years . The median post ILRR disease-free survival ( DFS ) was 6.5 years with TAM and 2.7 years with observation ( P = 0.053 ) . The difference was mainly due to reduction of further local relapses ( P = 0.011 ) . In postmenopausal patients , TAM led to an increase of DFS from 33 % to 61 % ( P = 0.006 ) . In premenopausal women , 5-year DFS was 60 % , independent of TAM medication . For the whole study population , the median post-recurrence overall survival ( OS ) was 11.2 and 11.5 years in the observation and the TAM group , respectively ; premenopausal patients experienced a 5-year OS of 90 % for observation compared with 67 % for TAM ( P = 0.175 ) , while the respective figures for postmenopausal patients were both 75 % . CONCLUSIONS These definitive results confirmed that TAM significantly improves the post-recurrence DFS of patients after local treatment for ILRR . This beneficial effect does not translate into a detectable OS advantage",
"Two r and omized clinical studies comparing the efficacy of oral UFT ( 2 years ) with that of classical cyclophosphamide , methotrexate , and 5-fluorouracil ( CMF ) ( six courses ) have been conducted in patients with resected early breast cancer . We have performed a pooled analysis of these two r and omized studies . A pooled analysis was performed using individual patient data from the two trials . Hazard ratios ( HRs ) were determined with a Cox model stratified by study and adjusted for clinical characteristics . We preplanned to verify the following two hypotheses : UFT is non-inferior to CMF in all patients ( hypothesis 1 ) or in ER-positive patients ( hypothesis 2 ) with respect to relapse-free survival ( RFS ) . Non-inferiority of UFT versus CMF was established if the upper limit of the two-sided confidence interval ( CI ) of the HR for RFS did not exceed 1.30 . Hochberg multiplicity adjustment for the significance level was performed . A total of 1,057 patients were analyzed ( CMF , n = 528 ; UFT , n = 529 ) . Median follow-up time was 5.6 years . The HR for RFS was 1.04 ( 95 % CI , 0.78–1.40 ) in all patients and 0.79 ( 97.5 % CI , 0.49–1.27 ) in ER-positive patients . UFT was shown to be non-inferior to CMF in ER-positive patients . An exploratory subgroup analysis showed that RFS was better with UFT than with CMF in ER-positive patients who were 50 years or older ( HR , 0.58 ; 95 % CI , 0.34–1.01 ) . UFT is non-inferior to CMF in terms of inhibiting recurrence of ER-positive , early breast cancer",
"BACKGROUND Adjuvant tamoxifen therapy is effective for postmenopausal women with endocrine-responsive breast cancer . Cytochrome P450 2D6 ( CYP2D6 ) enzyme metabolizes tamoxifen to clinical ly active metabolites , and CYP2D6 polymorphisms may adversely affect tamoxifen efficacy . In this study , we investigated the clinical relevance of CYP2D6 polymorphisms . METHODS We obtained tumor tissues and isolated DNA from 4861 of 8010 postmenopausal women with hormone receptor-positive breast cancer who enrolled in the r and omized , phase III double-blind Breast International Group ( BIG ) 1 - 98 trial between March 1998 and May 2003 and received tamoxifen and /or letrozole treatment . Extracted DNA was used for genotyping nine CYP2D6 single-nucleotide polymorphisms using polymerase chain reaction-based methods . Genotype combinations were used to categorize CYP2D6 metabolism phenotypes as poor , intermediate , and extensive metabolizers ( PM , IM , and EM , respectively ; n = 4393 patients ) . Associations of CYP2D6 metabolism phenotypes with breast cancer-free interval ( referred to as recurrence ) and treatment-induced hot flushes according to r and omized endocrine treatment and previous chemotherapy were assessed . Cox proportional hazards models were used to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) . All statistical tests were two-sided . RESULTS No association between CYP2D6 metabolism phenotypes and breast cancer-free interval was observed among patients who received tamoxifen monotherapy without previous chemotherapy ( P = .35 ) . PM or IM phenotype had a non-statistically significantly reduced risk of breast cancer recurrence compared with EM phenotype ( PM or IM vs EM , HR of recurrence = 0.86 , 95 % CI = 0.60 to 1.24 ) . CYP2D6 metabolism phenotype was associated with tamoxifen-induced hot flushes ( P = .020 ) . Both PM and IM phenotypes had an increased risk of tamoxifen-induced hot flushes compared with EM phenotype ( PM vs EM , HR of hot flushes = 1.24 , 95 % CI = 0.96 to 1.59 ; IM vs EM , HR of hot flushes = 1.23 , 95 % CI = 1.05 to 1.43 ) . CONCLUSIONS CYP2D6 phenotypes of reduced enzyme activity were not associated with worse disease control but were associated with increased hot flushes , contrary to the hypothesis . The results of this study do not support using the presence or absence of hot flushes or the pharmacogenetic testing of CYP2D6 to determine whether to treat postmenopausal breast cancer patients with tamoxifen",
"PURPOSE This article reports the results of a pooled analysis of six r and omized trials conducted to study the efficacy of uracil and tegafur ( UFT ) in the adjuvant treatment of node-negative breast cancer patients . PATIENTS AND METHODS Six r and omized controlled trials on node-negative breast cancer patients were conducted from 1992 through 1995 in Japan that included the three , three-arm trials ( control [ no adjuvant ] , UFT , and tamoxifen [ TAM ] groups ) and the three , four-arm trials ( control , UFT , TAM , and UFT plus TAM groups ) . Pooled analysis was performed on the data obtained from these six trials ( involving 2,934 patients ) . RESULTS Overall survival was compared between the UFT group ( including both the UFT group and the TAM plus UFT group ) and the non-UFT group ( control group and TAM group ) . A significant difference ( P = .04 ) was observed in 5-year survival rates between the UFT ( 95.9 % ) and the non-UFT ( 94.0 % ) groups . Overall survival was also compared between the TAM group ( TAM group and TAM plus UFT group ) and the non-TAM group ( control group plus UFT group ) . The 5-year survival rate ( 95.2 % ) in the TAM group was not significantly different from that ( 93.9 % ) in the non-TAM group , but the subset analysis showed a significant ( P = .01 ) improvement in the estrogen receptor-positive subset . CONCLUSION Adjuvant UFT improves the overall survival of node-negative breast cancer patients . Given that UFT has milder adverse effects , it is suggested that UFT can be a useful alternative to doxorubicin and cyclophosphamide , or cyclophosphamide , methotrexate , and fluorouracil in the adjuvant treatment for node-negative breast cancer",
"Summary Background For women with oestrogen receptor (ER)-positive early breast cancer , treatment with tamoxifen for 5 years substantially reduces the breast cancer mortality rate throughout the first 15 years after diagnosis . We aim ed to assess the further effects of continuing tamoxifen to 10 years instead of stopping at 5 years . Methods In the worldwide Adjuvant Tamoxifen : Longer Against Shorter ( ATLAS ) trial , 12 894 women with early breast cancer who had completed 5 years of treatment with tamoxifen were r and omly allocated to continue tamoxifen to 10 years or stop at 5 years ( open control ) . Allocation ( 1:1 ) was by central computer , using minimisation . After entry ( between 1996 and 2005 ) , yearly follow-up forms recorded any recurrence , second cancer , hospital admission , or death . We report effects on breast cancer outcomes among the 6846 women with ER-positive disease , and side-effects among all women ( with positive , negative , or unknown ER status ) . Long-term follow-up still continues . This study is registered , number IS RCT N19652633 . Findings Among women with ER-positive disease , allocation to continue tamoxifen reduced the risk of breast cancer recurrence ( 617 recurrences in 3428 women allocated to continue vs 711 in 3418 controls , p=0·002 ) , reduced breast cancer mortality ( 331 deaths vs 397 deaths , p=0·01 ) , and reduced overall mortality ( 639 deaths vs 722 deaths , p=0·01 ) . The reductions in adverse breast cancer outcomes appeared to be less extreme before than after year 10 ( recurrence rate ratio [ RR ] 0·90 [ 95 % CI 0·79–1·02 ] during years 5–9 and 0·75 [ 0·62–0·90 ] in later years ; breast cancer mortality RR 0·97 [ 0·79–1·18 ] during years 5–9 and 0·71 [ 0·58–0·88 ] in later years ) . The cumulative risk of recurrence during years 5–14 was 21·4 % for women allocated to continue versus 25·1 % for controls ; breast cancer mortality during years 5–14 was 12·2 % for women allocated to continue versus 15·0 % for controls ( absolute mortality reduction 2·8 % ) . Treatment allocation seemed to have no effect on breast cancer outcome among 1248 women with ER-negative disease , and an intermediate effect among 4800 women with unknown ER status . Among all 12 894 women , mortality without recurrence from causes other than breast cancer was little affected ( 691 deaths without recurrence in 6454 women allocated to continue versus 679 deaths in 6440 controls ; RR 0·99 [ 0·89–1·10 ] ; p=0·84 ) . For the incidence ( hospitalisation or death ) rates of specific diseases , RRs were as follows : pulmonary embolus 1·87 ( 95 % CI 1·13–3·07 , p=0·01 [ including 0·2 % mortality in both treatment groups ] ) , stroke 1·06 ( 0·83–1·36 ) , ischaemic heart disease 0·76 ( 0·60–0·95 , p=0·02 ) , and endometrial cancer 1·74 ( 1·30–2·34 , p=0·0002 ) . The cumulative risk of endometrial cancer during years 5–14 was 3·1 % ( mortality 0·4 % ) for women allocated to continue versus 1·6 % ( mortality 0·2 % ) for controls ( absolute mortality increase 0·2 % ) . Interpretation For women with ER-positive disease , continuing tamoxifen to 10 years rather than stopping at 5 years produces a further reduction in recurrence and mortality , particularly after year 10 . These results , taken together with results from previous trials of 5 years of tamoxifen treatment versus none , suggest that 10 years of tamoxifen treatment can approximately halve breast cancer mortality during the second decade after diagnosis . Funding Cancer Research UK , UK Medical Research Council , AstraZeneca UK , US Army , EU-Biomed",
"The clinical importance of CYP2D6 genotype as predictor of tamoxifen efficacy is still unclear . Recent genotyping studies on CYP2D6 using DNA derived from tumor blocks have been criticized because loss of heterozygosity ( LOH ) in tumors may lead to false genotype assignment . Postmenopausal early breast cancer patients who were r and omized to receive tamoxifen , followed by exemestane in a large r and omized controlled trial were genotyped for five CYP2D6 alleles . CYP2D6 genotypes and phenotypes were related to disease-free survival during tamoxifen use ( DFS-t ) in 731 patients . By analyzing microsatellites flanking the CYP2D6 gene , patients whose genotyping results were potentially affected by LOH were excluded . In addition , exploratory analyses on 24 genetic variants of other metabolic enzymes and the estrogen receptor were performed . For the CYP2D6 analysis , only 2.3 % of the sample s were excluded , because influence of LOH could not be ruled out . No association was found between the CYP2D6 genotype or predicted phenotype and DFS-t ( poor vs. extensive metabolizers : unadjusted hazard ratio 1.33 , 95 % CI 0.52–3.43 ; P = 0.55 ) . DFS-t was associated with UGT2B15 * 2 ( Vt/Vt + Wt/Vt vs. Wt/Wt : adjusted hazard ratio 0.47 , 95 % CI 0.25–0.89 ; P = 0.019 ) and the estrogen receptor-1 polymorphism ESR1 PvuII ( gene – dose effect : adjusted hazard ratio 1.63 , 95 % CI 1.04–2.54 ; P = 0.033 ) . In postmenopausal early breast cancer patients treated with adjuvant tamoxifen followed by exemestane neither CYP2D6 genotype nor phenotype did affect DFS-t . This is in accordance with two recent studies in the BIG1 - 98 and ATAC trials . Our study is the first CYP2D6 association study using DNA from paraffin-embedded tumor tissue in which potentially false interpretation of genotyping results because of LOH was excluded . Polymorphisms in the estrogen receptor-1 and UGT2B15 may be associated with tamoxifen efficacy , but these findings need replication",
"CONTEXT Premenopausal patients with breast cancer are at high risk of premature ovarian failure induced by systemic treatments , but no st and ard strategies for preventing this adverse effect are yet available . OBJECTIVE To determine the effect of the temporary ovarian suppression obtained by administering the gonadotropin-releasing hormone analogue triptorelin during chemotherapy on the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy . DESIGN , SETTING , AND PATIENTS The PROMISE-GIM6 ( Prevention of Menopause Induced by Chemotherapy : A Study in Early Breast Cancer Patients -Gruppo Italiano Mammella 6 ) study , a parallel , r and omized , open-label , phase 3 superiority trial , was conducted at 16 sites in Italy and enrolled 281 patients between October 2003 and January 2008 . The patients were premenopausal women with stage I through III breast cancer who were c and i date s for adjuvant or neoadjuvant chemotherapy . Assuming a 60 % rate of early menopause in the group treated with chemotherapy alone , it was estimated that 280 patients had to be enrolled to detect a 20 % absolute reduction in early menopause in the group treated with chemotherapy plus triptorelin . The intention-to-treat analysis was performed by including all r and omized patients and using imputed values for missing data . INTERVENTIONS Before beginning chemotherapy , patients were r and omly allocated to receive chemotherapy alone or combined with triptorelin . Triptorelin was administered intramuscularly at a dose of 3.75 mg at least 1 week before the start of chemotherapy and then every 4 weeks for the duration of chemotherapy . MAIN OUTCOME MEASURE Incidence of early menopause ( defined as no resumption of menstrual activity and postmenopausal levels of follicle-stimulating hormone and estradiol 1 year after the last cycle of chemotherapy ) . RESULTS The clinical and tumor characteristics of the 133 patients r and omized to chemotherapy alone and the 148 patients r and omized to chemotherapy plus triptorelin were similar . Twelve months after the last cycle of chemotherapy ( last follow-up , August 18 , 2009 ) , the rate of early menopause was 25.9 % in the chemotherapy-alone group and 8.9 % in the chemotherapy plus triptorelin group , an absolute difference of -17 % ( 95 % confidence interval , -26 % to -7.9 % ; P odds ratio for treatment-related early menopause was 0.28 ( 95 % confidence interval , 0.14 to 0.59 ; P triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00311636",
"BACKGROUND Adjuvant therapy with an aromatase inhibitor improves outcomes , as compared with tamoxifen , in postmenopausal women with hormone-receptor-positive breast cancer . METHODS In two phase 3 trials , we r and omly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years . Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin , oophorectomy , or ovarian irradiation . The primary analysis combined data from 4690 patients in the two trials . RESULTS After a median follow-up of 68 months , disease-free survival at 5 years was 91.1 % in the exemestane-ovarian suppression group and 87.3 % in the tamoxifen-ovarian suppression group ( hazard ratio for disease recurrence , second invasive cancer , or death , 0.72 ; 95 % confidence interval [ CI ] , 0.60 to 0.85 ; P rate of freedom from breast cancer at 5 years was 92.8 % in the exemestane-ovarian suppression group , as compared with 88.8 % in the tamoxifen-ovarian suppression group ( hazard ratio for recurrence , 0.66 ; 95 % CI , 0.55 to 0.80 ; P deaths ( 4.1 % of the patients ) , overall survival did not differ significantly between the two groups ( hazard ratio for death in the exemestane-ovarian suppression group , 1.14 ; 95 % CI , 0.86 to 1.51 ; P=0.37 ) . Selected adverse events of grade 3 or 4 were reported for 30.6 % of the patients in the exemestane-ovarian suppression group and 29.4 % of those in the tamoxifen-ovarian suppression group , with profiles similar to those for postmenopausal women . CONCLUSIONS In premenopausal women with hormone-receptor-positive early breast cancer , adjuvant treatment with exemestane plus ovarian suppression , as compared with tamoxifen plus ovarian suppression , significantly reduced recurrence . ( Funded by Pfizer and others ; TEXT and SOFT Clinical Trials.gov numbers , NCT00066703 and NCT00066690 , respectively . )",
"PURPOSE Locoregional failure after breast-conserving surgery is associated with increased risk of distant disease and death . The magnitude of this risk in patients receiving chemotherapy has not been adequately characterized . PATIENTS AND METHODS Our study population included 2,669 women r and omly assigned onto five National Surgical Adjuvant Breast and Bowel Project node-positive protocol s ( B-15 , B-16 , B-18 , B-22 , and B-25 ) , who were treated with lumpectomy , whole-breast irradiation , and adjuvant systemic therapy . Cumulative incidences of ipsilateral breast tumor recurrence ( IBTR ) and other locoregional recurrence ( oLRR ) were calculated . Kaplan-Meier curves were used to estimate distant-disease-free survival ( DDFS ) and overall survival ( OS ) after IBTR or oLRR . Cox models were used to model survival using clinical and pathologic factors jointly with IBTR or oLRR as time-varying predictors . RESULTS Four hundred twenty-four patients ( 15.9 % ) experienced locoregional failure ; 259 ( 9.7 % ) experienced IBTR , and 165 ( 6.2 % ) experienced oLRR . The 10-year cumulative incidence of IBTR and oLRR was 8.7 % and 6.0 % , respectively . Most locoregional failures occurred within 5 years ( 62.2 % for IBTR and 80.6 % for oLRR ) . Age , tumor size , and estrogen receptor status were significantly associated with IBTR . Nodal status and estrogen and progesterone receptor status were significantly associated with oLRR . The 5-year DDFS rates after IBTR and oLRR were 51.4 % and 18.8 % , respectively . The 5-year OS rates after IBTR and oLRR were 59.9 % and 24.1 % , respectively . Hazard ratios for mortality associated with IBTR and oLRR were 2.58 ( 95 % CI , 2.11 to 3.15 ) and 5.85 ( 95 % CI , 4.80 to 7.13 ) , respectively . CONCLUSION Node-positive breast cancer patients who developed IBTR or oLRR had significantly poorer prognoses than patients who did not experience these events",
"PURPOSE The primary aim of this study was to compare the effectiveness of oral uracil-tegafur ( UFT ) with that of classical cyclophosphamide , methotrexate , and fluorouracil ( CMF ) given as postoperative adjuvant treatment to women with node-negative , high-risk breast cancer . PATIENTS AND METHODS Women with node-negative , high-risk breast cancer were r and omly assigned to receive either 2 years of UFT or six cycles of CMF after surgery . The primary end point was relapse-free survival ( RFS ) . Overall survival ( OS ) , toxicity , and quality of life ( QOL ) were secondary end points . The hypothesis was that UFT was not inferior to CMF in terms of RFS . RESULTS Between October 1996 and April 2001 , a total of 733 patients were r and omly assigned to receive either treatment . The median follow-up time was 6.2 years . The RFS rates at 5 years were 88.0 % in the CMF arm and 87.8 % in the UFT arm . OS rates were 96.0 % and 96.2 % , respectively . The hazard ratios of the UFT arm relative to the CMF arm were 0.98 for RFS ( 95 % CI , 0.66 to 1.45 ; P = .92 ) and 0.81 for OS ( 95 % CI , 0.44 to 1.48 ; P = .49 ) . The toxicity profiles differed between the two groups . The QOL scores were better for patients given UFT than those given CMF . CONCLUSION RFS and OS with oral UFT were similar to those with classical CMF . Given the higher QOL scores , oral UFT is a promising alternative to CMF for postoperative adjuvant chemotherapy in women with node-negative , high-risk breast cancer",
"BACKGROUND We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carcinoma in situ ( DCIS ) . We did a double-blind r and omised controlled trial to find out whether lumpectomy , radiation therapy , and tamoxifen was of more benefit than lumpectomy and radiation therapy alone for DCIS . METHODS 1804 women with DCIS , including those whose resected sample margins were involved with tumour , were r and omly assigned lumpectomy , radiation therapy ( 50 Gy ) , and placebo ( n=902 ) , or lumpectomy , radiation therapy , and tamoxifen ( 20 mg daily for 5 years , n=902 ) . Median follow-up was 74 months ( range 57 - 93 ) . We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years . FINDINGS Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo ( 8.2 vs 13.4 % , p=0.0009 ) . The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4.1 % at 5 years : 2.1 % in the ipsilateral breast , 1.8 % in the contralateral breast , and 0.2 % at regional or distant sites . The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis . INTERPRETATION The combination of lumpectomy , radiation therapy , and tamoxifen was effective in the prevention of invasive cancer",
"PURPOSE The 21-gene recurrence score ( RS ) assay quantifies the likelihood of distant recurrence in women with estrogen receptor-positive , lymph node-negative breast cancer treated with adjuvant tamoxifen . The relationship between the RS and chemotherapy benefit is not known . METHODS The RS was measured in tumors from the tamoxifen-treated and tamoxifen plus chemotherapy-treated patients in the National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B20 trial . Cox proportional hazards models were utilized to test for interaction between chemotherapy treatment and the RS . RESULTS A total of 651 patients were assessable ( 227 r and omly assigned to tamoxifen and 424 r and omly assigned to tamoxifen plus chemotherapy ) . The test for interaction between chemotherapy treatment and RS was statistically significant ( P = .038 ) . Patients with high-RS ( > or = 31 ) tumors ( ie , high risk of recurrence ) had a large benefit from chemotherapy ( relative risk , 0.26 ; 95 % CI , 0.13 to 0.53 ; absolute decrease in 10-year distant recurrence rate : mean , 27.6 % ; SE , 8.0 % ) . Patients with low-RS ( chemotherapy treatment ( relative risk , 1.31 ; 95 % CI , 0.46 to 3.78 ; absolute decrease in distant recurrence rate at 10 years : mean , -1.1 % ; SE , 2.2 % ) . Patients with intermediate-RS tumors did not appear to have a large benefit , but the uncertainty in the estimate can not exclude a clinical ly important benefit . CONCLUSION The RS assay not only quantifies the likelihood of breast cancer recurrence in women with node-negative , estrogen receptor-positive breast cancer , but also predicts the magnitude of chemotherapy benefit ",
"BACKGROUND Analysis of the Austrian Breast and Colorectal Cancer Study Group trial-12 ( ABCSG-12 ) at 48 months ' follow-up showed that addition of zoledronic acid to adjuvant endocrine therapy significantly improved disease-free survival . We have now assessed long-term clinical efficacy including disease-free survival and disease outcomes in patients receiving anastrozole or tamoxifen with or without zoledronic acid . METHODS ABSCG-12 is a r and omised , controlled , open-label , two-by-two factorial , multicentre trial in 1803 premenopausal women with endocrine-receptor-positive early-stage ( stage I-II ) breast cancer receiving goserelin ( 3.6 mg every 28 days ) , comparing the efficacy and safety of anastrozole ( 1 mg per day ) or tamoxifen ( 20 mg per day ) with or without zoledronic acid ( 4 mg every 6 months ) for 3 years . R and omisation ( 1:1:1:1 ratio ) was computerised and based on the Pocock and Simon minimisation method to balance the four treatment arms across eight prognostic variables ( age , neoadjuvant chemotherapy , pathological tumour stage ; lymph-node involvement , type of surgery or locoregional therapy , complete axillary dissection , intraoperative radiation therapy , and geographical region ) . Treatment allocation was not masked . The primary endpoint was disease-free survival ( defined as disease recurrence or death ) and analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00295646 ; follow-up is ongoing . FINDINGS At a median follow-up of 62 months ( range 0 - 114.4 months ) , more than 2 years after treatment completion , 186 disease-free survival events had been reported ( 53 events in 450 patients on tamoxifen alone , 57 in 453 patients on anastrozole alone , 36 in 450 patients on tamoxifen plus zoledronic acid , and 40 in 450 patients on anastrozole plus zoledronic acid ) . Zoledronic acid reduced risk of disease-free survival events overall ( HR 0.68 , 95 % CI 0.51 - 0.91 ; p=0.009 ) , although the difference was not significant in the tamoxifen ( HR 0.67 , 95 % CI 0.44 - 1.03 ; p=0.067 ) and anastrozole arms ( HR 0.68 , 95 % CI 0.45 - 1.02 ; p=0.061 ) assessed separately . Zoledronic acid did not significantly affect risk of death ( 30 deaths with zoledronic acid vs 43 deaths without ; HR 0.67 , 95 % CI 0.41 - 1.07 ; p=0.09 ) . There was no difference in disease-free survival between patients on tamoxifen alone versus anastrozole alone ( HR 1.08 , 95 % CI 0.81 - 1.44 ; p=0.591 ) , but overall survival was worse with anastrozole than with tamoxifen ( 46 vs 27 deaths ; HR 1.75 , 95 % CI 1.08 - 2.83 ; p=0.02 ) . Treatments were generally well tolerated , with no reports of renal failure or osteonecrosis of the jaw . Bone pain was reported in 601 patients ( 33 % ; 349 patients on zoledronic acid vs 252 not on the drug ) , fatigue in 361 ( 20 % ; 192 vs 169 ) , headache in 280 ( 16 % ; 147 vs 133 ) , and arthralgia in 266 ( 15 % ; 145 vs 121 ) . INTERPRETATION Addition of zoledronic acid improved disease-free survival in the patients taking anastrozole or tamoxifen . There was no difference in disease-free survival between patients receiving anastrozole and tamoxifen overall , but those on anastrozole alone had inferior overall survival . These data show persistent benefits with zoledronic acid and support its addition to adjuvant endocrine therapy in premenopausal patients with early-stage breast cancer . FUNDING AstraZeneca ; Novartis",
"BACKGROUND Most recurrences in women with breast cancer receiving 5 years of adjuvant tamoxifen occur after 5 years . The MA.17 trial , which was design ed to determine whether extended adjuvant therapy with the aromatase inhibitor letrozole after tamoxifen reduces the risk of such late recurrences , was stopped early after an interim analysis showed that letrozole improved disease-free survival . This report presents up date d findings from the trial . METHODS Postmenopausal women completing 5 years of tamoxifen treatment were r and omly assigned to a planned 5 years of letrozole ( n = 2593 ) or placebo ( n = 2594 ) . The primary endpoint was disease-free survival ( DFS ) ; secondary endpoints included distant disease-free survival , overall survival , incidence of contralateral tumors , and toxic effects . Survival was examined using Kaplan-Meier analysis and log-rank tests . Planned subgroup analyses included those by axillary lymph node status . All statistical tests were two-sided . RESULTS After a median follow-up of 30 months ( range = 1.5 - 61.4 months ) , women in the letrozole arm had statistically significantly better DFS and distant DFS than women in the placebo arm ( DFS : hazard ratio [ HR ] for recurrence or contralateral breast cancer = 0.58 , 95 % confidence interval [ CI ] = 0.45 to 0.76 ; P Overall survival was the same in both arms ( HR for death from any cause = 0.82 , 95 % CI = 0.57 to 1.19 ; P = .3 ) . However , among lymph node-positive patients , overall survival was statistically significantly improved with letrozole ( HR = 0.61 , 95 % CI = 0.38 to 0.98 ; P = .04 ) . The incidence of contralateral breast cancer was lower in women receiving letrozole , but the difference was not statistically significant . Women receiving letrozole experienced more hormonally related side effects than those receiving placebo , but the incidences of bone fractures and cardiovascular events were the same . CONCLUSION Letrozole after tamoxifen is well-tolerated and improves both disease-free and distant disease-free survival but not overall survival , except in node-positive patients",
"PURPOSE Locoregional failure ( LRF ) after breast-conserving therapy ( BCT ) is associated with increased risk of distant disease and death . The magnitude of this risk has not been adequately characterized in patients with lymph node-negative disease . PATIENTS AND METHODS Our study population included 3,799 women r and omly assigned to five National Surgical Adjuvant Breast and Bowel Project protocol s of node-negative disease ( ie , B-13 , B-14 , B-19 , B-20 , and B-23 ) who underwent lumpectomy and whole breast irradiation with or without adjuvant systemic therapy . Cumulative incidences of ipsilateral breast tumor recurrence ( IBTR ) and other locoregional recurrence ( oLRR ) were calculated , along with distant-disease-free interval ( DDFI ) and overall survival ( OS ) after these events . Cox models were employed to model mortality by using clinical and pathologic factors jointly with these events . RESULTS Four hundred nineteen patients ( 11.0 % ) experienced LRF : 342 ( 9.0 % ) experienced IBTR , and 77 ( 2.0 % ) experienced oLRR . The 12-year cumulative incidences of IBTR and oLRR in patients treated with adjuvant systemic therapy were 6.6 % and 1.8 % , respectively . Overall , 37.1 % of IBTRs and 72.7 % of oLRRs occurred within 5 years of diagnosis . Older age , black race , higher body mass index ( BMI ) , larger tumors , and occurrence of IBTR or oLRR were significantly associated with increased mortality . The 5-year OS after IBTR and oLRR were 76.6 % and 34.9 % , respectively . Adjusted hazard ratios for mortality associated with IBTR and oLRR were significantly higher in estrogen receptor (ER)-negative patients than in ER-positive patients ( P = .002 and P worse OS and DDFI than those with later-occurring LRF . CONCLUSION Although LRF is uncommon in patients with node-negative breast cancer who are treated with lumpectomy , radiation , and adjuvant systemic therapy , those who do develop LRF have substantially worse OS and DDFI",
"To examine whether the concomitant administration of a gonadotrophin-releasing hormone agonist ( GnRHa ) during combination chemotherapy to young women with lymphoma may facilitate preservation of gonadal function , a prospect i ve clinical protocol was undertaken in 18 cycling women with lymphoma , aged 15 - 40 years . Thirteen patients suffered from Hodgkin disease ( HD ) and 5 from non-Hodgkin lymphoma . After informed consent a monthly injection of depot D-TRP6-GnRHa was administered for a maximum of 6 months starting prior to chemotherapy . Most of these patients ( 15/18 ) were treated with the MOPP/ABV(D ) combination chemotherapy followed by mantle field irradiation in 10 patients . Hormonal profile [ luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , oestradiol , testosterone , progesterone , insulin-like growth factor (IGF)-1 , prolactin ] was taken before the GnRHa/chemotherapy co-treatment , and monthly thereafter until resuming spontaneous ovulation and menses . This group of prospect ively treated lymphoma patients was compared to a matched control group of 18 women ( aged 17 - 40 years ) who have been treated with chemotherapy , mostly MOPP/ABV ( 14/18 ) , with ( 11 ) or without ( 7 ) mantle field radiotherapy . Fourteen had Hodgkin 's and four non-Hodgkin 's lymphoma . Gonadal function was determined clinical ly , hormonally ( LH , FSH , oestradiol , progesterone ) , and sonographically . Two of the patients in each group died from refractory disease . Of the remaining 16 patients , 15 ( 93.7 % ) resumed spontaneous ovulation and menses within 3 - 8 months of termination of the combined chemotherapy/GnRHa co-treatment . In contrast , only seven ( 39 % ) of the 18 similarly treated patients in the control group ( chemotherapy without GnRHa ) resumed ovarian cyclic activity ( regular menses ) . The other 11 experienced premature ovarian failure ( POF ) ( 61 % ) . Out preliminary data suggest a possible significant protective effect of GnRHa co-treatment with chemotherapy from irreversible ovarian damage ( POF )",
"BACKGROUND Adjuvant tamoxifen therapy substantially decreases the risk of recurrence and mortality in women with hormone ( estrogen and /or progesterone ) receptor-positive breast cancer . Previous studies have suggested that metabolic conversion of tamoxifen to endoxifen by cytochrome P450 2D6 ( CYP2D6 ) is required for patient benefit from tamoxifen therapy . METHODS Tumor specimens from a subset of postmenopausal patients with hormone receptor-positive early-stage ( stages I , II , and IIIA ) breast cancer , who were enrolled in the r and omized double-blind Arimidex , Tamoxifen , Alone or in Combination ( ATAC ) clinical trial , were genotyped for variants in CYP2D6 ( N = 1203 patients : anastrozole [ trade name : Arimidex ] group , n = 615 patients ; tamoxifen group , n = 588 patients ) and UDP-glucuronosyltransferase-2B7 ( UGT2B7 ) , whose gene product inactivates endoxifen ( N = 1209 patients ; anastrozole group , n = 606 patients ; tamoxifen group , n = 603 patients ) . Genotyping was performed using polymerase chain reaction-based TaqMan assays . Based on the genotypes for CYP2D6 , patients were classified as poor metabolizer ( PM ) , intermediate metabolizer ( IM ) , or extensive metabolizer ( EM ) phenotypes . We evaluated the association of CYP2D6 and UGT2B7 genotype with distant recurrence ( primary endpoint ) and any recurrence ( secondary endpoint ) by estimating the hazard ratios ( HRs ) and corresponding 95 % confidence intervals ( CIs ) using Cox proportional hazards models . All statistical tests were two-sided . RESULTS After a median follow-up of 10 years , no statistically significant associations were observed between CYP2D6 genotype and recurrence in tamoxifen-treated patients ( PM vs EM : HR for distant recurrence = 1.25 , 95 % CI = 0.55 to 3.15 , P = .64 ; HR for any recurrence = 0.99 , 95 % CI = 0.48 to 2.08 , P = .99 ) . A near-None association was observed between UGT2B7 genotype and recurrence in tamoxifen-treated patients . No associations were observed between CYP2D6 and UGT2B7 genotypes and recurrence in anastrozole-treated patients . CONCLUSION The results do not support the hypothesis that CYP2D6 genotype predicts clinical benefit of adjuvant tamoxifen treatment among postmenopausal breast cancer patients",
"Background : It has been reported that treatment with uracil-tegafur ( UFT ) has shown significantly better survival and relapse-free survival ( RFS ) than surgery alone . Therefore , we compared UFT with a combination therapy of cyclophosphamide , methotrexate , and fluorouracil ( CMF ) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer . Methods : A total of 377 node-positive patients with stage I , II , or IIIA disease were registered from September 1996 through July 2000 and were r and omly assigned to either 6 cycles of CMF or 2 years of UFT . In both arms , tamoxifen ( TAM ) was concurrently administered for 2 years . The primary end point in this study was the non-inferiority of UFT to CMF . Results : No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate ( 72.2 % in the UFT and 76.3 % in the CMF ) . Adverse event profiles differed between the two groups , with a significantly lower incidence of leukopenia and anaemia in the UFT group , as well as anorexia , nausea/vomiting , stomatitis , and alopecia , which have implication s for quality of life . Conclusion : UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer . On stratified analysis , the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients . Tegafur-based treatment should be evaluated by a prospect i ve r and omised trial conducted in ER-positive patients",
"In this phase III , multinational , r and omized trial , the International Breast Cancer Study Group , Breast International Group , and the National Surgical Adjuvant Breast and Bowel Project will attempt to define the effectiveness of cytotoxic therapy for patients with locoregional recurrence of breast cancer . We will evaluate whether chemotherapy prolongs disease-free survival and , secondarily , whether its use improves overall survival and systemic disease-free survival . Quality of life measurements will be monitored during the first 12 months of the study . Women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery and who have undergone complete surgical excision of all macroscopic disease but who subsequently develop isolated local and /or regional ipsilateral invasive recurrence are eligible . Patients are r and omized to observation/no adjuvant chemotherapy or to adjuvant chemotherapy ; all suitable patients receive radiation , hormonal , and trastuzumab therapy . Radiation therapy is recommended for patients who have not received previous adjuvant radiation therapy but is required for those with microscopically positive margins . The radiation field must encompass the tumor bed plus a surrounding margin to a dose of > or= 40 Gy . Radiation therapy will be administered before , during , or after chemotherapy . All women with estrogen receptor-positive and /or progesterone receptor-positive recurrence must receive hormonal therapy , with the agent and duration to be determined by the patient 's investigator . Adjuvant trastuzumab therapy is permitted for those with HER2- positive tumors , provided that intent to treat is declared before r and omization . Although multidrug regimens are preferred , the agents , doses , and use of supportive therapy are at the discretion of the investigator"
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HighlightsA broad range of domains of neuropsychological performance are significantly impaired in studies which have compared methadone population s with the healthy controls . However low power , poor quality and heterogenous population s limit the interpretation of these results .Short term ( less than 1 year ) abstinent groups , when compared with methadone groups , still exhibited cognitive impairments but results are inconclusive . It is still not clear what the role of global sedative effects of opioids such as methadone have on cognitive impairment . Only higher quality longitudinal studies using ecologically valid cognitive tests , in well‐defined population groups can address this question .Methadone population s present with a broad range of neuropsychological impairment when compared with healthy controls . Introduction : There is a presumption that neurocognition is commonly impaired in chronic methadone exposed individuals ( CM ) when compared with healthy controls ( HP ) . Additionally , it remains unclear if short term ( altered cognitive profile when compared with CM . Method : A r and om effect model approach was used on data assembled into the Comprehensive Meta‐ Analysis programme . Cohen 's d effect sizes and a significance levels of p total cohort of 1063 CM , 412 AP and 879 HP participants , from 23 independent studies indicate global impairments in neurocognitive function in CM relative to HP participants . The smaller body of evidence comparing CM to AP participants is inconclusive . Conclusion : Method ological issues such as small sample sizes , heterogeneity and poor quality limited the interpretation of the results and does not address whether the observed impairments reflect co‐morbid functioning , methadone‐related sedation and /or other factors . Only higher quality longitudinal studies will permit confident interpretation of the results observed in this meta‐ analysis | [
"Abstract . Rationale : Methadone is the most widespread pharmacological treatment for opiate dependency but relatively little is known of its effects on cognitive and psychomotor functioning , drug craving and mood . Objective : The present study aim ed to assess the acute effects of methadone in patients admitted to an opiate detoxification programme . Methods : Patients were r and omly allocated to one of two groups who received either 50 % or 100 % of their daily stabilisation dose , and a placebo , in a double-blind , cross-over design . Twenty patients completed the study , all were assessed pre- and post-drug on 2 separate testing days . Results : Performance on a task tapping episodic memory ( delayed recall of a prose passage ) was significantly impaired following the 100 % daily dose of methadone . Methadone treatment had no effect on craving or mood . Patients were unable to distinguish between methadone and placebo treatments . Conclusions : A single dose of methadone can induce episodic memory impairment in patients who have a history of heroin use averaging more than 10 years . Such impairment can be avoided by giving methadone in divided doses",
"This study tested whether opiate dependence , tobacco smoking , or their combination accompanied impaired performance on the gambling task ( GT ) , which tests decision-making . GT previously detected impairments in patients with lesions of the ventromedial prefrontal cortex and in substance abusers . Four groups were matched on demographic characteristics and intelligence : methadone-maintained smokers ( n = 9 ) and nonsmokers ( n = 9 ) , and control ( i.e. , not opiate-dependent ) smokers ( n = 9 ) and nonsmokers ( n = 10 ) . The Wisconsin Card Sorting Task ( WCST ) was administered to test whether differences in GT performance reflected generalized deficits in prefrontal cortical function . While there were no significant group differences on the WCST , groups differed significantly on GT performance ( F(3,31 ) = 2.95 , P = 0.048 ) , controlling for depressive symptom ratings and childhood attention deficit hyperactivity disorder . Methadone-maintained smokers ( but not nonsmokers ) performed more poorly than either of the two control groups ( P = 0.007 versus smokers ; P = 0.024 versus nonsmokers ) . In a planned analysis of methadone-maintained subjects , smokers scored more poorly on GT than nonsmokers ( F(1,18 ) = 5.64 , P = 0.032 ) and had more treatment failures ( 67 % heroin use during the last 30 days versus 20 % ) . The findings suggest that among opiate-dependent individuals , tobacco smoking may be a marker for a more severe form of substance abuse disorder , reflecting impaired decision-making , as modeled by GT",
"Reinforcing properties of psychoactive substances are considered to be critically involved in the development and maintenance of substance dependence . While accumulating evidence suggests that the sensitivity to reinforcement values may generally be altered in chronic substance users , relatively little is known about the influence reinforcing feedback exerts on ongoing decision-making in these individuals . Decision-making was investigated using the Cambridge Risk Task , in which there is a conflict between an unlikely large reward option and a likely small reward option . Responses on a given trial were analyzed with respect to the outcome on the previous trial , providing a measure of the impact of prior feedback in modulating behavior . Five different groups were compared : ( i ) chronic amphetamine users , ( ii ) chronic opiate users in methadone maintenance treatment ( MMT ) , ( iii ) chronic users of illicit heroin , ( iv ) ex-drug users who had been long-term amphetamine / opiate users but were abstinent from all drugs of abuse for at least 1 year and ( v ) matched controls without a history of illicit substance use . Contrary to our predictions , choice preference was modified in response to feedback only in opiate users enrolled in MMT . Following a loss , the MMT opiate group chose the likely small reward option significantly less frequently than controls and heroin users . Our results suggest that different opiates are associated with distinctive behavioral responses to feedback . These findings are discussed with respect to the different mechanisms of action of heroin and methadone",
"AIMS To assess the influence of methadone and buprenorphine maintenance treatment on the driving aptitude of opioid-dependent patients . DESIGN Prospect i ve , open label , outpatient maintenance , single-blind ( investigator ) study . PARTICIPANTS AND SETTING Thirty opioid-dependent patients maintained on either methadone or buprenorphine were recruited from the drug-addiction outpatient clinic in Vienna . MEASUREMENTS The traffic-relevant performance dimensions of the participants were assessed 22 h after receiving synthetic opioid maintenance therapy , by a series of seven tests constituting the Act & React Test System ( ART ) 2020 St and ard test battery , developed by the Austrian Road Safety Board ( ARSB ) . To test for additional consumption of illicit substances , blood and urine sample s were taken at the beginning of the tests . FINDINGS The patient group only differed from control subjects in two of the ART 2020 St and ard tests . During a task to test the subject 's attention under monotonous circumstances ( Q1 test ) , patients had a significantly greater number of reactions ( p = 0.027 ) and a significantly higher percentage of incorrect reactions than control subjects . When driving in a dynamic environment ( DR2 test ) patients had a significantly longer mean decision time ( p = 0.029 ) and mean reaction time ( p = 0.009 ) compared with control subjects . Interestingly , when separated into treatment groups , the mean decision and reaction times of buprenorphine-maintained patients in the DR2 test did not differ from controls , whereas patients maintained on methadone showed significantly prolonged mean decision ( p = 0.009 ) and reaction times ( p = 0.004 ) . In this same test , patients who had consumed additional illicit drugs had a longer mean reaction time compared with control subjects ( p = 0.036 ) . CONCLUSION The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls in the majority of the ART 2020 St and ard tests",
" Groups of subjects whose primary drug of abuse was amphetamine or heroin were compared , together with age- and IQ-matched control subjects . The study consisted of a neuropsychological test battery which included both conventional tests and also computerised tests of recognition memory , spatial working memory , planning , sequence generation , visual discrimination learning , and attentional set-shifting . Many of these tests have previously been shown to be sensitive to cortical damage ( including selective lesions of the temporal or frontal lobes ) and to cognitive deficits in dementia , basal ganglia disease , and neuropsychiatric disorder . Qualitative differences , as well as some commonalities , were found in the profile of cognitive impairment between the two groups . The chronic amphetamine abusers were significantly impaired in performance on the extra-dimensional shift task ( a core component of the Wisconsin Card Sort Test ) whereas in contrast , the heroin abusers were impaired in learning the normally easier intra-dimensional shift component . Both groups were impaired in some of tests of spatial working memory . However , the amphetamine group , unlike the heroin group , were not deficient in an index of strategic performance on this test . The heroin group failed to show significant improvement between two blocks of a sequence generation task after training and additionally exhibited more perseverative behavior on this task . The two groups were profoundly , but equivalently impaired on a test of pattern recognition memory sensitive to temporal lobe dysfunction . These results indicate that chronic drug use may lead to distinct patterns of cognitive impairment that may be associated with dysfunction of different components of cortico-striatal circuitry",
"Fifty-six heroin addicts and 60 age-matched controls were offered choices between monetary rewards ( $ 11-$80 ) available immediately and larger rewards ( $ 25-$85 ) available after delays ranging from 1 week to 6 months . Participants had a 1-in-6 chance of winning a reward that they chose on one r and omly selected trial . Delay-discounting rates were estimated from the pattern of participants ' choices . The discounting model of impulsiveness ( Ainslie , 1975 ) implies that delay-discounting rates are positively correlated with impulsiveness . On average , heroin addicts ' discount rates were twice those of controls ( p = .004 ) , and discount rates were positively correlated with impulsivity as measured by self-report question naires ( p delay-discounting rate as a measure of impulsiveness , a characteristic associated with substance abuse",
"BACKGROUND Slow-release oral morphine ( SROM ) has been proposed as an alternative maintenance pharmacotherapy to methadone for treatment of opioid dependence . However , the pharmacodynamics and pharmacokinetics of SROM have not been previously assessed in a methadone maintenance population . METHODS In 14 methadone maintenance patients reporting adequate ( holders , n=7 ) or inadequate ( non-holders , n=7 ) withdrawal suppression between doses , plasma drug concentrations and indices of opioid effect ( withdrawal severity , pupil diameter , and respiratory rate ) were determined across a 24 h inter-dosing interval on one occasion at steady-state for methadone and SROM ( once-daily Kapanol ) using an open-label , crossover design . RESULTS Opioid effects were of a similar overall magnitude following dosing for each drug and showed an inverse association with plasma drug concentrations , which peaked later for morphine compared to (R)-methadone ( 6.5 + /- 2.3 h vs. 2.5 + /- 1.4 h , P number of self-reported opioid withdrawal symptoms prior to dosing was less for SROM compared to methadone ( 3.4 + /- 2.6 vs. 9.0 + /- 3.2 , P plasma drug concentrations for SROM compared to methadone and may thus be more predictive of therapeutic response for the former medication . Twelve of the 14 subjects preferred SROM to methadone ( P=0.01 ) . CONCLUSIONS The pharmacodynamics and pharmacokinetics of SROM support its use as an alternative once-daily agonist option in the treatment of opioid dependence , particularly for patients responding poorly to methadone maintenance treatment",
"BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application",
"Longitudinal data from a representative sample of 1,978 Black and White adolescents were used to examine the role of personality in multiple risk or problem behaviors . Results indicate that covariation among diverse behaviors ( educational underachievement , delinquent behavior , substance use , sexual behavior ) can be adequately modeled by a single higher order factor , and that impulsivity and avoidance coping serve as generalized risk factors for involvement in these behaviors . Whereas none of the personality variables examined explained change in problem behaviors once established , avoidance coping prospect ively predicted involvement among a subgroup of adolescents with little or no prior involvement . Results suggest that dysfunctional styles of regulating emotions and emotionally driven behaviors are core features of risky or problem behaviors during adolescence",
"Cognitive impairment in drug-dependent patients receiving methadone ( MMP ) maintenance treatment has been reported previously . We assessed cognitive functioning after at least 14 days of stable substitution treatment with buprenorphine ( BUP ) or MMP and after 8 to 10 weeks . We performed a r and omized , nonblinded clinical trial in 59 drug-dependent patients receiving either BUP or MMP maintenance treatment and healthy normal controls ( n = 24 ) matched for sex , age , and educational level . Thirteen patients dropped out of the study before the second testing was performed ( BUP , n = 22 ; MMP , n = 24 ) . A neuropsychological test battery was used to measure selective attention , verbal memory , motor/cognitive speed , and cognitive flexibility . In addition , subjective perceived stress was assessed with a question naire . Patients in both treatment groups performed equally well in all of the cognitive domains tested . Both BUP and MMP patients showed significantly improved concentration and executive functions after 8 to 10 weeks of stable substitution treatment . The control group achieved better results than the BUP and MMP groups in most cognitive domains , indicating cognitive impairment in the patients . Perceived stress did not show any significant change after 8 to 10 weeks of treatment , and no major differences were detected between the 3 groups . No effects of perceived stress on cognitive function were found . Our results indicate a cognitive impairment in patients receiving maintenance treatment with BUP or MMP compared with healthy controls . Selective attention improved in both patient groups during treatment . We propose that the improvement of attention may facilitate rehabilitation of drug-dependent patients"
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The purpose of this review was to confirm a volumetric dilution of vitamin D in obesity . It was based on the hypothesis that weight loss , particularly fat loss , would increase serum 25-hydroxyvitamin D ( 25OHD ) in the obese . We conducted a systematic review of the literature over the last 21 years and included human trials that reported changes in 25OHD , weight , or body composition after weight loss . Study arms were excluded if vitamin D was supplemented , dietary intake exceeded 800 IU/d , or extreme sun exposure was reported . Eighteen of 23 trials that met our criteria documented an increase in vitamin D status with weight loss . Metaregression analyses indicated a marginally significant effect of weight loss on unadjusted weighted mean difference of 25OHD ( β = -0.60 [ 95 % confidence interval { CI } , -1.24 to + 0.04 ] nmol/L ; P = .06 ) and after adjustment for study quality ( Jadad score ≥3 ) ( β = -0.64 [ 95 % CI , -1.28 to + 0.01 ] nmol/L ; P = .05 ) . The effect of percent fat mass on weighted mean difference of 25OHD was also marginally significant before ( β = -0.91 [ 95 % CI , -1.96 to + 0.15 ] nmol/L ; P = .08 ) and after adjustment of study quality ( β = -1.05 [ 95 % CI , -2.18 to + 0.08 ] nmol/L ; P = .06 ) . Collectively , these outcomes support a volumetric dilution of vitamin D. The slopes of the respective regression lines , however , indicate a smaller increase in 25OHD than would be expected from a direct mobilization of stores into the circulation . Hence , sequestration of 25OHD and its conversion to inactive metabolites would also play a role . Future studies could relate changes in body fat compartments to the enzymatic regulation of 25OHD in response to weight loss | [
"Background The prevalence of micronutrient deficiencies is higher in obese individuals compared to normal-weight people , probably because of inadequate eating habits but also due to increased dem and s among overweight persons , which are underestimated by dietary reference intakes ( DRI ) intended for the general population . We therefore evaluated the dietary micronutrient intake in obese individuals compared to a reference population and DRI recommendations . Furthermore , we determined the micronutrient status in obese subjects undergoing a st and ardized DRI-covering low-calorie formula diet to analyze if the DRI meet the micronutrient requirements of obese individuals . Methods In 104 subjects baseline micronutrient intake was determined by dietary record collection . A r and omly assigned subgroup of subjects ( n = 32 ) underwent a st and ardized DRI-covering low-calorie formula diet over a period of three months . Pre- and post-interventional intracellular micronutrient status in buccal mucosa cells ( BMC ) was analyzed , as well as additional micronutrient serum concentrations in 14 of the subjects . Results Prior to dietetic intervention , nutrition was calorie-rich and micronutrient-poor . Baseline deficiencies in serum concentrations were observed for 25-hydroxyvitamin-D , vitamin C , selenium , iron , as well as ß-carotene , vitamin C , and lycopene in BMC . After a three-month period of formula diet even more subjects had reduced micronutrient levels of vitamin C ( serum , BMC ) , zinc , and lycopene . There was a significant negative correlation between lipophilic serum vitamin concentrations and body fat , as well as between iron and C-reactive protein . Conclusions The present pilot study shows that micronutrient deficiency occurring in obese individuals is not corrected by protein-rich formula diet containing vitamins and minerals according to DRI . In contrast , micronutrient levels remain low or become even lower , which might be explained by insufficient intake , increased dem and and unbalanced dispersal of lipophilic compounds in the body . Trial registration The study was registered at Clinical Trials.gov ( NCT01344525 ) . The study protocol comprises only a part of the approved trial protocol",
"BACKGROUND Weight loss is associated with bone loss , but this has not been examined in overweight premenopausal women . OBJECTIVE The aim of this study was to assess whether overweight premenopausal women lose bone with moderate weight loss at recommended or higher than recommended calcium intakes . DESIGN Overweight premenopausal women [ n = 44 ; x ( + /-SD ) age : 38 + /- 6.4 y ; body mass index ( BMI ): 27.7 + /- 2.1 kg/m(2 ) ] were r and omly assigned to either a normal ( 1 g/d ) or high ( 1.8 g/d ) calcium intake during 6 mo of energy restriction [ weight loss ( WL ) groups ] or were recruited for weight maintenance at 1 g Ca/d intake . Regional bone mineral density and content were measured by dual-energy X-ray absorptiometry , and markers of bone turnover were measured before and after weight loss . True fractional calcium absorption ( TFCA ) was measured at baseline and during caloric restriction by using a dual-stable calcium isotope method . RESULTS The WL groups lost 7.2 + /- 3.3 % of initial body weight . No significant decrease in BMD or rise in bone turnover was observed with weight loss at normal or high calcium intake . The group that consumed high calcium showed a strong relation ( r = 0.71 ) between increased femoral neck bone mineral density and increased serum 25-hydroxyvitamin D. No significant effect of weight loss on TFCA was observed , and the total calcium absorbed was adequate at 238 + /- 81 and 310 + /- 91 mg/d for the normal- and high-calcium WL groups , respectively . CONCLUSION Overweight premenopausal women do not lose bone during weight loss at the recommended calcium intake , which may be explained by sufficient amounts of absorbed calcium",
"BACKGROUND Overweight and obesity are increasing in young adults . However , moderate energy restriction aim ed at lowering body weight may promote bone turnover and bone loss . Inclusion of fish or fish oils in a weight-loss diet may attenuate these adverse skeletal effects . OBJECTIVE We examined the effects of incorporating fish or fish oil into an energy-restricted diet on bone turnover markers in young overweight adults . DESIGN While following a strict hypoenergetic ( -30 % relative to estimated requirements ) diet for 8 wk , 276 overweight men and women [ body mass index ( in kg/m(2 ) ) : 27.5 - 32.5 ; age : 20 - 40 y ) were r and omly assigned to 1 of 4 dietary groups : sunflower-oil capsules ( 3 g/d ; control ) , cod ( 3 x 150 g/wk ) , salmon ( 3 x 150 g/wk ) , and fish-oil capsules ( 3 g/d ) . Body weight , bone biomarkers , and 25-hydroxyvitamin D were measured at baseline and endpoint . Data were analyzed with repeated- measures analysis of variance and general linear models . RESULTS The mean ( + /-SD ) weight loss was 5.14 + /- 3.0 kg ( 5.8 % + /- 3.2 % body weight ) during the 8 wk in the 4 dietary groups combined . Urinary N-telopeptides of type I collagen and serum C-terminal telopeptide of type I collagen increased ( P serum osteocalcin ( but not bone-specific alkaline phosphatase ) decreased ( P fish or fish-oil consumption had no effect ( P > 0.1 ) on the changes in bone markers induced by weight loss . In contrast , increased salmon consumption increased serum 25-hydroxyvitamin D ( P weight loss , unfavorably altered bone turnover markers in young overweight adults . Such changes were not prevented by increased fish or fish-oil consumption",
"Experimental studies suggest that vitamin D modulates the activity of adipocytes . The authors examined baseline serum 25-hydroxyvitamin D ( 25(OH)D ) level in relation to prevalent and cumulative incident obesity in Norway . A cohort of 25,616 adults aged 19 - 55 years participated in both the second and third surveys of the Nord-Trøndelag Health Study ( HUNT 2 ( 1995 - 1997 ) and HUNT 3 ( 2006 - 2008 ) ) . Serum 25(OH)D levels measured at baseline and anthropometric measurements taken at both baseline and follow-up were available for a r and om sample of 2,460 subjects . Overall , 40 % of the 2,460 subjects had a serum 25(OH)D level less than 50.0 nmol/L , and 37 % had a level of 50.0 - 74.9 nmol/L. The prevalence and cumulative incidence of obesity , defined as body mass index ( weight (kg)/height (m)(2 ) ) ≥30 , were 12 % and 15 % , respectively . Lower serum 25(OH)D level was associated with a higher prevalence of obesity . In the 2,165 subjects with baseline BMI less than 30 , a serum 25(OH)D level less than 50.0 nmol/L was associated with a significantly increased odds ratio for incident obesity during follow-up ( adjusted odds ratio = 1.73 , 95 % confidence interval : 1.24 , 2.41 ) . When prevalent and incident obesity were classified according to waist circumference ( ≥88 cm for women , ≥102 cm for men ) , similar results were obtained . In addition to prevalent obesity , a serum 25(OH)D level less than 50.0 nmol/L was significantly associated with new-onset obesity in adults ",
"BACKGROUND The role of dairy calcium intake and serum vitamin D concentrations in weight loss is controversial . OBJECTIVE The objective was to assess the association of dairy calcium intake and serum vitamin D with weight loss . DESIGN We analyzed data from participants in the 2-y Dietary Intervention R and omized Controlled Trial ( DIRECT ) [ n = 322 ; mean body mass index ( BMI ; in kg/m² ) : 31 ; mean age : 52 y ] . A representative sample ( n = 126 ) was followed for 6 mo for serum vitamin D changes . RESULTS Baseline serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations decreased significantly across the tertiles of baseline BMI ( 25.6 ± 8.0 , 24.1 ± 8.9 , and 22.9 ± 6.8 ng/mL , respectively ; P for trend = 0.02 ) . Baseline concentrations of vitamin D and dairy calcium intake were not associated with subsequent weight loss . However , in repeated- measures models adjusted for age , sex , baseline BMI , total fat intake , and diet group assignment , higher 6-mo tertile levels of dairy calcium intake ( median for tertiles : 156.5 , 358.0 , and 582.9 mg/d , respectively ) and serum 25(OH)D ( 14.5 , 21.2 , and 30.2 ng/mL , respectively ) were associated with increased weight loss across the 2-y intervention ( -3.3 , -3.5 , and -5.3 kg , respectively , for dairy calcium ; P = 0.043 ; -3.1 , -3.8 , and -5.6 kg , respectively , for vitamin D ; P = 0.013 ) . In a multivariate logistic regression adjusted simultaneously for age , sex , baseline BMI , total fat intake , diet group , vitamin D concentration , and dairy calcium , an increase of 1 SD in dairy calcium intake increased the likelihood of weight loss of > 4.5 kg in the preceding 6 mo [ odds ratio ( OR ) : 1.45 ; P = 0.046 ] . A similar increase was seen for serum 25(OH)D at the 6-mo point ( OR : 1.7 ; P = 0.009 ) . CONCLUSION Our study suggests that both higher dairy calcium intake and increased serum vitamin D are related to greater diet-induced weight loss . This trial was registered at clinical trials.gov as NCT00160108",
"OBJECTIVE The objective of the study was to examine changes of 25-hydroxy-vitamin D ( 25OHD ) and PTH blood levels 4 and 20 wk after low-calorie diet-induced weight loss . METHODS Forty-four obese women [ aged 40.6 + /- 11.4 yr , body mass index ( BMI ) 36.7 + /- 4.9 kg/m(2 ) ] and 25 controls ( BMI 22.9 + /- 1.5 kg/m(2 ) ) were examined . Anthropometric and cardiometabolic parameters and 25OHD and PTH levels were determined at baseline and 4 and 20 wk after a low-calorie diet . RESULTS At baseline , 25OHD levels were lower in obese compared with control subjects ( 17 + /- 6.0 vs. 23.8 + /- 8.7 ng/ml , P PTH levels . In all women , a negative correlation was found between 25OHD levels and body weight ( BW ) ( r -0.32 , P BMI ( r -0.37 , P waist circumference ( r -0.26 , P percent fat mass ( r -0.38 , P = 0.001 ) as determined by bioelectrical impedance analysis . The 4-wk low-calorie diet ( n = 37 ) reduced BW and led to significant improvements in the homeostasis model assessment ( HOMA ) index and lipid levels . The 20-wk low-calorie diet ( n = 26 ) result ed in reduction of BW and BMI by 10 % , HOMA index ( 4.7 + /- 3.8 vs. 3.10 + /- 1.7 , P lipids levels ( except high density lipoprotein cholesterol ) and increase in 25OHD ( 15.4 + /- 6.0 vs. 18.3 + /- 5.1 ng/ml , P PTH levels were unchanged . The increase of 25OHD levels was associated with the reduction of insulin levels and HOMA index ( r -0.43 , P Blood 25OHD levels were low in obese women and correlated inversely with severity measures of obesity . Weight loss of 10 % after low-calorie diet increased 25OHD levels , and this increase was mainly associated with improvement of insulin resistance",
"Background . Research on dairy foods to enhance weight and fat loss when incorporated into a modest weight loss diet has had mixed results . Objective . A 15-week controlled feeding study to determine if dairy foods enhance central fat and weight loss when incorporated in a modest energy restricted diet of overweight and obese adults . Design . A 3-week run-in to establish energy needs ; a 12-week 500 kcal/d energy reduction with 71 low-dairy-consuming overweight and obese adults r and omly assigned to diets : ≤1 serving dairy/d ( low dairy , LD ) or ≤4 servings dairy/d ( adequate dairy , AD ) . All foods were weighed and provided by the metabolic kitchen . Weight , fat , intra-abdominal adipose tissue ( IAAT ) , subcutaneous adipose tissue ( SAT ) macrophage number , SAT inflammatory gene expression , and circulating cytokines were measured . Results . No diet differences were observed in weight , fat , or IAAT loss ; nor SAT mRNA expression of inflammation , circulating cytokines , fasting lipids , glucose , or insulin . There was a significant increase ( P = 0.02 ) in serum 25-hydroxyvitamin D in the AD group . Conclusion . Whether increased dairy intake during weight loss results in greater weight and fat loss for individuals with metabolic syndrome deserves investigation . Assessment of appetite , hunger , and satiety with followup on weight regain should be considered",
"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",
"Background : Dairy products not only reduce the risk of hypertension and cardiovascular diseases but may play a role in the treatment of obesity . As there is some evidence that calcium ( Ca ) and vitamin D may play a role in effective weight management , we decided to evaluate the influence of Ca and vitamin D supplementation on weight and fat loss in obese women . Material and Methods : Forty obese women were enrolled in this study . Subjects were divided into 2 groups comparable with body mass index ( BMI ) and age . Group 1 was provided with calcium carbonate and 1-(OH)-vitamin D supplementation . Group 2 was provided with only a diet . Subjects participated in a 3-month weight reduction therapy ( balanced diet , modification of life style , and regular physical exercise ) . Blood sample s ( serum concentration of Ca , phosphorus ( P ) , parathormone ( PTH ) , 25-(OH)-D3 ) and clinical characteristics ( weight , height , BMI , body composition ) were taken at baseline and after the 3-month program . Results : No significant differences of body weight , body fat content , serum parathormone , 25-(OH)-D3 concentration , and plasma total Ca and P concentration were observed between analyzed groups both before and after the treatment . Additionally , we did not observe any significant influence of Ca and vitamin D supplementation on weight and fat loss . Conclusion : Ca plus vitamin D supplementation during a 3-month low caloric diet has no additional effect on weight and fat loss in obese women",
"Weight loss can have substantial health benefits for overweight or obese persons ; however , the ratio of fat : lean tissue loss may be more important . We aim ed to determine how daily exercise ( resistance and /or aerobic ) and a hypoenergetic diet varying in protein and calcium content from dairy foods would affect the composition of weight lost in otherwise healthy , premenopausal , overweight , and obese women . Ninety participants were r and omized to 3 groups ( n = 30/group ) : high protein , high dairy ( HPHD ) , adequate protein , medium dairy ( APMD ) , and adequate protein , low dairy ( APLD ) differing in the quantity of total dietary protein and dairy food- source protein consumed : 30 and 15 % , 15 and 7.5 % , or 15 and Body composition was measured by DXA at 0 , 8 , and 16 wk and MRI ( n = 39 ) to assess visceral adipose tissue ( VAT ) volume at 0 and 16 wk . All groups lost body weight ( P fat ( P fat loss during wk 8–16 was greater in the HPHD group than in the APMD and APLD groups ( P gained lean tissue with a greater increase during 8–16 wk than the APMD group , which maintained lean mass and the APLD group , which lost lean mass ( P VAT as assessed by MRI ( P trunk fat as assessed by DXA ( P reduction in VAT in all groups was correlated with intakes of calcium ( r = 0.40 ; P total and visceral fat loss and lean mass gain ",
"Bone mobilization , lowering of bone mineral density ( BMD ) , and osteoporotic fractures are recognized in postmenopausal women with weight loss . Because a high-calcium intake suppresses bone loss in peri- and postmenopausal women , the present r and omized , double-blind , placebo-controlled study was design ed to test the hypothesis that calcium supplementation prevents net bone mobilization and consequent bone mineral loss during voluntary weight reduction in obese postmenopausal women . Subjects were placed on a moderate energy-restricted diet and either calcium supplementation ( 1 g/day ) or placebo for 6 months . Body weight , bone turnover markers ( pyridinium cross-links ) , osteocalcin , and parathyroid hormone ( PTH ) were measured at treatment weeks 1 - 5 , 7 , 10 , 13 , 16 , 20 , and 25 . Total body BMD , insulin-like growth factor , 25-hydroxyvitamin D , and sex hormone binding globulin ( SHBG ) were measured at baseline and week 25 . The calcium supplemented ( n = 15 ; age 60.9 + /- 9.4 years , body mass index [ BMI ] 33.2 + /- 4.6 kg/m2 ) and placebo ( n = 16 ; age 55.8 + /- 8.3 years , BMI 32.9 + /- 4.5 kg/m2 ) groups lost similar amounts of weight over the study interval ( 10.2 + /- 5.3 % vs. 10.0 + /- 5.2 % ) and both groups increased SHBG ( p pyridinium cross-links , osteocalcin , and PTH ( p Loss of BMD tended to be greater in the placebo group by 1.4 % ( p calcium supplementation normalizes the increased calcium-PTH axis activity and the elevated bone turnover rate observed during moderate voluntary energy restriction in postmenopausal women",
"Obesity has been linked with poorer vitamin D status . The aim of this work was to analyze the changes in vitamin D status and body weight of 61 young , overweight/obese women following two different weight control programs . The study subjects were r and omly assigned to one of two slightly hypocaloric diets : diet V , in which the consumption of greens and vegetables was increased , or diet C , in which the consumption of cereals ( some of which were enriched with vitamin D ) was increased . Dietary , anthropometric , and biochemical data were collected at the start of the study and at 2 weeks . At the beginning of the study , when taking into account only those women with a vitamin D intake below that recommended , obese women had a significantly lower mean serum 25(OH)D concentration than those who were lighter . Dietary intervention led to a greater reduction in energy intake among group C subjects ; their weight was also that which was most reduced . In addition , the vitamin D intake and serum 25(OH)D values were increased only in group C women . Excess body weight was associated with deterioration in vitamin D status , especially when the intake of this vitamin was lower than that recommended . Subjects with higher serum vitamin D at the beginning of the study lost more weight than those subjects with lower initial values . Diet C was associated with a greater weight loss than diet V , and led to a greater increase in vitamin D intake and serum 25(OH)D levels . This might be of interest in the improvement of health in people trying to lose weight",
"A significant relationship between body weight ( BW ) and bone mass ( BM ) has been established previously . A diet-induced weight loss is accompanied by a significant decrease in bone mineral density ( BMD ) and total body bone mineral ( TBBM ) , but the underlying mechanisms are not clarified . Sixty-two obese women were included in the study . Dual-energy X-ray absorptiometry ( DXA ) and measurements of a series of calcium-regulating hormones and biochemical markers of bone turnover were performed at baseline and after 1 month and 3 months on a low calorie diet . Thirty of the women were r and omized to a daily supplement of 1 g of calcium . After an additional 3 months without dietary prescriptions or calcium supplements , a subgroup of 48 subjects ( 24 from each group ) were scanned again using DXA . There was a significant decrease in TBBM after 1 month and 3 months . A similar pattern was observed in the bone mineral content ( BMC ) of the lumbar spine in the patients who did not receive a calcium supplement , whereas no changes occurred in the supplemented group . The initial calcium supplementation seemed to protect against bone loss in the lumbar spine but not in the TBBM . In the nonsupplemented group , a statistically significant inverse correlation was found between the calcium/creatinine ratio in the morning urine and the changes in BMC of the lumbar spine . Such a relationship was not seen in the calcium-supplemented group . In the nonsupplemented group , no significant biochemical changes were observed , whereas a significant decrease in serum parathyroid hormone ( PTH ) was seen in the calcium-supplemented group . This might explain some of the protective effects of calcium supplementation on trabecular bone mass . We conclude that a diet-induced weight loss is accompanied by a generalized bone loss , which probably is explained mainly by a reduced mechanical strain on the skeleton . This loss can be partly inhibited by a high calcium intake . Therefore , a calcium supplementation should be recommended during weight loss , even if the diet contains the officially recommended amounts of calcium",
"BACKGROUND Low concentrations of circulating vitamin D are common with obesity and may represent a potential mechanism explaining the elevated risk of certain cancers and cardiovascular outcomes observed in individuals who are overweight or obese . OBJECTIVE The objective of this study was to investigate the effects of 12 mo of weight loss through caloric restriction , exercise intervention , or both on serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations . DESIGN Overweight and obese postmenopausal women ( n = 439 ) were r and omly assigned to 1 of 4 groups : 1 ) diet modification ( n = 118 ) , 2 ) exercise ( n = 117 ) , 3 ) diet + exercise ( n = 117 ) , or 4 ) control ( n = 87 ) . The diet intervention was a group-based reduced-calorie program with a 10 % weight-loss goal . The exercise intervention consisted of 45 min of moderate-to-vigorous intensity aerobic activity daily for 5 d/wk . Serum 25(OH)D concentrations were measured by using a competitive chemiluminescent immunoassay at baseline and 12 mo . RESULTS No significant change in serum 25(OH)D was found between the intervention and control groups . Women who lost baseline weight had mean increases in 25(OH)D of 2.1 , 2.7 , 3.3 , and 7.7 ng/mL , respectively ( P for trend = 0.002 ) . Baseline vitamin D status did not modify the effect of the interventions on weight loss or body-composition changes at the 12-mo follow-up . CONCLUSION A greater degree of weight loss , achieved through either a reduced-calorie diet or increased exercise , is associated with increased circulating 25(OH)D concentrations . This trial is registered at clinical trials.gov as NCT00470119"
] | 4116593e-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Idiopathic short stature ( ISS ) refers to children who are very short compared with their peers for unknown or hereditary reasons . Recombinant human growth hormone ( GH ) has been used to increase growth and final height in children with ISS . OBJECTIVES To assess the effects of recombinant human GH on short-term growth and final height in children with ISS . SEARCH STRATEGY Studies were obtained from computerised search es of MEDLINE , EMBASE , The Cochrane Library , Science Citation Index , BIOSIS and Current Controlled Trials . Article reference lists were assessed for trials and experts and pharmaceutical companies were contacted . SELECTION CRITERIA R and omised controlled trials were included if they were carried out in children with ISS with normal GH secretion . GH had to be administered for a minimum of six months and be compared with placebo or no treatment . A growth or height outcome measure had to be assessed . DATA COLLECTION AND ANALYSIS Two review ers assessed studies for inclusion criteria and for method ological quality . Data were extracted by one review er and checked by a second . The primary outcome was final height and secondary outcomes included short term growth , health related quality of life and adverse effects . To estimate summary treatment effects , data were pooled , when appropriate using a r and om effects model . MAIN RESULTS Ten RCTs were included . One trial reported near final height in girls and found that girls treated with GH were 7.5 cm taller than untreated controls ( GH group , 155.3 cm + /- 6.4 ; control , 147.8 cm + /- 2.6 ; P = 0.003 ) ; another trial which reported adult height st and ard deviation score found that children treated with GH were 3.7 cm taller than children in a placebo-treated group ( 95 % confidence intervals 0.03 to 1.10 ; P short term outcomes . Results suggest that short-term height gains can range from none to approximately 0.7 SD over one year . One study reported health related quality of life and showed no significant improvement in GH treated children compared with those in the control group , whilst another found no significant evidence that GH treatment impacts psychological adaptation or self-perception in children with ISS . No serious adverse effects of treatment were reported . AUTHORS ' CONCLUSIONS GH therapy can increase short-term growth and improve ( near ) final height . Increases in height are such that treated individuals remain relatively short when compared with peers of normal stature . Large , multicentre RCTs are required which should focus on final height and address quality of life and cost issues | [
"GH , 0.1 IU/kg/day 6 days/week , was given to 30 early pubertal short patients for 3 years . There were 16 males , aged 14.4 + /- 0.8 years , and 14 females , aged 12.2 + /- 1.2 years , at pubertal stage 2 or 3 with slow growth ( 4.2 + /- 1.2 cm/year ) and no detected GH insufficiency or other cause for short stature . They were r and omized in 2 groups : group A with GH alone , and group B with GH and a gonadotropin-releasing hormone agonist during the first 2 years . 28 of the 30 patients completed 3 years of treatment . The annual growth rate increased during the 1st year in both groups and sexes , the increase being significant ( p growth velocity in the 2nd year , then returned to pretreatment growth rate in the 3rd year , while completing their sexual development and bone maturation . Their height , expressed as st and ard deviation score ( SDS ) for bone age , improved in the first 2 years , but decreased thereafter . Group B patients returned to pretreatment growth velocity in the 2nd year , and had no significant improvement in growth rate in the 3rd year with GH alone . Their bone maturation , slow when on the GnRH agonist , accelerated when sexual development resumed . At the end of the 3 years , height , expressed as SDS for age , improved in group A from -2.5 + /- 0.6 to -1.5 + /- 0.4 in males ( p < 0.05 ) and from -2.8 + /- 0.5 to -2.1 + /- 0.9 in females ( NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Short-term administration of human growth hormone to children with idiopathic short stature can improve mean growth rate and predicted adult height . It is yet unknown whether therapy would alter pubertal development or affect final height . Three-year treatment results in a group of children with idiopathic short stature are reported . For year 1 of the study , 121 prepubertal children were r and omly selected to receive somatotropin , 0.3 mg/kg per week , administered subcutaneously three times weekly ( n = 63 ) , or to be nontreatment control subjects ( n = 58 ) . After 1 year , all subjects were again r and omly selected to receive either three-times-weekly or daily dosing at the same total dose . For the 92 subjects who completed 36 months of treatment , mean growth rate increased from a mean of 4.6 cm/yr before treatment to a mean of 8.0 cm/yr in the first year of treatment . Daily dosing result ed in a significantly faster mean growth rate ( 9.0 cm/yr ) than three-times-weekly dosing ( 7.8 cm/yr ) ( p = 0.0005 ) . Mean growth rates were 7.6 and 7.2 cm/yr during years 2 and 3 , respectively , and did not differ by dosing group . Mean st and ardized height for all subjects improved from -2.7 to -1.6 after 3 years . When the growth rate was st and ardized for bone age , however , subjects who remained prepubertal had a significantly greater gain in mean height SD score than subjects who became pubertal during that 3-year period ( p Mean st and ardized Bayley-Pinneau predicted adult height SD score increased from -2.7 to -1.6 and was independent of the timing of pubertal onset , but for individuals this score was more variable . Year-1 growth response , expressed as growth rate or change in height SD score , was the best predictor of growth in subsequent years . Responses to therapy could not be reliably predicted from baseline anthropometric variables , plasma insulin-like growth factor I SD score , growth hormone levels . Final height assessment will be needed to determine the ultimate benefit of therapy",
"GH is often used to treat children with idiopathic short stature despite the lack of definitive , long-term studies of efficacy . We performed a r and omized , double-blind , placebo-controlled trial to determine the effect of GH on adult height in peripubertal children . Subjects ( n = 68 ; 53 males and 15 females ) , 9 - 16 yr old , with marked , idiopathic short stature [ height or predicted height received either GH ( 0.074 mg/kg ) or placebo sc three times per week until they were near adult height . At study termination , adult height measurements were available for 33 patients after mean treatment duration of 4.4 yr . Adult height was greater in the GH-treated group ( -1.81 + /- 0.11 SDS , least squares mean + /- sem ) than in the placebo-treated group ( -2.32 + /- 0.17 SDS ) by 0.51 SDS ( 3.7 cm ; P GH effect was demonstrated in terms of adult height SDS minus baseline height SDS and adult height SDS minus baseline predicted height SDS . Modified intent-to-treat analysis in 62 patients treated for at least 6 months indicated a similar GH effect on last observed height SDS ( 0.52 SDS ; 3.8 cm ; P GH treatment increases adult height in peripubertal children with marked idiopathic short stature",
"ABSTRACT . Overnight physiological growth hormone ( GH ) secretion was evaluated in 95 short , prepubertal children ( 73 boys , 22 girls ) . All the children were below the 3rd centile for height and achieved CH levels greater than 15 mU/1 following pharmacological stimulation . The mean average GH level was 7.1 mU/l and the mean sum of pulse amplitudes 80.4 mU/l . No relationship was found between age , height or height velocity and any of the parameters of GH secretion . The group was r and omized to receive placebo , GH or remain under observation for the first 6 months and then all patients received GH treatment for a further 6 months . Those treated with GH , 0.27 IU/kg ( 0.1 mg/kg ) three times weekly , in the first phase . demonstrated a mean increase in height velocity SDS of 3.24 . There was no difference in growth response between the placebo or observation groups . In the second 6‐month period . all children received GH according to the same dose regimen : they were then observed for a further 6 months following its discontinuation . In the 6 months following withdrawal of GH , all groups showed a significant fall in height velocity SDS , which returned to pretreatment levels , without demonstrating‘catch‐down’growth . Repeat sampling of overnight GH secretion within 3 days of discontinuing GH showed normal secretory patterns with a small reduction in mean peak amplitude . These results suggest that short children without classic GH insufficiency respond well to exogenous GH in the short term and return to pretreatment height velocities afterwards . Consequently , it may be possible to increase final adult height in such children by GH treatment",
"The aim of this study was to compare the growth response of 22 short pre‐pubertal children without growth hormone deficiency , treated with a single daily growth hormone injection ( group A ) , to the growth response of 27 similar children , treated with the same daily dose divided into 2 subcutaneous injections per day ( group B ) , for 1 y , in a r and omized study . GH treatment significantly promoted growth parameters , height st and ard deviation score and height velocity st and ard deviation score in both groups . Serum insulin‐like growth factor I was also increased . There were no significant differences in growth response , serum IGF‐I levels , or the advance in bone age between the two study groups after 1 y of GH therapy . We conclude that twice daily s.c . growth hormone injections provide no advantages over once daily injection of the same dose in promoting the linear growth of short children without growth hormone deficiency",
"Seventy-seven prepubertal short children with heights below the third centile for age and gender were divided into three groups according to their peak GH response to clonidine and insulin provocation . Group ( I ) included 30 children with peak GH response 10 micrograms/l . Each group was divided into two subgroups , a and b. Subgroups (I)b , (II)a and (III)b were treated daily for 1 year with subcutaneous recombinant human growth hormone ( GH ) 15 U/m2/week , and group (I)a was treated with GH ( 30 U/m2/week ) . Before initiation of treatment , the chronological age , the height st and ard deviation score ( HtSDS ) , and the bone age delay did not differ among the study subgroups . The height growth velocity ( GV ) and insulin-like growth factor-I concentrations were significantly higher in group ( III ) , with normal GH response to provocation , compared to those for group ( I ) with GH deficiency . All the children had normal thyroid function and normal glucose tolerance . CT examination of the hypothalamic-pituitary area revealed a picture of empty sella ( either partial or complete ) in 35 per cent of the children in group ( I ) and 21 per cent of children in group ( II ) . After 1 year of GH therapy , the HtSDS , GV , and IGF-I concentrations increased significantly in the four subgroups treated with GH compared to their pretreatment values and to their controls . All the children in group ( I ) were responders ( increment in GV of 2 cm2/year above the pretreatment GV ) , of the nine subjects treated in group (II)a , one child was a non-responder and of the 12 children in group (III)a three children were non-responders . GV was non-significantly higher in group (I)a ( 30 U/m2/week ) v. group (I)b ( 15 U/m2/week ) . GV of children in groups (I)b , with abnormal GH response to provocation , was significantly higher than GV of children in group (III)a . Bone age advanced by less than 1 year in the treated groups ( 0.84 + /- 0.14 years ) v. the untreated groups ( 0.73 + /- 0.3 years ) . None of the children had impaired glucose tolerance or abnormal thyroid function after 1 year of GH therapy . In all the treated children , GV after 1 year of GH treatment was correlated significantly with the pretreatment GV ( r = -0.63 , P peak GH response to provocation ( r = -0.59 , P IGF-I concentration ( r = -0.54 , P GH dose ( r = 0.589 , P III ) children , with normal GH reserve , GV correlated significantly with the pretreatment GV ( r = -0.48 , P GH peak response to provocation ( r = -0.25 , P GH therapy improved GV of children growing along or parallel to the 3rd centile , irrespective of their GH response to provocation , without untoward effect on skeletal maturation , thyroid function or glucose tolerance",
"Two hundred and thirty-six patients with idiopathic short stature ( ISS ) ( 184 m , 52 f ) who presented at a mean age of 12.2 ( range 2.8 - 17.5 ) years , a mean height of -2.16 st and ard deviation score ( SDS ) , a mean target height ( THT ) of -0.27 SDS ( m = f ) , were reinvestigated at a mean age of 20.5 ( range 18 - 24 ) years . 182(142 m , 37 f ) ( 67 % ) had reached normal adult height ( AHT ) while 54 ( 39 m , 15 f ) ( 23 % ) had not . However , only 23 ( 17 m , 6 f ) did not reach a height within their familial target . Patients were subdivided into 2 groups according to deviation from familial height target : 60(44 m , 16 f ) were considered adequate for their families ( group 1 ) , while 176 ( 140 m , 39 f ) were smaller ( group 2 ) . Children in group 1 were younger and bone age ( BA ) was less retarded . Patients in group 1 reached their THT , this was not the case in group 2 . Young age , low THT and low predicted adult height ( PAH ) at presentation were the factors associated with poor stratural outcome , but AHT could not be predicted in individuals . In boys , PAH ( Bayley-Pinneau ) ( 0.0 SDS ) exceeded AHT ( -0.7 SDS ) , in girls , both were almost identical ( -0.79 , -0.77 SDS ) . Since most children with ISS reach an AHT within the normal range , attempts to improve AHT by means of growth-promoting therapies appear to be justified only in a minority of selected patients with ISS . Methods to improve the accuracy of individual height prognoses are needed",
"We evaluated the effect of six-month treatment with growth hormone ( GH ) or low-dose ox and rolone in a group of boys with constitutional growth delay ( CGD ) . Sixteen boys were r and omly assigned to two treatment groups . Group 1 received GH ( 0.6 U/kg/week sc 5–6 times/week ) and Group 2 received ox and rolone ( 0.07 mg/kg po ) . The boys of the two groups were closely matched for age ( 13.7 ± 0.5 and 12.8 ± 0.4 years ) ( mean ± SE ) , chronologic age/bone age ratio ( 1.15 ± 0.04 and 1.16 ± 0.02 ) , height st and ard deviation score ( SDS ; −2.7 ± 0.4 and −2.5 ± 0.3 ) and pretreatment height velocity ( HV ) ( 3.7 ± 0.8 and 4.0 ± 0.4 cm/year ) . Other known causes of short stature were excluded in all subjects , and none had taken long-term medication prior to the study . After 6 months of treatment HV increased to 7.5 ± 0.4 and to 8.1 ± 0.5 cm/year in group 1 and 2 , respectively . Plasma IGF-I concentrations rose significantly after treatment in both groups . Predicted adult height was not significantly affected by either GH or ox and rolone treatment . We conclude that a short-term course of low-dose ox and rolone is as effective as GH to accelerate growth in boys with CGD . Low-dose ox and rolone represents an effective , cheap , and convenient therapeutic approach in boys with CGD",
"The purpose of this preliminary study was to evaluate tooth formation in children with idiopathic short stature , before and during treatment with recombinant growth hormone ( rhGH ) . Twenty-nine short-statured children ages 6 to 13 years were assigned into two treatment groups , an \" experimental \" group ( n = 18 ) , which received rhGH , and a \" control \" group ( n = 11 ) , which was observed for 1 year before commencing rhGH treatment . Clinical and radiographic records were obtained at the initial , year 1 , and year 2 visits . Tooth formation and stature were assessed by calculating Z-scores , appropriate for the age and gender of each child . Delta-Z scores , which measure the change in Z-score over time , were also calculated between annual visits . Height was measured and recorded every 3 months , and Z-score statural norms for age and gender were derived from the 1977 National Center for Health Services national probability sampling . Tooth formation st and ards were derived from Moorrees et al. A matched control sample for tooth development was derived from untreated children . Tooth formation was initially delayed although the degree of reduction in stature exceeded the initial degree of delay in tooth formation . During this 2-year study , rhGH therapy had a significant influence on acceleration or gain in stature , but did not have a significant influence on tooth formation",
"Background : Long term growth hormone ( GH ) treatment in children with idiopathic short stature ( ISS ) results in a relatively small mean gain in final height of 3–9 cm , which may not justify the cost of treatment . As it is unknown whether GH treatment during puberty adds to final height gain , we sought to improve the cost – benefit ratio , employing a study design with high dose GH treatment restricted to the prepubertal period . Aims : To assess the effect of short term , high dose GH treatment before puberty on growth , bone maturation , and pubertal onset . Methods : Five year results of a r and omised controlled study are reported . Twenty six boys and nine girls were r and omly assigned to a GH treatment group ( n = 17 ) or a control group ( n = 18 ) . Inclusion criteria were : no signs of puberty , height less than −2 SDS , age 4–8 years for girls or 4–10 years for boys , GH concentration > 10 μg/l after provocation , and normal body proportions . To assess GH responsiveness , children assigned to the GH treatment group received GH treatment for two periods of three months ( 1.5 IU/m2/day and 3.0 IU/m2/day ) , separated by three month washout periods , during the first year of study . High dose GH treatment ( 6.0 IU/m2/day ) was then started and continued for at least two full years . When puberty occurred , GH treatment was discontinued at the end of a complete year ’s treatment ( for example , three or four years of GH treatment ) . Results : In response to at least two years on high dose GH treatment , mean ( SD ) height SDS for chronological age increased significantly in GH treated children from −2.6 ( 0.5 ) to −1.3 ( 0.5 ) after two years and −1.4 ( 0.5 ) SDS after five years of study . No changes in height SDS were observed in controls . A rapid rate of bone maturation of 3.6 years/2 years in treated children compared to 2 years/2 years in controls was observed in response to two years high dose GH treatment . Height SDS for bone age was not significantly different between groups during the study period . GH treated children entered into puberty at a significantly earlier age compared to controls . Conclusions : High dose GH treatment before puberty accelerates bone age and induces an earlier onset of puberty . This may limit the potential therapeutic benefit of this regimen in ISS",
"OBJECTIVE It Is possible that high dose GH treatment may have beneficial effects on growth but important adverse effects on cardiac function . We have therefore Investigated the efficacy and cardiovascular effects of high dose biosynthetic human GH ( r‐hGH ) treatment in children with idiopathic short stature and a normal pretreatment height velocity",
"The influence of short stature on psychological adaptation in childhood and adolescence is controversial . GH is currently used to treat children with idiopathic short stature ( ISS , also known as non-GH-deficient short stature ) . This study represents the first double-blind , placebo-controlled trial of the effects of GH on the psychological adaptation of children and adolescents with ISS , treated with GH until adult height was attained . Sixty-eight children ( 53 males , 15 females ) , 9 - 16 yr old , with marked ISS ( measured height or predicted adult height -2.5 sd or less ) received either GH 0.074 mg/kg or placebo sc three times per week until height velocity decreased to less than 1.5 cm/yr . Parents completed the Child Behavior Checklist ( CBCL ) and children the Self-Perception Profile ( SPP ) and Silhouette Apperception Technique at baseline and annually thereafter . Baseline behavioral/emotional adjustment ( CBCL ) and self-concept ( SPP ) scores for children with ISS were within the normative range . The two study groups exhibited similar behavioral and self-concept profiles ( CBCL ) during the first 2 yr of the study . However , CBCL behavior problems ( internalizing , externalizing , and total problems ) appeared to decline , in yr 3 and 4 , in the GH-treated group relative to the placebo-treated group . Group differences in CBCL competency domains and the SPP were not observed at any point during the study . Short stature among children with ISS enrolled in this long-term , placebo-controlled study was not associated with problems in psychological adaptation or self-concept with the psychological instruments employed . GH treatment was associated with a trend toward improvement in problem behaviors , as measured by question naires ( CBCL ) completed by study participants ' parents . It remains to be determined whether GH treatment significantly impacts adaptation , psychosocial function , or quality of life in children with ISS",
"A multicenter r and omized trial of human growth hormone treatment was carried out in 121 children with short stature who did not meet the classic criteria for growth hormone deficiency . Patients treated for 1 year with recombinant somatropin , 0.1 mg/kg three times a week , had a significant increase in mean growth rate from 4.6 + /- 1.1 to 7.5 + /- 1.2 cm/yr , whereas untreated children 's growth rate did not change significantly ( 4.2 + /- 1.3 vs 5.0 + /- 1.4 cm/yr ) . There was a 1-year advance in bone age for each group ; thus there was a significant increase in the predicted height of the treated but not the control group . Among the treated children , the growth response did not differ among those classified on the basis of parental height and bone age as having familial short stature or constitutional delay of growth and development . Pre study anthropomorphic features were not related to subsequent growth in either the treated or control groups . The baseline plasma insulin-like growth factor I concentration was inversely related to the growth response to growth hormone treatment ( r = -0.50 , p = 0.0003 ) . By contrast , the serum growth hormone concentration measured in sample s obtained at 20-minute intervals for 12 or 24 hours or after clonidine administration did not predict the future growth rate . There were no side effects of growth hormone treatment . The results suggest that children who have significant short stature and slow growth may benefit from a trial of growth hormone therapy",
"OBJECTIVE Changes in health-related quality of life ( HRQOL ) and self-esteem were studied in children with idiopathic short stature ( ISS ) participating in a study on the effect of growth hormone treatment . STUDY DESIGN Prepubertal children ( n = 36 ) with ISS were r and omly assigned to a treatment or control group . Children with ISS , their parents , and the pediatrician completed HRQOL and self-esteem question naires 3 times in 2 years . RESULTS At the start , children with ISS did not have lower scores than the norm population , except for social functioning HRQOL . The pediatrician reported an improvement of HRQOL in the treatment group , the parents reported no change , and the children in the treatment group reported the same , or sometimes even worse , HRQOL or self-esteem than the control group . Changes related to the child 's satisfaction with height and hardly to growth itself . CONCLUSION The assumption that growth hormone treatment improves HRQOL in children with ISS could not be supported in this study",
"BACKGROUND There are few data on the long-term outcome of growth-hormone treatment in short normal children . We assessed the impact of growth-hormone treatment on pubertal development and near-final height in girls . METHODS In a r and omised controlled trial , we studied ten girls , with a mean age of 8.07 years and height 2 SDs or more below the mean for their age , and eight short untreated controls matched for age , and 20 short untreated girls who did not give consent for r and omisation . The girls received either 30 IU/m2 somatropin per week as daily subcutaneous injections or no treatment . We assessed pubertal staging and height gain every 6 months . FINDINGS Eight treated girls completed a mean of 6.2 years ' therapy . By a mean age of 16.4 years , their mean height SD score had changed significantly from -2.42 to -1.14 ( p=0.008 ) and they were , on average , 7.5 cm taller than the girls in the control group ( height SD scores did not change significantly from -2.55 ) and 6.0 cm taller than the non-consent group . The timing of each pubertal stage , and the age and amplitude of peak height velocity were similar for all groups . INTERPRETATION Growth-hormone therapy effectively increased height SD score among short normal girls started on treatment in early to mid childhood , with no untoward effect on pubertal progression",
"We evaluated the 12 month growth of 18 pubertal children with familial short stature r and omly assigned to clinical follow-up ( group A ) , GH treatment alone ( group B ) and GH+LHRH analogue ( LHRHa ) treatment ( group C ) . Height velocity increased significantly compared to baseline in groups A and B ( 4.7±0.4 vs 6.6±0.6 and 4.4±0.3 vs 8±1 respectively ) , but not in C ( 5±0.5 vs 6.5±0.4 ) . Moreover in group B height and height prognosis st and ard deviation score SDS ) also were higher ( −2.2±0.2 vs−1.7±0.2 and 1.8±0.3 vs −1±0.2 , respectively ) . Comparisons among the groups showed a significant increase in group B vs the other groups of height velocity SDS ( 3.9±1.3 vs 0.4 + 1 and 0.3±0.7 ) and of height prognosis SDS ( −1±0.2 vs −2.4±0.3 and −2.4±0.3 ) . In conclusion , after one-year treatment , GH seems to be more effective in stimulating growth than GH±LHRHa , even if studies of longer duration and /or follow-up are needed"
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Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia . However , many struggle to sustain these improvements over time . To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants ’ self-management behaviours after attending structured education and their need for support to sustain improvements in glycaemic control . Methods We undertook a meta-ethnography of relevant qualitative studies , identified using systematic search methods . Studies were included which focused on participants ’ experiences of self-managing type 1 diabetes after attending structured education which incorporated training in flexible intensive insulin therapy . A line of argument approach was used to synthesis e the findings . Results The search identified 18 papers from six studies . The studies included were judged to be of high method ological quality . The line of argument synthesis developed the Follow-Up Support for Effective type 1 Diabetes self-management ( FUSED ) model . This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned . To help participants maintain the skills taught during courses , the FUSED model presents ten recommendations abstract ed from the included papers to provide a logic model for a programme of individualised and responsive follow-up support . Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour . To help people sustain diabetes self-management skills after attending structured education , it is recommended that support be provided over the longer-term by appropriately trained healthcare professionals which is responsive to individuals ’ needs . Although developed to inform support for people with type 1 diabetes , the FUSED model provides a framework that could also be applied to support individuals with other long term conditions which require complex self-management skills to be learned and sustained over time . Trial registration PROSPERO registration : CRD42017067961 | [
"BACKGROUND Conventional insulin therapy requires patients with Type 1 diabetes to adhere to rigid dietary and insulin injection practice s. Recent trends towards flexible intensive insulin therapy enable patients to match insulin to dietary intake and lifestyle ; however , little work has examined patients ' experiences of incorporating these practice s into real-life context s. This qualitative longitudinal study explored patients ' experiences of using flexible intensive insulin therapy to help inform the development of effective long-term support . METHODS Semi-structured interviews were conducted with 30 adult patients with Type 1 diabetes following participation in a structured education programme on using flexible intensive insulin therapy , and 6 and 12 months post-course . Longitudinal data analysis used an inductive , thematic approach . RESULTS Patients consistently reported feeling committed to and wanting to sustain flexible intensive insulin therapy . This regimen was seen as a logical and effective method of self-management , as patients experienced improved blood glucose readings and /or reported feeling better . Implementing and sustaining flexible intensive insulin therapy was enhanced when patients had stable routines , with more challenges reported by those working irregular hours and during weekends/holidays . Some patients re-crafted their lives to make this approach work for them ; for instance , by creating dietary routines or adjusting dietary choices . CONCLUSIONS Clinical data have shown that flexible intensive insulin therapy can lead to improvement in glycaemic control . This study , drawing on patients ' perspectives , provides further endorsement for flexible intensive insulin therapy by demonstrating patients ' liking of , and their motivation to sustain , this approach over time . To help patients implement and sustain flexible intensive insulin therapy , follow-up support should encourage them to identify routines to better integrate this regimen into their lives",
"BACKGROUND Insulin is generally administered to people with type 1 diabetes mellitus ( T1DM ) using multiple daily injections ( MDIs ) , but can also be delivered using infusion pumps . In the UK , pumps are recommended for patients with the greatest need and adult use is less than in comparable countries . Previous trials have been small , of short duration and have failed to control for training in insulin adjustment . OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM , with both groups receiving equivalent structured training in flexible insulin therapy . DESIGN Pragmatic , multicentre , open-label , parallel-group cluster r and omised controlled trial , including economic and psychosocial evaluations . After participants were assigned a group training course , courses were r and omly allocated in pairs to either pump or MDI . SETTING Eight secondary care diabetes centres in the UK . PARTICIPANTS Adults with T1DM for > 12 months , willing to undertake intensive insulin therapy , with no preference for pump or MDI , or a clinical indication for pumps . INTERVENTIONS Pump or MDI structured training in flexible insulin therapy , followed up for 2 years . MDI participants used insulin analogues . Pump participants used a Medtronic Paradigm ® VeoTM ( Medtronic , Watford , UK ) with insulin aspart ( NovoRapid , Novo Nordisk , Gatwick , UK ) . MAIN OUTCOME MEASURES Primary outcome - change in glycated haemoglobin ( HbA1c ) at 2 years in participants whose baseline HbA1c was ≥ 7.5 % ( 58 mmol/mol ) . Key secondary outcome - proportion of participants with HbA1c ≤ 7.5 % at 2 years . Other outcomes at 6 , 12 and 24 months - moderate and severe hypoglycaemia ; insulin dose ; body weight ; proteinuria ; diabetic ketoacidosis ; quality of life ( QoL ) ; fear of hypoglycaemia ; treatment satisfaction ; emotional well-being ; qualitative interviews with participants and staff ( 2 weeks ) , and participants ( 6 months ) ; and ICERs in trial and modelled estimates of cost-effectiveness . RESULTS We r and omised 46 courses comprising 317 participants : 267 attended a Dose Adjustment For Normal Eating course ( 132 pump ; 135 MDI ) ; 260 were included in the intention-to-treat analysis , of which 235 ( 119 pump ; 116 MDI ) had baseline HbA1c of ≥ 7.5 % . HbA1c and severe hypoglycaemia improved in both groups . The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI . The mean difference ( MD ) in HbA1c change at 2 years , at which the baseline HbA1c was ≥ 7.5 % , was -0.24 % [ 95 % confidence interval ( CI ) -0.53 % to 0.05 % ] in favour of the pump ( p = 0.098 ) . The per- protocol analysis showed a MD in change of -0.36 % ( 95 % CI -0.64 % to -0.07 % ) favouring pumps ( p = 0.015 ) . Pumps were not cost-effective in the base case and all of the sensitivity analyses . The pump group had greater improvement in diabetes-specific QoL diet restrictions , daily hassle plus treatment satisfaction , statistically significant at 12 and 24 months and supported by qualitative interviews . LIMITATION Blinding of pump therapy was not possible , although an objective primary outcome was used . CONCLUSION Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM . RESEARCH PRIORITY To underst and why few patients achieve a HbA1c of glycaemic control is worse in the UK than in other European countries . TRIAL REGISTRATION Current Controlled Trials IS RCT N61215213 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 20 . See the NIHR Journals Library website for further project information",
"AIMS To evaluate the outcomes of an established programme to teach patients to match their insulin dose to their carbohydrate intake . RESEARCH DESIGN AND METHODS A prospect i ve observational study in Australia ( Newcastle , NSW ) of 137 consecutive patients with type 1 ( n=82 ) or type 2 diabetes ( n=55 ) over two successive years . Four educational principles were used to teach intensive insulin management and diabetes self-care skills including : carbohydrate counting and insulin dose adjustment , exercise , appropriate treatment of hypoglycaemia and hyperglycaemia , managing sickness , problem solving , communication with health professionals , goal setting , and the importance of support . Outcomes included changes at 4 and 12 months in HbA1c , self-efficacy measured by a diabetes empowerment scale ( DES ) , diabetes specific quality of life ( ADDQoL ) , and problem solving . Both intention to treat and efficacy analyses were performed . RESULTS Diabetes-related quality of life and diabetes problem solving skills improved significantly . Excluding 16 people who failed to adopt intensive insulin management and 24 who started with an HbA1c less than 7 % , intention to treat analysis showed the average HbA1c fell from 8.7 % initially to 8.1 % at 12 months and the number of people with an HbA1c of less than 8 % rose from 67 ( 48.9 % ) before the program to 86 ( 62.8 % ) afterwards . CONCLUSIONS An intensive diabetes self-management program led to improvements in HbA1c , empowerment , and quality of life that were largely sustained at 1 year . This is all the more remarkable given that the intervention was once only , entailed no long-term follow-up , and took place in normal clinical operations",
"OBJECTIVE DAFNE ( Dose Adjustment For Normal Eating ) , a structured education program in flexible insulin therapy , has been widely adopted in the U.K. after validation in a r and omized trial . To determine benefits in routine practice , we collected biomedical and psychological data from all participants attending during a 12-month period . RESEARCH DESIGN AND METHODS HbA1c , weight , self-reported hypoglycemia awareness , severe hypoglycemia frequency , PAID ( Problem Areas In Diabetes ) , HADS ( Hospital Anxiety and Depression Scale ) , and EuroQol Group 5-Dimension Self-Report Question naire scores were recorded prior to DAFNE and after 1 year . RESULTS Complete baseline and follow-up HbA1c data were available for 639 ( 54.9 % ) of 1,163 attendees . HbA1c fell from 8.51 ± 1.41 ( mean ± SD ) to 8.24 ± 1.29 % ( difference 0.27 [ 95 % CI 0.16–0.38 ] ; P 8.5 % . Severe hypoglycemia rate fell from 1.7 ± 8.5 to 0.6 ± 3.7 episodes per person per year ( 1.1 [ 0.7–1.4 ] ) and hypoglycemia recognition improved in 43 % of those reporting unawareness . Baseline psychological distress was evident , with a PAID score of 25.2 and HADS scores of 5.3 ( anxiety ) and 4.8 ( depression ) , falling to 16.7 ( 8.5 [ 6.6–10.4 ] ) , 4.6 ( 0.7 [ 0.4–1.0 ] ) , and 4.2 ( 0.6 [ 0.3–0.8 ] ) , respectively ( all P year ) . Clinical ly relevant anxiety and depression ( HADS ≥8 ) fell from 24.4 to 18.0 % and 20.9 to 15.5 % , respectively . CONCLUSIONS A structured education program delivered in routine clinical practice not only improves HbA1c while reducing severe hypoglycemia rate and restoring hypoglycemia awareness but also reduces psychological distress and improves perceived well-being ",
"Abstract Objectives : To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes . Design : R and omised design with participants either attending training immediately ( immediate DAFNE ) or acting as waiting list controls and attending “ delayed DAFNE ” training 6 months later . Setting : Secondary care diabetes clinics in three English health districts . Participants : 169 adults with type 1 diabetes and moderate or poor glycaemic control . Main outcome measures : Glycated haemoglobin ( HbA1c ) , severe hypoglycaemia , impact of diabetes on quality of life ( ADDQoL ) . Results : At 6 months , HbA1c was significantly better in immediate DAFNE patients ( mean 8.4 % ) than in delayed DAFNE patients ( 9.4 % ) ( t=6.1 , P impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients ( t=−5.4 , P impact of diabetes on overall quality of life ( t=2.9 , P . General wellbeing and treatment satisfaction were also significantly improved , but severe hypoglycaemia , weight , and lipids remained unchanged . Improvements in “ present quality of life ” did not reach significance at 6 months but were significant by 1 year . Conclusion : Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk . This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation",
"Summary The objectives of the present analyses were to assess the association between HbA1 c levels and severe hypoglycaemia ( SH , treatment with glucose i. v. or glucagon injection ) and to identify predictors of SH in a prospect i ve multicentre trial . The study population consisted of 636 insulin-dependent diabetic patients who had participated in a structured 5-day in-patient group treatment and teaching programme for intensification of insulin therapy ( ITTP ) in one of 10 hospitals and who were re-examined after 1 , 2 , 3 , and 6 years including assessment of demographic , disease and treatment related parameters , diabetes-related knowledge , behaviour , and emotional coping . At baseline , age ( mean ± SD ) was 27 ± 7 years , diabetes duration 9 ± 7 years and HbA1 c 8.3 ± 1.9 % . During the 6-year follow-up , the mean HbA1 c value improved to 7.6 % , and in patients with a diabetes duration of more than 1 year at entry into the study ( n = 538 ) the incidence of SH decreased from 0.28 cases/patient/year during the year preceding the ITTP to 0.17 cases/patient/year . The patient group was divided into decile groups according to mean follow-up HbA1 c values . In each group more than 230 patient years could be analysed . Groups with mean HbA1 c values of 5.7 , 7.0 , 7.4 , 7.7 and 8.9 % had comparable risks of SH ( 0.15–0.19 cases/patient/year ) . In a logistic regression analysis , mean HbA1 c during follow-up , a history of SH during the year preceding the ITTP , C-peptide level , emotional coping , carrying emergency carbohydrates ( as assessed at the 1-year follow-up ) , and age at onset of diabetes were significant independent predictors of SH . The incidence of SH between centres varied between 0.05 and 0.27 cases/patient/year . In conclusion , in the present analyses no linear or exponential relationship between HbA1 c and severe hypoglycaemia could be identified by using simple group comparisons . Applying complex regression analyses , various patient-related predictors of severe hypoglycaemia were identified . [ Diabetologia ( 1997 ) 40 : 926–932"
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Serotonin reuptake inhibiting drugs ( SRI ) have been used in the treatment of paediatric obsessive-compulsive disorder over the past 30 years . We performed a systematic review and meta- analysis of the literature to discuss the place of and evidence for the use of SRI in paediatric OCD , based on 14 publications of method ologically sound , r and omized and controlled studies . Both SRI and specific SRIs were examined and comparisons of SRI , placebo , cognitive behaviour therapy ( CBT ) , combined ( COMBO ) treatments ( SRI+CBT ) made to investigate their relative efficacy . Using the Cochrane methodology , and as measures of effect size mean difference and Hedge 's g , SRIs proved to be superior to drug placebo , with a modest effect size . From direct comparisons of CBT and SRI treatments , we conclude that CBT has the superior efficacy . COMBO versus CBT shows that SRI treatment adds little to concomitant CBT , while COMBO shows favourable outcome versus SRI alone . In pre-trial partial treatment responders , those who failed a SRI had better outcome from adding CBT as compared to continuing a SRI . Those who failed CBT treatment did as well with continued CBT as with switching to a SRI . The studies of combinations and sequences of treatments need to be developed further | [
"BACKGROUND Obsessive-compulsive disorder ( OCD ) often starts in childhood and adolescence and can be a chronic disorder with high persistence rates . There are few prospect i ve long-term follow-up studies . AIMS To follow up young people with OCD to clarify persistence rates and relevant predictors , presence of other psychiatric disorders , functional impairment , service utilisation and perceived treatment needs . METHOD All young people with OCD assessed over 9 years at the National and Specialist Paediatric OCD clinic , Maudsley Hospital , London , were included . Sixty-one per cent ( 142 of 222 ) of all contactable young people and parents completed computerised diagnostic interviews and question naires . RESULTS We found a persistence rate of OCD of 41 % ; 40 % of participants had a psychiatric diagnosis other than OCD at follow-up . The main predictor for persistent OCD was duration of illness at assessment . High levels of baseline psychopathology predicted other psychiatric disorders at follow-up . Functional impairment and quality of life were mildly to moderately affected . Approximately 50 % of participants were still receiving treatment and about 50 % felt a need for further treatment . CONCLUSIONS This study confirms that paediatric OCD can be a chronic condition that persists into adulthood . Early recognition and treatment might prevent chronicity . Important challenges for services are ensuring adequate treatment and a smooth transition from child to adult services",
"Expert guidelines recommend cognitive-behavior therapy ( CBT ) as a first-line treatment in pediatric obsessive – compulsive disorder ( OCD ) and the addition of selective serotonin reuptake inhibitors when CBT is not effective . However , the recommendations for CBT non-responders are not supported by empirical data . Our objective was to investigate the effectiveness of sertraline ( SRT ) versus continued CBT in children and adolescents that did not respond to an initial course of CBT . R and omized controlled trial conducted in five sites in Denmark , Sweden and Norway , 54 children and adolescents , age 7–17 years , with DSM-IV primary OCD were r and omized to SRT or continued CBT for 16 weeks . These participants had been classified as non-responders to CBT following 14 weekly sessions . Primary outcomes were the CY-BOCS total score and clinical response ( CY-BOCS included 50 participants , mean age 14.0 ( SD = 2.7 ) and 48 % ( n = 24 ) males . Twenty-one of 28 participants ( 75 % ) completed continued CBT and 15 of 22 participants ( 69.2 % ) completed SRT . Planned pairwise comparison of the CY-BOCS total score did not reveal a significant difference between the treatments ( p = .351 ) , the response rate was 50.0 % in the CBT group and 45.4 % in the SRT group . The multivariate χ2 test suggested that there were no statistically significant differences between groups ( p = .727 ) . Within-group effect sizes were large and significant across both treatments . These large within-group effect sizes suggest that continued treatment for CBT non-responders is beneficial . However , there was no significant between-group differences in SRT or continued CBT at post-treatment",
"OBJECTIVE This article describes the long-term effects of augmenting serotonin reuptake inhibitors ( SRIs ) with exposure and ritual prevention or stress management training in patients with DSM-IV obsessive-compulsive disorder ( OCD ) . METHOD Between November 2000 and November 2006 , 111 OCD patients from 2 academic outpatient centers with partial SRI response were r and omized to the addition of exposure and ritual prevention or stress management training , delivered twice weekly for 8 weeks ( acute phase ) ; 108 began treatment . Responders ( 38 of 52 in the exposure and ritual prevention condition , 11 of 52 in the stress management training condition ) entered a 24-week maintenance phase . The Yale-Brown Obsessive Compulsive Scale ( YBOCS ) was the primary outcome measure . RESULTS After 24 weeks , patients r and omized to and receiving exposure and ritual prevention versus stress management training had significantly better outcomes ( mean YBOCS scores of 14.69 and 21.37 , respectively ; t = 2.88 , P = .005 ) , higher response rates ( decrease in YBOCS scores ≥ 25 % : 40.7 % vs 9.3 % , Fisher exact test P rates of excellent response ( YBOCS score ≤ 12 : 24.1 % vs 5.6 % , Fisher exact test P = .01 ) . During the maintenance phase , the slope of change in YBOCS scores was not significant in either condition ( all P values ≥ .55 ) , with no difference between exposure and ritual prevention and stress management training ( P > .74 ) . Better outcome was associated with baseline variables : lower YBOCS scores , higher quality of life , fewer comorbid Axis I diagnoses , and male sex . CONCLUSIONS Augmenting SRIs with exposure and ritual prevention versus stress management training leads to better outcome after acute treatment and 24 weeks later . Maintenance outcome , however , was primarily a function of OCD severity at entrance . Greater improvement during the acute phase influences how well patients maintain their gains , regardless of treatment condition",
"Rigorously design ed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder ( OCD ) but not in patients below 18 years old . This report describes a r and omized , double-blind , placebo-controlled , fixed-dose ( 20 mg qd ) trial of fluoxetine in 14 children and adolescents with OCD , ages 8 to 15 years old ; the study was 20 weeks long with crossover at 8 weeks . Obsessive-compulsive symptom severity was measured on the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) and the Clinician 's Global Impression-Obsessive Compulsive Disorder scale ( CGI-OCD ) . The CY-BOCS total score decreased 44 % ( N = 7 , p = .003 ) after the initial 8 weeks of fluoxetine treatment , compared with a 27 % decrease ( N = 6 , p = .13 ) after placebo . During the initial 8 weeks , the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD ( p = .01 ) but not by the CY-BOCS ( p = .17 ) . The most common drug side effects were generally well tolerated . The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD",
"CONTEXT The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder ; however , empirical support for this assertion has been weaker for children and adolescents than for adults . OBJECTIVE To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder . DESIGN R and omized , double-blind , placebo-controlled trial . PATIENTS One hundred eighty-seven patients : 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years r and omized to receive either sertraline ( 53 children , 39 adolescents ) or placebo ( 54 children , 41 adolescents ) . SETTING Twelve US academic and community clinics with experience conducting r and omized controlled trials . INTERVENTION Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy , after which patients continued to receive this dosage of medication for 8 more weeks . Control patients received placebo . MAIN OUTCOME MEASURES The Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) , the National Institute of Mental Health Global Obsessive Compulsive Scale ( NIMH GOCS ) , and the NIMH Clinical Global Impressions of Severity of Illness ( CGI-S ) and Improvement ( CGI-I ) rating scales . RESULTS In intent-to-treat analyses , patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS ( adjusted mean , -6.8vs -3.4 , respectively ; P=.005 ) , the NIMH GOCS ( -2.2 vs -1.3 , respectively ; P=.02 ) , and the CGI-I ( 2.7 vs 3.3 , respectively ; P=.002 ) scales . Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study . Based on CGI-I ratings at end point , 42 % of patients receiving sertraline and 26 % of patients receiving placebo were very much or much improved . Neither age nor sex predicted response to treatment . The incidence of insomnia , nausea , agitation , and tremor were significantly greater in patients receiving sertraline ; 12 ( 13 % ) of 92 sertraline-treated patients and 3 ( 3.2 % ) of 95 placebo-treated patients discontinued prematurely because of adverse medical events ( P=.02 ) . No clinical ly meaningful abnormalities were apparent on vital sign determinations , laboratory findings , or electrocardiographic measurements . CONCLUSION Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder",
"OBJECTIVE To compare , via a pilot study , the effectiveness of behavior therapy and of drug treatment in children and adolescents with obsessive-compulsive disorder . METHOD Twenty-two children aged between 8 and 18 years were r and omly assigned to behavior therapy ( n = 12 ) or open clomipramine ( n = 10 ) in a parallel design lasting 12 weeks . Behavior therapy included exposure and response prevention administered in weekly sessions . The mean dosage of clomipramine was 2.5 mg/kg ( range = 1.4 - 3.3 mg/kg ) . The main outcome variables were the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) and the Leyton Obsessional Inventory-Child Version ( LOI-CV ) . RESULTS Significant improvement was obtained in both treatment conditions . Behavior therapy produced stronger therapeutic changes than clomipramine on the CY-BOCS ( p LOI-CV no significant differences between the results of the two treatments were found . Five of the nine initial nonresponders showed significant changes after extension of treatment for another 12 weeks . CONCLUSION Behavior therapy is shown to be a good alternative for drug treatment and deserves further study in larger sample s of children with obsessive-compulsive disorder",
"OBJECTIVE The efficacy of medications , consisting of serotonin partial and specific reuptake blockers , and behavior therapy , consisting of exposure and response prevention in addition to social skills training , cognitive therapy , and habit reversal , in the treatment of obsessive-compulsive disorder are well documented . The purpose of the study was to explore if adding behavior therapy to medication would enhance treatment efficacy . METHODS Ten children/adolescents who had not previously responded to behavior therapy were r and omly assigned to two groups : fluvoxamine alone or fluvoxamine with behavior therapy . All 10 patients received fluvoxamine for 10 weeks-five continued solely on fluvoxamine for one year and five engaged in behavior therapy for 20 sessions along with fluvoxamine and then continued solely on medication until the end of the year . RESULTS Eight of 10 patients improved significantly on fluvoxamine at week 10 on the primary outcome variable , the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) . According to the other measurements -National Institute of Mental Health-Global Obses-sive-Compulsive Scale , Clinical Global Impression-Improvement ( assessing level of im-provement from week to week ) , and Clinical Global Impression-Severity of Illness Scale ( as-sessing how ill the patient is from week to week)-improvement was not as evident . According to the CY-BOCS , those who received a combination of fluvoxamine and exposure with response prevention showed significantly more improvement than those who only took medication . At two-year follow-up , all patients continued to improve , with those in the combined approach improving more than those in the medication-alone group . CONCLUSIONS Future studies should determine the specific effect of each treatment group , combined and singularly . Reasons for discrepancy in improvement ratings as noted by the different instruments are discussed . The addition of behavior therapy to fluvoxamine seems to enhance treatment efficacy , according to the CY-BOCS",
"Concentrations of the serotonin metabolite 5-hydroxyindoleacetic acid ( 5-HIAA ) , the dopamine metabolite homovanillic acid , and the noradrenaline metabolite 4-hydroxy-3-methoxyphenyl glycol were measured in CSF before and after three weeks ' treatment of severe obsessive-compulsive disorder with clomipramine hydrochloride . Patients who responded to clomipramine treatment had significantly higher CSF levels of 5-HIAA before treatment . The amelioration of obsessive-compulsive symptoms was positively correlated to the reduction of CSF concentrations of 5-HIAA during clomipramine treatment but negatively correlated to plasma concentrations of clomipramine . Reduction of CSF concentrations of 5-HIAA , which probably reflects drug action on central serotonin neurons , was maximal at a plasma clomipramine concentration of about 300 nmole/L. At higher levels , the reduction of CSF levels of 5-HIAA was smaller . The antiobsessive effect of clomipramine may be connected to its capacity to inhibit serotonin uptake",
"OBJECTIVE To compare the effectiveness of group cognitive-behavioral therapy ( GCBT ) and of sertraline in treatment-naïve children and adolescents with obsessive-compulsive disorder . METHOD Between 2000 and 2002 , 40 subjects between 9 and 17 years old were r and omized to receive GCBT ( n = 20 ) or sertraline ( n = 20 ) . GCBT consisted of a manual-based 12-week cognitive-behavioral protocol adapted for groups , and treatment with sertraline involved medication intake for 12 weeks . Subjects were assessed before , during , and after treatment ( at 1 , 3 , 6 , and 9 months after treatment conclusion ) . Primary outcome measure was the Children 's Yale-Brown Obsessive-Compulsive Scale . Repeated- measures analyses of variance were done . RESULTS Both GCBT and sertraline conditions had significant improvement in obsessive-compulsive disorder symptoms as measured by the Children 's Yale-Brown Obsessive-Compulsive Scale after 12 weeks of treatment . After the 9-month follow-up period , subjects in the GCBT condition had a significantly lower rate of symptom relapse than those in the sertraline group . CONCLUSIONS The treatment with GCBT may be effective in decreasing obsessive-compulsive symptoms in childhood obsessive-compulsive disorder and should be considered as an alternative to either individual cognitive-behavioral therapy or a medication , such as sertraline . Results support the effectiveness and the maintenance of gains of GCBT in the treatment of youngsters with obsessive-compulsive disorder",
"OBJECTIVE To evaluate the safety and effectiveness of sertraline in the long-term treatment of pediatric obsessive-compulsive disorder ( OCD ) . METHOD Children ( 6 - 12 years ; n= 72 ) and adolescents ( 13 - 18 years ; n = 65 ) with DSM-III-R-defined OCD who had completed a 12-week , double-blind , placebo-controlled sertraline study were given open-label sertraline 50 to 200 mg/day in this 52-week extension study . Concomitant psychotherapy was allowed during the extension study Outcome was evaluated by the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) , National Institute of Mental Health Global Obsessive-Compulsive Scale , and Clinical Global Impression Severity ( CGI-S ) and Improvement ( CGI-I ) scores . RESULTS Significant improvement ( p 25 % decrease in CY-BOCS and a CGI-I score of 1 or 2 ) . Significant ( p sertraline during the 12-week , double-blind acute study . Long-term sertraline treatment was well tolerated , and there were no discontinuations due to changes in vital signs , laboratory values , or electrocardiograms . CONCLUSION Sertraline ( 50 - 200 mg/day ) was effective and generally well tolerated in the treatment of childhood and adolescent OCD for up to 52 weeks . Improvement was seen with continued treatment",
"Children and adolescents with obsessive compulsive disorder were studied in an 8-week , multicenter , double-blind , parallel groups trial of clomipramine hydrochloride ( CMI ) versus placebo . Efficacy assessment s included the child version of the Yale-Brown Obsessive Compulsive Scale and the National Institute of Mental Health Global rating scale . At the end of 8 weeks , CMI-treated patients showed a mean reduction in Yale-Brown Obsessive Compulsive Scale score of 37 % compared to 8 % in the placebo group . Side effects were typical of tricyclic antidepressants . In a 1-year open label treatment , CMI continued to be effective and well tolerated",
"OBJECTIVE To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder . METHOD Children ( 7 - 11 years of age ) and adolescents ( 12 - 17 years of age ) meeting DSM-IV criteria for obsessive-compulsive disorder were r and omized to paroxetine ( 10 - 50 mg/day ) or placebo for 10 weeks . The primary efficacy measure was change from baseline in the Children 's Yale-Brown Obsessive-Compulsive Scale ( CY-BOCS ) total score at week 10 last observation carried forward end point . Safety was assessed primarily through adverse event monitoring . RESULTS A total of 207 patients were r and omized to treatment . Of these , 203 were included in the intention-to-treat population . Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 ( SE=0.82 ) and -5.34 points ( SE=0.77 ) , respectively . The adjusted mean difference , -3.45 in favor of paroxetine , was statistically significant ( 95 % confidence interval=-5.60 to -1.29 , p=.002 ) . Adverse events were generally mild to moderate in intensity . A total of 10.2 % ( 10/98 ) of patients in the paroxetine group and 2.9 % ( 3 of 105 ) in the placebo group discontinued treatment because of adverse events . CONCLUSIONS Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents",
"CONTEXT The extant literature on the treatment of pediatric obsessive-compulsive disorder ( OCD ) indicates that partial response to serotonin reuptake inhibitors ( SRIs ) is the norm and that augmentation with short-term OCD-specific cognitive behavior therapy ( CBT ) may provide additional benefit . OBJECTIVE To examine the effects of augmenting SRIs with CBT or a brief form of CBT , instructions in CBT delivered in the context of medication management . DESIGN , SETTING , AND PARTICIPANTS A 12-week r and omized controlled trial conducted at 3 academic medical centers between 2004 and 2009 , involving 124 pediatric out patients between the ages of 7 and 17 years with OCD as a primary diagnosis and a Children 's Yale-Brown Obsessive Compulsive Scale score of 16 or higher despite an adequate SRI trial . INTERVENTIONS Participants were r and omly assigned to 1 of 3 treatment strategies that included 7 sessions over 12 weeks : 42 in the medication management only , 42 in the medication management plus instructions in CBT , and 42 in the medication management plus CBT ; the last included 14 concurrent CBT sessions . MAIN OUTCOME MEASURES Whether patients responded positively to treatment by improving their baseline obsessive-compulsive scale score by 30 % or more and demonstrating a change in their continuous scores over 12 weeks . RESULTS The medication management plus CBT strategy was superior to the other 2 strategies on all outcome measures . In the primary intention-to-treat analysis , 68.6 % ( 95 % CI , 53.9%-83.3 % ) in the plus CBT group were considered responders , which was significantly better than the 34.0 % ( 95 % CI , 18.0%-50.0 % ) in the plus instructions in CBT group , and 30.0 % ( 95 % CI , 14.9%-45.1 % ) in the medication management only group . The results were similar in pairwise comparisons with the plus CBT strategy being superior to the other 2 strategies ( P CBT strategy was not statistically superior to medication management only ( P = .72 ) . The number needed-to-treat analysis with the plus CBT vs medication management only in order to see 1 additional patient at week 12 , on average , was estimated as 3 ; for the plus CBT vs the plus instructions in CBT strategy , the number needed to treat was also estimated as 3 ; for the plus instructions in CBT vs medication management only the number needed to treat was estimated as 25 . CONCLUSIONS Among patients aged 7 to 17 years with OCD and partial response to SRI use , the addition of CBT to medication management compared with medication management alone result ed in a significantly greater response rate , whereas augmentation of medication management with the addition of instructions in CBT did not . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00074815",
"OBJECTIVE To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder ( OCD ) with a double-blind , placebo-controlled , multicenter study . METHOD Subjects , aged 8 to 17 years , meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994 . After a 7- to 14-day single-blind , placebo washout/screening period , subjects were r and omly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks . Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term , open-label trial of fluvoxamine . Analyses used an intent-to-treat sample with a last-observation-carried-forward method . RESULTS Mean Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) scores with fluvoxamine were significantly ( p placebo at weeks 1 , 2 , 3 , 4 , 6 , and 10 . Significant ( p placebo were observed for all secondary outcome measures at all visits . Based on a 25 % reduction of CY-BOCS scores , 42 % of subjects taking fluvoxamine were responders compared with 26 % taking placebo . Forty-six ( 19 fluvoxamine , 27 placebo ) of 120 r and omized subjects discontinued early . Adverse events with a placebo-adjusted rate greater than 10 % were insomnia and asthenia . CONCLUSIONS Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD",
"BACKGROUND Despite its high chronicity , few studies have evaluated the effectiveness of long-term treatment for pediatric obsessive-compulsive disorder ( OCD ) . The goal of the current analysis is to evaluate remission among children and adolescents with OCD treated with sertraline for 12 months . METHODS Children ( 6 - 12 years old , n = 72 ) and adolescents ( 13 - 18 years old , n = 65 ) with Diagnostic and Statistical Manual of Mental Disorders ( third edition , revised ) OCD , who had completed a 12-week , double-blind , placebo-controlled sertraline study , were administered open-label sertraline 50 - 200 mg for 52 weeks . Full remission was defined by a Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) score of 8 or less , and partial remission was defined as a CY-BOCS score of 15 or less . RESULTS Using an last observation carried forward analysis , 47 % of patients achieved a full remission , and an additional 25 % achieved a partial remission . Among study completers , full remission was achieved by 55 % of patients and partial remission by 31 % . Two thirds of patients with severe OCD at baseline ( CY-BOCS of 26 or greater ) achieved full or partial remission . Children were more likely to achieve a full remission than adolescents . CONCLUSION Sertraline is effective in the treatment of childhood and adolescent OCD , with initial acute response converting to remission and improved functional status in a substantial proportion of patients . More research is needed to develop pharmacologic and psychotherapeutic strategies that facilitate the achievement of full remission in the remaining patients suffering from this chronic and disabling illness",
"BACKGROUND To examine the efficacy of sequential sertraline and cognitive-behavioral therapy ( CBT ) treatment relative to CBT with pill placebo over 18 weeks in children and adolescents with obsessive-compulsive disorder ( OCD ) . METHODS Forty-seven children and adolescents with OCD ( Range = 7 - 17 years ) were r and omized to 18-weeks of treatment in one of three arms : 1 ) sertraline at st and ard dosing + CBT ( RegSert + CBT ) ; 2 ) sertraline titrated slowly but achieving at least 8 weeks on the maximally tolerated daily dose + CBT ( SloSert + CBT ) ; or 3 ) pill placebo + CBT ( PBO + CBT ) . Assessment s were conducted at screening , baseline , weeks 1 - 9 , 13 , and 17 , and post-treatment . Raters and clinicians were blinded to sertraline ( but not CBT ) r and omization status . Primary outcomes included the Children 's Yale-Brown Obsessive-Compulsive Scale , and response and remission status . Secondary outcomes included the Child Obsessive Compulsive Impact Scale-Parent/Child , Children 's Depression Rating Scale-Revised , Multidimensional Anxiety Scale for Children , and Clinical -Global Impressions-Severity . RESULTS All groups exhibited large within-group effects across outcomes . There was no group by time interaction across all outcomes suggesting that group changes over time were comparable . CONCLUSIONS Among youth with OCD , there was no evidence that sequentially provided sertraline with CBT differed from those receiving placebo with CBT . CLINICAL TRIALSGOV IDENTIFIER NCT00382291"
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Graphical abstract Figure . No Caption available . Abstract The role of gut microbiota in the management of diabetes has been shown . Several current trials are investigating the effect of probiotics and prebiotics , which are widely used to modulate intestinal microbiota , on inflammatory factors and biomarkers of oxidative stress in diabetic patients ; however , their findings are controversial . The aim of the current meta‐ analysis was to evaluate the effects of probiotic and synbiotic supplementation on levels of serum high‐sensitivity C‐reactive protein ( hs‐CRP ) and biomarkers of oxidative stress in diabetic patients . We search ed the PubMed , Web of Science , and The Cochrane Library data bases from the inception to October 31 , 2018 . R and omized controlled trials ( RCTs ) which reported the effect of probiotics or synbiotics on circulating ( serum and plasma ) inflammatory marker ( hs‐CRP ) and oxidative stress indicators ( malondialdehyde [ MDA ] , glutathione [ GSH ] , nitric oxide [ NO ] , and total antioxidant capacity [ TAC ] ) among patients with diabetes were included . Eligible studies were assessed for risk of bias and subjected to qualitative and quantitative synthesis using either fixed‐ or r and om‐effects models accounting for clinical heterogeneity . Our meta‐ analysis identified 16 eligible RCTs ( n = 1060 ) . The method ological quality varied across these trials . Pooled data from these trials demonstrated that probiotic and synbiotic consumption significantly decreased hs‐CRP level ( st and ardized mean difference [SMD]=‐0.38 ; 95 % confidence interval [CI]:‐0.51,‐0.24 ; P = 0.000 ) and MDA ( SMD=‐0.61 ; 95 % CI : ‐0.89 , ‐0.32 ; P = 0.000 ) in diabetic patients compared to those in subjects receiving placebos . In addition , probiotic and symbiotic supplementation was found to increase TAC ( SMD = 0.31 ; 95 % CI : 0.09 , 0.52 ; P = 0.006 ) , NO ( SMD , 0.62 ; 95 % CI , 0.25 to 0.99 ; P = 0.001 ) and GSH ( SMD = 0.41 ; 95 % CI : 0.26 , 0.55 , P = 0.000 ) levels . The results of this systematic review and meta‐ analysis suggest that probiotic and synbiotic supplementation may help to improve biomarkers of inflammation and oxidative stress in diabetic patients . Further studies are needed to develop clinical practice guidelines for the management of inflammation and oxidative stress in these patients | [
"BACKGROUND & AIMS Type 2 diabetes has been associated with dysbiosis and one of the possible routes to restore a healthy gut microbiota is by the regular ingestion of probiotics . We aim ed to investigate the effects of probiotics on glycemic control , lipid profile , inflammation , oxidative stress and short chain fatty acids in T2D . METHODS In a double-blind , r and omized , placebo-controlled trial , 50 volunteers consumed daily 120 g/d of fermented milk for 6 wk . Participants were assigned into two groups : probiotic group , consuming fermented milk containing Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp lactis BB-12 ( 109 colony-forming units/d , each ) and control group , consuming conventional fermented milk . Anthropometric measurements , body composition , fasting blood and faecal sample s were taken at baseline and after 6 wk . RESULTS 45 subjects out of 50 ( 90 % ) completed follow-up . After 6 wk , there was a significant decrease in fructosamine levels ( -9.91 mmol/L ; p = 0.04 ) and hemoglobin A1c tended to be lower ( -0.67 % ; p=0.06 ) in probiotic group . TNF-α and resistin were significantly reduced in probiotic and control groups ( -1.5 and -1.3 pg/mL , -.1 and -2.8 ng/mL , respectively ) , while IL-10 was significantly reduced ( - 0.65 pg/mL ; p group . Fecal acetic acid was increased in both groups ( 0.58 and 0.59 % in probiotic and control groups , respectively ; p mean changes of HbA1c ( + 0.31 for control group vs -0.65 for probiotic group ; p=0.02 ) , total cholesterol ( + 0.55 for control group vs -0.15 for probiotic group ; p=0.04 ) and LDL-cholesterol ( + 0.36 for control group vs -0.20 for probiotic group p=0.03 ) . CONCLUSIONS Probiotic consumption improved the glycemic control in T2D subjects , however , the intake of fermented milk seems to be involved with others metabolic changes , such as decrease in inflammatory cytokines ( TNF-α and resistin ) and increase in the acetic acid",
"Microbial modulation of diabetes Short-chain fatty acids ( SCFAs ) are produced by various human gut microbes . SCFAs act as an energy source to the colonic epithelium and are also sensed by host signaling pathways that modulate appetite and inflammation . Deficiency of gut SCFAs is associated with type 2 diabetes . Zhao et al. found that adopting a high-fiber diet promoted the growth of SCFA-producing organisms in diabetic humans . The high-fiber diet induced changes in the entire gut microbe community and correlated with elevated levels of glucagon-like peptide-1 , a decline in acetylated hemoglobin levels , and improved blood-glucose regulation . Science , this issue p. 1151 Increasing dietary fiber intake increases the abundance of short-chain fatty acid – producing gut microbes and relieves diabetes . The gut microbiota benefits humans via short-chain fatty acid ( SCFA ) production from carbohydrate fermentation , and deficiency in SCFA production is associated with type 2 diabetes mellitus ( T2DM ) . We conducted a r and omized clinical study of specifically design ed isoenergetic diets , together with fecal shotgun metagenomics , to show that a select group of SCFA-producing strains was promoted by dietary fibers and that most other potential producers were either diminished or unchanged in patients with T2DM . When the fiber-promoted SCFA producers were present in greater diversity and abundance , participants had better improvement in hemoglobin A1c levels , partly via increased glucagon-like peptide-1 production . Promotion of these positive responders diminished producers of metabolically detrimental compounds such as indole and hydrogen sulfide . Targeted restoration of these SCFA producers may present a novel ecological approach for managing T2DM",
"Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing . However , the effect of multi-strain probiotics in people with type 2 diabetes remains unclear . This study investigated the effect of multi-strain microbial cell preparation — also refers to multi-strain probiotics — on glycemic control and other diabetes-related outcomes in people with type 2 diabetes . Design A r and omized , double-blind , parallel-group , controlled clinical trial . Setting Diabetes clinic of a teaching hospital in Kuala Lumpur , Malaysia . Participants A total of 136 participants with type 2 diabetes , aged 30–70 years , were recruited and r and omly assigned to receive either probiotics ( n = 68 ) or placebo ( n = 68 ) for 12 weeks . Outcomes Primary outcomes were glycemic control-related parameters , and secondary outcomes were anthropomorphic variables , lipid profile , blood pressure and high-sensitivity C-reactive protein . The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract . Statistical analysis Intention-to-treat ( ITT ) analysis was performed on all participants , while per- protocol ( PP ) analysis was performed on those participants who had successfully completed the trial with good compliance rate . Results With respect to primary outcomes , glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis ( p . Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis . These changes were significant between groups at both analyses ( p did not change significantly . Probiotics successfully passed through the gastrointestinal tract . Conclusion Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes",
"Introduction : The role of inflammatory cytokines in diabetes and its complications has been shown in some studies . The purpose of this study was to compare the effect of probiotic and conventional yogurt on inflammatory markers in patients with type 2 diabetes . Methods : Forty-four patients with type 2 diabetes were participated in this r and omized , double-blind controlled clinical trial and assigned to two intervention and control groups . The subjects in the intervention group consumed 300 g/d probiotic yogurt and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks . Anthropometric indices , dietary intakes , and serum levels of glucose , HbA1c , IL-6 , TNF-α and hs-CRP were evaluated at the beginning and end of the intervention . Results : For anthropometric indices and dietary intakes , no significant differences were seen within and between groups post intervention ( p > 0.05 ) . The consumption of probiotic yogurt caused significant decrease in HbA1c and TNF-α levels ( p= 0.032 and p= 0.040 , respectively ) in the intervention group . Conclusion : It is suggested that probiotic yogurt may be used as an alternative prevention approach and treatment method to control diabetic complications ",
"OBJECTIVE Oxidative stress plays a major role in the pathogenesis and progression of diabetes . Among various functional foods with an antioxidant effect , probiotic foods have been reported to repress oxidative stress . The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients . METHODS Sixty-four patients with type 2 diabetes mellitus , 30 to 60 y old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk . Fasting blood sample s , 24-h dietary recalls , and anthropometric measurements were collected at the baseline and at the end of the trial . RESULTS Probiotic yogurt significantly decreased fasting blood glucose ( P hemoglobin A1c ( P erythrocyte superoxide dismutase and glutathione peroxidase activities and total antioxidant status ( P serum malondialdehyde concentration significantly decreased compared with the baseline value in both groups ( P insulin concentration and erythrocyte catalase activity within either group ( P > 0.05 ) . CONCLUSION The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients . These results suggest that probiotic yogurt is a promising agent for diabetes management",
"Objectives : To our knowledge , no reports are available indicating the effects of synbiotic bread consumption on nitric oxide ( NO ) , biomarkers of oxidative stress , and liver enzymes among patients with type 2 diabetes mellitus ( T2DM ) . This study was performed to determine the effects of the daily consumption of synbiotic bread on NO , biomarkers of oxidative stress , and liver enzymes in patients with T2DM . Methods : This r and omized , double-blind , placebo-controlled trial was performed among 81 patients with diabetes , aged 35–70 years old . After a 2-week run-in period , patients were r and omly divided into 3 groups : group A ( n = 27 ) received synbiotic bread containing viable and the heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin per 1 g , group B ( n = 27 ) received probiotic bread containing Lactobacillus sporogenes ( 1 × 108 CFU ) , and group C ( n = 27 ) received control bread for 8 weeks . Patients were asked to consume the synbiotic , probiotic , or control breads 3 times a day in 40 g packages for a total of 120 g/day . Fasting blood sample s were taken at baseline and after an 8-week intervention for quantificationof related markers . Results : After 8 weeks , the consumption of synbiotic bread compared to the probiotic and control breads result ed in a significant rise in plasma NO ( 40.6 ± 34.4 vs 18.5 ± 36.2 and −0.8 ± 24.5 µmol/L , respectively , p significant reduction in malondialdehyde ( MDA ) levels ( −0.7 ± 0.7 vs 0.6 ± 1.7 and 0.5 ± 1.5 µmol/L , respectively , p = 0.001 ) . We did not find any significant effect of the synbiotic bread consumption on plasma total antioxidant capacity ( TAC ) , plasma glutathione ( GSH ) , catalase , serum liver enzymes , calcium , iron , magnesium levels , and blood pressure compared to the probiotic and control breads . Conclusion : In conclusion , consumption of the synbiotic bread for 8 weeks among patients with T2DM had beneficial effects on plasma NO and MDA levels ; however , it did not affect plasma TAC , GSH , catalase levels , serum liver enzymes , calcium , iron , magnesium levels , and blood pressure",
"OBJECTIVE Diabetic kidney disease ( DKD ) is one the most important complications of diabetes leading to end-stage renal disease . This study aim ed to determine the effects of probiotic soy milk consumption on oxidative stress biomarkers in type 2 DKD patients . METHODS Forty-eight patients were r and omly assigned to consume a diet containing 200 mL/day probiotic soy milk in the intervention group or soy milk in the control condition . As determinants of oxidative stress , malondialdehyde , 8-iso-prostagl and in F2α , oxidized glutathione , total antioxidant capacity , reduced glutathione ( GSH ) , glutathione peroxidase , and glutathione reductase were measured after 8 weeks of intervention according to the st and ard protocol . RESULTS Between groups analysis showed that DKD patients in the probiotic soy milk group had a higher mean value of GSH compared with those in the soy milk group . In the final adjusted model , this difference remained significant . Consistently , oxidized glutathione concentration was significantly reduced among patients in the probiotic soy milk group . Also , for activity levels of antioxidant enzymes including glutathione peroxidase and glutathione reductase , significant increased levels were observed between 2 intervention groups in the final adjusted model . However , no significant reduction of the serum 8-iso-prostagl and in F2α or malondialdehyde and no induction of TAC concentrations within and between the 2 groups in the crude and adjusted models were detected . CONCLUSION Overall , the results demonstrate that probiotic soy milk consumption could improve some oxidative stress factors among DKD patients . Further longitudinal studies with consideration of individual variation should be conducted",
"Gut microflora and dysbiosis as an environmental factor has been linked to the pathogenesis of enthesitis‐related arthritis ( JIA‐ERA ) ; thus , we performed a proof‐of‐concept study of probiotics to modulate the gut‐flora and study the effects on immune and clinical parameters of children having JIA‐ERA . Forty‐six children with active JIA‐ERA were r and omized to placebo or probiotic therapy along with non‐steroidal anti‐inflammatory drugs ( NSAIDs ) for 12 weeks . Patients were assessed using a six‐point composite disease activity index ( mJSpADA ) based on morning stiffness , joint count , enthesitis count , sacroiliitis/inflammatory back pain , uveitis and erythrocyte sedimentation rate/C‐reactive protein ( ESR/CRP ) . Frequencies of T helper type 1 ( Th1 ) , Th2 , Th17 and regulatory T cells in blood were measured using flow cytometry . Serum cytokines interferon (IFN)‐γ , interleukin (IL)−4 , IL‐17 , IL‐10 , tumour necrosis factor (TNF)‐α and IL‐6 were measured by cytokine bead array using flow cytometer . The average age of 46 children ( 44 boys ) was 15 ± 2.5 years and duration of disease was 3.5 ± 3 years . There was no significant difference in improvement in mJSpADA between the two groups ( P = 0·16 ) . Serum IL‐6 levels showed a decrease ( P probiotic‐group . Th2 cell frequency ( P 0·05 ) and serum IL‐10 levels ( P in immune parameters when compared to the placebo . Adverse effects among the probiotic and placebo groups were diarrhea ( 36 versus 45 % ) , abdominal pain ( 9 versus 20 % ) , minor infections ( 4·5 versus 20 % ) and flatulence ( 23 versus 15 % ) , respectively . Thus , we can conclude that probiotic therapy in JIA‐ERA children is well tolerated , but failed to show any significant immune or clinical effects over NSAID therapy",
"Probiotics are widely prescribed for prevention of antibiotics-associated dysbiosis and related adverse effects . However , probiotic impact on post-antibiotic reconstitution of the gut mucosal host-microbiome niche remains elusive . We invasively examined the effects of multi-strain probiotics or autologous fecal microbiome transplantation ( aFMT ) on post-antibiotic reconstitution of the murine and human mucosal microbiome niche . Contrary to homeostasis , antibiotic perturbation enhanced probiotics colonization in the human mucosa but only mildly improved colonization in mice . Compared to spontaneous post-antibiotic recovery , probiotics induced a markedly delayed and persistently incomplete indigenous stool/mucosal microbiome reconstitution and host transcriptome recovery toward homeostatic configuration , while aFMT induced a rapid and near-complete recovery within days of administration . In vitro , Lactobacillus-secreted soluble factors contributed to probiotics-induced microbiome inhibition . Collectively , potential post-antibiotic probiotic benefits may be offset by a compromised gut mucosal recovery , highlighting a need of developing aFMT or personalized probiotic approaches achieving mucosal protection without compromising microbiome recolonization in the antibiotics-perturbed host",
"Empiric probiotics are commonly consumed by healthy individuals as means of life quality improvement and disease prevention . However , evidence of probiotic gut mucosal colonization efficacy remains sparse and controversial . We metagenomically characterized the murine and human mucosal-associated gastrointestinal microbiome and found it to only partially correlate with stool microbiome . A sequential invasive multi-omics measurement at baseline and during consumption of an 11-strain probiotic combination or placebo demonstrated that probiotics remain viable upon gastrointestinal passage . In colonized , but not germ-free mice , probiotics encountered a marked mucosal colonization resistance . In contrast , humans featured person- , region- and strain-specific mucosal colonization patterns , hallmarked by predictive baseline host and microbiome features , but indistinguishable by probiotics presence in stool . Consequently , probiotics induced a transient , individualized impact on mucosal community structure and gut transcriptome . Collectively , empiric probiotics supplementation may be limited in universally and persistently impacting the gut mucosa , meriting development of new personalized probiotic approaches",
"Background Gastroenteritis accounts for approximately 1.7 million visits to the emergency department ( ED ) by children in the United States every year . Data to determine whether the use of probiotics improves outcomes in these children are lacking . Methods We conducted a r and omized , double‐blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric EDs in Canada . Participants received a 5‐day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052 , at a dose of 4.0 × 109 colony‐forming units twice daily or placebo . The primary outcome was moderate‐to‐severe gastroenteritis , which was defined according to a post‐enrollment modified Vesikari scale symptom score of 9 or higher ( scores range from 0 to 20 , with higher scores indicating more severe disease ) . Secondary outcomes included the duration of diarrhea and vomiting , the percentage of children who had unscheduled physician visits , and the presence or absence of adverse events . Results Moderate‐to‐severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants ( 26.1 % ) who were assigned to probiotics and 102 of 413 participants ( 24.7 % ) who were assigned to placebo ( odds ratio , 1.06 ; 95 % confidence interval [ CI ] , 0.77 to 1.46 ; P=0.72 ) . After adjustment for trial site , age , detection of rotavirus in stool , and frequency of diarrhea and vomiting before enrollment , trial‐group assignment did not predict moderate‐to‐severe gastroenteritis ( odds ratio , 1.06 ; 95 % CI , 0.76 to 1.49 ; P=0.74 ) . There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea ( 52.5 hours [ interquartile range , 18.3 to 95.8 ] and 55.5 hours [ interquartile range , 20.2 to 102.3 ] , respectively ; P=0.31 ) or vomiting ( 17.7 hours [ interquartile range , 0 to 58.6 ] and 18.7 hours [ interquartile range , 0 to 51.6 ] , P=0.18 ) , the percentages of participants with unscheduled visits to a health care provider ( 30.2 % and 26.6 % ; odds ratio , 1.19 ; 95 % CI , 0.87 to 1.62 ; P=0.27 ) , and the percentage of participants who reported an adverse event ( 34.8 % and 38.7 % ; odds ratio , 0.83 ; 95 % CI , 0.62 to 1.11 ; P=0.21 ) . Conclusions In children who presented to the emergency department with gastroenteritis , twice‐daily administration of a combined L. rhamnosus – L. helveticus probiotic did not prevent the development of moderate‐to‐severe gastroenteritis within 14 days after enrollment . ( Funded by the Canadian Institutes of Health Research and others ; PROGUT Clinical Trials.gov number , NCT01853124 ."
] | 41165a38-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Acute appendicitis is the most common surgical diagnosis in young patients , with lifetime prevalence of about 7 % . Debate remains on whether uncomplicated AA should be operated or not . Aim of this meta- analysis of r and omized controlled trials was to assess current evidence on antibiotic treatment for uncomplicated AA compared to st and ard surgical treatment . METHODS Systematic literature search was performed using PubMed , EMBASE , Medline , Google Scholar and Cochrane Central Register of Controlled Trials data bases for r and omized controlled trials comparing antibiotic therapy ( AT ) and surgical therapy-appendectomy ( ST ) for uncomplicated AA . Trials were review ed for primary outcome measures : treatment efficacy based on 1 year follow-up , recurrence at 1 year follow-up , complicated appendicitis with peritonitis identified at the time of surgical operation and post-intervention complications . Secondary outcomes were length of hospital stay and period of sick leave . RESULTS Five RCTs comparing AT and ST qualified for inclusion in meta- analysis , with 1.351 patients included : 632 in AT group and 719 in ST group . Higher rate of treatment efficacy based on 1 year follow-up was found in ST group ( 98.3 % vs 75.9 % , P ) , recurrence at 1 year was reported in 22.5 % of patients treated with antibiotics . Rate of complicated appendicitis with peritonitis identified at time of surgical operation was higher in AT group ( 19.9 % vs 8.5 % , P = 0.02 ) . No statistically significant differences were found when comparing AT and ST groups for the outcomes of overall post-intervention complications ( 4.3 % vs 10.9 % , P = 0.32 ) , post-intervention complications based on the number of patients who underwent appendectomy ( 15.8 % vs 10.9 % , P = 0.35 ) , length of hospital stay ( 3.24 ± 0.40 vs 2.88 ± 0.39 , P = 0.13 ) and period of sick leave ( 8.91 ± 1.28 vs 10.27 ± 0.24 , P = 0.06 ) . CONCLUSIONS With significantly higher efficacy and low complication rates , appendectomy remains the most effective treatment for patients with uncomplicated AA . The subgroups of patients with uncomplicated AA where antibiotics can be more effective , should be accurately identified | [
"Background Intra-abdominal infections are one of the most common infections encountered by a general surgeon . However , despite this prevalence , st and ardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment . The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity . Methods This study is a prospect i ve , multi-center , r and omized investigation performed in the Department of General , Emergency , and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna , Italy . Discrete data were analyzed using the Chi-squared and Fisher exact tests . Differences between the two study groups were considered statistically significant for p-values less than 0.05 . Results 71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam . The two groups were comparable in terms of age and gender as well as the site of abdominal infection . Post-operative infection was identified in 12 patients : 10 with wound infections and 2 with intra-abdominal infections . In the Ertapenem group , 69 of the 71 patients ( 97 % ) were treated successfully , while the therapy failed in 2 cases ( 3 % ) . Therapy failures were more frequent in the Unasyn group , amounting to 10 of 71 cases ( p = 0.03 ) . Conclusion According to these preliminary findings , the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity . Trial registration Trial registration : Clinical Trials.gov :",
"OBJECTIVE The aim of this study was to evaluate the feasibility and safety of nonoperative treatment of acute nonperforated appendicitis with antibiotics in children . METHODS A pilot r and omized controlled trial was performed comparing nonoperative treatment with antibiotics versus surgery for acute appendicitis in children . Patients with imaging-confirmed acute nonperforated appendicitis who would normally have had emergency appendectomy were r and omized either to treatment with antibiotics or to surgery . Follow-up was for 1 year . RESULTS Fifty patients were enrolled ; 26 were r and omized to surgery and 24 to nonoperative treatment with antibiotics . All children in the surgery group had histopathologically confirmed acute appendicitis , and there were no significant complications in this group . Two of 24 patients in the nonoperative treatment group had appendectomy within the time of primary antibiotic treatment and 1 patient after 9 months for recurrent acute appendicitis . Another 6 patients have had an appendectomy due to recurrent abdominal pain ( n = 5 ) or parental wish ( n = 1 ) during the follow-up period ; none of these 6 patients had evidence of appendicitis on histopathological examination . CONCLUSIONS Twenty-two of 24 patients ( 92 % ) treated with antibiotics had initial resolution of symptoms . Of these 22 , only 1 patient ( 5 % ) had recurrence of acute appendicitis during follow-up . Overall , 62 % of patients have not had an appendectomy during the follow-up period . This pilot trial suggests that nonoperative treatment of acute appendicitis in children is feasible and safe and that further investigation of nonoperative treatment is warranted",
"BACKGROUND In this prospect i ve study , operative and nonoperative management of acute appendicitis were evaluated regarding their safety and cost effectiveness . METHODS Two hundred ninety patients presenting to our Emergency Department between March 2005 and March 2006 with acute appendicitis were included in this prospect i ve study . Nonoperative medical therapy was performed in 107 patients ( Group 1 ) , and 183 patients were treated surgically ( Group 2 ) . Routine follow-up controls were done on the 10th day , at the 3rd and 6th months and at the first year after discharge in Group 1 . Both groups were compared regarding age , gender , mean hospital stay , modified Alvarado score , morbidity , mortality , and cost effectiveness . RESULTS The male/female ratio of Groups 1 and 2 were 65/42 ( mean age : 30.98+/-1.30 ) and 125/58 ( mean age : 26.25+/-0.79 ) , respectively . In Group 1 , 19 patients were operated . Operation indications were resistance to therapy , patient 's request , and operation in another hospital . Although the mean hospital stay of Group 1 was statistically significantly longer than Group 2 , the mean cost of the therapy was $ 559 in Group 2 and $ 433 in Group 1 . Morbidity rates were similar , with no mortality in either group . CONCLUSION With its high success rate and cost effectiveness , medical treatment seems to be a good alternative to the gold st and ard therapy of surgery in management of acute appendicitis",
"The editors of the Journal of Gastrointestinal Surgery as well as the SSAT Board of Directors have retracted the article Malik , A.A. & Bari , S.U. Conservative management of acute appendicitis . J Gastrointest . Surg 13 , 966–970 ( 2009 ) since significant portions of the article were published earlier in the following articles : Eriksson , S. & Granstrom , L. R and omized controlled trial of appendectomy versus antibiotic therapy for acute appendicitis . Br J Surg 82 , 166–169 ( 1995 ) . Horton , M.D. , Counter , S.F. , Florence , M.G. & Hart , M.J. A prospect i ve trial of computed tomography and ultrasonography for diagnosing appendicitis in the atypical patient . Am J Surg 179 , 379–381 ( 2000 )",
"OBJECTIVES This study determined excess mortality and length of hospital stay ( LOS ) attributable to bloodstream infection ( BSI ) caused by third-generation-cephalosporin-resistant Escherichia coli in Europe . METHODS A prospect i ve parallel matched cohort design was used . Cohort I consisted of patients with third-generation-cephalosporin-resistant E. coli BSI ( REC ) and cohort II consisted of patients with third-generation-cephalosporin-susceptible E. coli BSI ( SEC ) . Patients in both cohorts were matched for LOS before infection with patients free of the respective BSI . Thirteen European tertiary care centres participated between July 2007 and June 2008 . RESULTS Cohort I consisted of 111 REC patients and 204 controls and cohort II consisted of 1110 SEC patients and 2084 controls . REC patients had a higher mortality at 30 days ( adjusted odds ratio = 4.6 ) and a higher hospital mortality ( adjusted hazard ratio = 5.7 ) than their controls . LOS was increased by 8 days . For SEC patients , these figures were adjusted odds ratio = 1.9 , adjusted hazard ratio = 2.0 and excess LOS = 3 days . A 2.5 times [ 95 % confidence interval ( 95 % CI ) 0.9 - 6.8 ] increase in all-cause mortality at 30 days and a 2.9 times ( 95 % CI 1.2 - 6.9 ) increase in mortality during entire hospital stay as well as an excess LOS of 5 days ( 95 % CI 0.4 - 10.2 ) could be attributed to resistance to third-generation cephalosporins in E. coli BSI . CONCLUSIONS Morbidity and mortality attributable to third-generation-cephalosporin-resistant E. coli BSI is significant . If prevailing resistance trends continue , high societal and economic costs can be expected . Better management of infections caused by resistant E. coli is becoming essential"
] | 41165a74-06ff-11f0-808a-c43d1ab1c353 |
Physical therapy is common following a knee surgery . With rising healthcare costs there is debate as to the appropriateness of outpatient physical therapy following such interventions . Many of the existing controlled trials have concluded that there is no benefit to subjects that receive supervised physical therapy when compared to subjects that perform their exercises at home . The purpose of this systematic review was to consider the existing evidence regarding benefit following knee surgery and evaluate the quality , internal and external validity of such evidence . Ten studies , all r and omized control trials , were found to be applicable to our review . Using the PEDro scale all studies were considered at least moderate in quality . Many of the studies had design s that biased the home exercise group , providing supervision similar to that provided by outpatient physical therapy . In select young and healthy population with few co morbidities supervised physical therapy is no more beneficial than a home exercise program following relatively simple knee surgical procedures ( arthroscopic meniscetomy ) . However there is a lack of evidence regarding older population s with co morbidities or for more complicated knee surgical procedures ( ACL reconstruction , Total Knee Arthroplasty ) prohibiting a conclusion at this time for these population s and /or these procedures | [
"BACKGROUND AND PURPOSE Controversy exists about the effectiveness of physical therapy after arthroscopic partial meniscectomy . This r and omized controlled trial evaluated the effectiveness of supervised physical therapy with a home program versus a home program alone . SUBJECTS Eighty-four patients ( 86 % males ; overall mean age=39 years , SD=9 , range=21 - 58 ; female mean age=39 years , SD=9 , range=24 - 58 ; male mean age=40 , SD=9 , range=21 - 58 ) who underwent an uncomplicated arthroscopic partial meniscectomy participated . METHODS Subjects were r and omly assigned to either a group who received 6 weeks of supervised physical therapy with a home program or a group who received only a home program . Blinded test sessions were conducted 5 and 50 days after surgery . Outcome measures were : ( 1 ) Hughston Clinic question naire , ( 2 ) Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and EuroQol EQ-5D ( EQ-5D ) question naires , ( 3 ) number of days to return to work after surgery divided by the Factor Occupational Rating System score , ( 4 ) kinematic analysis of knee function during level walking and stair use , and ( 5 ) horizontal and vertical hops . RESULTS No differences between groups were found for any of the outcomes measured . DISCUSSION AND CONCLUSION The results indicate that the supervised physical therapy used in this study is not beneficial for patients in the early period after uncomplicated arthroscopic partial meniscectomy",
"Abstract To evaluate the effect of physiotherapy after partial arthroscopic meniscectomy , we performed a prospect i ve , r and omised and partially blinded study . This pilot study was performed from October 1996 to June 1997 . The control group received the st and ard treatment , consisting of verbal and written advice and exercises . The physiotherapy group performed exercises according to a dynamic protocol under the supervision of a physiotherapist . During a 3-week period , nine treatment sessions were given of 30 min each . Twenty patients , who had undergone arthroscopic meniscectomy without any other pathology of the knee , were r and omised into two groups of ten patients each . The effects of therapy were evaluated by a blinded observer . We measured the distance and height of one-leg jumps ( hops ) , the VAS pain scale , the Tegner and Lysholm scores and the SARS/FORS score . Recovery and satisfaction with the treatment were also evaluated . The effect measurements were performed at 7 ( T1 ) , 14 ( T2 ) , 21 ( T3 ) and 28 days ( T4 ) following surgery . Statistical analysis was performed with the Student ’s t-test . The physiotherapy group showed significantly better results than the control group regarding the SARS score , the hop test and the distance jumps . Moreover , the measurements showed clear progression in favour of the physiotherapy group . In conclusion , exercising under the supervision of a physiotherapist led to high patient satisfaction and good functional rehabilitation after partial arthroscopic meniscectomy",
"In a r and omised controlled trial comparing the outcome of two groups of men aged 16 - 45 one group received outpatient physiotherapy after medial meniscectomy and the other did not . In clinical aspects of knee function there was no significant difference between the test group and control group measured at specified intervals up to 26 weeks postoperatively . Similarly , there was no significant difference between the groups in the time taken to return to work or in the mean fall in take-home pay as a result of meniscectomy . The mean cost per patient of providing outpatient physiotherapy in the test group was 23 pounds at 1976 prices . Thus the least costly way of returning male patients aged 16 - 45 to activity is by not providing routine outpatient physiotherapy after medial meniscectomy . Further r and omised controlled trials are , however , required to determine the value of physiotherapy in other age groups and other conditions",
"We evaluated the outcome of and compared two rehabilitation programs ( clinic-based versus home ) after a mid-third patellar autograft reconstruction of the anterior cruciate ligament . Thirty-seven patients ( 28 male , 9 female ; average age , 24.1 years ) completed the study . Fifteen of these patients received clinic-based rehabilitation ( three visits per week for 6 weeks prescribed ) , and 22 patients received home-based physical therapy ( number of visits determined by patient response ) . Knee ROM , Lysholm , Visual Analogy Scale , ( VAS ) pain rating , hop test , KT-1000 , and Sickness Impact Profile ( SIP ) were evaluated preoperatively and postoperatively . All patients reported good satisfaction with the function of their knee at average follow-up of 21.6 months ( range , 12 to 48 ) . Patients managed by home rehabilitation averaged 2.85 visits as compared with 14.2 for clinic-centered patient ( P functional or subjective outcomes in the different postoperative rehabilitation regimens , with both groups reporting high satisfaction and improved quality of life . Cost savings in the home rehabilitation group were significant",
"One hundred sixty patients ( mean age , 68 ± 8 years ) having primary total knee arthroplasty were assigned r and omly to two rehabilitation programs : ( 1 ) clinic-based rehabilitation provided by outpatient physical therapists ; or ( 2 ) home-based rehabilitation monitored by periodic telephone calls from a physical therapist . Both rehabilitation programs emphasized a common home exercise program . Before surgery , and at 12 and 52 weeks after surgery , no statistically significant differences were observed between the clinic- and the home-based groups on any of the following measures : ( 1 ) total score on the Knee Society clinical rating scale ; ( 2 ) total score on the Western Ontario and McMaster Universities Osteoarthritis Index ; ( 3 ) total score on the Medical Outcomes Study Short Form ; ( 4 ) pain scale of the Knee Society clinical rating scale ; ( 5 ) pain scale of the Western Ontario and McMaster Universities Osteoarthritis Index ; ( 6 ) functional scale of the Western Ontario and McMaster Universities Osteoarthritis Index ; ( 7 ) distance walked in 6 minutes ; ( 8) number of stairs ascended and descended in 30 seconds ; and ( 9 ) knee flexion range of motion , on either the per protocol or the intent-to-treat or the analyses . After primary total knee arthroplasty , patients who completed a home exercise program ( home-based rehabilitation ) performed similarly to patients who completed regular outpatient clinic sessions in addition to the home exercises ( clinic-based rehabilitation ) . Additional studies need to determine which patients are likely to benefit most from clinic-based rehabilitation programs",
"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 .",
"This prospect i ve study compared 30 patients r and omly assigned to either a home exercise program or supervised outpatient physical therapy following arthroscopic partial medial meniscectomy . Their knee functions were assessed at 2 , 4 , and 8 weeks postoperatively using isokinetic analysis and subjective question naires . At each evaluation , the home exercise group performed as well or better than the supervised physical therapy group . There were no statistically significant differences between the two groups . At 4 weeks postoperation , the mean percent deficit in torque ( strength ) between the affected and unaffected limbs was 22.1 % in the supervised rehabilitation group and 22.0 % in the home exercise . The percent deficit in terms of endurance was 7.7 % in the supervised group and 3.6 % in the home group . Similar results were noted with regard to the patients ' subjective evaluations of their knee function and ability to resume work and recreational activities . We conclude that a well-planned , unsupervised home exercise knee rehabilitation program can produce equally good postoperative recovery as compared to a supervised outpatient physical therapy regimen in properly selected patients following arthroscopic partial meniscectomy of the knee",
"BACKGROUND We have not found any reports on the effect of physiotherapy after knee replacement . PATIENTS AND METHODS In a prospect i ve r and omized controlled trial , we r and omized two groups to receive or not receive outpatient physiotherapy following total knee arthroplasty . 120 patients were recruited over 2 years , each followed up for 1 year . Inclusion criteria were age between 55 - 90 years , less than 40 degrees of fixed flexion contracture and the ability to walk at least 10 meters unaided preoperatively with monoarticular arthrosis . RESULTS We found no statistically significant benefit of outpatient physiotherapy at any of the three times measured . After adjusting for baseline differences between the two treatment groups , the mean difference in knee flexion 1 year postoperatively was only 2.9 degrees . This mean difference is of no clinical significance . INTERPRETATION We concluded that in a preselected group of patients following primary total knee arthroplasty , inpatient physiotherapy with good instructions and a well-structured home exercise regime can dispense with the need for outpatient physiotherapy ",
"The efficacy of an early , intensive , supervised rehabilitation program to accelerate knee strength recovery in the first 3 weeks postmeniscectomy by arthroscopy was evaluated using a r and omized controlled trial design . The maximal voluntary isokinetic strength of 31 men , r and omly allocated to either a treatment ( EXP ) or a control ( CTL ) group , was measured twice by a blind rater : preoperatively ( pretest ) and 3 weeks postsurgery ( posttest ) , using a computer-controlled Kin-Com dynamometer ( Chattecx Corporation , Chattanooga , TN ) . Strength deficits of the operated leg at the pretest and posttest were established in percent of the values obtained for the sound leg at the pretest . In the interval between the surgery and the posttest , the patients of the EXP group ( n = 15 ) received nine supervised treatments combined to home exercises whereas patients of the control group ( n = 16 ) had no specific physiotherapy treatment but were given instructions in postsurgical management and prescribed exercises by the orthopedic surgeons . Patients of the EXP group had better knee extensor strength recovery than patients of the CTL group ( ANCOVA , p size of the strength difference ( 3 weeks postsurgery ) between EXP and CTL subgroups ( n = 8) matched according to preoperative deficits was as large as 26 % and the residual deficits of the untreated patients were two to three times larger than those of the treated patients . The results of this study highlight the importance of instituting an early intensive and supervised rehabilitation program , especially for workers returning to a strenuous job requiring good knee extensor muscle function ",
"Background Because of health care funding and policy changes , there is a need to examine the effects of an evolution toward patient-directed ( ie , home-based ) rehabilitation programs on clinical outcomes of patients undergoing anterior cruciate ligament reconstruction . Hypothesis There will be no difference in the effectiveness of a home-based rehabilitation program and a st and ard physical therapy-supervised rehabilitation program in patients 3 months after nonacute anterior cruciate ligament reconstruction with bone-patellar tendon-bone grafts . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods There were 145 patients ( 16 - 59 years ) who attended a presurgery education class . Home-based patients attended 4 physical therapy sessions , and physical therapy-supervised patients attended 17 physical therapy sessions over the first 12 weeks after surgery . All patients followed the same st and ardized rehabilitation program . Study outcome measures included active-assisted knee flexion and passive knee extension range of motion , knee range of motion during walking , KT computerized arthrometer results , and isokinetic quadriceps and hamstrings strength . Patient outcomes were dichotomized as either clinical ly acceptable or unacceptable . Rehabilitation programs were compared by the proportion of acceptable patients in each group . Results The home-based group had a significantly higher percentage of patients with acceptable flexion and extension range of motion compared to the st and ard physical therapy group ( flexion , 67 % vs 47 % ; extension , 97 % vs 83 % ) . There were no significant differences between the groups in range of motion during walking , ligament laxity , and strength . Conclusion A structured , minimally supervised rehabilitation program was more effective in achieving acceptable knee range of motion in the first 3 months after anterior cruciate ligament reconstruction than a st and ard physical therapy-based program . Clinical Relevance Recreational athletes undergoing nonacute anterior cruciate ligament reconstruction can successfully reach acceptable rehabilitation goals in the first 3 months after surgery with a limited number of purpose ful physical therapy education sessions , allowing recreational athletes more flexibility when integrating the necessary postoperative rehabilitation into their daily activities"
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OBJECTIVE To review the performance characteristics of the instruments most commonly used to measure clinical outcomes in juvenile idiopathic arthritis ( JIA ) , including global assessment s , articular indices , functional/disability assessment s , and quality of life measures . METHODS As part of an Agency for Healthcare Research and Quality comparative effectiveness review of antirheumatic drugs , we explored the characteristics of commonly used outcome measures for JIA . English- language studies of children with JIA were identified from Medline and Embase . Two independent review ers screened titles and abstract s , with subsequent full-text review of studies selected based on predetermined criteria . RESULTS We included 35 publications describing 34 unique studies and involving 14,831 patients . The Childhood Health Assessment Question naire ( C-HAQ ) was the most extensively studied instrument and had high reliability , but only moderate correlations with other indices of disease activity and poor responsiveness to change in disease status . The physician global assessment of disease activity ( PGA ) and articular indices had the strongest association with disease activity and were the most responsive to change . Measures of psychosocial function and quality of life were moderately associated with measures of disease activity , but were less responsive to changes in disease status . CONCLUSION In children with JIA , no single instrument was superior in reliability or validity or in describing the impact of JIA . Although the C-HAQ has been extensively evaluated , the PGA and articular indices appear to have the highest responsiveness to change and , therefore , the highest potential for detecting important differences in treatment response | [
"OBJECTIVE To develop preliminary criteria for inactive disease and clinical remission for select categories of juvenile idiopathic arthritis ( JIA ) , and to decide what such clinical states should predict in terms of probability of disease recurrence . METHODS A Delphi serial question naire consensus-formation approach was used initially to gather criteria in use by pediatric rheumatologists ( PR ) for defining clinical remission in oligoarticular ( persistent and extended ) , rheumatoid factor ( RF ) positive and negative polyarticular , and systemic JIA . Results from sequential question naires provided an agenda for a nominal group technique ( NGT ) conference to reach consensus on unresolved questions . RESULTS One hundred and thirty PR from 34 countries responded to the question naires and 20 PR from 9 countries attended the conference . Draft criteria for inactive disease include the following : no active arthritis ; no fever , rash , serositis , splenomegaly , or generalized lymphadenopathy attributable to JIA ; no active uveitis ; normal erythrocyte sedimentation rate or C-reactive protein ; and a physician 's global assessment of disease activity rated at the best score possible for the instrument used . According to consensus vote , 6 continuous months of inactive disease on medication defines clinical remission on medication , while 12 months of inactive disease off all anti-arthritis ( and anti-uveitis ) medications defines clinical remission off medication . The finalized criteria for remission off medication ideally should predict that a patient has disease recurrence within the next 5 years . CONCLUSION Using consensus formation techniques , we formulated preliminary criteria for inactive disease and clinical remission on and off medication for use in select categories of JIA . Retrospective validation is in progress ; prospect i ve validation will follow . Future efforts will include other categories of JIA",
"OBJECTIVE To determine the reliability of formal exercise testing and the reliability of functional and activity question naires in children with juvenile idiopathic arthritis ( JIA ) . METHODS Children with JIA of any subtype ages 8 - 16 years who were recruited to a r and omized trial comparing different exercise therapies participated in 2 preintervention sessions of exercise testing 2 - 6 weeks apart . Exercise testing included 1 ) submaximal oxygen uptake ( VO(2submax ) ) , 2 ) peak VO(2 ) ( VO(2peak ) ) , and 3 ) anaerobic power using modified Wingate tests ( W(ant ) ) . Two physical function question naires ( the Childhood Health Assessment Question naire [ C-HAQ ] and Revised Activity Scale for Kids [ ASK ] ) and 1 daily physical activity question naire ( the Habitual Activity Estimation Scale [ HAES ] ) were also completed at these times . Test-retest reliability was assessed using type 3 , intrarater intraclass correlation coefficient ( ICC(3,1 ) ) and Bl and and Altman plots were used to determine limits of agreement . RESULTS Data were available for 74 patients ( 58 girls ) . VO(2submax ) , VO(2peak ) , and W(ant ) demonstrated high reliability ( ICC(3,1 ) 0.82 , 0.91 , and 0.94 , respectively ) . C-HAQ and ASK question naires also had very high reliability ( ICC(3,1 ) 0.82 and 0.91 , respectively ) . The HAES demonstrated low reliability for total activity score ( ICC(3,1 ) 0.15 ) and moderate reliability when the number of very active hours was analyzed separately ( ICC(3,1 ) 0.59 ) . CONCLUSION Results of this investigation suggest that exercise testing and functional question naires in children with JIA are consistent and reliable . Reliability of the HAES total score was poor , but moderate when the very active hours subscale score was used",
"OBJECTIVE To develop preliminary criteria for defining disease flare in patients with polyarticular-course juvenile rheumatoid arthritis ( JRA ) . METHODS Data from a r and omized clinical trial of etanercept in JRA ( 51 patients ) and the 6 core response variables ( CRV ) for JRA were used to derive flare definitions . The criterion st and ard of flare was treatment with placebo . C and i date flare definitions were assessed by receiver-operator characteristic ( ROC ) curve properties and other statistics for diagnostic tests . RESULTS Of the possible flare definitions tested with acceptable statistical properties , the one that seemed to be the most useful was worsening in any 2/6 CRV by > or = 40 % without improvement in more than 1 of the remaining CRV by > or = 30 % . Two other superior flare definitions were ( 1 ) worsening in 3/6 CRV by > or = 30 % and ( 2 ) any worsening of the Childhood Health Assessment Question naire , worsening of erythrocyte sedimentation rate by > or = 30 % and worsening of the active joint count by > or = 10 % . CONCLUSIONS CRV are useful for defining flare in JRA . Worsening in any 2/6 CRV by > or = 40 % without concomitant improvement of more than one of the remaining CRV by > or = 30 % appears to be the most suitable preliminary flare definition . Because the proposed flare criteria were derived from a small number of patients , it is essential to perform more definitive testing of this and several alternative flare definitions in larger patient population",
"The aim of this 12-month prospect i ve study was to compare reports describing the health-related quality of life ( HRQL ) of children with Juvenile idiopathic arthritis ( JIA ) obtained from parents and children , to investigate the extent to which the children ’s HRQL changed over a 12-month period , and to describe the relationship between children ’s HRQL , and their experience of pain and use of pain coping strategies . Fifty-four children aged 8–18 years with JIA and their parents completed st and ard question naires assessing children ’s HRQL , pain intensity , and pain coping strategies at baseline , 6 months , and 12 months . In general , children reported that their HRQL was better than was reported by parents . Both informants described children ’s HRQL as being very stable over the 12 months of the study . Consistent with the Biobehavioural Model of Pain , there was a significant negative relationship between children ’s HRQL and their experience of pain . However , there was little evidence that pain coping strategies mediated the relationship between children ’s experience of pain and their HRQL",
"Background Many people suffer with Osteoarthritis ( OA ) and subsequent morbidity . Therefore , measuring outcome associated with OA is important . The Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) has been a widely used patient reported outcome in OA . However , there is relatively little evidence to support the use of the Visual Analogue Scale ( VAS ) version of the scale . We aim ed to explore the internal validity and responsiveness of this VAS version of the WOMAC . Methods Patients with chronic hip or knee pain of mechanical origin , waiting for a hip or knee joint replacement completed the WOMAC as part of a study to investigate the effects of acupuncture and placebo controls . Validity was tested using factor analysis and Rasch analysis , and responsiveness using st and ardised response means . Results Two hundred and twenty one patients ( mean age 66.8 , SD 8.29 , 58 % female ) were recruited . Factor and Rasch analysis confirmed unidimensional Pain and Physical Functioning scales , capable of transformation to interval scaling and invariant over time . Some Differential Item Functioning ( DIF ) was observed , but this cancelled out at the test level . The Stiffness scale fitted the Rasch model but adjustments for DIF could not be made due to the shortness of the scale . Using the interval transformed data , St and ardised Response Means were smaller than when using the raw , ordinal data . Conclusions The WOMAC Pain and Physical Functioning subscales satisfied unidimensionality and ordinal scaling tests , and the ability to transform to an interval scale . Some Differential Item Functioning was observed , but this cancelled out at the test level and , by doing so , at the same time removed the disturbance of unidimensionality . The scaling characteristics of sets of items which use VAS require further analysis , as it would appear that they can lead to spurious levels of responsiveness and scale compression because they exaggerate the distortion of the ordinal scale . Trial numberUKCRN study ID : 4881IS RCT",
"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",
"OBJECTIVE To assess the determinants and responsiveness of the Norwegian version of the Child Health Question naire ( CHQ ) in patients with early juvenile idiopathic arthritis ( JIA ) and to compare health status in patients and controls . METHODS A total of 116 children ( median age 8.4 yrs ) with JIA and were examined by a pediatric rheumatologist and reassessed after a median of 10.0 months . Physical and psychosocial health were assessed by means of the CHQ , which provides summary scores for physical and psychosocial health , the Childhood Health Assessment Question naire ( CHAQ ) , and the Child Behavior Checklist ( CBCL , n = 32 ) . Matched controls ( n = 116 ) , r and omly selected from the general population , completed the CHQ at baseline . RESULTS The patients with JIA had poorer physical health and slightly impaired psychosocial health compared with the controls [ 41.2 + /- 13.6 vs 55.2 + /- 7.3 ( p CHQ physical summary score were the child 's pain , morning stiffness , the CHAQ disability index , erythrocyte sedimentation rate ( ESR ) , overall well-being , and physician 's global assessment of disease activity . The psychosocial summary score correlated with the CBCL level of internalizing , externalizing , and total behavior problems . The st and ardized response mean for the physical summary score was large ( 0.96 ) for those who improved , and moderate ( -0.60 ) for those who became worse . CONCLUSION The CHQ discriminated between patients with early JIA and controls . The most important determinants of the CHQ physical summary score were the child 's pain , morning stiffness , CHAQ , ESR , overall well-being , and physician 's global assessment of disease activity . The CHQ was sensitive to clinical changes in children with JIA",
"OBJECTIVES To examine the change in health-related quality of life ( HRQOL ) and its determinants in children with juvenile idiopathic arthritis ( JIA ) treated with methotrexate ( MTX ) . METHODS Patients were extracted from the PRINTO clinical trial which aim ed to evaluate the efficacy and safety profile of MTX administered in st and ard , intermediate or higher doses ( 10 , 15 and 30 mg/m(2)/week respectively ) . Children with polyarticular-course JIA , who were less than 18 years and had a complete HRQOL assessment were included . RESULTS A total of 521 children were included . At baseline , patients with JIA showed poorer HRQOL ( p HRQOL values were 2 st and ard deviations below the mean of healthy controls in the physical and psychosocial summary scale , respectively . After 6 months of treatment with st and ard dose MTX , there was a statistically significant improvement in all HRQOL health concepts , particularly the physical ones . Similar improvements were observed in those who did not respond to a st and ard dose of MTX and were subsequently r and omised to a higher dose . The presence of marked disability at baseline was associated with a fivefold increased risk of retaining poor physical health after 6 months of active treatment with st and ard dose MTX . Other less important determinants of retaining poor physical well-being were the baseline level of systemic inflammation , pain intensity and an antinuclear-antibody-negative status . CONCLUSIONS MTX treatment produces a significant improvement across a wide range of HRQOL components , particularly in the physical domains , in patients with JIA",
"OBJECTIVE To identify a core set of outcome variables for the assessment of children with juvenile arthritis ( JA ) , to use the core set to develop a definition of improvement to determine whether individual patients demonstrate clinical ly important improvement , and to promote this definition as a single efficacy measure in JA clinical trials . METHODS A core set of outcome variables was established using a combination of statistical and consensus formation techniques . Variables in the core set consisted of 1 ) physician global assessment of disease activity ; 2 ) parent/patient assessment of overall well-being ; 3 ) functional ability ; 4 ) number of joints with active arthritis ; 5 ) number of joints with limited range of motion ; and 6 ) erythrocyte sedimentation rate . To establish a definition of improvement using this core set , 21 pediatric rheumatologists from 14 countries met , and , using consensus formation techniques , scored each of 72 patient profiles as improved or not improved . Using the physicians ' consensus as the gold st and ard , the chi-square , sensitivity , and specificity were calculated for each of 240 possible definitions of improvement . Definitions with sensitivity or specificity of of improvement with the highest final score was as follows : at least 30 % improvement from baseline in 3 of any 6 variables in the core set , with no more than 1 of the remaining variables worsening by > 30 % . The second highest scoring definition was closely related to the first ; the third highest was similar to the Paulus criteria used in adult rheumatoid arthritis trials , except with different variables . This indicates convergent validity of the process used . CONCLUSION We propose a definition of improvement for JA . Use of a uniform definition will help st and ardize the conduct and reporting of clinical trials , and should help practitioners decide if a child with JA has responded adequately to therapy . We are in the process of prospect ively validating this definition and several others that scored highly",
"OBJECTIVE To begin the validation process of the preliminary criteria for inactive disease ( ID ) , clinical remission on medication ( CRM ) , and clinical remission off medication ( CR ) in children with select forms of juvenile idiopathic arthritis ( JIA ) . METHODS We used the OMERACT filter paradigm to estimate the validity of the criteria within each of the filter 's 3 components : truth , discrimination , and feasibility , in 5 categories of JIA : systemic arthritis , persistent and extended oligoarthritis , and rheumatoid factor-positive and negative polyarthritis . Data sources for determining validity estimates included a Delphi question naire survey sent to 246 pediatric rheumatologists in 34 countries , a consensus conference attended by 20 senior pediatric rheumatologists representing 9 countries , a retrospective chart review of 437 patients with JIA from 3 tertiary care clinics who had been followed between 4 and 22 years , and the literature . RESULTS Truth component : face and content validity . These aspects of validity were largely established via the Delphi question naire exercise and the consensus conference . Using an 80 % consensus level , participants felt that a set of non-redundant variables could effectively differentiate the clinical states of ID , CRM , and CR . Criterion validity could not be irrefutably established because no gold st and ard for inactive disease exists for JIA . As an alternative , published investigations of remission in JIA were used to estimate concurrent and convergent validity , as surrogates for criterion validity and as indicators of overall construct validity . Correlational analyses revealed the new criteria to have good construct validity . Discrimination component : the criteria demonstrated moderate to high levels of classification , prognosis , and responsiveness ( sensitivity to change ) using data from the chart review . Patients who were able to attain CR remained disease-free for substantially longer periods than did those who attained only ID or CRM . Responsiveness was evidence d by the ability of the criteria to allow movement of most patients between the disease states , consistent with what is known of the course of the disease . Feasibility component : Results of the Delphi and consensus conference produced a set of criteria that are easily , quickly , and inexpensively completed in the physician 's office , and present minimal or no risk to the patient . CONCLUSION The preliminary criteria demonstrated moderate to excellent validity characteristics in some , but not all components of the OMERACT filter . Prospect i ve validation studies are under way",
"OBJECTIVE The Childhood Health Assessment Question naire ( CHAQ ) , Juvenile Arthritis Functional Assessment Report ( JAFAR ) , and Juvenile Arthritis Functional Status Index ( JASI ) are widely used functional measures for juvenile idiopathic arthritis ( JIA ) that differ in content , format , and completion time . We compared the responsiveness and child-parent agreement of the JAFAR , CHAQ , and JASI in a prospect i ve , multicenter study . METHODS Children and adolescents from 5 rheumatology centers were enrolled . Subjects were about to undergo therapy ( intraarticular corticosteroid injections [ IAS ] and methotrexate or hip surgery ( MTX/hip ] ) expected to produce a functional improvement . All subjects were studied before the intervention and at 6 weeks and 6 months posttreatment . At each study visit , the 3 measures were administered in r and omized , balanced order to both parents and children . RESULTS A total of 92 subjects ( mean age 12.8 years ) were enrolled in the study , 74 of which were in the IAS group . The responsiveness of all 3 measures was moderate to strong . The st and ardized response mean at 6 weeks for the IAS group on the JAFAR , CHAQ , and JASI was 0.41 ( 95 % confidence interval [ 95 % CI ] 0.18 , 0.64 ) , 0.70 ( 95 % CI 0.47 , 0.93 ) , and 0.36 ( 95 % CI 0.13 , 0.59 ) , respectively . The CHAQ was somewhat more responsive to change at 6 weeks ( IAS group : relative efficiency 0.34 [ JAFAR ] , 0.27 [ JASI ] ) , but less responsive at 6 months ( MTX/hip group : relative efficiency 5.1 [ JAFAR ] , 3.9 [ JASI ] ) . All 3 question naires showed acceptable parent-child agreement , and overall , there were few differences between the 3 question naires . CONCLUSION The functional outcome measures currently used for JIA are all adequately responsive for use in trials or in the clinic setting . The choice of which measure to use should therefore be based on the time available for completion , the intended clinical / research use , and the depth of content required",
"OBJECTIVE To develop a reliable and user-friendly digital Childhood HAQ ( CHAQ ) to facilitate systematic monitoring of disease activity at the outpatient clinic in juvenile idiopathic arthritis ( JIA ) patients . METHODS The digital CHAQ was tested with patients who visited the outpatient paediatric rheumatology clinic of the Erasmus MC Sophia Children 's Hospital . These patients completed in a r and omized order the paper form and digital CHAQ while being observed . Validity was tested by comparing outcomes with the paper form CHAQ . User-friendliness was evaluated through a short question naire . RESULTS A digital CHAQ was developed and revised several times according to our observations . Outcome is automatically calculated and can be printed . Fifty-one patients completed both the digital and paper form CHAQ . Correlation coefficient between both outcomes of the CHAQ Disability Index was 0.974 . No statistically significantly differences in median outcome were found in visual analogue scale ( VAS ) pain ( 25.6 vs 25.9 mm ) and VAS well-being ( 20.1 vs 19.5 mm ) . Although the mean time ( 5.06 min ) to complete the digital CHAQ was significantly longer than the mean time ( 3.75 min ) to complete the paper form , the majority of patients ( 75 % ) preferred the digital version . User-friendliness received maximum positive score . CONCLUSION We developed a reliable and user-friendly digital CHAQ , which can be easily and systematic ally completed during routine clinic visits . Such digitalization of question naires can be applied in any field to make systematic monitoring of disease activity in daily practice possible"
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Background : Although sleep has been identified as an important modifiable risk factor for injury , the effect of decreased sleep on sports injuries in adolescents is poorly studied . The objective of this study was to quantitatively and qualitatively review published literature to examine if a lack of sleep is associated with sports injuries in adolescents and to delineate the effects of chronic versus acute lack of sleep . Methods : PubMed ( includes MEDLINE ) and EMBASE data bases were systematic ally search ed using the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines . Studies were included if they reported statistics regarding the relationship between sleep and sports injury in adolescents aged 19 years or younger published between January 1 , 1997 and December 21 , 2017 . From these included studies , the following information was extracted : bibliographic and demographic information , reported outcomes related to injury and sleep , and definitions of injury and decreased sleep . A r and om effects model was then created to quantify the odds of injury with decreased sleep in adolescents . Results : Of 907 identified articles , 7 met inclusion criteria . Five studies reported that adolescents who chronically slept poorly were at a significantly increased likelihood of experiencing a sports or musculoskeletal injury . Two studies reported on acute sleep behaviors . One reported a significant positive association between acutely poor sleep and injury , whereas the other study reported no significant association . In our r and om effects model , adolescents who chronically slept poorly were more likely to be injured than those who slept well ( OR , 1.58 ; 95 % CI , 1.05 - 2.37 ; P=0.03 ) . Conclusions : Chronic lack of sleep in adolescents is associated with greater risk of sports and musculoskeletal injuries . Current evidence can not yet definitively determine the effect of acute lack of sleep on injury rates . Level of Evidence : Level IV— systematic review of level II studies and one level IV study | [
"Study Objectives Napping is a useful countermeasure to the negative effects of acute sleep loss on alertness . The efficacy of naps to recover from chronic sleep loss is less well understood . Methods Following 2 baseline nights ( 10 hours ' time-in-bed ) , participants were restricted to 7 nights of 5-hour sleep opportunity . Ten adults participated in the No-Nap condition , and a further 9 were assigned to a Nap condition with a daily 45-minute nap opportunity at 1300 h. Sleepiness was assessed using the multiple sleep latency test and a visual analogue scale at 2-hour intervals . Both objective and subjective indexes of sleepiness were normalized within subject as a difference from those at baseline prior to sleep restriction . Mixed-effects models examined how the daytime nap opportunity altered sleepiness across the day and across the protocol . Results Short daytime naps attenuated sleepiness due to chronic sleep restriction for up to 6 - 8 hours after the nap . Benefits of the nap did not extend late into evening . Subjective sleepiness demonstrated a similar short-lived benefit that emerged later in the day when objective sleepiness already returned to pre-nap levels . Neither measure showed a benefit of the nap the following morning after the subsequent restriction night . Conclusions These data indicate a short daytime nap may attenuate sleepiness in chronic sleep restriction , yet subjective and objective benefits emerge at different time scales . Because neither measure showed a benefit the next day , the current study underscores the need for careful consideration before naps are used as routine counter measures to chronic sleep loss",
"Background The epidemiology of sports-related concussion is not well-described in the literature . This paper presents a descriptive epidemiology of concussion in seven high school and collegiate sports . Methods We used the data from Concussion Prevention Initiative ( CPI ) , which enrolled 8905 athletes at 210 high schools and 26 colleges in a prospect i ve cohort study of 7 sports ( football , men ’s and women ’s soccer , men ’s and women ’s lacrosse , and men ’s and women ’s ice hockey ) between 1999 and 2001 . Injury risks and injury rates were used to characterize the incidence of concussion , and changes in symptoms over time were described . Results A total of 375 concussions were observed . The incidence of concussion was highest in football , followed by women ’s lacrosse , men ’s lacrosse , men ’s soccer , and women ’s soccer ( only 10 ice hockey teams were included , too few to quantify incidence ) . The rate of incident concussion was strongly associated with history of concussion in the previous 24 months ( rate ratio = 5.5 ; 95 % CI : 3.9 , 7.8 , for 2 or more concussions relative to no previous concussion ) . The most common symptoms at time of injury were headache ( 87 % ) , balance problems/dizziness ( 77 % ) , and feeling “ in a fog ” ( 62 % ) . Loss of consciousness and amnesia were present in relatively few cases ( 9 and 30 % ) . The most common mechanism of injury was collision with another player . Conclusions Sports-related concussions present with a diverse range of symptoms and are associated with previous concussion history",
"OBJECTIVES To inform the debate over whether human sleep can be chronically reduced without consequences , we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation . DESIGN The chronic sleep restriction experiment involved r and omization to one of three sleep doses ( 4 h , 6 h , or 8 h time in bed per night ) , which were maintained for 14 consecutive days . The total sleep deprivation experiment involved 3 nights without sleep ( 0 h time in bed ) . Each study also involved 3 baseline ( pre-deprivation ) days and 3 recovery days . SETTING Both experiments were conducted under st and ardized laboratory conditions with continuous behavioral , physiological and medical monitoring . PARTICIPANTS A total of n = 48 healthy adults ( ages 21 - 38 ) participated in the experiments . INTERVENTIONS Noctumal sleep periods were restricted to 8 h , 6 h or 4 h per day for 14 days , or to 0 h for 3 days . All other sleep was prohibited . RESULTS Chronic restriction of sleep periods to 4 h or 6 h per night over 14 consecutive days result ed in significant cumulative , dose-dependent deficits in cognitive performance on all tasks . Subjective sleepiness ratings showed an acute response to sleep restriction but only small further increases on subsequent days , and did not significantly differentiate the 6 h and 4 h conditions . Polysomnographic variables and delta power in the non-REM sleep EEG-a putative marker of sleep homeostasis -- displayed an acute response to sleep restriction with negligible further changes across the 14 restricted nights . Comparison of chronic sleep restriction to total sleep deprivation showed that the latter result ed in disproportionately large waking neurobehavioral and sleep delta power responses relative to how much sleep was lost . A statistical model revealed that , regardless of the mode of sleep deprivation , lapses in behavioral alertness were near-linearly related to the cumulative duration of wakefulness in excess of 15.84 h ( s.e . 0.73 h ) . CONCLUSIONS Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation , it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults . Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits , which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign . Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses , but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions . This suggests that sleep debt is perhaps best understood as result ing in additional wakefulness that has a neurobiological \" cost \" which accumulates over time",
"OBJECTIVES To examine the potential relationship between sleep duration and efficiency and injury incidence in elite Australian footballers . DESIGN Prospect i ve cohort study . METHODS Australian footballers ( n=22 ) from one AFL club were studied across the 2013 competitive season . In each week sleep duration and efficiency were recorded via actigraphy for 5 nights ( the 3 nights preceding a game , the night of the game and the night after the game ) . Injury incidence was monitored and matched with sleep data : n=9 players suffered an injury that caused them to miss a game . Sleep in the week of the injury ( T2 ) was compared to the average of the previous 2 weeks ( T1 ) . A two-way repeated measures ANOVA was used to determine any effect of sleep duration and efficiency on injury . Significance was accepted at p Injury incidence was not significantly affected by sleep duration , sleep efficiency or a combination of these factors . Analysis of individual nights for T2 versus T1 also showed no differences in sleep quality or efficiency . However , a main effect for time was found for sleep duration and efficiency , with these being slightly , but significantly greater ( p sleep duration and efficiency on injury occurrence was found in elite Australian footballers"
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Several r and omized controlled trials ( RCTs ) have investigated the use of probiotic/synbiotic in PCOS patients , without clarifying the real use in clinical practice . The aim of this meta- analysis was to evaluate the effectiveness of probiotics and synbiotics on metabolic , hormonal and inflammatory parameters of PCOS . Electronic data bases ( MEDLINE , Scopus , EMBASE , ScienceDirect , The Cochrane Data base of Systematic Review s and Clinical Trials.gov ) were search ed from their inception until May 2019 . The study protocol was registered in PROSPERO with number CRD42018111534 . R and omized controlled trials ( RCTs ) of PCOS ’s women undergoing therapy at least 8 weeks with probiotics or synbiotics or without therapy were included . The primary outcomes were changes in anthropometric parameters , glucose/insulin metabolism , lipid profile , sex hormones profile , inflammation markers . 587 patients were included in nine RCT . The administration of probiotic/synbiotic were associated with a significant improvement in FPG , FBI , HOMA I-R , BMI . It also modified Ferriman-Gallway , serum triglycerides , serum testosterone , hs-CRP , NO , TAC , GSH , and MDA . Subgroup analysis of the type of intervention showed that probiotics were associated with greater testosterone and FPG reduction ; synbiotics administration result ed in a more pronounced decrease of the FBI . Subgroup analyses on the duration of therapy showed that , probiotic/synbiotic administration had a significantly greater effect on QUICK-I in the case of women with 12-weeks of therapy than in the 8-weeks therapy group . Nevertheless , we did not observe any significant difference was observed in terms of FBI , HOMA-IR , and FPG . Probiotics and synbiotics seem to either an effect on/influence metabolic , hormonal and inflammatory parameters , or can influence them . Consequently , it could lead to an improvement of fertility in PCOS | [
"Context A majority of women with polycystic ovary syndrome ( PCOS ) have metabolic abnormalities that result in an increased risk of developing type 2 diabetes and heart disease . Correlative studies have shown an association between changes in the gut microbiome and metabolic disorders . Two recent studies reported a decrease in α diversity of the gut microbiome in women with PCOS compared with healthy women . Objective We investigated whether changes in the gut microbiome correlated with specific clinical parameters in women with PCOS compared with healthy women . We also investigated whether there were changes in the gut microbiome in women with polycystic ovarian morphology ( PCOM ) who lacked the other diagnostic criteria of PCOS . Participants Subjects were recruited at the Poznan University of Medical Sciences . Fecal microbial diversity profiles of healthy women ( n = 48 ) , women with PCOM ( n = 42 ) , and women diagnosed with PCOS using the Rotterdam criteria ( n = 73 ) were analyzed using 16S ribosomal RNA gene sequencing . Results Lower α diversity was observed in women with PCOS compared with healthy women . Women with PCOM had a change in α diversity that was intermediate between that of the other two groups . Regression analyses showed that hyper and rogenism , total testosterone , and hirsutism were negatively correlated with α diversity . Permutational multivariate analysis of variance in UniFrac distances showed that hyper and rogenism was also correlated with β diversity . A r and om forest identified bacteria that discriminated between healthy women and women with PCOS . Conclusion These results suggest that hyper and rogenism may play a critical role in altering the gut microbiome in women with PCOS",
"Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27",
"Many studies have been done on the hypocholesterolaemic effect of probiotic yoghurt . The results , however , are not conclusive . The aim of the present study was to test the effect of probiotic and conventional yoghurt on the lipid profile in women . In a r and omised trial , ninety female volunteers aged 19 - 49 years were assigned to three groups . Subjects consumed daily 300 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g conventional yoghurt or no yoghurt for 6 weeks . Fasting blood sample s , 3 d dietary records and anthropometric measurements were collected at baseline ( T1 ) , end of week 3 ( T2 ) and end of week 6 ( T3 ) . Lipid profile parameters were determined by enzymic methods . Results showed no significant difference in lipid profile within any group throughout the study . Comparing mean differences ( T1 - T3 ) among the three groups showed : no difference in TAG and LDL-cholesterol , a decrease in cholesterol in both conventional ( P probiotic yoghurt groups ( P total : HDL-cholesterol ratio for conventional ( P probiotic yoghurt groups ( P HDL-cholesterol in the probiotic yoghurt group ( P lipid profile were observed in both yoghurt groups . Any added effect , therefore , is due to the consumption of fermented milk products",
"The present study investigated the impact of a Lactobacillus rhamnosus CGMCC1.3724 ( LPR ) supplementation on weight loss and maintenance in obese men and women over 24 weeks . In a double-blind , placebo-controlled , r and omised trial , each subject consumed two capsules per d of either a placebo or a LPR formulation ( 1.6 × 10(8 ) colony-forming units of LPR/capsule with oligofructose and inulin ) . Each group was su bmi tted to moderate energy restriction for the first 12 weeks followed by 12 weeks of weight maintenance . Body weight and composition were measured at baseline , at week 12 and at week 24 . The intention-to-treat analysis showed that after the first 12 weeks and after 24 weeks , mean weight loss was not significantly different between the LPR and placebo groups when all the subjects were considered . However , a significant treatment × sex interaction was observed . The mean weight loss in women in the LPR group was significantly higher than that in women in the placebo group ( P = 0.02 ) after the first 12 weeks , whereas it was similar in men in the two groups ( P= 0.53 ) . Women in the LPR group continued to lose body weight and fat mass during the weight-maintenance period , whereas opposite changes were observed in the placebo group . Changes in body weight and fat mass during the weight-maintenance period were similar in men in both the groups . LPR-induced weight loss in women was associated not only with significant reductions in fat mass and circulating leptin concentrations but also with the relative abundance of bacteria of the Lachnospiraceae family in faeces . The present study shows that the Lactobacillus rhamnosus CGMCC1.3724 formulation helps obese women to achieve sustainable weight loss",
"Abstract The aim of the current study was to assess the effects of probiotic supplementation on weight loss , glycaemia and lipid profiles in women with polycystic ovary syndrome ( PCOS ) . In a r and omized , double-blind , placebo-controlled trial , 60 women with PCOS were r and omized to receive probiotic capsule ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Consumption of probiotic supplements result ed in a significant reduction in weight ( −0.5 ± 0.4 vs. + 0.1 ± 1.0 kg , p = 0.004 ) and BMI ( −0.2 ± 0.2 vs. + 0.03 ± 0.4 kg/m2 , p = 0.004 ) compared with the placebo . In addition , compared with the placebo , probiotic administration was associated with a significant decrease in fasting plasma glucose ( −2.4 ± 8.4 vs. + 2.1 ± 7.0 mg/dL , p = 0.02 ) , serum insulin concentrations ( −2.0 ± 5.8 vs. + 1.6 ± 5.0 μIU/mL , p = 0.01 ) , homoeostasis model of assessment -insulin resistance ( −0.5 ± 1.4 vs. + 0.3 ± 1.1 , p = 0.01 ) , homoeostatic model assessment -beta cell function ( −7.5 ± 22.3 vs. + 6.3 ± 21.7 , p = 0.01 ) , serum triglycerides ( −13.3 ± 51.3 vs. + 13.6 ± 37.1 mg/dL , p= 0.02 ) and a significant increase in quantitative insulin sensitivity check index ( QUICKI ) ( + 0.006 ± 0.01 vs. −0.005 ± 0.02 , p = 0.01 ) . When we adjusted the analysis for baseline values of biochemical parameters , age and baseline BMI , except for QUICKI ( p = 0.08 ) , other findings did not alter . We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss , markers of insulin resistance , triglycerides and VLDL-cholesterol concentrations ",
"Background : Polycystic ovary syndrome ( PCOS ) is a polygenic endocrine disorder in women of reproductive age that lead to infertility . The aim of this study was to investigate the effects of probiotic on pancreatic β-cell function and C-reactive protein ( CRP ) in PCOS patients . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted among 72 women aged 15–40 years old diagnosed with PCOS . Participants were r and omly assigned to two groups receiving : ( 1 ) Probiotic supplements ( n = 36 ) , ( 2 ) placebo ( n = 36 ) for 8-week . Fasting blood sample s were taken at baseline and after 8-week of intervention . Results : Probiotic supplementation , compare with placebo , reduced fasting blood sugar ( −4.15 ± 2.87 vs. 2.57 ± 5.66 mg/dL , respectively P = 0.7 ) , serum insulin levels in crude model ( −0.49 ± 0.67 vs. 0.34 ± 0.82 μIU/mL , respectively , P = 0.09 ) , homeostasis model of assessment -insulin resistance score ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) nonsignificantly . Serum insulin levels after adjustment with covariates reduced significantly in probiotic group ( P = 0.02 ) . We did not found any significant differences in mean changes of CRP between groups ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) . Conclusions : A 8-week multispecies probiotics supplementation had nonsignificantly beneficial effect on pancreatic β-cell function and CRP in PCOS patients . After adjustment for some covariates , serum insulin changes were significantly different between groups",
"Background The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health , hormonal profiles , and biomarkers of inflammation and oxidative stress in women with PCOS . Data on the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters of patients with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters in women with PCOS . Methods This r and omized , double-blinded , placebo-controlled clinical trial was conducted on 60 subjects , aged 18–40 years old . Participants were r and omly allocated into two groups to intake 8 × 109 CFU/day probiotic plus 200 μg/day selenium supplements ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Hormonal and inflammatory parameters were measured at baseline and after the 12-week intervention . Results Probiotic and selenium co-supplementation result ed in a significant improvement in beck depression inventory ( β − 0.76 ; 95 % CI , − 1.26 , − 0.26 ; P = 0.003 ) , general health question naire scores ( β − 1.15 ; 95 % CI , − 1.97 , − 0.32 ; P = 0.007 ) and depression anxiety and stress scale scores ( β − 1.49 ; 95 % CI , − 2.59 , − 0.39 ; P = 0.009 ) compared with the placebo . Furthermore , probiotic and selenium co-supplementation significantly reduced total testosterone ( β − 0.26 ng/mL ; 95 % CI , − 0.51 , − 0.02 ; P = 0.03 ) , hirsutism ( β − 0.43 ; 95 % CI , − 0.74 , − 0.11 ; P = 0.008 ) , high-sensitivity C-reactive protein ( hs-CRP ) ( β − 0.58 mg/L ; 95 % CI , − 0.97 , − 0.19 ; P = 0.004 ) and malondialdehyde ( MDA ) levels ( β − 0.29 μmol/L ; 95 % CI , − 0.56 , − 0.02 ; P = 0.03 ) , and significantly increased total antioxidant capacity ( TAC ) ( β + 84.76 mmol/L ; 95 % CI , + 48.08 , + 121.44 ; P glutathione ( GSH ) levels ( β + 26.78 μmol/L ; 95 % CI , + 4.33 , + 49.23 ; P = 0.02 ) compared with the placebo . Conclusions Overall , the co-administration of probiotic and selenium for 12 weeks to women with PCOS had beneficial effects on mental health parameters , serum total testosterone , hirsutism , hs-CRP , TAC , GSH and MDA levels . This study was prospect ively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( http://www.i rct .ir : I RCT 20170513033941N22).Trial registration I RCT 20170513033941N22"
] | 41165b64-06ff-11f0-808a-c43d1ab1c353 |
Background The Timed Up and Go test ( TUG ) is a commonly used screening tool to assist clinicians to identify patients at risk of falling . The purpose of this systematic review and meta- analysis is to determine the overall predictive value of the TUG in community-dwelling older adults . Methods A literature search was performed to identify all studies that vali date d the TUG test . The method ological quality of the selected studies was assessed using the QUADAS-2 tool , a vali date d tool for the quality assessment of diagnostic accuracy studies . A TUG score of ≥13.5 seconds was used to identify individuals at higher risk of falling . All included studies were combined using a bivariate r and om effects model to generate pooled estimates of sensitivity and specificity at ≥13.5 seconds . Heterogeneity was assessed using the variance of logit transformed sensitivity and specificity . Results Twenty-five studies were included in the systematic review and 10 studies were included in meta- analysis . The TUG test was found to be more useful at ruling in rather than ruling out falls in individuals classified as high risk ( > 13.5 sec ) , with a higher pooled specificity ( 0.74 , 95 % CI 0.52 - 0.88 ) than sensitivity ( 0.31 , 95 % CI 0.13 - 0.57 ) . Logistic regression analysis indicated that the TUG score is not a significant predictor of falls ( OR = 1.01 , 95 % CI 1.00 - 1.02 , p = 0.05 ) . Conclusion The Timed Up and Go test has limited ability to predict falls in community dwelling elderly and should not be used in isolation to identify individuals at high risk of falls in this setting | [
" The eight FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) sites test different intervention strategies in selected target groups of older adults . To compare the relative potential of these interventions to reduce frailty and fall-related injuries , all sites share certain descriptive ( risk-adjustment ) measures and outcome measures . This article describes the shared measures , which are referred to as the FICSIT Common Data Base ( CDB ) . The description is divided into four sections according to the four FICSIT committees responsible for the CDB : ( 1 ) psychosocial health and demographic measures ; ( 2 ) physical health measures ; ( 3 ) fall-related measures ; and ( 4 ) cost and cost-effectiveness measures . Because the structure of the FICSIT trial is unusual , the CDB should expedite secondary analyses of various research questions dealing with frailty and falls",
"OBJECTIVES To test the hypothesis that scores on 4 falls risk measures will differ significantly in patients reporting recurrent falls compared with those who do not ; and to explore the validity of each measure to predict such falls status . DESIGN A convenience sample was tested to establish the sensitivity and specificity of the Functional Reach Test , Timed Up & Go test , one-leg stance test ( OLST ) , and balance subsection of the Performance Oriented Mobility Assessment ( B-POMA ) . A 12-month retrospective falls history was used to identify recurrent fallers . SETTING A day hospital for the elderly . PARTICIPANTS Convenience sample of 30 day hospital patients . The inclusion criteria were : ability to rise from a chair and walk 6 m ; no severe cognitive impairment or blindness ; age 65 years or older . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Scores on the 4 tests and retrospective falls histories . RESULTS Scores on the B-POMA and OLST showed significant differences between fallers and nonfallers ( P OLST time of 1.02 seconds or less ( odds ratio [OR]=15.2 ; 95 % confidence interval [ CI ] , 1.72 - 133.95 ) and B-POMA score of 11 or less ( OR=18.5 ; 95 % CI , 2.05 - 167.79 ) were predictive of day hospital patients having a history of recurrent falls . CONCLUSIONS OLST and B-POMA both have potential as screening tools for risk of falls , but this observation requires confirmation in a prospect i ve study",
"Objective To determine the efficacy of a targeted multifactorial falls prevention programme in elderly care wards with relatively short lengths of stay . Design Cluster r and omised trial . Setting 24 elderly care wards in 12 hospitals in Sydney , Australia . Participants 3999 patients , mean age 79 years , with a median hospital stay of seven days . Interventions A nurse and physiotherapist each worked for 25 hours a week for three months in all intervention wards . They provided a targeted multifactorial intervention that included a risk assessment of falls , staff and patient education , drug review , modification of bedside and ward environments , an exercise programme , and alarms for selected patients . Main outcome measure Falls during hospital stay . Results Intervention and control wards were similar at baseline for previous rates of falls and individual patient characteristics . Overall , 381 falls occurred during the study . No difference was found in fall rates during follow-up between intervention and control wards : respectively , 9.26 falls per 1000 bed days and 9.20 falls per 1000 bed days ( P=0.96 ) . The incidence rate ratio adjusted for individual lengths of stay and previous fall rates in the ward was 0.96 ( 95 % confidence interval 0.72 to 1.28 ) . Conclusion A targeted multifactorial falls prevention programme was not effective among older people in hospital wards with relatively short lengths of stay . Trial registration Australian New Zeal and Clinical Trials Registry ACTRNO 12605000467639",
"BACKGROUND Executive function ( EF ) deficits may increase fall risk , even among older adults with no overt cognitive impairment . Indeed , the effects of dual tasking ( DT ) on gait , a challenge to executive control , are more exaggerated in persons with a history of falls . Prospect i ve evidence is , however , lacking . METHODS We prospect ively evaluated whether EF predicts falls over a 2-year period among 262 community-living , healthy , and well-functioning older adults , focusing on the 201 who reported no falls during the previous year . At baseline , participants completed a computerized cognitive battery that generated an index of EF and other cognitive domains . Gait was assessed using performance-based tests and by quantifying walking during single- and dual-task conditions . RESULTS The 262 participants ( mean age : 76.3 ± 4.3 years , 60.3 % women ) had intact cognitive function on testing , a low comorbidity index , and good mobility . The EF index predicted future falls . Among those who reported no previous falls , participants in the worst EF quartile were three times more likely to fall during the 2 years of follow-up , and they were more likely to transition from nonfaller to faller sooner . DT gait variability also predicted future falls and multiple falls , whereas other measures of cognitive function , gait , and mobility did not . CONCLUSIONS Among healthy older adults , individuals with poorer EF are more prone to falls . Higher-level cognitive functions such as those regulated by the frontal lobes are apparently needed for safe everyday navigation that dem and s multitasking . Optimal screening , early detection , and treatment of falls should , apparently , also target this cognitive domain",
"Background Falling is a common problem in the fast-growing elderly population . Multitasking or engaging in two or more activities at the same time is common in daily living . Objective To determine the usefulness of the trail-walking test ( TWT ) for predicting a fall in community-dwelling elderly individuals . Methods This was a prospect i ve study in which the TWT was used to evaluate the risk of falling among a group of community-dwelling elderly individuals ( n = 171 ) with a mean age of 80.5 ± 5.6 years . The following tests were conducted : TWT , trail-making test ( TMT ) , timed-up- and -go test ( TUG ) , functional reach ( FR ) test , one-leg st and ing ( OLS ) test , and 10-m walking time test . Test – retest reliability was assessed by repeating the TWT within 2 weeks of the first trial , and there was a 1-year follow-up . Stepwise logistic regression analysis was used to analyze whether the TWT , TMT , TUG , FR , OLS , or 10-m walking tests predicted falling . Results The test – retest reliability of TWT was high ( intraclass correlation coefficient 0.945 , p Fifty-nine participants ( 34.5 % ) had reported a fall during the year preceding the 1-year follow-up . The stepwise logistic regression analysis revealed that only the TWT was significantly related to falling ( odds ratio 1.160 , 95 % confidence interval 1.107–1.214 ; p the TWT was most useful test of those evaluated for assessing the risk of fall among our elderly cohort",
"OBJECTIVE To establish whether changes in a spoken verbal task performance while walking compared with being at rest could predict falls among older adults . DESIGN Prospect i ve cohort study of 12 months ' duration . SETTING Twenty-seven senior housing facilities . PARTICIPANTS Sample of 187 subjects aged 75 - 100 ( mean age 84.8 + /- 5.2 ) . During enrollment , participants were asked to count aloud backward from 50 , both at rest and while walking and were divided into two groups according to their counting performance . Information on incident falls during the follow-up year was monthly collected . MEASUREMENTS The number of enumerated figures while sitting on a chair and while walking , and the first fall that occurred during the follow up year . RESULTS The number of enumerated figures under dual-task as compared to single task increased among 31.5 % of the tested subjects ( n = 59 ) and was associated with lower scores in MMSE ( P = 0.034 ) , and higher scores in Geriatric Depression Scale ( P = 0.007 ) and Timed Up & Go ( P = 0.005 ) . During the 12 months follow-up , 54 subjects ( 28.9 % ) fell . After adjusting for these variables , the increase in counting performance was significantly associated with falls ( adjusted OR = 53.3 , P Kaplan-Meier distributions of falls differed significantly between subjects who either increased or decreased their counting performance ( P falls , suggesting that better performance in an additional verbal counting task while walking might represent a new way to predict falls among older adults",
"Background and aims The aim of this study was to describe the prevalence of falls in a general older population , especially among the most elderly , and the risk markers associated with falls . Methods This is a cross-sectional study in which 38 fall risk markers were analysed in non- , occasional- and frequent-fallers . The population was 2,865 individuals ( aged 60–93 ) , r and omly selected from the general population register . The risk of falling was calculated as age-adjusted odds ratios . The relation between the number of risk markers for an individual and falls was also analysed . Results About one in ten reported falling during the past 6 months , 35 % of which were over 90 years old . Twenty-one risk markers were significantly related to falls confirming falling as a multifactorial problem . These included a variety of diseases , symptoms , medical and physical functions , life-style factors and the taking of certain drugs . The five risk markers with the highest odds ratio in frequent fallers were ‘ tendency to fall ’ ( 37.9 ) , ‘ low walking speed ’ ( 12.8 ) , consumption of ‘ neuroleptics ’ ( 10.9 ) , ‘ impaired mobility ’ ( 10.0 ) and ‘ dementia ’ ( 5.4 ) . Subjects with more than four and seven risk markers showed a 9- respectively 28-fold increase in the risk of falling , especially among frequent fallers and those aged over 90 years . Conclusion Falls are common in the elderly population and the risk is multifactorial . The results imply that there is an overrepresentation of fallers in a distinct subgroup of the very elderly and those with multiple risk markers . The self-perceived clinical sign ‘ tendency to fall ’ seems highly sensitive as indicator of individuals at risk . Several risk markers may be treatable . Fall risk seems to increase in a non-linear , almost exponential way with increasing number of risk markers",
"OBJECTIVES To compare the practicality , reliability , validity , and responsiveness of the timed up and go ( TUG ) , one-leg st and ( OLS ) , functional reach ( FR ) , and Tinetti balance ( TB ) performance measures in people aged 65 and older . DESIGN A prospect i ve study . SETTING Shin-Sher Township of Taichung County , west- central Taiwan . PARTICIPANTS Twelve hundred community-dwelling older people . MEASUREMENTS During an initial assessment at their residences , participants were interviewed for demographics , cognition , fall history , use of a walking aid , and activities of daily living ( ADLs ) , in addition to completing the four balance tests . Falls were ascertained by telephone every 3 months for a 1-year follow-up ; the four balance measures and ADLs were also reassessed at the end of the follow-up year . RESULTS Of the four balance measures , the OLS had the lowest participation rate , and participation of people who were cognitively impaired had fallen in the previous year , used a walking aid , or suffered from an ADL disability was lower than for their counterparts . The time to complete the tests ranged from 58 seconds for OLS , to 160 seconds for the TB . All four balance measures exhibited excellent test-retest reliability and discriminant validity but poor responsiveness to fall status . The TB showed better discriminant , convergent , and predictive validities and responsiveness to ADL changes than the other three tests . CONCLUSION According to psychometric properties , the most suitable performance measure for evaluating balance in community-dwelling older people was the TB , followed by the TUG",
"OBJECTIVE To determine the accuracy of the Timed Up and Go Test ( TUGT ) for screening the risk of falls among community-dwelling elderly individuals . METHOD This is a prospect i ve cohort study with a r and omly by lots without reposition sample stratified by proportional partition in relation to gender involving 63 community-dwelling elderly individuals . Elderly individuals who reported having Parkinson 's disease , a history of transitory ischemic attack , stroke and with a Mini Mental State Exam lower than the expected for the education level , were on a wheelchair and that reported a single fall in the previous six months were excluded . The TUGT , a mobility test , was the measure of interested and the occurrence of falls was the outcome . The performance of basic activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) was determined through the Older American Re sources and Services , and the socio-demographic and clinical data were determined through the use of additional question naires . Receiver Operating Characteristic Curves were used to analyze the sensitivity and specificity of the TUGT . RESULTS Elderly individuals who fell had greater difficulties in ADL and IADL ( p TUGT ( p=0.02 ) . No differences were found in socio-demographic and clinical characteristics between fallers and non-fallers . Considering the different sensitivity and specificity , the best predictive value for discriminating elderly individuals who fell was 12.47 seconds [ ( RR=3.2 ) 95%CI : 1.3 - 7.7 ] . CONCLUSIONS The TUGT proved to be an accurate measure for screening the risk of falls among elderly individuals . Although different from that reported in the international literature , the 12.47 second cutoff point seems to be a better predictive value for Brazilian elderly individuals",
"Background The Functional Gait Assessment ( FGA ) is a reliable and valid measure of gait-related activities . Objective The purpose of this study was to determine the concurrent , discriminative , and predictive validity of the FGA in community-dwelling older adults . Design This was a prospect i ve cohort study . Methods Thirty-five older adults aged 60 to 90 years completed the Activities-specific Balance Confidence Scale ( ABC ) , Berg Balance Scale ( BBS ) , Dynamic Gait Index ( DGI ) , Timed “ Up & Go ” Test ( TUG ) , and Functional Gait Assessment ( FGA ) during one session . Falls were tracked by having participants complete a monthly fall calendar for 6 months . Spearman correlation coefficients were used to determine concurrent validity among the ABC , BBS , TUG , DGI , and FGA . To determine the optimum scores to classify fall risk , sensitivity ( Sn ) , specificity ( Sp ) , and positive and negative likelihood ratios ( LR+ and LR− ) were calculated for the FGA in classifying fall risk based on the published criterion scores of the DGI and TUG and for the FGA , TUG , and DGI in identifying prospect i ve falls . Receiver operator curves with area under the curve were used to determine the effectiveness of the FGA in classifying fall risk and of the DGI , TUG , and FGA in identifying prospect i ve falls . Results The FGA correlated with the ABC ( r=.053 , P TUG ( r=−.84 , P FGA score of ≤22/30 provides both discriminative and predictive validity . The FGA ( scores ≤22/30 ) provided 100 % Sn , 72 % Sp , LR+ of 3.6 , and LR− of 0 to predict prospect i ve falls . Limitations The study was limited by the length of time of follow-up and the small sample size that did not allow for evaluation of criterion scores by decade . Conclusions The FGA with a cutoff score of 22/30 is effective in classifying fall risk in older adults and predicting unexplained falls in community-dwelling older adults",
"To determine the physiological factors and medications predicting injurious falls among the elderly population , the authors conducted a prospect i ve study in a rural home-dwelling population aged 70 years or over , initially 979 persons ( 377 men and 602 women ) , from 1 January 1991 to 31 December 1992 , in Northern Finl and . The independent risk factors for all falling injuries , falls leading to minor injuries and ones leading to major injuries were determined . In men , the independent risk factors for all injuries were gait disturbances [ odds ratio ( OR ) = 3.5 ] and the use of digitalis ( OR = 2.2 ) , those for minor injuries were gait disturbances ( OR = 2.7 ) and the use of calcium blockers ( OR = 3.0 ) , and those for major injuries were the absence of a quadriceps reflex ( OR = 4.8 ) , gait disturbances ( OR = 2.8 ) and the use of digitalis ( OR = 2.9 ) . In women , the corresponding independent risk factors were short step length ( OR = 32.1 ) , the use of calcium blockers ( OR = 2.5 ) and the use of medications for improving peripheral circulation ( OR = 3.7 ) for all injurious falls , path deviation ( OR = 2.3 ) the use of calcium blockers ( OR = 2.8 ) and the use of anti-inflammatory drugs ( OR = 2.1 ) for minor injuries , and foot deformity ( OR = 2.0 ) , short step length ( OR = 15.8 ) , the use of long-acting benzodiazepines ( OR = 4.0 ) and the use of calcium blockers ( OR = 2.4 ) for major injuries . In order to prevent injurious falls , attention should be given to the prescription of tranquillizers , cardiovascular medications and anti-inflammatory drugs . The walking abilities of elderly people should be maintained and chronic diseases leading to peripheral neuropathy should be treated adequately",
"Diagnosis is a critical component of health care , and clinicians , policymakers , and patients routinely face a range of questions regarding diagnostic tests . They want to know whether testing improves outcome ; what test to use , purchase , or recommend in practice guidelines ; and how to interpret test results . Well- design ed diagnostic test accuracy studies can help in making these decisions , provided that they transparently and fully report their participants , tests , methods , and results as facilitated , for example , by the STARD ( St and ards for Reporting of Diagnostic Accuracy ) statement ( 1 ) . That 25-item checklist was published in many journals and is now adopted by more than 200 scientific journals worldwide . As in other areas of science , systematic review s and meta- analysis of accuracy studies can be used to obtain more precise estimates when small studies addressing the same test and patients in the same setting are available . Review s can also be useful to establish whether and how scientific findings vary by particular subgroups , and may provide summary estimates with a stronger generalizability than estimates from a single study . Systematic review s may help identify the risk for bias that may be present in the original studies and can be used to address questions that were not directly considered in the primary studies , such as comparisons between tests . The Cochrane Collaboration is the largest international organization preparing , maintaining , and promoting systematic review s to help people make well-informed decisions about health care ( 2 ) . The Collaboration decided in 2003 to make preparations for including systematic review s of diagnostic test accuracy in their Cochrane Data base of Systematic Review s. To enable this , a working group ( Appendix ) . was formed to develop methodology , software , and a h and book The first diagnostic test accuracy review was published in the Cochrane Data base in October 2008 . In this paper , we review recent method ological developments concerning problem formulation , location of literature , quality assessment , and meta- analysis of diagnostic accuracy studies by using our experience from the work on the Cochrane H and book . The information presented here is based on the recent literature and up date s previously published guidelines by Irwig and colleagues ( 3 ) . Definition of the Objectives of the Review Diagnostic test accuracy refers to the ability of a test to distinguish between patients with disease ( or more generally , a specified target condition ) and those without . In a study of test accuracy , the results of the test under evaluation , the index test , are compared with those of the reference st and ard determined in the same patients . The reference st and ard is an agreed-on and accurate method for identifying patients who have the target condition . Test results are typically categorized as positive or negative for the target condition . By using such binary test outcomes , the accuracy is most often expressed as the test 's sensitivity ( the proportion of patients with positive results on the reference st and ard that are also positive on the index test ) and specificity ( the proportion of patients with negative results on the reference st and ard that are also negative on the index test ) . Other measures have been proposed and are in use ( 46 ) . It has long been recognized that test accuracy is not a fixed property of a test . It can vary between patient subgroups , with their spectrum of disease , with the clinical setting , or with the test interpreters and may depend on the results of previous testing . For this reason , inclusion of these elements in the study question is essential . In order to make a policy decision to promote use of a new index test , evidence is required that using the new test increases test accuracy over other testing options , including current practice , or that the new test has equivalent accuracy but offers other advantages ( 79 ) . As with the evaluation of interventions , systematic review s need to include comparative analyses between alternative testing strategies and should not focus solely on evaluating the performance of a test in isolation . In relation to the existing situation , 3 possible roles for a new test can be defined : replacement , triage , and add-on ( 7 ) . If a new test is to replace an existing test , then comparing the accuracy of both tests on the same population and with the same reference st and ard provides the most direct evidence . In triage , the new test is used before the existing test or testing pathway , and only patients with a particular result on the triage test continue the testing pathway . When a test is needed to rule out disease in patients who then need no further testing , a test that gives a minimal proportion of falsenegative results and thus a relatively high sensitivity should be used . Triage tests may be less accurate than existing ones , but they have other advantages , such as simplicity or low cost . A third possible role of a new test is add-on . The new test is then positioned after the existing testing pathway to identify false-positive or false-negative results after the existing pathway . The review should provide data to assess the incremental change in accuracy made by adding the new test . An example of a replacement question can be found in a systematic review of the diagnostic accuracy of urinary markers for primary bladder cancer ( 10 ) . Clinicians may use cytology to triage patients before they undergo invasive cystoscopy , the reference st and ard for bladder cancer . Because cytology combines high specificity with low sensitivity ( 11 ) , the goal of the review was to identify a tumor marker with sufficient accuracy to either replace cytology or be used in addition to cytology . For a marker to replace cytology , it has to achieve equally high specificity with improved sensitivity . New markers that are sensitive but not specific may have roles as adjuncts to conventional testing . The review included studies in which the test under evaluation ( several different tumor markers and cytology ) was evaluated against cystoscopy or histopathology . Included studies compared 1 or more of the markers , cytology only , or a combination of markers and cytology . Although information on accuracy can help clinicians make decisions about tests , good diagnostic accuracy is a desirable but not sufficient condition for the effectiveness of a test ( 8) . To demonstrate that using a new test does more good than harm to patients tested , r and omized trials of test- and -treatment strategies and review s of such trials may be necessary . However , with the possible exception of screening , in most cases , such r and omized trials are not available and systematic review s of test accuracy may provide the most useful evidence available to guide clinical and health policy decision making and use as input for decision and cost-effectiveness analysis ( 12 ) . Identification and Selection of Studies Identifying test accuracy studies is more difficult than search ing for r and omized trials ( 13 ) . There is not a clear , unequivocal keyword or indexing term for an accuracy study in literature data bases comparable with the term r and omized , controlled trial . The Medical Subject Heading sensitivity and specificity may look suitable but is inconsistently applied in most electronic bibliographic data bases . Furthermore , data on diagnostic test accuracy may be hidden in studies that did not have test accuracy estimation as their primary objective . This complicates the efficient identification of diagnostic test accuracy studies in electronic data bases , such as MEDLINE . Until indexing systems properly code studies of test accuracy , search ing for them will remain challenging and may require additional manual search es , such as screening reference lists . In the development of a comprehensive search strategy , review authors can use search strings that refer to the test(s ) under evaluation , the target condition , and the patient description or a subset of these . For tests with a clear name that are used for a single purpose , search ing for publications in which those tests are mentioned may suffice . For other review s , adding the patient description may be necessary , although this is also often poorly indexed . A search strategy in MEDLINE should contain both Medical Subject Headings and free text words . A search strategy for articles about tests for bladder cancer , for example , should include as many synonyms for bladder cancer as possible in the search strategy , including neoplasm , carcinoma , transitional cell , and hematuria . Several method ological electronic search filters for diagnostic test accuracy studies have been developed , each attempting to restrict the search to articles that are most likely to be test accuracy studies ( 1316 ) . These filters rely on indexing terms for research methodology and text words used in reporting results , but they often miss relevant studies and are unlikely to decrease the number of articles one needs to screen . Therefore , they are not recommended for systematic review s ( 17 , 18 ) . The incremental value of search ing in language s other than English and in the gray literature has not yet been fully investigated . In systematic review s of intervention studies , publication bias is an important and well-studied form of bias in which the decision to report and publish studies is linked to their findings . For clinical trials , the magnitude and determinants of publication bias have been identified by tracing the publication history of cohorts of trials review ed by ethics committees and research boards ( 19 ) . A consistent observation has been that studies with significant results are more likely to be published than studies with nonsignificant findings ( 19 ) . Investigating publication bias for diagnostic tests is problematic , because many studies are done without ethical review or study registration ; therefore , identification of cohorts of studies from registration to final publication status",
"OBJECTIVE This study aim ed to determine whether ordinary clinical performance on the timed \" up- and -go \" and one-leg-balance tests varied with additional cognitive tasks and the predictive value of this combination for future falls . METHODOLOGY The sample comprised 95 women with osteoporosis who lived independently in the community and were older than 70 years ( mean 73.4+/-1.7 years ) who were r and omized to perform the timed \" up- and -go \" ( TUG ) and one-leg-balance ( OLB ) tests . The tests were performed with or without an additional cognitive task ( math task involving subtraction by 2 s or 5 s or addition by 3 s ) . RESULTS For both TUG and OLB , performance decreased in the dual-task condition ( P older women with and without a history of falling , whatever the test , and with or without an additional cognitive load . CONCLUSION Performance on the TUG and OLB tests was less efficient when patients simultaneously performed a cognitive task . Performance on these tests , without or with cognitive tasks , did not predict falls in a sample of women who lived independently",
"Background : The ‘ timed up and go ’ test ( TUG ) is a simple , quick and widely used clinical performance-based measure of lower extremity function , mobility and fall risk . We speculated that its properties may be different from other performance-based tests and assessed whether cognitive function may contribute to the differences among these tests in a cohort of healthy older adults . Objective : To evaluate psychometric properties of the TUG in healthy older adults in comparison to the Berg balance test ( BBT ) and the Dynamic Gait Index ( DGI ) . Methods : The TUG , DGI and BBT were assessed in 265 healthy older adults ( 76.4 ± 4.3 years ; 58.3 % women ) who participated in a 3-year prospect i ve study . The Mini-Mental State Examination , digit span and verbal fluency measured cognitive function . The one- sample Kolmogorov-Smirnov test evaluated deviations from a normal distribution and Pearson ’s correlation coefficients quantified associations . Results : The mean scores of the BBT , DGI and TUG were : 54.0 ± 2.4 , 22.8 ± 1.5 , 9.5 ± 1.7 s , respectively . The BBT and the DGI were not normally distributed ( p with digit span and verbal fluency and were related to future falls , while the BBT and the DGI were not . Conclusions : The TUG appears to be an appropriate tool for clinical assessment of functional mobility even in healthy older adults . It does not suffer from ceiling effect limitations , is normally distributed and is apparently related to executive function . The BBT and the DGI do not share these beneficial properties . Perhaps the transferring and turning components of the TUG help to convert this relatively simple motor task into a more complex measure that also depends on cognitive re sources",
"Purpose : Which functional tests on mobility and balance can better screen older people at risk of falls is unclear . This study aims to compare the Berg Balance Scale ( BBS ) , Tinetti Mobility Score ( TMS ) , Elderly Mobility Scale ( EMS ) and Timed Up and Go test ( TUG ) in discriminating fallers from non-fallers in older people . Method : This was a case-control study involving one rater who conducted a mobility and balance assessment on subjects using the four functional tests in r and om sequence . Subjects recruited included 17 and 22 older people with a history of single and multiple falls respectively from a public Falls Clinic , and 39 community-dwellers without fall history and whose age , sex and BMI matched those of the fallers . All subjects underwent the mobility and balance assessment within one day . Results : Single fallers performed better than multiple fallers in all four functional tests but were worse than non-fallers in the BBS , TMS and TUG . The BBS demonstrated the best discriminating ability , with high sensitivity and specificity . The BBS item ` pick up an object from the floor ' was the best at screening fallers . Conclusion : BBS was the most powerful functional test of the four in discriminating fallers from non-faller",
"Background and aims : Stepping reactions play a critical role in responding to balance perturbations , whether they are a consequence of external perturbation or self-induced in nature . The aim of the present study was to determine prospect ively the capacity of voluntary stepping performance in single and dual-task conditions , to predict future falls among older community-dwelling persons . We also aim ed to assess whether dual task conditions have an added value over single tasks for fall prediction . Methods : A total of 100 healthy old volunteers ( mean age 78.4±5.7 yrs ) , from two self-care protected retirement homes for older adults , performed the Voluntary Step Execution Test in single- and dual-task conditions as a reaction time task while st and ing on a single force platform . Step initiation , preparatory and swing phases , and foot-contact time were extracted from data on center of pressure and ground reaction force . One-year fall incidences were monitored . Results : Ninety-eight subjects completed the one-year follow-up , 49 non-fallers , 32 one-time fallers , and 17 recurrent fallers ( two or more falls ) . Recurrent fallers had significantly slower voluntary step execution times in both single- and dual-task conditions , especially due to a slower preparation phase . Two stepwise ( backward ) logistic regression models showed that longer step execution times have strong predictive value for falls in both single- and dual-task conditions ( odds ratio ( OR ) 8.7 and 5.4 , respectively , p both single- and dual-task conditions is a simple and safe examination which can potentially and effectively predict future falls , with no added value to dual- over single-task condition",
"Background : Falls are the most common cause of injury and hospitalization and one of the principal causes of death and disability in older adults worldwide . This study aim ed to determine if a method based on body-worn sensor data can prospect ively predict falls in community-dwelling older adults , and to compare its falls prediction performance to two st and ard methods on the same data set . Methods : Data were acquired using body-worn sensors , mounted on the left and right shanks , from 226 community-dwelling older adults ( mean age 71.5 ± 6.7 years , 164 female ) to quantify gait and lower limb movement while performing the ‘ Timed Up and Go ’ ( TUG ) test in a geriatric research clinic . Participants were contacted by telephone 2 years following their initial assessment to determine if they had fallen . These outcome data were used to create statistical models to predict falls . Results : Results obtained through cross-validation yielded a mean classification accuracy of 79.69 % ( mean 95 % CI : 77.09–82.34 ) in prospect ively identifying participants that fell during the follow-up period . Results were significantly ( p for falls risk estimation using two st and ard measures of falls risk ( manually timed TUG and the Berg balance score , which yielded mean classification accuracies of 59.43 % ( 95 % CI : 58.07–60.84 ) and 64.30 % ( 95 % CI : 62.56–66.09 ) , respectively ) . Conclusion : Results suggest that the quantification of movement during the TUG test using body-worn sensors could lead to a robust method for assessing future falls risk",
"Background Falls often result from failed responses to unexpected , externally applied perturbations . Whether performance-based , reaction-based , and /or adaptation-based assessment tools can predict future falls among community-dwelling older adults is unknown . Purpose This preliminary prospect i ve study examined the relationship between older adults ' future fall risk and their reactive responses and adaptations to repeated slips , and their functional status . Methods Thirteen community-dwelling adults ( > 64 years ) were exposed initially to a session of repeated slips . About 30 months later , self-reported falls experience data were collected for the preceding year from these participants . Slip outcome ( fall , loss of balance , or recovery ) , slip score ( weighted sum of slip outcomes ) , Timed Up and Go scores , and future fall incidence were recorded . Results Four participants who reported at least 1 fall had significantly higher slip scores than the rest . In contrast , neither failed recovery on the first slip nor a higher TUG score predicted greater odds of future falls . Conclusion Community-dwelling older adults ' adaptability to externally imposed perturbations may reveal their future fall risk",
"Background and aims : In the elderly , balance and walking impairments are assumed to play an important role in causing falls . We have assessed prospect ively the predictive ability of health , function and balance variables regarding falls and their location . Methods : Falls which occurred during one year in a r and om sample of 307 women aged 75 years and over ( mean 80.8 years , response rate 74.5 % ) living in the community were recorded and related to baseline registration s of health , medication and tests of walking and balance . Results : In all , 155 women ( 50.5 % ) reported 308 falls . Outdoor falls were significantly more frequent than indoor falls ( 57.5 vs 42.5 % ) . The variables having had a fall before the start of the study , osteoporosis , hypertension , feeling depressed , unable to climb 40 cm high steps and walking slowly , all independently predicted a higher number of falls overall . Regarding fall location , having experienced a fall before study start was associated with more falls indoors as well as outdoors . Vision impairment , symptoms of depression , a faster comfortable walking speed , and being able to cope with higher steps were all independent predictors of more outdoor falls also after adjustment for outdoor exposure . A slower comfortable walking speed , a higher amplitude of the center of pressure movements in the frontal plane , a poorer score on the Timed Up & Go test , multi-morbidity , poor cognition and hypertension were independent risk factors for indoor falls . Neither number of drugs used nor any specific medication appeared as independent risk factors for falls in this study . Conclusions : The findings of this study suggest that risk factors for indoor and outdoor falls are different . Location of fall may be an important confounder in studies of predictors of falls in the elderly which should encompass this type of information",
"To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling",
"BACKGROUND the Falls Risk for Older People in the Community assessment ( FROP-Com ) tool was design ed for use in targeted multi-factorial falls prevention programmes . It fills the gap between the short screening tools and the longer assessment tools , e.g. the physiological profile assessment ( PPA ) . The aim of this study was to determine the reliability and predictive accuracy of the FROP-Com . METHODS the intra-rater and inter-rater reliability studies were performed with 20 participants each . The prospect i ve study was performed with 344 community-dwelling older people presenting to an emergency department after a fall and being discharged directly home . Following a home-based assessment , including the FROP-Com , Timed Up and Go ( TUG ) and functional Reach ( FR ) , participants were monitored for falls for 12 months . RESULTS the intra-class correlation coefficient ( ICC ) for intra-rater reliability and inter-rater reliability for the FROP-Com was 0.93 ( 95 % CI 0.84 - 0.97 ) and 0.81 ( 95 % CI 0.59 - 0.92 ) respectively . The AUC for the FROP-Com was 0.68 ( 95 % CI 0.63 - 0.74 ) . At the cut-off 18/19 , sensitivity was 71.3 % ( 95 % CI 64.4 - 78.3 ) and specificity was 56.1 % ( 95 % CI 48.9 - 63.4 ) . The AUC for the TUG was 0.63 ( 95 % CI 0.57 - 0.69 ) and for the FR was 0.60 ( 95 % CI 0.54 - 0.66 ) . CONCLUSION the FROP-Com demonstrated good reliability and a moderate capacity to predict falls",
"Background Correct identification of people at risk for recurrent falls facilitates the establishment of preventive and rehabilitative strategies in older adults . Objective The purpose s of this study were : ( 1 ) to develop and vali date a simple clinical scale to stratify risk for recurrent falls in community-dwelling elderly people based on easily obtained social and clinical items and ( 2 ) to evaluate the added value of 3 clinical balance tests in predicting this risk . Design This was a prospect i ve measurement study . Methods A population of 1,618 community-dwelling people over 65 years of age underwent a health checkup , including performance of 3 clinical balance tests : the One-Leg-Balance Test , the Timed “ Up & Go ” Test , and the Five-Times-Sit-to-St and Test . Falls were recorded using a self-administered question naire that was completed a mean ( SD ) of 25±5 months after the visit . Participants were r and omly divided into either group A ( n=999 ) , which was used to develop the scale , or group B ( n=619 ) , which was used to prospect ively vali date the scale . Results Logistic regression analysis identified 4 variables that independently predicted recurrent falls in group A : history of falls , living alone , taking ≥4 medications per day , and female sex . Thereafter , 3 risk categories of recurrent falls ( low , moderate , and high ) were determined . Predicted probability of recurrent falls increased from 4.1 % to 30.1 % between the first and third categories . This scale subsequently was vali date d with great accuracy in group B. Only the Five-Times-Sit-to-St and Test provided added value in the estimation of risk for recurrent falls , especially for the participants who were at moderate risk , in whom failure on the test ( duration of > 15 seconds ) doubled the risk . Limitations Falls were assessed only once , and length of follow-up was heterogeneous ( 18–36 months ) . Conclusions Clinicians could easily classify older patients in low- , moderate- , or high-risk groups of recurrent falls by using 4 easy-to-obtain items . The Five-Times-Sit-to-St and Test provides added value to stratify risk for falls in people at moderate risk",
"OBJECTIVES To assess whether the Timed Up and Go ( TUG ) is superior to gait speed in predicting multiple geriatric outcomes . DESIGN Prospect i ve cohort study . SETTING Medicare health maintenance organization and Veterans Affairs primary care clinics . PARTICIPANTS Adults aged 65 and older ( N=457 ) . MEASUREMENTS Baseline gait speed and TUG were used to predict health decline according to EuroQol and Medical Outcomes Study 36-item Short Form Survey ( SF-36 ) global health ; functional decline according to National Health Interview Survey ( NHIS ) activities of daily living ( ADLs ) score and SF-36 physical function index ; hospitalization ; and any falls and multiple falls over 1 year . RESULTS Mean age was 74 , and 44 % of participants were female . Odds ratios for all outcomes were equivalent for gait speed and TUG . Using area under the receiver operating characteristic curve of 0.7 or greater for acceptable predictive ability , gait speed and TUG each alone predicted decline in global health , new ADL difficulty , and falls , with no difference in predictive ability between performance measures . Neither performance measure predicted hospitalization , EuroQol decline , or physical function decline . As a continuous variable , TUG did not add predictive ability to gait speed for any outcome . CONCLUSION Gait speed predicts most geriatric outcomes , including falls , as does TUG . The time taken to complete TUG may not add to information provided by gait speed , although its qualitative elements may have other utility",
"Objective : To determine if self-reported data recalling at least one fall over a sixmonth recall period could be used as a reliable measure of falls by comparing retrospective self-report with a ‘ gold st and ard ' method of reporting these events using a prospect i ve calendar-reported method . Design : Prospect i ve study . Setting : Community-dwelling older people living in New South Wales ( NSW ) and Queensl and in Australia . Subjects : A stratified sample of 264 r and omly selected participants from a concurrent r and omized controlled trial ( RCT ) of preventive health assessment for people over the age of 70 years . Interventions : Intervention and control group participants in the RCT kept a calendar of fall events for a six-month validation sub study . At the end of six months , participants were asked to retrospectively report their falls over the six-month period . Main results : Results indicated that percentage agreement between retrospective self-report and the calendar report of falls was 84 % , however , sensitivity was 56 % ( 95 % confidence interval ( CI ) 44.1−67.5 ) . Ten participants ( 4 % ) gave false positive self-reports of falls , and 33 ( 13 % ) participants gave false negative self-reports of falls . Therefore , retrospective self-reported fall rates were likely to involve under-reporting of falls . Significant differences were found in the sensitivity of retrospectively selfreported falls reported by the intervention group participants ( sensitivity=71 % ; 95 % CI 56.6−85.5 ) compared with the control group ( sensitivity=40.5 % ; 95 % CI 24.7−56.4 , P = 0.008 ) . Validity of self-reported injuries as a result of a fall was less accurate ( 71 % agreement ; sensitivity 24 % ( 95 % CI 16.0−33.6 ) . Conclusions : As recall of falls was more accurate in the intervention group than in the control group , it could appear that the intervention had the effect of increasing falls compared to the control group . Using these results , a method was devised to weight self-reported retrospective data to compensate for the poorer recall demonstrated in the control group , so that a more accurate estimate of falls could be derived from the self-reported data",
"Background : A poor postural stability in older people is associated with an increased risk of falling . The posturographic tool has widely been used to assess balance control ; however , its value in predicting falls remains unclear . Objective : The purpose of this prospect i ve study was to determine the predictive value of posturography in the estimation of the risk of recurrent falls , including a comparison with st and ard clinical balance tests , in healthy non-institutionalized persons aged over 65 . Methods : Two hundred and six healthy non-institutionalized volunteers aged over 65 were tested . Postural control was evaluated by posturographic tests , performed on static , dynamic and dynamized platforms ( static test , slow dynamic test and Sensory Organization Test [ SOT ] ) and clinical balance tests ( Timed ‘ Up & Go ’ test , One-Leg Balance , Sit-to-St and -test ) . Subsequent falls were monitored prospect ively with self- question naire sent every 4 months for a period of 16 months after the balance testing . Subjects were classified prospect ively in three groups of Non-Fallers ( 0 fall ) , Single-Fallers ( 1 fall ) and Multi-Fallers ( more than 2 falls ) . Results : Loss of balance during the last trial of the SOT sensory conflicting condition , when visual and somatosensory inputs were distorted , was the best factor to predict the risk of recurrent falls ( OR = 3.6 , 95 % CI = 1.3–10.11 ) . Multi-Fallers showed no postural adaptation during the repetitive trials of this sensory condition , contrary to Non-Fallers and Single-Fallers . The Multi-Fallers showed significantly more sway when visual inputs were occluded . The clinical balance tests , the static test and the slow dynamic test revealed no significant differences between the groups . Conclusion : In a sample of non-institutionalized older persons aged over 65 , posturographic evaluation by the SOT , especially with repetition of the same task in sensory conflicting condition , compared to the clinical tests and the static and dynamic posturographic test , appears to be a more sensitive tool to identify those at high-risk of recurrent falls",
"Background : Dual-task-based assessment tests failed to establish a dependable relationship between dual-task-related gait changes and the risk of falls in the elderly . Objective : The aim of this study was to examine whether changes in gait while counting backward could be associated with the occurrence of a first fall among older adults . Methods : Walking while counting backward was investigated prospect ively in a cohort of 187 older adults living independently in senior housing facilities . During enrollment , walking time , number of steps , and frequency of lateral line stepping-over and stops were measured while walking only and while walking with backward counting aloud . Information on the incident falls during the follow-up year was collected monthly . Results : Walking time and the number of steps increased significantly under the dual-task condition compared to the single-task condition among fallers and non-fallers ( p Mini-Mental State Examination ( p = 0.029 ) and higher scores in the 15-item Geriatric Depression Scale ( p = 0.003 ) and Timed Up & Go Test ( p = 0.006 ) and increased walking time under both walking conditions ( p = 0.030 for single-task condition and p = 0.007 for dual-task condition ) . After adjusting for these variables , depressive symptoms ( adjusted OR = 2.6 with p = 0.041 and adjusted OR = 2.5 with p = 0.045 when walking time while walking only and walking with backward counting is considered , respectively ) and walking time while walking only ( OR = 2.3 with p = 0.032 ) were significantly associated with falls . Conclusion : Dual-task-related gait changes were poorly associated with the occurrence of a first fall and provided no additional predictive value compared to gait performance under a single task , suggesting that changes in basic clinical gait parameters while counting backward are unsuccessful to predict the first fall among older adults",
"Background : The use of falls risk screening tools may aid in targeting fall prevention interventions in older individuals most likely to benefit . Objective : To determine the optimal physical or cognitive test to screen for falls risk in frail older people . Methods : This prospect i ve cohort study involved recruitment from 213 day-care centers in Japan . The feasibility study included 3,340 ambulatory individuals aged 65 years or older enrolled in the Tsukui Ordered Useful Care for Health ( TOUCH ) program . The external validation study included a sub sample of 455 individuals who completed all tests . Physical tests included grip strength ( GS ) , chair st and test ( CST ) , one-leg st and ing test ( OLS ) , functional reach test ( FRT ) , t and em walking test ( TWT ) , 6-meter walking speed at a comfortable pace ( CWS ) and at maximum pace ( MWS ) , and timed up- and -go test ( TUG ) . The mental status question naire ( MSQ ) was used to measure cognitive function . The incidence of falls during 1 year was investigated by self-report or an interview with the participant ’s family and care staff . Results : The most practicable tests were the GS and MSQ , which could be administered to more than 90 % of the participants regardless of the activities of daily living status . The FRT and TWT had lower feasibility than other lower limb function tests . During the 1-year retrospective analysis of falls , 99 ( 21.8 % ) of the 455 validation study participants had fallen at least once . Fallers showed significantly poorer performance than non-fallers in the OLS ( p = 0.003 ) , TWT ( p = 0.001 ) , CWS ( p = 0.013 ) , MWS ( p = 0.007 ) , and TUG ( p = 0.011 ) . The OLS , CWS , and MWS remained significantly associated with falls when performance cut-points were determined . Logistic regression analysis revealed that the TWT was a significant and independent , yet weak predictor of falls . A weighting system which considered feasibility and validity scored the CWS ( at a cut-point of 0.7 m/s ) as the best test to predict risk of falls . Conclusion : Clinical tests of neuromuscular function can predict risk of falls in frail older people . When feasibility and validity were considered , the CWS was the best test for use as a screening tool in frail older people , however , these preliminary results require confirmation in further research"
] | 41165ba0-06ff-11f0-808a-c43d1ab1c353 |
The objective of this systematic review was to examine the relationship between outdoor time and : ( 1 ) physical activity , ( 2 ) cardiorespiratory fitness , ( 3 ) musculoskeletal fitness , ( 4 ) sedentary behaviour ; or ( 5 ) motor skill development in children aged 3 - 12 years . We identified 28 relevant studies that were assessed for quality using the GRADE framework . The systematic review revealed overall positive effects of outdoor time on physical activity , sedentary behaviour , and cardiorespiratory fitness , although causality could not be assumed due to a lack of RCTs . Motor skill development was unrelated to outdoor time ; however , this relationship was only examined in a single study of preschool children . No studies were found that examined associations between outdoor time and musculoskeletal fitness | [
"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",
"Background The question of whether air pollution contributes to asthma onset remains unresolved . Objectives In this study , we assessed the association between asthma onset in children and traffic-related air pollution . Methods We selected a sample of 217 children from participants in the Southern California Children ’s Health Study , a prospect i ve cohort design ed to investigate associations between air pollution and respiratory health in children 10–18 years of age . Individual covariates and new asthma incidence ( 30 cases ) were reported annually through question naires during 8 years of follow-up . Children had nitrogen dioxide monitors placed outside their home for 2 weeks in the summer and 2 weeks in the fall – winter season as a marker of traffic-related air pollution . We used multilevel Cox models to test the associations between asthma and air pollution . Results In models controlling for confounders , incident asthma was positively associated with traffic pollution , with a hazard ratio ( HR ) of 1.29 [ 95 % confidence interval ( CI ) , 1.07–1.56 ] across the average within-community interquartile range of 6.2 ppb in annual residential NO2 . Using the total interquartile range for all measurements of 28.9 ppb increased the HR to 3.25 ( 95 % CI , 1.35–7.85 ) . Conclusions In this cohort , markers of traffic-related air pollution were associated with the onset of asthma . The risks observed suggest that air pollution exposure contributes to new-onset asthma ",
"Background Physical inactivity among children is an increasing problem that adversely affects children ’s health . A better underst and ing of factors which affect physical activity ( PA ) will help create effective interventions aim ed at raising the activity levels of children . This cross-sectional study examined the associations of PA with individual ( biological , social , behavioral , psychological ) and environmental ( East vs. West Germany , rural vs. urban regions ) characteristics in children . Methods Information on PA and potential correlates was collected from 1843 girls and 1997 boys using question naires during the 10-year follow-up of two prospect i ve birth cohort studies ( GINIplus and LISAplus ) . Study regions represent urban and rural sites as well as East and West of Germany . Logistic regression modeling was applied to examine cross-sectional associations between individual as well as environmental factors and PA levels . Results Five of fourteen variables were significantly associated with PA . Among children aged 10 , girls tended to be less active than boys , especially with respect to vigorous PA ( OR = 0.72 for summer ) . Children who were not a member of a sports club showed a substantially reduced amount of PA in winter ( OR = 0.15 ) . Rural environments promote moderate PA , particularly in winter ( OR = 1.88 ) , whereas an increased time outdoors primarily promotes moderate PA in summer ( OR = 12.41 ) . Children with abnormal emotional symptoms exhibited reduced physical activity , particularly in winter ( OR = 0.60 ) . BMI , puberty , parental BMI , parental education , household income , siblings , TV/PC consumption , and method of arriving school , were not associated with PA . Conclusions When considering correlates of PA from several domains simultaneously , only few factors ( sex , sports club membership , physical environment , time outdoors , and emotional symptoms ) appear to be relevant . Although the causality needs to be ascertained in longitudinal studies , variables which can not be modified should be used to identify risk groups while modifiable variables , such as sports club activities , may be addressed in intervention programs",
"Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity . Levels of physical activity track through childhood into adulthood , thus establishing habitual physical activity early in life is vital . Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children . There are few pre-school , playground-based interventions , and evaluations of these have found mixed results . A recent report published by the UK Chief Medical Officer ( CMO ) highlighted that new interventions to promote movement in the early years ( 0–5 years old ) are needed . The aim of this study is to undertake a pilot cluster r and omised controlled trial ( RCT ) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old ( “ Pre-schoolers in the Playground ” ; PiP ) and to assess the feasibility of conducting a full scale cluster RCT . The PiP intervention is grounded in behavioural theory ( Social Cognitive Theory ) , and is in accordance with the CMO guidance for physical activity in the early years . It is informed by existing literature and data collected from focus groups with parents . Methods / Design One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited . Schools will be r and omised to either the PiP intervention arm or the control arm ( usual practice ) . Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks ( 3 school terms ) at the school . Feasibility will be assessed by examining recruitment rates , attendance , attrition , acceptability of the trial and of the PiP intervention to parents , fidelity of intervention implementation , capability and capacity for schools to deliver the intervention . Health outcomes and the feasibility of outcome measurement tools will be assessed . These include physical activity via triaxial , accelerometry ( Actigraph GT3X+ ) , anthropometry ( height , body mass , BMI , waist and upper arm circumference ) , health related quality of life for child ( PedsQL ) and parent ( EQ5D ) , parent wellbeing ( ComQol-A5 ) , injuries and health service use . A health economic evaluation will also be undertaken . Discussion It is anticipated that results of this pilot trial will be published in spring 2015.Trial registration Current controlled trials : IS RCT",
"Elevated blood pressure ( BP ) during childhood and adolescence increases the risk of hypertension in later life . Although physical activity is known to positively moderate BP , data regarding this relationship are limited in prepubertal children . We aim ed to assess the association between a range of physical activities ( including indoor and outdoor activity ) and BP in a large community-based sample of prepubertal schoolchildren . Eligible year-1 schoolchildren ( n=1765 ; mean age 6.7±0.4 years ) from a r and om cluster sample of 34 schools in Sydney , Australia , were examined . Parents completed detailed question naires about their child 's activity . Height and weight were measured , and body mass index ( BMI ) was calculated . BP was measured using a st and ard protocol , and elevated BP was defined using published guidelines . Physical activity was classified as low , medium or high ( that is , as tertiles ) . After adjusting for age , sex , ethnicity , height , BMI , parental qualifications and family history of hypertension and /or cardiovascular disease , children in the highest tertile of outdoor and indoor activities had significantly lower diastolic BP ( ∼1.5 mm Hg ; Ptrend=0.01 ) and systolic BP ( ∼1.3 mm Hg ; Ptrend=0.03 ) , respectively , compared with those in the lowest tertile ( reference ) . Linearly , time spent in indoor activities ( each hour per day ) was associated with ∼2.4 mm Hg decrease in diastolic BP ( P=0.001 ) . Physical activity was independently associated with lower BP in this sample of prepubertal children . The findings emphasize the importance of ensuring regular physical activity programs in primary schools to potentially reduce the risk of elevated BP in childhood and in later life",
"Objective : This study aim ed to determine whether time spent outdoors was associated with objective ly measured physical activity , body mass index ( BMI ) z-score and overweight in elementary-school aged children , cross-sectionally and prospect ively over 3 years . Methods : Three-year cohort study with data collected during 2001 and 2004 . Nineteen r and omly selected state elementary schools across Melbourne , Australia . One hundred and eighty eight 5–6-year-old and 360 10–12-year-old children . Baseline parent reports of children 's time spent outdoors during warmer and cooler months , on weekdays and weekends . At baseline and follow-up , children 's moderate and vigorous physical activity ( MVPA ) was objective ly assessed by accelerometry , and BMI z-score and overweight was calculated from measured height and weight . Results : Cross-sectionally , each additional hour outdoors on weekdays and weekend days during the cooler months was associated with an extra 27 min week−1 MVPA among older girls , and with an extra 20 min week−1 MVPA among older boys . Longitudinally , more time outdoors on weekends predicted higher MVPA on weekends among older girls and boys ( 5 min week−1 ) . The prevalence of overweight among older children at follow-up was 27–41 % lower among those spending more time outdoors at baseline . Conclusion : Encouraging 10–12-year-old children to spend more time outdoors may be an effective strategy for increasing physical activity and preventing increases in overweight and obesity . Intervention research investigating the effect of increasing time outdoors on children 's physical activity and overweight is warranted",
"This study analyzed time-use interviews to report levels of active and inactive behavior during the after-school period ( 3 - 6 pm ) . Interviews were conducted on r and om days from three separate seasons during third and fourth grade . Youth with at least two interviews during third ( 356 completed 2 interviews ; 506 completed 3 interviews [ 9 yrs ; 50 % boys ] ) and fourth ( 186 completed 2 interviews ; 768 completed 3 interviews [ 10 yrs ; 50 % boys ] ) grade were included to report levels of moderate-to-vigorous physical activity ( MVPA ) , light physical activity , inactive screen time , inactive nonscreen time , and travel by location and who the activity was undertaken with . Reporting time outside the home and with peers ( single or group ) was related to higher levels of MVPA . While inside the home , screen and nonscreen proportions were comparable ( 38 % and 40 % , respectively ) , despite unique patterns ( screen : boys > girls ; nonscreen : girls > boys ) . Reporting time with both parents was associated with more nonscreen time ; whereas reporting time with peer groups was associated with lower screen time . Underst and ing active and inactive patterns of children 's behavior outside of school hours can be very important in contributing toward the development of innovative interventions for increasing physical activity",
"PURPOSE To evaluate an incentive-based intervention to increase time spent outdoors among children in a 9-month cluster r and omised controlled trial . METHODS Two hundred and eighty-five children aged 6 - 12 years of age were r and omised to the intervention ( n = 147 ) or control arm ( n = 138 ) in the Family incentive trial ( FIT ) . The FIT intervention comprised of targeted education on myopia and good eye care habits , structured weekend outdoor activities and incentives for children to increase their daily steps via pedometers . The main outcome measure was outdoor time , measured by the WHO question naire and a 1-week diary . RESULTS Interim analysis at 6 months showed a significant increase in mean outdoor time per week in the intervention arm ( 14.75 h week(-1 ) ) compared to the control arm ( 12.40 h week(-1 ) ) as measured by the question naire ( p = 0.04 ) . However , greater outdoor time was not statistically significant at the end of the trial ( 15.95 h week(-1 ) vs 14.34 h in the control group ( p = 0.29 ) . CONCLUSIONS There was an increase in outdoor time for children in the incentive-based physical activity outdoor program after 6 months but not at the end of the trial . Further larger school trials with better compliance with the intervention and longer duration could be conducted to evaluate clinical outcomes such as myopic shifts"
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Objective Given the high prevalence of suboptimal nutrition and low activity levels in children , we systematic ally review ed the literature on the relationship between physical activity and dietary patterns and cognitive development in early childhood ( six months to five years ) . Methods In February 2016 , we conducted two different search es of MEDLINE , PsycINFO , and ERIC . Each search included either physical activity ( including gross motor skills ) or diet terms , and neurocognitive development outcome terms . Included studies were in English , published since 2005 , and of any study design in which the physical activity or diet measure occurred prior to age five . Results For physical activity , twelve studies ( 5 cross-sectional , 3 longitudinal and 4 experimental ) were included . Eleven studies reported evidence suggesting that physical activity or gross motor skills are related to cognition or learning . Both acute bouts and longer term exposures showed benefit . For diet , eight studies were included consisting of secondary analyses from longitudinal cohort studies . A healthier dietary pattern was associated with better cognitive outcomes in all studies , although some of the reported associations were weak and the measures used varied across the studies . Conclusions Physical activity and healthy diets in early childhood are associated with better cognitive outcomes in young children . The paucity of literature and the variability in the type and quality of measures used highlight the need for more rigorous research . Given that the early childhood years are critical for both obesity prevention and neurocognitive development , evidence that the same healthy behaviors could promote both should inform future interventions | [
"Objective : To examine the link between childhood overweight status and elementary school outcomes . Design : Prospect i ve study design : multivariate regression models examining the association between changes in overweight status and school outcomes between kindergarten entry and end of third grade , after controlling for various child , family and school characteristics . Subjects : Nationally representative sample of US children who entered kindergarten in 1998 , with longitudinal data on body mass index ( BMI ) and school outcomes at kindergarten entry and end of third grade . Measurements : Wide range of elementary school outcomes collected in each wave including academic achievement ( math and reading st and ardized test scores ) ; teacher reported internalizing and externalizing behavior problems ( BP ) , social skills ( self-control , interpersonal skills ) and approaches to learning ; school absences ; and grade repetition . Measurements of height and weight in each wave were used to compute BMI and indicators of overweight status based on CDC growth charts . A rich set of control variables capturing child , family , and school characteristics . Results : Moving from not-overweight to overweight between kindergarten entry and end of third grade was significantly associated ( P reductions in test scores , and teacher ratings of social-behavioral outcomes and approaches to learning among girls . However , this link was mostly absent among boys , with two exceptions – boys who became overweight had significantly fewer externalizing BPs ( P absences from school compared to boys who remained normal weight . Being always-overweight was associated with more internalizing BP among girls but fewer externalizing BPs among boys . Conclusion : Change in overweight status during the first 4 years in school is a significant risk factor for adverse school outcomes among girls but not boys . Girls who become overweight during the early school years and those who start school being overweight and remain that way may need to be monitored carefully",
"IMPORTANCE Many early life risk factors for childhood obesity are more prevalent among blacks and Hispanics than among whites and may explain the higher prevalence of obesity among racial/ethnic minority children . OBJECTIVE To examine the extent to which racial/ethnic disparities in adiposity and overweight are explained by differences in risk factors during pregnancy ( gestational diabetes and depression ) , infancy ( rapid infant weight gain , feeding other than exclusive breastfeeding , and early introduction of solid foods ) , and early childhood ( sleeping , presence of a television set in the room where the child sleeps , and any intake of sugar-sweetened beverages or fast food ) . DESIGN Prospect i ve prebirth cohort study . SETTING Multisite group practice in Massachusetts . PARTICIPANTS Participants included 1116 mother-child pairs ( 63 % white , 17 % black , and 4 % Hispanic ) EXPOSURE Mother 's report of child 's race/ethnicity . MAIN OUTCOMES AND MEASURES Age- and sex-specific body mass index ( BMI ) z score , total fat mass index from dual-energy x-ray absorptiometry , and overweight or obesity , defined as a BMI in the 85th percentile or higher at age 7 years . RESULTS Black ( 0.48 U [ 95 % CI , 0.31 to 0.64 ] ) and Hispanic ( 0.43 [ 0.12 to 0.74 ] ) children had higher BMI z scores , as well as higher total fat mass index and overweight/obesity prevalence , than white children . After adjustment for socioeconomic confounders and parental BMI , differences in BMI z score were attenuated for black and Hispanic children ( 0.22 U [ 0.05 to 0.40 ] and 0.22 U [ -0.08 to 0.52 ] , respectively ) . Adjustment for pregnancy risk factors did not substantially change these estimates . However , after further adjustment for infancy and childhood risk factors , we observed only minimal differences in BMI z scores between whites , blacks ( 0.07 U [ -0.11 to 0.26 ] ) , and Hispanics ( 0.04 U [ -0.27 to 0.35 ] ) . We observed similar attenuation of racial/ethnic differences in adiposity and prevalence of overweight or obesity . CONCLUSIONS AND RELEVANCE Racial/ethnic disparities in childhood adiposity and obesity are determined by factors operating in infancy and early childhood . Efforts to reduce obesity disparities should focus on preventing early life risk factors",
"Early nutrition in animals affects both behavior and brain structure . In humans , r and omized trials show that early nutrition affects later cognition , notably in males . We hypothesized that early nutrition also influences brain structure , measurable using magnetic resonance imaging . Prior research suggested that the cau date nucleus may be especially vulnerable to early environment and that its size relates to IQ . To test the hypothesis that the cau date nucleus could be a neural substrate for cognitive effects of early nutrition , we compared two groups of adolescents , assigned a St and ard- or High-nutrient diet in the postnatal weeks after preterm birth . Groups had similar birth status and neonatal course . Scans and IQ data were obtained from 76 adolescents and volumes of several subcortical structures were calculated . The High-nutrient group had significantly larger cau date volumes and higher Verbal IQ ( VIQ ) . Cau date volumes correlated significantly with VIQ in the St and ard-nutrient group only . Cau date volume was influenced by early nutrition and related selectively to VIQ in males , but not in females . Our findings may partly explain the effects of early diet on cognition and the predominant effects in males . They are among the first to show that human brain structure can be influenced by early nutrition",
"Determinants of a child 's diet shortly after weaning and lactation have been relatively understudied . The aim of the present study was hence to identify common dietary patterns in toddlers and to explore parental and child indicators of these dietary patterns . The study was a population -based , prospect i ve birth-cohort study in Rotterdam , the Netherl and s. Food consumption data of 2420 children aged 14 months were used . A ' Health conscious ' dietary pattern characterised by pasta , fruits , vegetables , oils , legumes and fish , and a ' Western-like ' dietary pattern characterised by snacks , animal fats , confectionery and sugar-containing beverages were extracted using principal component analysis . Low paternal education , low household income , parental smoking , multiparity , maternal BMI , maternal carbohydrate intake and television-watching of child were determinants of a ' Western-like ' diet , whereas parental age , dietary fibre intake during pregnancy , introduction of solids after 6 months and female sex were inversely associated with a ' Western-like ' diet of the child . Maternal co-morbidity , alcohol consumption during pregnancy and female sex were inversely associated with a ' Health conscious ' dietary pattern of the child , while single parenthood , folic acid use and dietary fibre intake during pregnancy were positively associated . All aforementioned associations were statistically significant . In conclusion , both ' Western-like ' and ' Health conscious ' diets can already be identified in toddlers . Particularly , adherence to a ' Western-like ' diet is associated with unfavourable lifestyle factors of the parents and child , and low socio-economic background . These findings can form a basis for future epidemiological studies regarding dietary patterns and health outcomes in young children",
"IMPORTANCE Breastfeeding may benefit child cognitive development , but few studies have quantified breastfeeding duration or exclusivity , nor has any study to date examined the role of maternal diet during lactation on child cognition . OBJECTIVES To examine relationships of breastfeeding duration and exclusivity with child cognition at ages 3 and 7 years and to evaluate the extent to which maternal fish intake during lactation modifies associations of infant feeding with later cognition . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study ( Project Viva ) , a US prebirth cohort that enrolled mothers from April 22 , 1999 , to July 31 , 2002 , and followed up children to age 7 years , including 1312 Project Viva mothers and children . MAIN EXPOSURE Duration of any breastfeeding to age 12 months . MAIN OUTCOMES AND MEASURES Child receptive language assessed with the Peabody Picture Vocabulary Test at age 3 years , Wide Range Assessment of Visual Motor Abilities at ages 3 and 7 years , and Kaufman Brief Intelligence Test and Wide Range Assessment of Memory and Learning at age 7 years . RESULTS Adjusting for sociodemographics , maternal intelligence , and home environment in linear regression , longer breastfeeding duration was associated with higher Peabody Picture Vocabulary Test score at age 3 years ( 0.21 ; 95 % CI , 0.03 - 0.38 points per month breastfed ) and with higher intelligence on the Kaufman Brief Intelligence Test at age 7 years ( 0.35 ; 0.16 - 0.53 verbal points per month breastfed ; and 0.29 ; 0.05 - 0.54 nonverbal points per month breastfed ) . Breastfeeding duration was not associated with Wide Range Assessment of Memory and Learning scores . Beneficial effects of breastfeeding on the Wide Range Assessment of Visual Motor Abilities at age 3 years seemed greater for women who consumed 2 or more servings of fish per week ( 0.24 ; 0.00 - 0.47 points per month breastfed ) compared with less than 2 servings of fish per week ( −0.01 ; −0.22 to 0.20 points per month breastfed ) ( P = .16 for interaction ) . CONCLUSIONS AND RELEVANCE Our results support a causal relationship of breastfeeding duration with receptive language and verbal and nonverbal intelligence later in life",
"Objective We examined whether trajectories of dietary patterns from 6 to 24 months of age are associated with intelligence quotient ( IQ ) in childhood and adolescence . Methods Participants were children enrolled in a prospect i ve UK birth cohort ( n = 7652 ) who had IQ measured at age 8 and /or 15 years . Dietary patterns were previously extracted from question naires when children were aged 6 , 15 and 24 months using principal component analysis . Dietary trajectories were generated by combining scores on similar dietary patterns across each age , using multilevel mixed models . Associations between dietary trajectories and IQ were examined in generalized linear models with adjustment for potential confounders . Results Four dietary pattern trajectories were constructed from 6 to 24 months of age and were named according to foods that made the strongest contribution to trajectory scores ; Healthy ( characterised by breastfeeding at 6 months , raw fruit and vegetables , cheese and herbs at 15 and 24 months ) ; Discretionary ( biscuits , chocolate , crisps at all ages ) , Traditional ( meat , cooked vegetables and puddings at all ages ) and , Ready-to-eat ( use of ready-prepared baby foods at 6 and 15 months , biscuits , bread and breakfast cereals at 24 months ) . In fully-adjusted models , a 1 SD change in the Healthy trajectory was weakly associated with higher IQ at age 8 ( 1.07 ( 95%CI 0.17 , 1.97 ) ) but not 15 years ( 0.49 ( −0.28 , 1.26 ) ) . Associations between the Discretionary and Traditional trajectories with IQ at 8 and 15 years were as follows ; Discretionary ; 8 years −0.35(−1.03 , 0.33 ) , 15 years −0.73(−1.33 , −0.14 ) Traditional ; 8 years −0.19(−0.71 , 0.33)15 years −0.41(−0.77 , −0.04 ) ) . The Ready-to-eat trajectory had no association with IQ at either age ( 8 years 0.32(−4.31 , 4.95 ) , 15 years 1.11(−3.10 , 5.33 ) . Conclusions The Discretionary and Traditional dietary pattern trajectories from 6 to 24 months of age , over the period when food patterns begin to emerge , are weakly associated with IQ in adolescence",
"PURPOSE This study evaluated the effects of a classroom-based physical activity program on children 's in-school physical activity levels and on-task behavior during academic instruction . METHODS Physical activity of 243 students was assessed during school hours . Intervention-group students ( N = 135 ) received a classroom-based program ( i.e. , Energizers ) . The control group ( N = 108 ) did not receive Energizers . On-task behavior during academic instruction time was observed for 62 third- grade ( N = 37 ) and fourth- grade students ( N = 25 ) before and after Energizers activities . An independent groups t-test compared in-school physical activity levels between intervention and control classes . A multiple-baseline across-classrooms design was used to evaluate the effectiveness of the Energizers on on-task behavior . Additionally , a two-way ( time [ pre- vs postobservation ] x period [ baseline vs intervention ] ) repeated- measures analysis of variance compared on-task behavior between observation periods . Magnitudes of mean differences were evaluated with Cohen 's delta ( ES ) . RESULTS Students in the intervention group took significantly ( P in-school steps ( 5587 + /- 1633 ) than control-group students ( 4805 + /- 1543 ) , and the size of this difference was moderate ( ES = 0.49 ) . The intervention was effective in improving on-task behavior ; after the Energizers were systematic ally implemented , on-task behavior systematic ally improved . The improvement in on-task behavior of 8 % between the pre-Energizers and post-Energizers observations was statistically significant ( P on-task behavior by 20 % after Energizers activities . This improvement was statistically significant ( P classroom-based physical activity program was effective for increasing daily in-school physical activity and improving on-task behavior during academic instruction",
"BACKGROUND The relationship between obesity and academic outcomes remains unclear . We evaluated the association between obesity and cognitive performance in US children . METHODS We analyzed two nationally representative prospect i ve cohorts of children in the 1979 National Longitudinal Survey of Youth , ages 2 through 8 at baseline and followed for 6 years , from 1988 to 1994 ( cohort 1 , n=2672 ) and 1994 to 2000 ( cohort 2 , n=1991 ) . The main exposure variable was obesity ( defined as never obese , became obese , always obese , and became nonobese ) . The main outcomes were st and ardized scores on four cognitive assessment s. Univariate regression analyses of test scores on obesity were performed . Fixed-effects regression models , controlling for measured and unmeasured time-invariant confounders , were additionally adjusted for time-variant confounders to analyze the impact of change in obesity status on change in test scores . RESULTS Unadjusted analyses revealed a significant association between obesity and Peabody Individual Achievement Test ( PIAT ) scores . In cohort 1 , always obese children had lower PIAT math scores than never obese children ( β=-7.48 ; p had lower PIAT math scores than those who were never obese ( β=-16.45 ; p , PIAT math scores were lower in the became obese category than the never obese category ( β=-4.10 ; p had lower PIAT reading scores than those who were never obese ( β=-11.28 ; p the Environment , Short Form score and height percentile showed no significant relationship between obesity and test scores in either cohort . CONCLUSION Childhood obesity is unlikely to be causally related to cognitive performance",
"A growing body of research has illuminated beneficial effects of a single bout of physical activity ( i.e. , acute exercise ) on cognitive function in school-age children . However , the influence of acute exercise on preschoolers ' cognitive function has not been reported . To address this shortcoming , the current study examined the effects of a 30-min bout of exercise on preschoolers ' cognitive function . Preschoolers ' cognitive function was assessed following a single bout of exercise and a single sedentary period . Results revealed that , after engaging in a bout of exercise , preschoolers exhibited markedly better ability to sustain attention , relative to after being sedentary ( p = .006 , partial eta square = .400 ) . Based on these findings , providing exercise opportunities appears to enhance preschoolers ' cognitive function"
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BACKGROUND AND PURPOSE There is increasing interest in the potential benefits of circuit class training after stroke , but its effectiveness is uncertain . Our aim was to systematic ally review r and omized , controlled trials of task-oriented circuit class training on gait and gait-related activities in patients with stroke . METHODS A computer-aided literature search was performed to identify r and omized , controlled trials in which the experimental group received task-oriented circuit class training focusing on the lower limb . Studies published up to March 2008 were included . The method ological quality of each study was assessed and studies with the same outcome variable were pooled by calculating the summary effect sizes using fixed or r and om effects models . RESULTS Six of the 445 studies screened , comprising 307 participants , were included . Physiotherapy Evidence Data base scores ranged from 4 to 8 points with a median of 7.5 points . The meta- analysis demonstrated significant homogeneous summary effect sizes in favor of task-oriented circuit class training for walking distance ( 0.43 ; 95 % CI , 0.17 to 0.68 ; P gait speed ( 0.35 ; 95 % CI , 0.08 to 0.62 ; P=0.012 ) , and a timed up- and -go test ( 0.26 ; 95 % CI , 0.00 to 0.51 ; P=0.047 ) . Nonsignificant summary effect sizes in favor of task-oriented circuit class training were found for the step test and balance control . CONCLUSIONS This meta- analysis supports the use of task-oriented circuit class training to improve gait and gait-related activities in patients with chronic stroke . Further research is needed to investigate the cost-effectiveness and its effects in the subacute phase after stroke , taking comorbidity into account , and to investigate how to help people maintain and improve their physical abilities after their rehabilitation program ends | [
"Background and Purpose — A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training . This study compares the effects of structured speed-dependent treadmill training ( STT ) ( with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology ) with limited progressive treadmill training ( LTT ) and conventional gait training ( CGT ) on clinical outcome measures for patients with hemiparesis . Methods — Sixty ambulatory poststroke patients were each r and omly selected to receive 1 of the 3 different gait therapies : 20 subjects were treated with STT , 20 subjects were trained to walk on a treadmill with a 20 % increase of belt speed over the treatment period ( LTT ) , and 20 subjects were treated with CGT . Treatment outcomes were assessed on the basis of overground walking speed , cadence , stride length , and Functional Ambulation Category scores . Results — After a 4-week training period , the STT group scored significantly higher than the LTT and CGT groups for overground walking speed ( STT versus LTT , P cadence ( STT versus LTT , P = 0.007 ; STT versus CGT , P stride length ( STT versus LTT , P Functional Ambulation Category scores ( STT versus LTT , P = 0.007 ; STT versus CGT , P STT in poststroke patients result ed in better walking abilities than LTT or CGT . This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke",
"Background and Purpose — This study compared the psychometric properties of 3 clinical balance measures , the Berg Balance Scale ( BBS ) , the Balance subscale of the Fugl-Meyer test ( FM-B ) , and the Postural Assessment Scale for Stroke Patients ( PASS ) , in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 180 days after onset . Methods — One hundred twenty-three stroke patients were followed up prospect ively with the 3 balance measures 14 , 30 , 90 , and 180 days after stroke onset ( DAS ) . Reliability ( interrater reliability and internal consistency ) and validity ( concurrent validity , convergent validity , and predictive validity ) of each measure were examined . A comparison of the responsiveness of each of the 3 measures was made on the basis of the entire group of patients and 3 separate groups classified by degree of neurological severity . Results — The FM-B and BBS showed a significant floor or ceiling effect at some DAS points , whereas the PASS did not show these effects . The BBS , FM-B , and PASS all had good reliability and validity for patients at different recovery stages after stroke . The results of effect size demonstrated fair to good responsiveness of all 3 measures within the first 90 DAS but , as expected , only a low level of responsiveness at 90 to 180 DAS . The PASS was more responsive to changes in severe stroke patients at the earliest period after stroke onset , 14 to 30 DAS . Conclusions — All 3 measures tested showed very acceptable levels of reliability , validity , and responsiveness for both clinicians and research ers . The PASS showed slightly better psychometric characteristics than the other 2 measures",
"OBJECTIVE To evaluate the effectiveness of a treadmill and overground walking program in reducing the disability and h and icap associated with poor walking performance after stroke . DESIGN R and omized , placebo-controlled clinical trial with a 3-month follow-up . SETTING General community . PARTICIPANTS A volunteer sample of 29 ambulatory individuals ( less 2 dropouts ) who were living in the community after having suffered a stroke more than 6 months previously . INTERVENTIONS The experimental group participated in a 30-minute treadmill and overground walking program , 3 times a week for 4 weeks . The control group received a placebo consisting of a low-intensity , home exercise program and regular telephone contact . MAIN OUTCOME MEASURES Walking speed ( over 10 m ) , walking capacity ( distance over 6 min ) , and h and icap ( stroke-adapted 30-item version of the Sickness Impact Profile ) measured by a blinded assessor . RESULTS The 4-week treadmill and overground walking program significantly increased walking speed ( P=.02 ) and walking capacity ( P h and icap ( P=.85 ) compared with the placebo program . These gains were largely maintained 3 months after the cessation of training ( P treadmill and overground walking program was effective in improving walking in persons residing in the community after stroke . This suggests that the routine provision of accessible , long-term , community-based walking programs would be beneficial in reducing disability after stroke",
"The purpose of this study was to compare the effects of a task-oriented exercise program with and without altered sensory input on postural stability in subjects with stroke . Sixteen hemiparetic subjects , at least 6 months post-stroke , were r and omly assigned to the experimental or control group , and participated in an 8-week task-oriented exercise program focusing on balance and mobility exercises . Exercises were performed under normal conditions by the control group , and under conditions of vision and surface manipulation by the experimental group . Pre- and post-test assessment s involved the measurement of the center of pressure ( COP ) displacement during double-legged stance and sit-to-st and under four sensory conditions : ( 1 ) eyes open , normal surface ; ( 2 ) eyes open , soft surface ; ( 3 ) eyes closed , normal surface ; and ( 4 ) eyes closed , soft surface , as well as the 10-m walking test . Results showed significant improvements ( P COP displacement under sensory conditions ( 1 ) and ( 2 ) for the experimental group only , and limited changes for the sit-to-st and in both groups after training . Significant improvements ( P task-oriented exercise program , assisted by sensory manipulation , is more effective at improving the st and ing balance of stroke subjects than a conventional task-oriented program . Die vorliegende Studie vergleicht die Wirkung eines anforderungsspezifischen Übungsprogramms mit und ohne Sinnesreizänderung auf die posturale Stabilität von Schlaganfallpatienten . Insgesamt 16 Hemiparetiker wurden mindestens sechs Monate nach dem Schlaganfall r and omisiert der Versuchs- oder der Kontrollgruppe zugeordnet , innerhalb derer sie acht Wochen an einem anforderungsspezifischen Programm mit speziellen Gleichgewichts- und Mobilitätsübungen teilnahmen . Die Kontrollgruppe führte die Übungen unter normalen Bedingungen durch , die Versuchsgruppe dagegen unter Manipulation der Aspekte Sicht und Gehflächen . Bei den Bewertungen vor und nach dem Test wurde die Verlagerung des Druckmittelpunkts ( COP ) während der zweibeinigen Haltung und der Aufstehübung anh and von vier Sinneszuständen gemessen : ( 1 ) offene Augen , normale Fläche , ( 2 ) offene Augen , weiche Fläche , ( 3 ) geschlossene Augen , normale Fläche und ( 4 ) geschlossene Augen , weiche Fläche sowie anh and des 10 m Gehtests . Die Ergebnisse wiesen nur bei der Versuchsgruppe bei der COP-Verlagerung unter den Sinneszuständen ( 1 ) und ( 2 ) beachtliche Verbesserungen ( P Verbesserungen ( P anforderungsspezifisches Übungsprogramm mit begleitender Sinnesmanipulation das Gleichgewicht von Schlaganfallpatienten bei aufrechter Körperhaltung effektiver verbessert als ein herkömmliches anforderungsspezifisches Programm . El propósito de este estudio fue comparar los efectos de un programa de ejercicios dirigidos , con estimulación sensorial alterada o sin ella , sobre la estabilidad postural de sujetos con accidente vascular cerebral . Dieciséis sujetos hemiparéticos que habían sufrido un accidente vascular cerebral hacía al menos 6 meses , fueron distribuidos al azar en dos grupos : uno experimental y uno control . Los mismos participaron durante 8 semanas en un programa de ejercicios dirigidos , el cual se centraba en ejercicios de balance y de movilidad . El grupo control realizó los ejercicios en condiciones normales , mientras que el grupo experimental los realizó en condiciones en que la visión y las superficies fueron alteradas . En las evaluaciones realizadas antes y después de los ejercicios se midió la desviación del centro de presión ( CP ) durante la postura de pie utiliz and o ambas piernas , así como en la postura sentada , listo para ponerse de pie , bajo cuatro condiciones sensoriales deferentes : 1 ) ojos abiertos , superficie normal ; 2 ) ojos abiertos , superficie bl and a ; 3 ) ojos cerrados , superficie normal ; y 4 ) ojos cerrados , superficie bl and a. Se realizó además la prueba de la marcha de los 10 m. Los result ados mostraron mejoras significativas ( P ejercicios dirigidos , en los que se utilicen manipulaciones sensoriales , es más efectivo que un programa convencional de ejercicios dirigidos para mejorar el balance durante la postura de pie en sujetos con accidente vascular cerebral . Le but de cette étude était de comparer les effets d'un programme d'exercices fonctionnels assistés ou non de stimulations sensorielles sur la stabilité posturale de sujets atteints d'un accident vasculaire cérébral ( AVC ) . Seize sujets hémiparétiques atteints d'un AVC depuis au moins 6 mois et répartis de façon aléatoire au sein du groupe expérimental et du groupe témoin ont participé à un programme d'exercices fonctionnels de huit semaines portant sur des exercices d'équilibre et de mobilité . Les exercices étaient exécutés en situation normale par le groupe témoin et en situation de manipulation de la vision et de la surface de support par le groupe expérimental . Les évaluations pré et post exercices ont été effectuées à l'aide de la mesure du déplacement du centre de pression ( CP ) lors du maintien de la position debout en appui bipodal et du transfert assis-debout selon les quatre conditions sensorielles suivantes : yeux ouverts , surface normale ( 1 ) ; yeux ouverts , surface moelleuse ( 2 ) ; yeux fermés , surface normale ( 3 ) ; yeux fermés , surface moelleuse ( 4 ) . Le test de marche de 10 mètres a aussi été inclus dans l'évaluation . Les résultats ont démontré une amélioration significative ( P du CP dans les conditions 1 et 2 pour le groupe expérimental seulement ainsi que des changements limités pour le transfert assis-debout chez les deux groupes de sujets à la suite de l'entraînement . Une amélioration significative ( P programme d'exercices fonctionnels assistés de stimulations sensorielles est plus efficace pour l'amélioration du maintien de l'équilibre en position debout chez les sujets atteints d'un AVC qu'un programme d'exercices fonctionnels conventionnnel ",
"OBJECTIVES To identify the most responsive method of measuring gait speed , to estimate the responsiveness of other outcome measures , and to determine whether gait speed predicts discharge destination in acute stroke . DESIGN A prospect i ve cohort study . SETTING Five acute-care hospitals . PATIENTS Fifty subjects with residual gait deficits after a first-time stroke . INTERVENTIONS Five- ( 5mWT ) and 10-meter walk tests ( 10mWT ) at comfortable and maximum speeds , with 2 evaluations conducted an average + /- st and ard deviation ( SD ) of 8 + /- 3 and 38 + /- 5 days poststroke . MAIN OUTCOME MEASURE St and ardized response mean ( SRM = mean change/SD of change ) was used to estimate responsiveness for each walk test , the Berg Balance Scale , the Barthel Index , the Stroke Rehabilitation Assessment of Movement ( STREAM ) , and the Timed Up and Go ( TUG ) . RESULTS The SRMs were 1.22 and 1.00 for the 5mWT , and .92 and .83 for the 10mWT performed at a comfortable and maximum pace , respectively . The SRMs for the Berg Balance Scale , the Barthel Index , the STREAM , and the TUG were 1.04,.99,.89 , and .73 , respectively . The probability of discharge to a rehabilitation center for persons walking at 0.6 m/s at the first evaluation was.95 and .22 , respectively . CONCLUSIONS The 5mWT at a comfortable pace is recommended as the measure of choice for clinicians and research ers who need to detect longitudinal change in walking disability in the first 5 weeks poststroke",
"Objective : To evaluate the effect of repetitive locomotor training on an electromechanical gait trainer plus physiotherapy in subacute stroke patients . Design : R and omized controlled trial . Setting : Four German neurological rehabilitation centres . Subjects : One hundred and fifty-five non-ambulatory patients ( first-time stroke Intervention : Group A received 20 min locomotor training and 25 min physiotherapy ; group B had 45 min physiotherapy every week day for four weeks . Main outcome measures : Primary variables were gait ability ( Functional Ambulation Category , 0 - 5 ) and the Barthel Index ( 0 - 100 ) , blindly assessed at study onset , end , and six months later for follow-up . Responders to the therapy had to become ambulatory ( Functional Ambulation Category 4 or 5 ) or reach a Barthel Index of ≥ 75 . Secondary variables were walking velocity , endurance , mobility and leg power . Results : The intention-to-treat analysis revealed that significantly greater number of patients in group A could walk independently : 41 of 77 versus 17 of 78 in group B ( P B a Barthel Index ≥ 75 : 44 of 77 versus 21 of 78 ( P B superior gait ability in group A persisted ( 54 of 77 versus 28 of 78 , P B Conclusions : Intensive locomotor training plus physiotherapy result ed in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone",
"Background and Purpose — Gait velocity is a powerful indicator of function and prognosis after stroke . Gait velocity can be stratified into clinical ly meaningful functional ambulation classes , such as household ambulation ( limited community ambulation ( 0.4 to 0.8 m/s ) , and full community ambulation ( > 0.8 m/s ) . The purpose of the current study was to determine whether changes in velocity-based community ambulation classification were related to clinical ly meaningful changes in stroke-related function and quality of life . Methods — In subacute stroke survivors with mild to moderate deficits who participated in a r and omized clinical trial of stroke rehabilitation and had a baseline gait velocity of 0.8 m/s or less , we assessed the effect of success versus failure to achieve a transition to the next class on function and quality of life according to domains of the Stroke Impact Scale ( SIS ) . Results — Of 64 eligible participants , 19 were initially household ambulators , and 12 of them ( 68 % ) transitioned to limited community ambulation , whereas of 45 initially limited community ambulators , 17 ( 38 % ) became full community ambulators . Function and quality -of-life SIS scores after treatment were significantly higher among survivors who achieved a favorable transition compared with those who did not . Among household ambulators , those who transitioned to limited or full community ambulation had significantly better SIS scores in mobility ( P=0.0299 ) and participation ( P=0.0277 ) . Among limited community ambulators , those who achieved the transition to full community ambulatory status had significantly better scores in SIS participation ( P=0.0085 ) . Conclusions — A gait velocity gain that results in a transition to a higher class of ambulation results in better function and quality of life , especially for household ambulators . Household ambulators possibly had more severe stroke deficits , reducing the risk of “ ceiling ” effects in SIS-measured activities of daily living and instrumental activities of daily living . Outcome assessment based on transitions within a mobility classification scheme that is rooted in gait velocity yields potentially meaningful indicators of clinical benefit . Outcomes should be selected that are clinical ly meaningful for all levels of severity",
"Objective : To evaluate the efficacy of a task-orientated intervention in enhancing competence in walking in people with stroke . Design : Two-centre observer-blinded stratified block-r and omized controlled trial . Setting : General community . Subjects : Between May 2000 and February 2003 , 91 individuals with a residual walking deficit within one year of a first or recurrent stroke consented to participate . Interventions : The experimental intervention comprised 10 functional tasks design ed to strengthen the lower extremities and enhance walking balance , speed and distance . The control intervention involved the practice of upper extremity activities . Subjects in both groups attended sessions three times a week for six weeks . Main measures : Six-minute walk test ( SMWT ) , 5-m walk ( comfortable and maximum pace ) , Berg Balance Scale , timed ‘ up and go ’ . Results : At baseline , subjects in the experimental ( n = 44 ) and control ( n = 47 ) groups walked an average distance of 209 m ( SD = 126 ) and 204 m ( SD = 131 ) , respectively , on the SMWT . Mean improvements of 40 m ( SD = 72 ) , and 5 m ( SD = 66 ) were observed following the experimental and control interventions , respectively . The between-group difference was 35 m ( 95 % confidence interval ( CI ) 7 , 64 ) . Significant between-group effects of 0.21 m/s ( 95 % CI 0.12 , 0.30 ) and of 0.11 m/s ( 95 % CI 0.03 , 0.19 ) in maximum and comfortable walking speed , respectively , were observed . People with a mild , moderate or severe walking deficit at baseline improved an average of 36 ( SD = 96 ) , 55 ( SD = 56 ) and 18 m ( SD = 23 ) , respectively , in SMWT performance following the experimental intervention . Conclusions : Study findings support the efficacy of a task-orientated intervention in enhancing walking distance and speed in the first year post stroke , particularly in people with moderate walking deficits",
"BACKGROUND AND PURPOSE To facilitate optimal stroke rehabilitation , valid interpretation of observed functional recovery is required . The purpose of this study was to examine the longitudinal relationship between comfortable walking speed and Functional Ambulation Categories ( FAC ) scores for physically independent gait . SUBJECTS This study was a prospect i ve cohort study with 73 subjects who were severely affected by acute stroke . METHODS Functional Ambulation Categories classification and walking speed were measured between weeks 4 and 26 after stroke . The responsiveness of walking speed measurements for detecting clinical ly important speed changes was determined , and the longitudinal association between walking speed and FAC scores and its time dependency were established . This relationship subsequently was scrutinized for possible speed changes occurring within specific FAC scores . Responsiveness ratios , r and om coefficient analysis , paired Student t tests , and the Cohen kappa statistic were used for statistical analyses . RESULTS Responsiveness ratios exceeded the smallest detectable differences . R and om coefficient analysis demonstrated a significant between- and within-subject coefficient and a significant negative interaction between timing of measurements and FAC scores . Paired Student t tests revealed mostly significant pretest-posttest differences in walking speeds , and all kappa values for pretest-posttest FAC scores were significant . DISCUSSION AND CONCLUSION Walking speed measurements are sensitive for detecting clinical ly important changes . Functional Ambulation Categories scores are dependent on the timing of comfortable walking speed measurements after stroke . Moreover , there are indications that , in this relationship , repeated FAC appraisal s are not only based on steady walking speeds , but that the walking speeds related to a specific FAC appraisal also change and , over time , may shift gradually from higher to lower speeds",
"OBJECTIVES To evaluate the efficacy of a task-oriented walking intervention in improving balance self-efficacy in persons with stroke and to determine whether effects were task-specific , influenced by baseline level of self-efficacy and associated with changes in walking and balance capacity . DESIGN Secondary analysis of a two-center , observer-blinded , r and omized , controlled trial . SETTING General community . PARTICIPANTS Ninety-one individuals with a residual walking deficit within 1 year of a first or recurrent stroke . INTERVENTION Task-oriented interventions targeting walking or upper extremity ( UE ) function were provided three times a week for 6 weeks . MEASUREMENTS Activities-specific Balance Confidence Scale , Six-Minute Walk Test , 5-m walk , Berg Balance Scale , and Timed \" Up and Go \" administered at baseline and postintervention . RESULTS The walking intervention was associated with a significantly greater average proportional change in balance self-efficacy than the UE intervention . Treatment effects were largest in persons with low self-efficacy at baseline and for activities relating to tasks practice d. In the walking group , change in balance self-efficacy correlated with change in functional walking capacity ( correlation coefficient=0.45 , 95 % confidence interval=0.16 - 0.68 ) . Results of multivariable modeling suggested effect modification by the baseline level of depressive symptoms and a prognostic influence of age , sex , comorbidity , time poststroke , and functional mobility on change in self-efficacy . CONCLUSION Task-oriented walking retraining enhances balance self-efficacy in community-dwelling individuals with chronic stroke . Benefits may be partially the result of improvement in walking capacity . The influence of baseline level of self-efficacy , depressive symptoms , and prognostic variables on treatment effects are of clinical importance and must be verified in future studies",
"BACKGROUND AND PURPOSE Physiologically , it appears plausible for physical activity to decrease stroke risk ; however , epidemiological studies have produced mixed findings . Furthermore , few studies have examined specific kinds and intensities of activities . The purpose of this study was to examine the association between physical activity , including its various components ( walking , climbing stairs , participation in sports and recreational activities ) , and stroke risk . METHODS This was a prospect i ve cohort study of 11 130 Harvard University alumni ( mean age , 58 years ) without cardiovascular disease and cancer at baseline . Men reported their walking , stair climbing , and participation in sports or recreation on baseline question naires in 1977 . Stroke occurrence was assessed with another question naire in 1988 . Death certificates were obtained for decedents through 1990 to determine strokes not previously reported ( total strokes=378 ) . We used Cox proportional hazards regression to estimate the relative risks and 95 % CIs for stroke occurrence associated with physical activity . RESULTS After adjustment for age , smoking , alcohol intake , and early parental death , the relative risks of stroke associated with /=4000 kcal/wk of energy expenditure at baseline were 1.00 ( referent ) , 0.76 ( 95 % CI , 0.59 to 0.98 ) , 0.54 ( 0.38 to 0 . 76 ) , 0.78 ( 0.53 to 1.15 ) , and 0.82 ( 0.58 to 1.14 ) , respectively ; P=0 . 05 for linear trend . Walking > /=20 km/wk was associated with significantly lower risk , independent of other physical activity components . Climbing stairs and activities of at least moderate intensity ( > /=4.5 METs , or multiples of resting metabolic rate ) each showed U-shaped relations to stroke risk , with the risk being significantly lower at the nadir of the curve . Light intensity activities ( stroke risk . CONCLUSIONS Physical activity is associated with decreased stroke risk in men . A decreased risk was observed at energy expenditures of 1000 to 1999 kcal/wk , with further risk decrement seen at 2000 to 2999 kcal/wk but not beyond . Confirmation of the U-shaped relation observed in these data requires similar observations in other population",
"Objective : To investigate the effects of balance training , using force platform biofeedback , on quantitative gait characteristics of hemiparetic patients late after stroke . Design : R and omized , controlled , assessor-blinded trial . Setting : Rehabilitation ward and gait laboratory of a university hospital . Subjects : Forty-one patients ( mean ( st and ard deviation ; SD ) age of 60.9 ( 11.7 ) years ) with hemiparesis late after stroke ( median time since stroke six months ) were r and omly assigned to an experimental or a control group . Interventions : The control group ( n = 19 ) participated in a conventional stroke inpatient rehabilitation programme , whereas the experimental group ( n = 22 ) received 15 sessions of balance training ( using force platform biofeedback ) in addition to the conventional programme . Main outcome measures : Selected paretic side time-distance , kinematic and kinetic gait parameters in sagittal , frontal and transverse planes were measured using a three-dimensional computerized gait analysis system , one week before and after the experimental treatment programme . Results : The control group did not show any statistically significant difference regarding gait characteristics . Pelvic excursion in frontal plane improved significantly ( P = 0.021 ) in the experimental group . The difference between before-after change scores of the groups was significant for pelvic excursion in frontal plane ( P = 0.039 ) and vertical ground reaction force ( P = 0.030 ) in favour of experimental group . Conclusion : Balance training using force platform biofeedback in addition to a conventional inpatient stroke rehabilitation programme is beneficial in improving postural control and weight-bearing on the paretic side while walking late after stroke",
"The purpose of this study was to investigate whether additional practice of either upper limb or mobility tasks improved functional outcome during inpatient stroke rehabilitation . This prospect i ve , r and omised , single blind clinical trial recruited 30 stroke subjects into either an Upper Limb or a Mobility Group . All subjects received their usual rehabilitation and an additional session of task-related practice using a circuit class format . Independent assessors , blinded to group allocation , tested all subjects . Outcome measures used were three items of the Jebsen Taylor H and Function Test ( JTHFT ) , two arm items of the Motor Assessment Scale ( MAS ) , and three mobility measures , the Timed Up and Go Test ( TUGT ) , Step Test , and Six Minute Walk Test ( 6MWT ) . Both groups improved significantly between pre- and post-tests on all of the mobility measures , however only the Upper Limb Group made a significant improvement on the JTHFT and MAS upper arm items . Following four weeks training , the Mobility Group had better locomotor ability than the Upper Limb Group ( between-group differences in the 6MWT of 116.4 m , 95 % CI 31.4 to 201.3 m , Step Test 2.6 repetitions , 95 % CI -1.0 to 6.2 repetitions , and TUGT -7.6 sec , 95 % CI -15.5 to 0.2 sec ) . The JTHFT dexterity scores in the Upper Limb Group were 6.5 sec ( 95 % CI -7.4 to 20.4 sec ) faster than the Mobility Group . Our findings support the use of additional task-related practice during inpatient stroke rehabilitation . The circuit class format was a practical and effective means to provide supervised additional practice that led to significant and meaningful functional gains",
"OBJECTIVE To compare the effectiveness of circuit class therapy and individual physiotherapy ( PT ) sessions in improving walking ability and functional balance for people recovering from stroke . DESIGN Nonr and omized , single-blind controlled trial . SETTING Medical rehabilitation ward of a rehabilitation hospital . PARTICIPANTS Sixty-eight persons receiving inpatient rehabilitation after a stroke . INTERVENTIONS Subjects received group circuit class therapy or individual treatment sessions as the sole method of PT service delivery for the duration of their inpatient stay . MAIN OUTCOME MEASURES Five-meter walk test ( 5MWT ) , two-minute walk test ( 2MWT ) , and the Berg Balance Scale ( BBS ) measured 4 weeks after admission . Secondary outcome measures included the Iowa Level of Assistance Scale , Motor Assessment Scale upper-limb items , and patient satisfaction . Measures were taken on admission and 4 weeks later . RESULTS Subjects in both groups showed significant improvements between admission and week 4 in all primary outcome measures . There were no significant between group differences in the primary outcome measures at week 4 ( 5MWT mean difference , .07 m/s ; 2MWT mean difference , 1.8 m ; BBS mean difference , 3.9 points ) . A significantly higher proportion of subjects in the circuit class therapy group were able to walk independently at discharge ( P=.01 ) and were satisfied with the amount of therapy received ( P=.007 ) . CONCLUSIONS Circuit class therapy appeared as effective as individual PT sessions for this sample of subjects receiving inpatient rehabilitation poststroke . Favorable results for circuit classes in terms of increased walking independence and patient satisfaction suggest this model of service delivery warrants further investigation",
"PURPOSE The purpose of this study was to evaluate the physical and psychosocial effects of an 8-wk community-based functional exercise program in a group of individuals with chronic stroke . METHODS Twenty-five subjects ( mean age 63 yr ) participated in a repeated measures design that evaluated the subjects with two baseline assessment s 1 month apart , one postintervention assessment , and one retention assessment 1 month postintervention . Physical outcome measures assessed were the Berg Balance Test , 12-Minute Walk Test distance , gait speed , and stair climbing speed . Psychosocial measures assessed were the Reintegration to Normal Living Index ( RNL ) and Canadian Occupational Performance Measure ( COPM ) . The 8-wk training consisted of a 60-min , 3 x wk-1 group program that focused on balance , mobility , functional strength , and functional capacity . The program was design ed to be accessible by reducing the need for costly one-on-one supervision , specialized setting s , and expensive equipment . RESULTS Improvements from the exercise program were found for all physical measures and these effects were retained 1-month postintervention . Subjects with lower function improved the most relative to their initial physical status . Significant effects were found for the COPM , but not the RNL Index ; however , subjects with lower RNL improved the most relative to their initial RNL Score . CONCLUSION A short-term community-based exercise program can improve and retain mobility , functional capacity , and balance and result in a demonstrable impact upon the performance of activities and abilities that were considered meaningful to the subjects . Implementation of such community-based programs has potential for improving activity tolerance and reducing the risk for secondary complications common to stroke ( e.g. , falls result ing in fractures and cardiac events ) ",
"OBJECTIVE To evaluate the immediate and retention effects of a 4-week training program on the performance of locomotor-related tasks in chronic stroke . DESIGN R and omized , controlled pilot study with 2-month follow-up . SETTING Rehabilitation center . SUBJECTS A convenience sample consisting of 12 chronic stroke subjects was used . Subjects were r and omly assigned to the experimental or the control group . Three subjects withdrew from the study . INTERVENTION Both experimental and control groups participated in exercise classes three times a week for 4 weeks . The exercise class for the experimental group focused on strengthening the affected lower limb and practicing functional tasks involving the lower limbs , while the control group practice d upper-limb tasks . MAIN OUTCOME MEASURES Lower-limb function was evaluated by measuring walking speed and endurance , peak vertical ground reaction force through the affected foot during sit-to-st and , and the step test . RESULTS The experimental group demonstrated significant immediate and retained ( 2-month follow-up ) improvement ( p walking speed and endurance , force production through the affected leg during sit-to-st and , and the number of repetitions of the step test . CONCLUSION The pilot study provides evidence for the efficacy of a task-related circuit class at improving locomotor function in chronic stroke",
"OBJECTIVES We sought to assess a training program focused on muscle strength and endurance in persons with prior stroke . METHODS Thirty men with a slight hemiparesis caused by a first occurrence of stroke at least 6 months earlier were included with an average age of 54 years . The following was assessed before and after an 8-week period : muscle strength , endurance , work capacity , and activity level . The training group consisted of 21 persons and 9 served as control subjects . There were no differences between the groups in the various assessment s from the start . The training was set up as circuit training with 5 stations aim ing to strengthen the muscles and increase endurance in the bilateral lower limbs . The session lasted for 45 minutes , 3 times per week , for 8 weeks . On eligible persons in the training group , double-sided muscle biopsies were also performed before and after . RESULTS There was significance in improved muscle strength and improved peak oxygen uptake for the paretic leg , which was reflected in the muscle enzymes . The nonparetic side also showed improvement , but to a lesser extent . The control group remained unchanged . CONCLUSIONS Stroke survivors can improve muscle strength , endurance , and work capacity in both the paretic and nonparetic leg with a circuit training program",
"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 .",
"We prospect ively evaluated gait recovery in 197 elderly subjects after hemiplegic stroke by measuring serial walking speed . Fifty-seven per cent of subjects ( 113/197 ) could not walk without human assistance on day 7 post-stroke . About 40 % of this group achieved gait independence at months 1 , 2 , 3 , and 4 post-stroke . In contrast , about 95 % of those walking on day 7 maintained gait independence 1 , 2 , 3 , and 4 months post-stroke . Using multiple logistic regression , the best predictors of independent ambulation among the 113 subjects not walking on day 7 were age , line bisection error , and leg power",
"OBJECTIVES To examine the effects of a community-based group exercise program for older individuals with chronic stroke . DESIGN Prospect i ve , single-blind , r and omized , controlled intervention trial . SETTING Intervention was community-based . Data collection was performed in a research laboratory located in a rehabilitation hospital . PARTICIPANTS Sixty-three older individuals ( aged > or = 50 ) with chronic stroke ( poststroke duration > or = 1 year ) who were living in the community . INTERVENTION Participants were r and omized into intervention group ( n=32 ) or control group ( n=31 ) . The intervention group underwent a fitness and mobility exercise ( FAME ) program design ed to improve cardiorespiratory fitness , mobility , leg muscle strength , balance , and hip bone mineral density ( BMD ) ( 1-hour sessions , three sessions/week , for 19 weeks ) . The control group underwent a seated upper extremity program . MEASUREMENTS Cardiorespiratory fitness ( maximal oxygen consumption ) , mobility ( 6-minute walk test ) , leg muscle strength ( isometric knee extension ) , balance ( Berg Balance Scale ) , activity and participation ( Physical Activity Scale for Individuals with Physical Disabilities ) , and femoral neck BMD ( using dual-energy x-ray absorptiometry ) . RESULTS The intervention group had significantly more gains in cardiorespiratory fitness , mobility , and paretic leg muscle strength than controls . Femoral neck BMD of the paretic leg was maintained in the intervention group , whereas a significant decline of the same occurred in controls . There was no significant time-by-group interaction for balance , activity and participation , nonparetic leg muscle strength , or nonparetic femoral neck BMD . CONCLUSION The FAME program is feasible and beneficial for improving some of the secondary complications result ing from physical inactivity in older adults living with stroke . It may serve as a good model of a community-based fitness program for preventing secondary diseases in older adults living with chronic conditions",
"Objective : To discover if the provision of additional inpatient physiotherapy after stroke speeds the recovery of mobility . Design : A multisite single-blind r and omized controlled trial ( RCT ) comparing the effects of augmented physiotherapy input with normal input on the recovery of mobility after stroke . Setting : Three rehabilitation hospitals in North Glasgow , Scotl and . Subjects : Patients admitted to hospital with a clinical diagnosis of stroke , who were able to tolerate and benefit from mobility rehabilitation . Intervention : We aim ed to provide double the amount of physiotherapy to the augmented group . Main measures : Primary outcomes were mobility milestones ( ability to st and , step and walk ) , Rivermead Mobility Index ( RMI ) and walking speed . Results : Seventy patients were recruited . The augmented therapy group received more direct contact with a physiotherapist ( 62 versus 35 minutes per weekday ) and were more active ( 8.0 % versus 4.8 % time st and ing or walking ) than normal therapy controls . The augmented group tended to achieve independent walking earlier ( hazard ratio 1.48 , 95 % confidence interval 0.90–2.43 ; p=0.12 ) and had higher Rivermead Mobility Index scores at three months ( mean difference 1.6 ; 0.1 to 3.3 ; p=0.068 ) but these differences did not reach statistical significance . There was no significant difference in any other outcome . Conclusions : A modest augmented physiotherapy programme result ed in patients having more direct physiotherapy time and being more active . The inability to show statistically significant changes in outcome measures could indicate either that this intervention is ineffective or that our study could not detect modest changes",
"The Berg Balance Scale ( BBS ) was design ed to help determine change in functional st and ing balance over time . The purpose of this paper was to estimate the minimum detectable change score ( MDC ) using the st and ard error of measure ( SEM ) , thereby providing a means to decide if genuine change had occurred . Calculation of the agreement regarding the presence of change as determined by the MDC and clinicians ' perceptions was performed to give an indication of the validity of this criterion value . Forty-eight subjects who were receiving inpatient rehabilitation after stroke were assessed on consecutive days by two raters using the BBS . The MDC analysis suggests that a change of + /- 6 BBS points is necessary to be 90 % confident of genuine change . Only 25/45 subjects showed agreement between the statistically derived presence of change and clinicians ' perceptions of change . The lack of agreement may relate to the validity of the SEM/MDC methodology to determine the criterion BBS value , the heterogeneity of the subjects , or the use of clinician gestalt impressions of change",
"Time course and degree of the recovery of walking function after stroke and the influence of initial lower extremity ( LE ) paresis were studied prospect ively in a community-based population of 804 consecutive acute stroke patients . Walking function and degree of LE paresis were assessed weekly using the Barthel index and the Sc and inavian Neurological Stroke scale , respectively . Initially , 51 % had no walking function , 12 % could walk with assistance , and 37 % had independent walking function . At the end of rehabilitation , 21 % had died , 18 % had no walking function , 11 % could walk with assistance , and 50 % had independent walking function . Recovery of walking function occurs in 95 % of the patients within the first 11 weeks after stroke . The time and the degree of recovery are related to both the degree of initial impairment of walking function and to the severity of LE paresis , p of walking function in patients with initially no/mild/moderate leg paresis can be made in 3 weeks , and further recovery should not be expected after 9 weeks . A valid prognosis of walking function in patients with initially severe leg paresis or paralysis can be made in 6 weeks , and further improvement of walking function should not be expected later than 11 weeks after stroke",
"This paper describes PEDro , the Physiotherapy Evidence Data base . PEDro is a web-based data base of r and omized controlled trials and systematic review s in physiotherapy . It can be accessed free of charge at http://ptwww.cchs.usyd.edu.au/pedro . The data base contains bibliographic details and abstract s of most English- language r and omized trials and systematic review s in physiotherapy , and of many trials and review s in other language s. Trials on the data base are rated on the basis of their method ological quality so that users of the data base can quickly identify trials of high quality . Trials and systematic review s are extensively indexed to facilitate search ing . PEDro provides an important information re source to support evidence -based clinical practice",
"A r and omized controlled pilot trial was conducted to estimate the effects of early , intensive , gait-focused physical therapy on ambulatory ability in acute , stroke patients . Twenty-seven patients with middle cerebral artery infa rct of thromboembolic origin confirmed by computed axial tomography scan were stratified and r and omly assigned to the experimental group , to a control group that received early , intensive and conventional therapy , or to a group receiving routine conventional therapy that started later and was not intense . Assessment s at entry , six weeks , and three and six months by independent evaluators permitted comparisons with reference to clinical measures of motor performance , balance , and functional capacity , and laboratory measures of gait movements . Group results at six weeks demonstrated that gait velocity was similar in the two conventional groups thereby eliminating the timing of the interventions as an important factor . At that point , gait velocity was faster in the experimental group . The difference translated into a moderate effect size of 0.58 . The time dedicated to gait training but not to total therapy time was correlated ( rs = 0.63 ) to gait velocity . This effect disappeared at three and six months after stroke . These pilot results justify planning a large trial to test the effectiveness of a therapeutic protocol that focuses on early and intense gait therapy in an effort to facilitate early ambulation following stroke",
"OBJECTIVES To determine the feasibility and effect of exercise training after stroke . DESIGN R and omized exploratory trial comparing exercise training ( including progressive endurance and resistance training ) with relaxation ( attention control ) . SETTING Interventions were performed in a rehabilitation hospital . PARTICIPANTS Sixty-six independently ambulatory patients ( mean age 72 , 36 men ) without significant dysphasia , confusion , or medical contraindications to exercise training who had completed their usual rehabilitation and had been discharged from hospital . INTERVENTION Both interventions were held three times a week for 12 weeks . Up to seven patients attended each session . MEASUREMENTS The Functional Independence Measure ; Nottingham Extended Activities of Daily Living ; Rivermead Mobility Index ; functional reach ; sit-to-st and ; elderly mobility score ; timed up- and -go ; Medical Outcomes Study 36-Item Short Form Question naire , version 2 ( SF-36 ) ; Hospital Anxiety and Depression Score ; aspects of physical fitness ( comfortable walking speed , walking economy , and explosive leg extensor power ) were measured at baseline , immediately after interventions ( 3 months ) , and 7 months after baseline . RESULTS The median number of intervention sessions attended was 36 ( interquartile range ( IQR ) 30.00 - 36.75 ) for exercise and 36 ( IQR 30.50 - 37.00 ) for relaxation . Adherence to the individual exercises ranged from 94 % to 99 % . At 3 months , role-physical ( an item in SF-36 ) , timed up- and -go , and walking economy were significantly better in the exercise group ( analysis of covariance ) . At 7 months , role-physical was the only significant difference between groups . CONCLUSION Exercise training for ambulatory stroke patients was feasible and led to significantly greater benefits in aspects of physical function and perceived effect of physical health on daily life",
"Background and Purpose : A phase II , single-blinded , r and omized clinical trial was conducted to determine the effects of combined task-specific and lower-extremity ( LE ) strength training to improve walking ability after stroke . Subjects : The participants were 80 adults who were ambulatory 4 months to 5 years after a unilateral stroke . Method : The exercise interventions consisted of body-weight – supported treadmill training ( BWSTT ) , limb-loaded resistive leg cycling ( CYCLE ) , LE muscle-specific progressive-resistive exercise ( LE-EX ) , and upper-extremity ergometry ( UE-EX ) . After baseline assessment s , participants were r and omly assigned to a combined exercise program that included an exercise pair . The exercise pairs were : BWSTT/UE-EX , CYCLE/UE-EX , BWSTT/CYCLE , and BWSTT/LE-EX . Exercise sessions were 4 times per week for 6 weeks ( total of 24 sessions ) , with exercise type completed on alternate days . Outcomes were self-selected walking speed , fast walking speed , and 6-minute walk distance measured before and after intervention and at a 6-month follow-up . Results : The BWSTT/UE-EX group had significantly greater walking speed increases compared with the CYCLE/UE-EX group ; both groups improved in distance walked . All BWSTT groups increased walking speed and distance whether BWSTT was combined with LE strength training or not . Discussion and Conclusion : After chronic stroke , task-specific training during treadmill walking with body-weight support is more effective in improving walking speed and maintaining these gains at 6 months than resisted leg cycling alone . Consistent with the overtraining literature , LE strength training alternated daily with BWSTT walking did not provide an added benefit to walking outcomes",
"Objective : To examine the effectiveness of task-oriented progressive resistance strength training on lower extremity strength and functional performance in chronic stroke subjects . Design : Single-blind , r and omized controlled trial . Setting : Medical centre and district hospital . Subjects : Forty-eight subjects at least one year post stroke . Interventions : Participants r and omly allocated to two groups , control ( n-/24 ) and experimental ( n-/24 ) . Subjects in the control group did not receive any rehabilitation training . Subjects in the experimental group were put on a four-week task-oriented progressive resistance strength training . Main measures : Lower extremity muscle strength , gait velocity , cadence , stride length , six-minute walk test , step test , and timed up and go test . Results : Muscle strength significantly improved in the experimental group for strong side muscle groups ( ranged from 23.9 % to 36.5 % ) and paretic side muscle groups ( ranged from 10.1 % to 77.9 % ) . In the control group muscle strength changes ranged from 6.7 % gain to 11.2 % decline . The experimental group showed significant improvement in all selected measures of functional performance except for the step test . In the control group , the number of repetitions of the step test significantly decreased ( -20.3 % ) with no change in other functional tests . There was a significant difference between groups for muscle strength and all functional measures . The strength gain was significantly associated with gain in the functional tests . Conclusions : The task-oriented progressive resistance strength training programme could improve lower extremity muscle strength in individuals with chronic stroke and could carry over into improvement in functional abilities",
"BACKGROUND AND PURPOSE In hemiparetic individuals , low endurance to exercise may compound the increased energy cost of movement and contribute to poor rehabilitation outcomes . The purpose of this investigation was to describe how hemiparetic stroke patients responded to intense exercise and aerobic training . METHODS Forty-two subjects were r and omly assigned to an exercise training group or to a control group . Treatments were given three times per week for 10 weeks in similar laboratory setting s. Baseline and posttest measurements were made of maximal oxygen consumption , heart rate , workload , exercise time , resting and submaximal blood pressures , and sensorimotor function . RESULTS Only experimental subjects showed significant improvement in maximal oxygen consumption , workload , and exercise time . Improvement in sensorimotor function was significantly related to the improvement in aerobic capacity . After treatment , experimental subjects showed significantly lower systolic blood pressure at submaximal workloads during the grade d exercise test . CONCLUSIONS We conclude that hemiparetic stroke patients may improve their aerobic capacity and submaximal exercise systolic blood pressure response with training . Sensorimotor improvement is related to the improvement in aerobic capacity"
] | 41165c54-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE The six-minute walk test ( 6MWT ) is a sub-maximal exercise test measuring the distance that a patient can walk quickly in a period of 6 minutes ( 6MWD ) . The objectives of this systematic review are to evaluate the 6MWT 's suitability for measuring the impact of an intervention , to compare the 6MWD walked by patients with schizophrenia with data for the general population or matched controls , to identify the determinants of 6MWD and to examine the measurement properties and quality procedures of the 6MWT . METHODS Using five data bases , we performed a systematic review of full-text articles published through August 2013 . RESULTS Sixteen studies met our selection criteria . The assessment of the 6MWT 's suitability for measuring the impact of interventions was not made because none of the interventional studies reported a significant increase in 6MWD . The distance walked by adults with schizophrenia seemed generally shorter than that walked by healthy adults . Mean 6MWDs ranged from 421 m to 648 m in the included studies . The 6MWD is usually negatively associated with a higher Body Mass Index , increased cigarette consumption , higher doses of antipsychotic medication and lower physical self-worth in individuals with schizophrenia . The 6MWT demonstrates high reliability . To date , however , its criterion validity has not been investigated . In spite of existing guidelines , the test procedures used in the studies review ed varied significantly . CONCLUSIONS Future physical health monitoring recommendations for patients with schizophrenia should include the 6MWT . Future studies should investigate its predictive role and continue to assess its measurement properties . IMPLICATION S FOR REHABILITATION The Six-Minute Walk Test reliably assesses the functional exercise capacity in patients with schizophrenia . The impact of therapeutic interventions on patients , as measured by the 6MWT , can not be confirmed . Clinicians should take into account overweight , antipsychotic medication use and the physical self-perception when considering the functional exercise capacity in schizophrenia . Clinicians should follow International st and ards such as these of the American Thoracic Society when using the Six-Minute Walk Test in patients with severe mental illnesses | [
"Objective : Overweight and obesity are epidemic in population s with serious mental illnesses . We developed and pilot-tested a behavioral weight-loss intervention appropriately tailored for persons with serious mental disorders . Methods : We conducted a single-arm pilot study in two psychiatric rehabilitation day programs in Maryl and , and enrolled 63 overweight or obese adults . The 6-month intervention provided group and individual weight management and group physical activity classes . The primary outcome was weight change from baseline to 6 months . Results : A total of 64 % of those potentially eligible enrolled at the centers . The mean age was 43.7 years ; 56 % were women ; 49 % were white ; and over half had schizophrenia or a schizoaffective disorder . One-third had hypertension and one-fifth had diabetes . In total , 52 ( 82 % ) completed the study ; others were discharged from psychiatric centers before completion of the study . Average attendance across all weight management sessions was 70 % ( 87 % on days participants attended the center ) and 59 % for physical activity classes ( 74 % on days participants attended the center ) . From a baseline mean of 210.9 lbs ( s.d . 43.9 ) , average weight loss for 52 participants was 4.5 lb ( s.d . 12.8 ) ( P body weight . Mean waist circumference change was 3.1 cm ( s.d . 5.6 ) . Participants on average increased the distance on the 6-minute walk test by 8 % . Conclusion : This pilot study documents the feasibility and preliminary efficacy of a behavioral weight-loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers . The results may have implication s for developing weight-loss interventions in other institutional setting s such as schools or nursing homes",
"The 6-minute walk test is used in clinical practice and clinical trials of lung diseases ; however , it is not clear whether replicate tests need to be performed to assess performance . Furthermore , little is known about the impact of walking course layout on test performance . We conducted 6-minute walks on 761 patients with severe emphysema ( mean + /- SD FEV1 % predicted = 26.3 + /- 7.2 ) who were participants in the National Emphysema Treatment Trial . Four hundred seventy participants had repeated walks on a separate day . The second test was improved by an average of 7.0 + /- 15.2 % ( 66.1 + /- 146 feet , p distance walked . Participants tested on continuous ( circular or oval ) courses had a 92.2-foot longer walking distance than those tested on straight ( out and back ) courses . Course length had no significant effect on walking distance . The training effect found in these patients with severe emphysema is less than in previous reports of patients with chronic obstructive pulmonary disease . Furthermore , the layout of the track may influence the 6-minute walk performance",
"Background : Patients with schizophrenia have a high risk of cardiovascular disease ( CVD ) . High aerobic intensity training ( HIT ) improve peak oxygen uptake ( VO2peak ) , net mechanical efficiency of walking and risk factors for CVD but has not been investigated in patients with schizophrenia . Aims : To investigate effects from HIT on VO2peak , net mechanical efficiency of walking and risk factors for CVD in patients with schizophrenia . Methods : 25 in patients ( F20–29 , ICD-10 ) were allocated to either HIT or playing computer games ( CG ) , 3 days per week for 8 weeks . HIT consisted of 4 × 4-min intervals with 3-min break periods , at 85–95 % and 70 % of peak heart rate , respectively . Results : 12 and seven patients completed HIT and CG , respectively . The baseline VO2peak in both groups combined ( n = 19 ) was 36.8 ± 8.2 ml/kg/min and 3.12 ± 0.55 l/min . The HIT group improved VO2peak by 12 % from 3.17 ± 0.59 to 3.56 ± 0.68 l/min ( P ( P = 0.014 ) . Net mechanical efficiency of walking improved by 12 % in the HIT group from 19.8 ± 3.0 % to 22.2 ± 4.5 % ( P = 0.005 ) , more than the CG group ( P = 0.031 ) . The psychiatric symptoms , expressed as the Positive and Negative Syndrome Scale ( PANSS ) and the Calgary Depression Scale for Schizophrenia ( CDSS ) , did not improve in either group . Conclusions : VO2peak and net mechanical efficiency of walking improved significantly by 8 weeks of HIT . HIT should be included in rehabilitation in order to improve physical capacity and contribute risk reduction of CVD",
"Background Weight gain is common for people with schizophrenia and this has serious implication s for health and well being . Objectives To determine the effects of both pharmacological ( excluding medication switching ) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia . Search methods We search ed key data bases and the Cochrane Schizophrenia Group 's trials register ( April 2006 ) , reference sections within relevant papers , h and search ed key journals , and contacted the first author of each relevant study and other experts to collect further information . Selection criteria We included all clinical r and omised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain ( diet and exercise counselling ) with st and ard care or other treatments for people with schizophrenia or schizophrenia-like illnesses . Data collection and analysis We reliably selected , quality assessed and extracted data from studies . As weight is a continuous outcome measurement , weighted mean differences ( WMD ) of the change from baseline were calculated . The primary outcome measure was weight loss . Main results Twenty-three r and omised controlled trials met the inclusion criteria for this review . Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct . In terms of prevention , two cognitive/behavioural trials showed significant treatment effect ( mean weight change ) at end of treatment ( n=104 , 2 RCTs , WMD -3.38 kg CI -4.2 to -2.0 ) . Pharmacological adjunct treatments were significant with a modest prevention of weight gain ( n=274 , 6 RCTs , WMD - 1.16 kg CI -1.9 to -0.4 ) . In terms of treatments for weight loss , we found significantly greater weight reduction in the cognitive behavioural intervention group ( n=129 , 3 RCTs , WMD -1.69 kg CI -2.8 to -0.6 ) compared with st and ard care . Authors ' conclusions Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions . However , interpretation is limited by the small number of studies , small sample size , short study duration and by variability of the interventions themselves , their intensity and duration . Future studies adequately powered , with longer treatment duration and rigorous methodology will be needed in further evaluating the efficacy and safety of weight loss interventions for moderating weight gain . At this stage , there is insufficient evidence to support the general use of pharmacological interventions for weight management in people with schizophrenia",
"Although the benefits of exercise are well documented , few published research studies have examined exercise in persons with schizophrenia . This pilot examined a 16-week walking program for out patients diagnosed with schizophrenia ( N = 10 ) . Six-minute walking distance , body mass index , percent body fat and severity of psychiatric symptoms were measured . Experimental participants in the walking group experienced significant reductions in body fat ( p = 0.03 ) compared to a control group not participating in the exercises during the same time period . Experimental participants also had greater aerobic fitness , lower body mass indexes , and fewer psychiatric symptoms than controls at the conclusion of the program . Research is needed to identify effective exercise interventions and feasible delivery modalities for persons with schizophrenia in community setting",
"RATIONALE Although commonly used as the primary outcome measure of clinical trials in pulmonary arterial hypertension ( PAH ) , the minimal important difference ( MID ) of the 6-minute walk test ( 6MWT ) has not been well defined for this population of patients . OBJECTIVES To estimate the MID in the 6MWT in patients with PAH . METHODS Study subjects from the clinical trial of tadalafil in PAH , a 16-week , parallel-group , r and omized clinical trial of patients who were treatment naive or on background therapy with an endothelin receptor antagonist , were eligible . 6MWT was performed using a st and ardized protocol . Distributional and anchor-based methods were used to estimate the MID ; the latter method used the Physical Component Summary Score ( PCS ) of the Medical Outcomes Study 36-item short form ( SF-36 ) . MEASUREMENTS AND MAIN RESULTS Four hundred five subjects were analyzed . Domains of the SF-36 were weakly to modestly associated with 6MWT . Change in the PCS of the SF-36 was most strongly associated with change in 6MWT ( r = 0.40 , P MID ranging from 25.1 to 38.5 m , whereas anchor-based analyses yielded an estimate of 38.6 m. CONCLUSIONS Using both distributional and anchor-based methods , the estimated consensus MID in the 6MWT for PAH is approximately 33 m. These results have important implication s for ( 1 ) assessing treatment responses from clinical trials and metaanalyses of specific PAH therapy , and ( 2 ) sample size calculations for future study design",
"Background : Increasingly alarmed by the health risks ( that is , weight gain , elevated lipids , and poor glucose tolerance ) posed by novel antipsychotic medications , clinicians who treat schizophrenia are attempting to help patients improve lifestyle factors . Unfortunately , schizophrenia research has neglected exercise as a legitimate adjunctive treatment for schizophrenia . Objective : To assess the extent to which stable patients with schizophrenia would adhere to an exercise program if offered access to a fitness facility . Methods : Ten of 20 stable patients with schizophrenia or schizoaffective disorder who were treated with olanzapine for at least 4 weeks had the opportunity to receive access to a Young Men 's Christian Association ( YMCA ) fitness facility , based on r and om allocation . The intervention included a free membership to the YMCA for 6 months , with access to all the fitness amenities and equipment . The mean dosage of olanzapine was 11.5 mg daily for the YMCA group . Results : Of the 10 subjects , 2 did not attend at all . One subject met criteria for full attendance for each of the 6 months and lost 15 kg . Dropout rates were as follows : 90 % at 6 months , 70 % at 5 months , and 40 % at 4 months . The main reason they gave for poor attendance was lack of motivation . The mean weight gain was 2 kg in the YMCA group . Conclusion : Most subjects did not regularly exercise or attend . They cited poor motivation as the main reason . The subject who exercised regularly lost a significant amount of weight",
"Purpose . To evaluate the feasibility and effects of an exercise programme on people with severe , chronic schizophrenia . Method . A single-group , pre-post pilot study incorporating a baseline familiarisation phase was followed by a 24-week , small-group aerobic exercise programme for up to 30-min each session , twice a week and a 30-min weekly walking session . Adherence was assessed by attendance , and by analysing the exercise supervisor 's comments in a programme diary and in each participant 's exercise logbook . Body weight , cardio-respiratory fitness ( VO2 max ) , walking endurance ( 6-min walk test ) and psychiatric symptoms ( the Positive and Negative Syndrome Scale ) were measured at each time point . Results . Eight participants ( 6 men , 2 women ; mean age 45 years , 9 months ( SD 10 years , 1 month ) ; mean body mass index 27.0 ( SD 4.2 ) ) attended a mean of 73%% of the scheduled exercise sessions , and 83%% of the walking sessions , with no adverse events and no dropouts . All participants displayed positive and negative behaviours during training sessions . There were significant reductions in weight ( 2.4%% ) and body mass index ( 2.2%% ) , but no changes in other measures . Conclusions . It was feasible and safe to conduct a small-group aerobic exercise programme for adults with severe chronic schizophrenia that reduced body weight"
] | 41165c90-06ff-11f0-808a-c43d1ab1c353 |
Currently the effects of bariatric surgery are generally expressed in excess weight loss or comorbidity reduction . Therefore the aim of this review was to provide insight in the available prospect i ve evidence regarding the short and long-term effects of bariatric surgery on Quality of Life ( QoL ) and a comparison with community norms . A systematic multi- data base search was conducted for ‘ QoL ’ and ‘ Bariatric surgery ’ . Only prospect i ve studies with QoL before and after bariatric surgery were included . The ‘ Quality Assessment Tool for Before – After Studies with No Control Group ’ was used to assess the method ological quality . Thirty-six studies met the inclusion criteria . Most studies were assessed to be of ‘ fair ’ to ‘ good ’ method ological quality . Ten different question naires were used to measure QoL. Follow-up ranged from 6 months to 10 years , sample sizes from 26 to 1276 and follow-up rates from 45 to 100 % . A significant increase in QoL after bariatric surgery was found in all studies ( P⩽0.05 ) , however , mostly these outcomes stay below community norms . Only outcomes of the IWQoL , SF-36 and OWQoL show QoL outcomes that exceed community norms . The QoL is increased after bariatric surgery on both the short and long term . However , due to the heterogeneity of the studies and the generality of the question naires is it hard to make a distinction between different surgeries and difficult to see a relation with medical profit . Therefore , tailoring QoL measurements to the bariatric population is recommended as the focus of future studies | [
"BACKGROUND We analyzed the health-related quality of life ( HRQOL ) and its determinants in the first year after laparoscopic adjustable gastric b and ing ( LAGB ) . The setting was 10 Italian public and private bariatric surgery centers . METHODS Data collected in an ongoing , prospect i ve , 3-year multicenter Italian study on the changes in HRQOL after LAGB were used . HRQOL was investigated using the Medical Outcomes Study Short-Form 36 question naire . Hunger , satiety , and the self-perceived effects of LAGB were recorded . RESULTS A total of 334 patients were enrolled . The follow-up rate was 92.2 % . The percentage of excess weight loss was 39.6 % ± 25.8 % , with very few side effects or complications . Hunger in the morning ( 0 - 10 scale ) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year ( P .001 ) . Satiety after a meal ( 0 - 10 scale ) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year ( P The self-perceived effect of LAGB on caloric intake ( 0 - 10 scale ) was 8.4 ± 1.9 after 1 year . The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery . The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year ( P .001 ) . The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 ( P improvement was independently associated with a low initial physical component summary ( P ( P = .002 ) , a high percentage of excess weight loss ( P = .013 ) , and a high self-perceived effect of the LAGB ( P = .026 ) . Greater mental component summary improvement was associated with a low initial mental component summary ( P ( P ( P = .004 ) , and a high percentage of excess weight loss ( P = .012 ) . CONCLUSIONS Significant improvements in HRQOL were observed in the first year after LAGB . A poor baseline HRQOL , a high efficacy of the b and ing in eating control , and better weight loss might influence HRQOL changes",
"BACKGROUND Improvements in health-related quality of life ( HR-QoL ) occur after bariatric surgery . However , sustainability of these changes over time remains debated . METHODS Data collected in a prospect i ve 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric b and ing were used . HR-QoL has investigated with the SF-36 question naire . Hunger , satiety , and the self-perceived effects of LAGB were recorded . RESULTS A total of 230 patients ( 53 male and 177 female ) were analyzed . Body mass index was 41.4±5.4 kg/m2 at baseline , declined to 33.8±5.8 kg/m2 12 months after surgery ( P . Scores in the SF-36 subscales were lower than in the general Italian population at baseline . The physical component summary score was 51.9±11.6 at baseline , improved to 79.2±15.4 at 12 months ( P . The mental summary score was 52.3±11.8 at baseline , improved to 75.2±17.3 at 12 months ( P10 points between 12 and 36 months in the summary scores was observed in 22.0 % of the patients for PCS and in 26.8 % for MCS . In a multiple linear regression analysis , deterioration in HR-QoL in the 12 - 36 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the b and ing at 36 months . CONCLUSION Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric b and ing",
"BACKGROUND Being overweight or obese has substantial effects on individuals ' perceptions of their health and quality of life ( QoL ) . Generic measures often miss important QoL information , and existing obesity-specific instruments have shortcomings with respect to cross-cultural input , application to differing levels of severity , conceptual clarity , and patient burden . OBJECTIVE This study aim ed to develop culturally sensitive measures of QoL and symptoms in overweight or obese persons , both those trying to lose weight and those not trying to lose weight . METHODS Currently accepted criteria and guidelines for question naire development were streamlined and augmented to include cross-cultural input from 5 European countries and the United States . The preliminary pool of items was created based on qualitative interviews conducted in the United States , followed by an early check of item translatability and preharmonization across all language s. Ten additional qualitative in-country interviews were then conducted to produce further culture-specific items . This was followed by 2 forward and 1 backward translation , plus cognitive debriefing interviews in each country . Finally , an exp and ed international harmonization meeting was held to ensure inclusion of appropriate new items and their acceptability across all 6 cultures . RESULTS The procedures described result ed in development of the 41-item Obesity and Weight Loss Quality of Life question naire and the 20-item Weight-Related Symptom Measure . These question naires are subject to further psychometric validation . CONCLUSIONS Augmentation of the initial item-generation and international harmonization steps of question naire development through integration of cross-cultural input allowed greater validity of cross-cultural content while meeting time , budget , and re source constraints",
"Background Severe obesity is a complex condition that is associated with a wide range of serious health complications and reduced health-related quality of life ( HRQoL ) . In addition to physiological factors , activity and participation , environmental factors , and personal factors are related to an individual ’s overall quality of life HRQoL. In Norway , a course based on cognitive behavioral principles is offered to people seeking medical treatment for weight management . The aim is to assist participants to achieve a healthier lifestyle and thereby improve their HRQoL. We therefore investigated changes in HRQoL in participants after they attended this learning and mastery course , and explored how well sociodemographic variables , paid work , social support , personal factors , and surgery predicted HRQoL at 12-month follow-up . Methods A single-group longitudinal study was conducted . Data were collected by self-reported question naires . This article reports on those who had completed the question naire at the 12-month ( n = 69 ) follow-up . HRQoL was assessed with the EQ-5D . Other st and ardized instruments measured employment , social support , self-efficacy , and surgery . Results At the 12-month follow-up , participants scored higher on all dimensions of the EQ-5D and on the EQ-VAS . Generalized linear model showed that having paid work , and social support were statistically significant predictors of HRQoL at the 12-month follow-up . Sex , self-efficacy , and surgery were not statistically significant associated with HRQoL. Conclusions Participation in paid work , and receiving social support from persons with whom they had a close relationship were strongly related to HRQoL in obese people 12 months after participating in a learning and mastery course . Trial registration The study is registered in Clinical Trials : NCT01336725",
"BACKGROUND There is a lack of adequate prospect i ve data on quality -of-life ( QOL ) and its predictors in patients undergoing laparoscopic sleeve gastrectomy ( LSG ) . The aim of this study was to assess longitudinal changes in QOL after LSG with the use of the obesity-specific Moorehead-Ardelt II question naire ( MAII ) and to identify clinical parameters associated with QOL outcome . METHODS Morbidly obese patients consecutively admitted for LSG , over a 30-month period , were prospect ively studied . QOL was assessed using the vali date d Greek version of the MAII question naire and a visual analogueue scale ( VAS ) , preoperatively and at 6 , 12 , and 24 months postoperatively . Anthropometric data and obesity-related co-morbidities were recorded . RESULTS A total of 111 patients with a mean age 36.8±9.2 years were included . Mean preoperative body mass index ( BMI ) was 49.1±7.5 kg/m2 . Percentage excess BMI loss ( % EBL ) was 51.1±14.9 , 64.2±17.9 and 66.4±18.0 at 6 , 12 , and 24 months , respectively . Postoperatively , all obesity-related co-morbidities were significantly improved . MAII score increased from -.40±1.30 preoperatively to 1.75±.83 , 2.18±.80 , and 1.95±.71 at 6 , 12 , and 24 months postoperatively ( trend P was 3 ( 1 ) increasing to 9 ( 2 ) , 10 ( 1 ) , and 9 ( 1 ) at 6 , 12 , and 24 months postoperatively ( P , correlated significantly with higher QOL during the course of the study . CONCLUSION LSG , a safe and effective bariatric operation , results in sustained weight loss and significant improvements in QOL . Both weight loss and amelioration of co-morbidities contribute to higher level of postsurgical QOL ",
"BACKGROUND Few weight loss surgery trials have evaluated the changes in health-related quality of life ( HRQOL ) relative to obese individuals not participating in weight loss interventions . In a prospect i ve study at a bariatric surgery practice , we evaluated the 2-year changes in HRQOL in gastric bypass patients compared with 2 severely obese groups who did not undergo surgical weight loss . METHODS A total of 308 gastric bypass patients were compared with 253 individuals who sought but did not undergo gastric bypass and 272 population -based obese individuals using the weight-related ( Impact of Weight on Quality of Life-Lite ) and general ( Medical Outcomes Study 36-item Short-Form Health Survey ) HRQOL question naires at baseline and 2 years of follow-up . RESULTS The percentage of weight loss was 34.2 % for the gastric bypass and 1.4 % for the no gastric bypass groups , with a .5 % gain for population -based obese group . Both measures of HRQOL showed greater improvements for the gastric bypass group , even after controlling for baseline differences . Effect sizes for changes in physical and weight-related HRQOL were very large for gastric bypass , but small to medium for the 2 comparison groups . Effect sizes for changes in the psychosocial aspects of HRQOL were moderate to very large for gastric bypass , but small for the 2 comparison groups . Of the gastric bypass patients , 97 % had meaningful improvements in the Impact of Weight on Quality of Life-Lite total score compared with 43 % of the no gastric bypass group and 30 % of the population -based obese group . CONCLUSION Dramatic improvements had occurred in weight-related and physical HRQOL for gastric bypass patients at 2 years after surgery compared with 2 severely obese groups who had not undergone surgery . These results support the effectiveness of gastric bypass surgery in improving patients ' HRQOL",
"Objective To evaluate the impact of Roux-en-Y gastric bypass ( RYGB ) on quality of life in obese diabetic patients compared to st and ard medical therapy for type 2 diabetes mellitus . Methods We prospect ively studied two matched obese population s with type 2 diabetes . Thirty patients underwent laparoscopic RYGB and 31 received st and ard medical therapy combined with a diabetes support and education program ( DSE ) , consisting of educational sessions on diet and exercise . Groups were matched by age , gender , weight , glucostatic parameters , and use of glucose-lowering medications ( oral agents and insulin therapy ) . Health-related quality of life ( HRQOL ) was assessed using the normalized SF-36 question naire , and data were collected at baseline and at 12-month follow-up . Results Diabetic patients who underwent RYGB experienced a statistically significant increase in their overall HRQOL . However , the role-physical and mental health domains increased but did not reach statistical significance . Diabetic patients in the medical therapy and DSE group did not show any significant increase in HRQOL . The between-group differences for the HRQOL changes from baseline were significant , other than for role-physical and mental health domains . Percentage changes in glucostatic parameters , discontinuation of glucose-lowering medications , and T2DM remission were not found to predict the percentage change in SF-36 scores at 12 months after RYGB . Conclusions For the first time , with a prospect i ve matched control study , we demonstrate a significant improvement in HRQOL in obese diabetic patients who underwent RYGB , but not in those who were offered st and ard medical therapy and DSE",
"Background : The objective of this study was to determine the weight loss , changes in co-morbidities , medication usage and general health status at 1 year after laparoscopic adjustable gastric b and ing ( LAGB ) . Methods : Prospect i ve data were obtained from all subjects undergoing LAGB . These measurements included a medical history and review of systems , medications , height and weight and the SF-36 general health survey . Patients were seen for b and adjustments as needed throughout the year . At the 1-year follow-up visit , patients were weighed and interviewed about the status of their health conditions and their current medications , and the SF-36 was repeated . Results : Between November 2002 and November 2003 , 195 patients had LAGB . The majority of subjects were female ( 82.8 % ) , married ( 65.1 % ) , and white ( 94.9 % ) . Complications occurred in 18 subjects ( 9.2 % ) . These included 3 slipped b and s ( 1.5 % ) , 4 port problems ( 2.1 % ) , 8 patients with temporary stoma occlusion ( 4.1 % ) , 1 explantation ( 0.5 % ) , and 1 mortality ( 0.5 % ) . Mean BMI decreased from 45.8 kg/m2 ( ± 7.7 ) to 32.3 kg/m2 ( ± 7.0 ) . Mean percent excess body weight lost was 45.7 % ( ± 17.1 ) during the first year . Major improvements occurred in arthritis , asthma , depression , diabetes , gastro-esophageal reflux disease , hyperlipidemia , hypertension , joint and back pain , sleep apnea and stress incontinence . Medication usage declined remarkably . Quality of life ( QoL ) by the SF-36 showed highly significant improvements . Conclusions : At 1 year after LAGB , patients had experienced significant weight loss , resolution of comorbidities , decreases in medication usage , and improvements in",
"IMPORTANCE Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus . OBJECTIVE To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass ( RYGB ) surgery compared with an intensive diabetes medical and weight management ( Weight Achievement and Intensive Treatment [ Why WAIT ] ) program for type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A 1-year pragmatic r and omized clinical trial was conducted in an academic medical institution . Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study ; their body mass index was 30 to 42 ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A1c ( HbA1c ) was greater than or equal to 6.5 % . All participants were receiving antihyperglycemic medications . INTERVENTIONS RYGB ( n = 19 ) or Why WAIT ( n = 19 ) including 12 weekly multidisciplinary group lifestyle , medical , and educational sessions with monthly follow-up thereafter . MAIN OUTCOMES AND MEASURES Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5 % , measures of cardiometabolic health , and patient-reported outcomes . RESULTS At 1 year , the proportion of patients achieving HbA1c below 6.5 % and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT ( 58 % vs 16 % , respectively ; P = .03 ) . Other outcomes , including HbA1c , weight , waist circumference , fat mass , lean mass , blood pressure , and triglyceride levels , decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT . Improvement in cardiovascular risk scores was greater in the surgical group . At baseline the participants exhibited moderately low self-reported quality -of-life scores reflected by Short Form-36 total , physical health , and mental health , as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores . At 1 year , improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups . The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT . CONCLUSIONS AND RELEVANCE In obese patients with type 2 diabetes , RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management , with emergent differences over 1 year . Both treatments improve general quality -of-life measures , but RYGB provides greater improvement in the effect of weight on quality of life . These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger r and omized trials are performed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01073020",
"The study objectives were to assess 2-year changes in health-related quality of life ( HRQL ) after gastric bypass in patients with severe obesity and to analyze HRQL improvements in relation to weight loss after bariatric surgery . This was a prospect i ve intervention study with consecutive patients referred to two bariatric surgical units in the Basque Country . We used both generic ( Short Form Health Survey , SF-36 and EuroQol , EQ-5D ) , and specific question naires ( Moorehead-Ardelt , MA II and Obesity-related Problems Scale , OP ) . Effect sizes and receiver operating characteristic ( ROC ) curves were calculated to assess the change in quality of life . Spearman ’s correlation coefficient was calculated to assess whether there was an association between changes in body mass index ( BMI ) and HRQL . Of 82 patients who underwent surgery , 79 were followed-up for 2 years . Mean weight loss was 37 % of body weight ( 49 kg ) and BMI fell from 50.6 to 31.8 . The initial problems and final improvements were greater in the physical dimensions . Considerable benefits were observed in assessment s with all the instruments used . However , the changes in weight/ BMI and HRQL were not linear . The comparison with general population showed a similar profile in SF-36 dimensions after surgery . Severely obese patients have lower perceived health across all dimensions of quality of life . Moreover , the impact on functioning is so important that severe obesity can be described as a cause of disability that disappears 2 years after surgical treatment . ROC curves indicate that most of the HRQL measures are poor predictors of change in terms of reduction in body weight or BMI",
"Background : The Bariatric Quality of Life Index ( BQL ) was created and vali date d as a nine-factor model in 2005 for the measurement of quality of life (QoL)in patients before and after bariatric surgery . Even though the results were acceptable , the statistical structure of the test was very unclear . Methods : A total·f466 patients were enrolled in an ongoing prospect i ve longitudinal German study . The assessment took place preoperatively and at 1 , 3 , 6 , 9 , and 12 months postoperatively . After that period , reevaluations were done on a yearly basis . In addition to demographic and clinical data , QoL data were collected using the BQL , the Short Form12 ( SF-12v2 ) , the Gastrointestinal Quality of Life Index ( GIQLI ) , and the Bariatric Analysis and Reporting Outcome System ( BAROS ; old version since the study started in 2001 ) . Statistical parameters for contingency ( Cronbach ’s Α),construct and criterion validity ( Pearson ’s r ) , and responsiveness ( st and ardized effect sizes ) were calculated . The data of the assessment s conducted preoperatively and after 6 and 12 months were used for the validation . Results : The factor analysis and the screeplot showed that a one-factor solution explained 45.37%of variance . The selectivity of the items ranged between 0.61 and 0.85 , and Cronbach ’s Α was 0.898 . The measurements showed similar excellent results with the analysis of all measurement points . Pearson ’s test showed a good retest reliability ( r = 0.9 ) . The correlations with the SF-12 and the Moorehead-Ardelt I question naire ( MA-I ) were significant , while the correlation with the GIQLI was low . The results of the correlation with the excess weight loss (EWL)(0.45 and 0.49 ) and the BMI ( –0.38 and –0.47 ) were good . Conclusion : The BQL is a valid instrument and should be preferred over generic question naires as it provides betterresponsiveness",
"Background Guidelines and experts describe 5 % to 10 % reductions in body weight as ` clinical ly important ’ ; however , it is not clear if 5 % to 10 % weight reductions correspond to clinical ly important improvements in health-related quality of life ( HRQL ) . Our objective was to calculate the amount of weight loss required to attain established minimal clinical ly important differences ( MCIDs ) in HRQL , measured using three vali date d instruments . Methods Data from the Alberta Population -based Prospect i ve Evaluation of Quality of Life Outcomes and Economic Impact of Bariatric Surgery ( APPLES ) study , a population -based , prospect i ve Canadian cohort including 150 wait-listed , 200 medically managed and 150 surgically treated patients were examined . Two-year changes in weight and HRQL measures ( Short-Form (SF)-12 physical ( PCS ; MCID = 5 ) and mental ( MCS ; MCID = 5 ) component summary score , EQ-5D Index ( MCID = 0.03 ) and Visual Analog Scale ( VAS ; MCID = 10 ) , Impact of Weight on Quality of Life (IWQOL)-Lite total score ( MCID = 12 ) ) were calculated . Separate multivariable linear regression models were constructed within medically and surgically treated patients to determine if weight changes achieved HRQL MCIDs . Pooled analysis in all 500 patients was performed to estimate the weight reductions required to achieve the pre-defined MCID for each HRQL instrument . Results Mean age was 43.7 ( SD 9.6 ) years , 88 % were women , 92 % were white , and mean initial body mass index was 47.9 ( SD 8.1 ) kg/m2 . In surgically treated patients ( two-year weight loss = 16 % ) , HRQL MCIDs were reached for all instruments except the SF-12 MCS . In medically managed patients ( two-year weight loss = 3 % ) , MCIDs were attained in the EQ-index but not the other instruments . In all patients , percent weight reductions to achieve MCIDs were : 23 % ( 95 % confidence interval ( CI ) : 17.5 , 32.5 ) for PCS , 25 % ( 17.5 , 40.2 ) for MCS , 9 % ( 6.2 , 15.0 ) for EQ-Index , 23 % ( 17.3 , 36.1 ) for EQ-VAS , and 17 % ( 14.1 , 20.4 ) for IWQOL-Lite total score . Conclusions Weight reductions to achieve MCIDs for most HRQL instruments are markedly higher than the conventional threshold of 5 % to 10 % . Surgical , but not medical treatment , consistently led to clinical ly important improvements in HRQL over two years . Trial registration Clinical trials.gov NCT00850356",
"OBJECTIVE The aim of this investigation was to assess the effect of malabsorptive bariatric surgery ( BS ) on the quality of life ( QoL ) , applying the Nottingham Health Profile ( NHP ) and the bariatric analysis and reporting outcome system ( BAROS ) . DESIGN A prospect i ve cohort study was performed in 100 adult patients ( > 18 years ) undergoing bariatric surgery by malabsorptive technique for one year . RESEARCH METHODS AND PROCEDURES Patients were monitored from the beginning of the BS program until a year after the intervention , applying the NHP and the BAROS test . At baseline , the mean weight of the women was 132 ± 22 kg and the Body Mass Index ( BMI ) was 50.7 kg/m² . RESULTS The values obtained from different areas applying the NHP question naire showed statistical significant differences ( p lost 25 - 49 % of weight excess and 80.8 % had resolved major comorbidities at 1 yr . According to the Moorehead-Ardelt QoL score , there were major improvements in employment and self-esteem in 89 % and 87 % of patients , respectively , and improvements in physical activity , sexual and social relationships . According to the total mean BAROS score , the outcome was considered \" very good \" . CONCLUSION NHP and BAROS question naires appear to be useful and easily applicable tools to assess the QoL of obese patients",
"The purpose of this study was to determine whether pre- to postoperative increases in physical activity ( PA ) are associated with weight loss and health-related quality of life ( HRQoL ) following bariatric surgery . Participants were 199 Roux-en-Y gastric bypass ( RYGB ) surgery patients . The International Physical Activity Question naire ( IPAQ ) was used to categorize participants into three groups according to their preoperative and /1-year postoperative PA level : ( i ) Inactive/Active ( or=200-min/week ) , ( ii ) Active/Active ( > or=200-min/week/>or=200-min/week ) and ( iii ) Inactive/Inactive ( ) . The Medical Outcomes Study Short Form-36 ( SF-36 ) was used to assess HRQoL. Analyses of covariance were conducted to examine the effects of PA group on weight and HRQoL changes . Inactive/Active participants , compared with Inactive/Inactive individuals , had greater reductions in weight ( 52.5 + /- 15.4 vs. 46.4 + /- 12.8 kg ) and BMI ( 18.9 + /- 4.6 vs. 16.9 + /- 4.2 kg/m(2 ) ) . Weight loss outcomes in the Inactive/Active and Active/Active groups were similar to each other . Inactive/Active and Active/Active participants reported greater improvements than Inactive/Inactive participants on the mental component summary ( MCS ) score and the general health , vitality and mental health domains ( P RYGB patients who become active postoperatively achieve weight losses and HRQoL improvements that are greater than those experienced by patients who remain inactive and comparable to those attained by patients who stay active . Future r and omized controlled trials should examine whether assisting patients who are inactive preoperatively to increase their PA postoperatively contributes to optimization of weight loss and HRQoL outcomes",
"Background There is little robust evidence relating to changes in health related quality of life ( HRQL ) in morbidly obese patients following a multidisciplinary non-surgical weight loss program or laparoscopic Roux-en-Y Gastric Bypass ( RYGB ) . The aim of the present study was to describe and compare changes in five dimensions of HRQL in morbidly obese subjects . In addition , we wanted to assess the clinical relevance of the changes in HRQL between and within these two groups after one year . We hypothesized that RYGB would be associated with larger improvements in HRQL than a part residential intensive lifestyle-intervention program ( ILI ) with morbidly obese subjects . Methods A total of 139 morbidly obese patients chose treatment with RYGB ( n=76 ) or ILI ( n=63 ) . The ILI comprised four stays ( seven weeks ) at a specialized rehabilitation center over one year . The daily schedule was divided between physical activity , psychosocially-oriented interventions , and motivational approaches . No special diet or weight-loss drugs were prescribed . The participants completed three HRQL- question naires before treatment and 1 year thereafter . Both linear regression and ANCOVA were used to analyze differences between weight loss and treatment for five dimensions of HRQL ( physical , mental , emotional , symptoms and symptom distress ) controlling for baseline HRQL , age , age of onset of obesity , BMI , and physical activity . Clinical relevance was assessed by effect size ( ES ) where ES.80 as large . Results The adjusted between group mean difference ( 95 % CI ) was 8.6 ( 4.6,12.6 ) points ( ES=.83 ) for the physical dimension , 5.4 ( 1.5–9.3 ) points ( ES=.50 ) for the mental dimension , 25.2 ( 15.0–35.4 ) points ( ES=1.06 ) for the emotional dimension , 8.7 ( 1.8–15.4 ) points ( ES=.37 ) for the measured symptom distress , and 2.5 for ( .6,4.5 ) fewer symptoms ( ES=.56 ) , all in favor of RYGB . Within-group changes in HRQOL in the RYGB group were large for all dimensions of HRQL . Within the ILI group , changes in the emotional dimension , symptom reduction and symptom distress were moderate . Linear regression analyses of weight loss on HRQL change showed a st and ardized beta-coefficient of –.430 ( p the physical dimension , –.288 ( p=.004 ) on the mental dimension , –.432 ( p the emotional dimension , .287 ( p=.008 ) on number of symptoms , and .274 ( p=.009 ) on reduction of symptom pressure . Conclusions Morbidly obese participants undergoing RYGB and ILI had improved HRQL after 1 year . The weaker response of ILI on HRQL , compared to RYGB , may be explained by the difference in weight loss following the two treatments . Trial registration Clinical Trials.gov number",
"Objective : Laparoscopic sleeve gastrectomy ( LSG ) has been proposed as an effective alternative to the current st and ard procedure , laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . Prospect i ve data comparing both procedures are rare . Therefore , we performed a r and omized clinical trial assessing the effectiveness and safety of these 2 operative techniques . Methods : Two hundred seventeen patients were r and omized at 4 bariatric centers in Switzerl and . One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line , and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb . The mean body mass index of all patients was 44 ± 11.1 kg/m2 , the mean age was 43 ± 5.3 years , and 72 % were female . Results : The 2 groups were similar in terms of body mass index , age , sex , comorbidities , and eating behavior . The mean operative time was less for LSG than for LRYGB ( 87 ± 52.3 minutes vs 108 ± 42.3 minutes ; P = 0.003 ) . The conversion rate was 0.9 % in both groups . Complications ( the difference in severe complications did not reach statistical significance ( 4.5 % for LRYGB vs 1 % for LSG ; P = 0.21 ) . Excessive body mass index loss 1 year after the operation was similar between the 2 groups ( 72.3 % ± 22 % for LSG and 76.6 % ± 21 % for LRYGB ; P = 0.2 ) . Except for gastroesophageal reflux disease , which showed a higher resolution rate after LRYGB , the comorbidities and quality of life were significantly improved after both procedures . Conclusions : LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB . Both procedures were almost equally efficient regarding weight loss , improvement of comorbidities , and quality of life 1 year after surgery . Long-term follow-up data are needed to confirm these facts",
"Background : This study is a trial to compare the effects and outcomes of three different bariatric procedures performed in two centers . St and ard Roux-en-Y gastric bypass was performed by Dr. Norman Samuels in Fort Lauderdale ( Florida ) ; vertical b and ed gastroplasty and laparoscopic adjustable silicone gastric b and ing were done in Hallein ( Salzburg ) by Dr. Emanuel Hell and Dr. Karl Miller . Methods : In a prospect i ve comparative study 30 matched patients from each group were followed to assess post-operative improvement in health status and quality of life , to compare the three different techniques . The Bariatric Analysis and Reporting Outcome System ( BAROS ) as described by Oria and Moorehead has been used for evaluation . Results : The observation time was at least 3 years ( 3 to 8 years ) in each individual case . A significant increase in quality of life and health status in 75 % of the surgically-treated patients was observed when compared with a non-operated control group of morbidly obese patients . Conclusions : By utilizing BAROS it has been found possible to compare the results of different procedures done by different surgeons with different techniques , utilizing patients from different cultures and with different language s. The results of this comparative study favor the st and ard gastric bypass for the treatment of morbid obesity . This operation is superior to purely gastric restrictive procedures in weight loss and improvement of quality of life",
"OBJECTIVE To analyze quality of life and observe the prevalence of musculoskeletal pain in patients su bmi tted to bariatric surgery . METHODS A prospect i ve , observational and comparative study with 26 individuals aged 18 to 60 years , 25 women , which included two evaluations , one preoperative and the other approximately 42 months after surgery . The Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) and the Human Body Diagram with Visual Analogue Scale were employed . RESULTS The individual sample s showed grade III obesity , with a predominance of postoperative overweight , hypertension and diabetes in 65.4 % and 42.3 % of the sample s , with remission of hypertension in 50 % and of diabetes mellitus in 38.5 % ( p quality of life , especially in aspects related to motricity ; vitality and mental health showed no significant changes . Osteoarticular pain was reported and identified in various sites by the subjects ; however , 87.5 % of patients in the preoperative period and 88.5 % in the postoperative period reported not having any physical therapy orientation , while 65.4 % reported being engaged in some type of regular physical activity after surgery ( p Morbidly obese individuals have a high probability of suffering from clinical , psychic , and musculoskeletal alterations , compromising their quality of life and showing improvement after bariatric surgery ; on the other h and , the psycho-emotional manifestations did not progress in the same way",
"Background : Laparoscopic vertical b and ed gastroplasty ( LVBG ) is a safe and effective treatment for morbid obesity . Previous studies disclosed a significant improvement in the health-related quality of life after substantial weight loss following VBG . Data regarding the specific gastrointestinal quality of life following LVBG is lacking . Material s and Methods : 223 patients who underwent LVBG for morbid obesity were studied prospect ively . Quality of life was measured by the Gastrointestinal Quality of life Index ( GIQLI ) , a 36- item question naire before surgery , and at 6 months , 1 year and 2 years after surgery . The question naire is divided into 5 domains , and the maximum score is 144 . Results : After LVBG , weight loss has been good . Mean BMI decreased from 43.2 to 31.3 after 2 years . Co-morbidities were eliminated in 71 % . 84.3 % of patients were satisfied with the results . However , the score of GIQLI remained similar before and after surgery . Preoperative score was 106.2±19 points . The score became 116.6±9 , 106.8±21 , and 108.5±20 at 6 months , 1 year and 2 years after surgery respectively . The patients had improvement in 3 domains of the question naire ( social function , physical status and psychological emotions ) but decreased in domains of core symptoms and disease-specific items . Conclusion : Although LVBG was effective in reduction of weight and resolution of co-morbidities in morbidly obese patients , the specific gastrointestinal quality of life did not improve . Many patients developed some specific gastrointestinal symptoms in order to obtain weight reduction",
"Background : Laparoscopic adjustable gastric b and ing ( LAGB ) is a safe and effective method for the treatment of obesity . The most common problem after LAGB has been the occurrence of prolapse ( slippage ) of the stomach through the b and . It has been proposed that the pars flaccida ( PF ) pathway ( dissection from the base of the right crus , along the left crus to the angle of His ) is less likely to be associated with prolapse than the traditional perigastric ( PG ) pathway ( dissection between the lesser curvature of stomach and lesser omentum , across the apex of the lesser sac , to the angle of His ) . We have tested this hypothesis using a r and omized controlled trial format . Methods : We have performed a r and omized controlled trial to compare the outcomes after LAGB using PF and PG pathways . 202 patients ( mean age 40 years , mean weight 123 kg , mean BMI 45 ) were r and omly allocated to the PF or PG pathway and followed for 2 years . Results : At 24 months , there have been 16 revisional procedures for prolapse , 4 in the PF group ( all anterior prolapse ) and 15 in the PG group ( 12 posterior and 3 anterior ) . This difference is significant ( P mean % excess weight lost was 53 % for the PF group and 46 % for the PG group . There was equally significant improvements in the metabolic syndrome in both groups ( 59 % preoperatively and 19 % at 2 years ) . All 8 paired domain scores of the SF-36 measures of quality of life were improved significantly in both group ( P substantial weight loss , improved health and improved quality of life and is significantly less likely to be associated with prolapse ( slippage ) . It is recommended as the primary dissection pathway",
"Objective To compare outcomes , quality of life ( QOL ) , and costs of laparoscopic and open gastric bypass ( GBP ) . Summary Background Data Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity . The authors performed a prospect i ve r and omized trial to compare outcomes , QOL , and costs of laparoscopic GBP with those of open GBP . Methods From May 1999 to March 2001 , 155 patients with a body mass index ( BMI ) of 40 to 60 kg/m2 were r and omly assigned to undergo laparoscopic ( n = 79 ) or open ( n = 76 ) GBP . The two groups were similar in age , sex ratio , mean BMI , and comorbidities . Main outcome measures included operative time , estimated blood loss , length of hospital stay , operative complications , percentage of excess body weight loss , and time to return to activities of daily living and work . Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system ( BAROS ) . Operative and hospital costs of the two operations were also compared . Results There were no deaths in either group . Mean operative time was longer for laparoscopic GBP than for open GBP , but operative blood loss was less . Two ( 2.5 % ) of the 79 patients in the laparoscopic group required conversion to laparotomy . Median length of hospital stay was shorter for laparoscopic GBP patients ( 3 vs 4 days ) . The rate of postoperative anastomotic leak was similar between groups . Wound-related complications such as infection ( 10.5 vs 1.3 % ) and incisional hernia ( 7.9 vs 0 % ) were more common after open GBP ; late anastomotic stricture was less frequent after open GBP ( 2.6 vs 11.4 % ) . Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP . Weight loss at 1 year was similar between groups . Preoperative SF-36 scores were similar between groups ; however , at 1 month after surgery , laparoscopic patients had better physical conditioning , social functioning , general health , and less body pain than open GBP patients . At 6 months , the BAROS outcome was classified as good or better in 97 % of laparoscopic GBP patients compared with 82 % of open GBP patients . Operative costs were higher for laparoscopic GBP patients , but hospital costs were lower . Conclusions Laparoscopic GBP is a safe and cost-effective alternative to open GBP . Despite a longer operative time , patients undergoing laparoscopic GBP benefited from less blood loss , a shorter hospital stay , and faster convalescence . Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients . The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs",
"The aim of the study is to answer the question : what is the range and character of changes within health-related quality of life ( HRQL ) in obese patients who have undergone surgical treatment ( VBG - vertical b and ed gastroplasty or RYGBP - Roux-en-Y gastric bypass ) in the period of three and six months after operation ? Three groups of patients participated in the study : G I ( n=33 ; BMI 49.90 + /- 6.74 kg/m(2 ) ) - tested prior to the operation , G II ( n=17 ; BMI 34.26 + /- 5.28 kg/m(2 ) ) - tested six months after the operation , and G III ( n=11 ) - examined prior to the operation ( BMI 45.72 + /- 5.27 kg/m(2 ) ) as well as three months after the operation ( BMI 36.10 + /- 4.60 kg/m(2 ) ) . The Nottingham Health Profile ( NHP ) question naire was used as an indicator of HRQL . Surgical treatment of obesity result ed in significant positive changes in relation to the basic dimensions of NHP : energy , pain , physical mobility and in the influence of the current health state on selected spheres of life : paid employment , jobs around the house , social life , sex life , interests and hobbies , holidays . Significant changes in HRQL result ing from bariatric surgery occur in a relatively short period of time and are related not only to physical but also to social functioning",
"Background This study examined the prognostic significance of depressive symptoms in bariatric surgery patients over 24 months of follow-ups . Methods Three hundred fifty-seven patients completed a battery of assessment s before and at 6 , 12 , and 24 months following gastric bypass surgery . In addition to weight loss and depressive symptoms , the assessment s targeted eating disorder psychopathology and quality of life . Results Clinical ly significant depressive symptoms , defined as a score of 15 or greater on the Beck Depression Inventory , characterized 45 % of patients prior to surgery , and 12 % at 6-month follow-up , 13 % at 12-month follow-up , and 18 % at 24-month follow-up . Preoperative depressive symptoms did not predict postoperative weight outcomes . In contrast , postsurgery depressive symptoms were predictive of weight loss outcomes . Higher postsurgery depressive symptoms at each time point predicted a greater degree of concurrent and subsequent eating disorder psychopathology and lower quality of life . Conclusions The frequency of elevated depressive symptoms decreases substantially following gastric bypass surgery but increases gradually over 24 months . Postoperative depressive symptoms are significantly associated with poorer weight outcomes at 6 and 12 months following surgery but do not predict longer-term weight outcomes at 24 months . Postoperative depressive symptoms prospect ively predict greater eating disorder psychopathology and poorer quality of life through 24 months . Elevated depressive symptoms , readily assessed by self-report , may signal a need for clinical attention after surgery",
"IMPORTANCE There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than 50 . OBJECTIVE To compare 5-year outcomes after Roux-en-Y gastric bypass ( gastric bypass ) and biliopancreatic diversion with duodenal switch ( duodenal switch ) . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical open-label trial at Oslo University Hospital , Oslo , Norway , and Sahlgrenska University Hospital , Gothenburg , Sweden . Participants were recruited between March 17 , 2006 , and August 20 , 2007 , and included 60 patients aged 20 to 50 years with a body mass index of 50 to 60 . The current study provides the 5-year follow-up analyses by intent to treat , excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was r and omized . INTERVENTIONS Laparoscopic gastric bypass and laparoscopic duodenal switch . MAIN OUTCOMES AND MEASURES Body mass index and secondary outcomes including anthropometric measures , cardiometabolic risk factors , pulmonary function , vitamin status , gastrointestinal symptoms , health-related quality of life , and adverse events . RESULTS Sixty patients were r and omly assigned and operated on with gastric bypass ( n = 31 ) and duodenal switch ( n = 29 ) . Fifty-five patients ( 92 % ) completed the study . Five years after surgery , the mean reductions in body mass index were 13.6 ( 95 % CI , 11.0 - 16.1 ) and 22.1 ( 95 % CI , 19.5 - 24.7 ) after gastric bypass and duodenal switch , respectively . The mean between-group difference was 8.5 ( 95 % CI , 4.9 - 12.2 ; P Remission rates of type 2 diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups . Reductions in total cholesterol , low-density lipoprotein cholesterol , triglycerides , and fasting glucose were significantly greater after duodenal switch compared with gastric bypass . Serum concentrations of vitamin A and 25-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass . Duodenal switch was associated with more gastrointestinal adverse effects . Health-related quality of life was similar between groups . Patients with duodenal switch underwent more surgical procedures related to the initial procedure ( 13 [ 44.8 % ] vs 3 [ 9.7 % ] patients ; P = .002 ) and had significantly more hospital admissions compared with patients with gastric bypass . CONCLUSIONS AND RELEVANCE In patients with a body mass index of 50 to 60 , duodenal switch result ed in greater weight loss and greater improvements in low-density lipoprotein cholesterol , triglyceride , and glucose levels 5 years after surgery compared with gastric bypass while improvements in health-related quality of life were similar . However , duodenal switch was associated with more surgical , nutritional , and gastrointestinal adverse effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00327912",
"CONTEXT Extreme obesity is associated with health and cardiovascular disease risks . Although gastric bypass surgery induces rapid weight loss and ameliorates many of these risks in the short term , long-term outcomes are uncertain . OBJECTIVE To examine the association of Roux-en-Y gastric bypass ( RYGB ) surgery with weight loss , diabetes mellitus , and other health risks 6 years after surgery . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve Utah-based study conducted between July 2000 and June 2011 of 1156 severely obese ( body mass index [ BMI ] ≥ 35 ) participants aged 18 to 72 years ( 82 % women ; mean BMI , 45.9 ; 95 % CI , 31.2 - 60.6 ) who sought and received RYGB surgery ( n = 418 ) , sought but did not have surgery ( n = 417 ; control group 1 ) , or who were r and omly selected from a population -based sample not seeking weight loss surgery ( n = 321 ; control group 2 ) . MAIN OUTCOME MEASURES Weight loss , diabetes , hypertension , dyslipidemia , and health-related quality of life were compared between participants having RYGB surgery and control participants using propensity score adjustment . RESULTS Six years after surgery , patients who received RYGB surgery ( with 92.6 % follow-up ) lost 27.7 % ( 95 % CI , 26.6%-28.9 % ) of their initial body weight compared with 0.2 % ( 95 % CI , -1.1 % to 1.4 % ) gain in control group 1 and 0 % ( 95 % CI , -1.2 % to 1.2 % ) in control group 2 . Weight loss maintenance was superior in patients who received RYGB surgery , with 94 % ( 95 % CI , 92%-96 % ) and 76 % ( 95 % CI , 72%-81 % ) of patients receiving RYGB surgery maintaining at least 20 % weight loss 2 and 6 years after surgery , respectively . Diabetes remission rates 6 years after surgery were 62 % ( 95 % CI , 49%-75 % ) in the RYGB surgery group , 8 % ( 95 % CI , 0%-16 % ) in control group 1 , and 6 % ( 95 % CI , 0%-13 % ) in control group 2 , with remission odds ratios ( ORs ) of 16.5 ( 95 % CI , 4.7 - 57.6 ; P incidence of diabetes throughout the course of the study was reduced after RYGB surgery ( 2 % ; 95 % CI , 0%-4 % ; vs 17 % ; 95 % CI , 10%-24 % ; OR , 0.11 ; 95 % CI , 0.04 - 0.34 compared with control group 1 and 15 % ; 95 % CI , 9%-21 % ; OR , 0.21 ; 95 % CI , 0.06 - 0.67 compared with control group 2 ; both P bariatric surgery-related hospitalizations were 33 ( 7.9 % ) , 13 ( 3.9 % ) , and 6 ( 2.0 % ) for the RYGB surgery group and 2 control groups , respectively . CONCLUSION Among severely obese patients , compared with nonsurgical control patients , the use of RYGB surgery was associated with higher rates of diabetes remission and lower risk of cardiovascular and other health outcomes over 6 years",
"Few studies have investigated changes in health-related quality of life ( HRQOL ) in surgical patients who have undergone a laparoscopic sleeve gastrectomy . Prospect i ve data were obtained from 78 consecutive patients undergoing laparoscopic sleeve gastrectomy ( LSG ; mean age , 42.4 years ; mean body weight , 131 kg ; mean body mass index ( BMI ) , 47 kg/m2 ( 24.4 % of superobese patients ) ) . Two HRQOL question naires were administered preoperatively and 12 months postsurgery : the generic Medical Outcomes Study Short Form-36 and the weight-specific IWQOL-Lite question naire . Excess weight loss at 12 months was 57.18 % . No mortality was recorded . HRQOL scores revealed a significant improvement in all areas of both question naires . However , changes in HRQOL were not associated consistently with amount of weight loss . Laparoscopic sleeve gastrectomy is an effective and safe procedure , with positive changes in health-related quality of life as well as weight reduction . A fruitful area for future research is the investigation of long-term changes in HRQOL after LSG",
"In a prospect i ve study of 188 patients with morbid obesity , the time-dependent changes in the quality of life of individual patients were analyzed following laparoscopic gastric b and ing ( LGB ) . These 188 patients ( 148 females and 40 males ; age 19 to 59 years ; body mass index 33 to 72 kg/m(2 ) ) underwent evaluation of the LGB according to a strict protocol that included psychological testing using st and ardized instruments , detailed medical evaluation , upper gastrointestinal function studies , and evaluation of quality of life using the Gastrointestinal Quality of Life Index ( GIQLI ) . Following this evaluation , 73 patients ( 57 females and 16 males ; age 37 years [ range 19 to 59 years ] ; body mass index 48 kg/m(2 ) [ range 37 to 72 kg/m(2 ) ] ) underwent LGB and were followed up for 2 years focusing on weight loss , postoperative morbidity , weight-related comorbidity , and quality of life . The results demonstrate that LGB is well able to allow for a significant loss of excess weight and a significant improvement in patients ' quality of life , both after a rather short period of time after surgery and at a continuous rate throughout the follow-up . The price for this success that was found in approximately 90 % of patients is a complication rate of 38 % ; 85 % of these patients , almost one third of all patients , must undergo some type of revision surgery . However , once the complications are resolved , these patients achieve the same level of weight loss and improvement in quality of life as patients with an uncomplicated postoperative course",
"Many surgeons support some sort of restriction of the gastric pouch outlet by placing a ring around the gastric reservoir . Previous studies have shown positive results of b and ed gastric bypass ( BGBP ) ; however , there are not many comparative long-term studies to assess the real advantage of placing a ring during gastric bypass ( GBP ) surgery . This study aims to evaluate the long-term outcome of patients subjected to BGBP and nonb and ed GBP procedures . We studied 260 retrospective , nonr and omized obese patients who underwent BGBP and 218 patients without the ring ( i.e. , GBP ) . They were followed up for 10 years , and the following parameters were evaluated : excess weight loss ( EWL ) , quality of life ( QOL ) , food tolerance , and correction of comorbidities . The study was approved by the Committee on Ethics , and all the patients gave their informed consent . There is a significant difference in % EWL from the third year until the tenth year of observation , with the proportion being 82 % in BGBP versus 63 % in nonb and ed GBP patients at the end of the study . Although there was some increased intolerance to food intake in the BGBP patients , this was not felt to reduce the QOL . The outcome in terms of comorbidities was not conclusive . There is a clear advantage in terms of % EWL in the BGBP patients . No differences in QOL were found in both groups . Further , selecting the right type of material and the right size of the ring is important to improve results and avoid complications",
"Bariatric surgery ameliorates obesity‐associated diseases , result ing in psychological and social benefits . Long‐term studies of its effects on quality of life ( QOL ) assessed with well established instruments are lacking . This prospect i ve study investigated the long‐term effects of gastric b and ing on health‐related QOL using an obesity‐specific vali date d measure",
"The quality of life in adult patients with chronic liver disease who were considered for transplantation was assessed prospect ively over a 2 year period , for both those who did and did not subsequently receive transplants . The main outcome measures were the Nottingham Health Profile and survival . Of the 109 patients who completed an entry profile , 27 were transplanted , 71 not transplanted during the study period , and 11 rejected for transplant . Quality of life and severity of liver disease at entry was worse for the transplant group , whose survival at 15 months from entry was 81 % compared with 78 % for those not transplanted . Among transplant survivors there were marked improvements in quality of life , whilst amongst those not receiving transplants there was little change . In conclusion , liver transplantation was effective in improving quality of life in patients with chronic liver disease , but comparison between transplant and non-transplant patients is difficult because of differences between the groups",
"Background : Quality of life ( QoL ) was tested in a 2- year postoperative study using the Medical Outcome Study Short Form 36 ( MOS SF-36 ) to assess preoperative and 1 and 2 year postoperative QoL among one group of female patients ( group 1 , n = 42 ) and a 2 year postoperative QoL study in a second group of female patients ( group 2 , n = 9 ) who underwent a stomach reduction operation involving open surgical placement of a Lap-B and during the year 1997 . Methods : The QoL of 42 patients ( group 1 ) was assessed at most 20 hours before surgery and 1 and 2 years ( 12 and 24 months ) postoperatively using a r and omized pre-test/post-test design . The QoL of 9 patients ( group 2 ) was assessed 2 years ( 24 months ) postoperatively using a r and omized post-test design only . The results were compared with the st and ardized Dutch norm data scale . Statistical data were analyzed with SPSS versions 10.0 . Results : The placement of a Lap-B and in group 1 result ed in a significant reduction in Body Mass Index ( BMI ) in the first and second-year follow-up . Mean BMI declined significantly from 40.7 kg/m2 preoperatively to 33.1 kg/m2 at the 1-year follow-up , to 31.3 kg/m2 at 2-year follow-up . In group 2 BMI also declined significantly from 43.0 kg/m2 preoperatively to 34.2 kg/m2 at 1-year follow-up to 32.1 kg/m2 at the 2-year follow-up . Compared to the MOS SF-36 st and ardized Dutch norm data , a significant improvement in the QoL was seen on the effect variable bodily pain , mental health and general health perceptions in group 1 . Although the bodily pain , general health and mental health perceptions increased significantly 2 years postoperatively ( group 1 ) com pared with the Dutch st and ardized norm data , the preoperative general health and mental health perceptions of morbidly obese patients were , like all other preoperative effect variables , not significantly different from the scores on the Dutch st and ardized norm scale . Conclusion : Although other authors found that QoL improves after surgical-induced weight loss , showing significant improvements on patients ' perception of their health status , these findings were not confirmed in the present study . The findings show only a significant difference in bodily pain , general health and mental health perception before and after surgical intervention and preoperatively in group 1 compared to the Dutch st and ardized norm data . Because of small sample size ( n = 9 ) , no significant results were found in group 2 compared to the Dutch St and ardized norm data . Based on earlier and present findings , further study is recommended to ascertain whether the MOS SF-36 is valid in morbidly obese patients and whether the response set has an influence on QoL studies of these patients",
"INTRODUCTION This study explored whether health-related quality of life ( HRQOL ) changes following Roux-en-Y gastric bypass surgery were associated with identifiable socio-demographic or clinical characteristics , and it examined the impact on health outcomes of changes in the Danish criteria for bariatric surgery . MATERIAL AND METHODS Participants ( n = 55 ) completed the Short Form Health Survey v2 ( SF-36 ) before and 22 ± 4.2 months after surgery . Information on socio-demographics , body mass index ( BMI ) , co-morbidity and satisfaction with surgery were collected through patient question naires and hospital records . RESULTS There was overall improvement on all SF-36 subscales and in the mean physical score ( PCS ) and mean mental score ( MCS ) ( p = 0.001 ) . A total of five patients had lower PCS and 13 patients had lower MCS after surgery , but we identified no particular characteristics associated with this poorer outcome . Co-morbidity and preoperative PCS/MCS showed a strong correlation with change in PCS/MCS score . CONCLUSION Gastric bypass had a positive overall effect on HRQOL , but further investigation of individual variations is needed . We found no significant differences in HRQOL outcome between those patients who would be accepted for bariatric surgery under the current Danish criteria for bariatric surgery and those patients who only fulfilled the criteria for bariatric surgery before 2011 . FUNDING not relevant . TRIAL REGISTRATION Clinical Trials.gov : NCT02032199",
"Our purpose was to assess the cost , quality of life impact , and the cost – utility of bariatric surgery in a managed care population . We studied 221 patients who underwent bariatric surgery between 2001 and 2005 . We analyzed medical cl aims data for all patients and survey data for 122 survey respondents ( 55 % response rate ) . Patients were generally middle-aged , female , and white . Sixty-four percent underwent open and 33 % underwent laparoscopic Roux-en-Y procedures . One year after surgery , mean body mass index fell from 51 to 31 kg/m2 in women and from 59 to 35 kg/m2 in men with substantial improvements in comorbidities . Postsurgical mortality and morbidity were low . Total per member per month costs increased in the 6 months before bariatric surgery , were lower in the 12 months after bariatric surgery , but increased somewhat over the next 12 months . When presurgical quality of life was assessed prospect ively , average health utility scores improved by 0.14 one year after surgery . In analyses that took a lifetime time horizon , projected future costs based on age and obesity and discounted costs and health utilities at 3 % per year , the cost – utility ratio for bariatric surgery versus no surgery was approximately $ 1,400 per quality -adjusted life-year gained . In sensitivity analyses , bariatric surgery was more cost-effective in women , non-whites , more obese patients , and when performed laparoscopically . Although not cost-saving , bariatric surgery represents a very good value for money . Its long-term cost effectiveness appears to depend on the natural history and cost of late postsurgical complications and the natural history and cost of untreated morbid obesity",
"Background / Aims : Improving health-related quality of life ( HRQoL ) along with decreasing obesity-related morbidity is one of the cornerstones of bariatric surgery . The aim of the study was to investigate how losing weight influences the HRQoL 1 year after gastric bypass and whether HRQoL prior to surgery predicts the amount of weight loss 1 year after gastric bypass . Methods : One hundred and thirty-nine obese women [ median ( range ) : age 45 years ( 20–71 ) , BMI 44 ( 29–88 ) ] admitted for gastric bypass were selected prospect ively and completed the Nottingham Health Profile ( NHP ) quality of life question naire before and 1 year after surgery . Results : Weight loss 1 year after gastric bypass was significant [ –37 kg ( 9–74 ) , p improvement of quality of life [ NHP total score before surgery 62 ( 39–76 ) and after surgery 20 ( 7–65 ) , p HRQoL improves dramatically 1 year after gastric bypass . This HRQoL improvement is not influenced by the amount of weight loss , but rather by the BMI achieved at that time",
"BACKGROUND The main associations of body-mass index ( BMI ) with overall and cause-specific mortality can best be assessed by long-term prospect i ve follow-up of large numbers of people . The Prospect i ve Studies Collaboration aim ed to investigate these associations by sharing data from many studies . METHODS Collaborative analyses were undertaken of baseline BMI versus mortality in 57 prospect i ve studies with 894 576 participants , mostly in western Europe and North America ( 61 % [ n=541 452 ] male , mean recruitment age 46 [ SD 11 ] years , median recruitment year 1979 [ IQR 1975 - 85 ] , mean BMI 25 [ SD 4 ] kg/m(2 ) ) . The analyses were adjusted for age , sex , smoking status , and study . To limit reverse causality , the first 5 years of follow-up were excluded , leaving 66 552 deaths of known cause during a mean of 8 ( SD 6 ) further years of follow-up ( mean age at death 67 [ SD 10 ] years ) : 30 416 vascular ; 2070 diabetic , renal or hepatic ; 22 592 neoplastic ; 3770 respiratory ; 7704 other . FINDINGS In both sexes , mortality was lowest at about 22.5 - 25 kg/m(2 ) . Above this range , positive associations were recorded for several specific causes and inverse associations for none , the absolute excess risks for higher BMI and smoking were roughly additive , and each 5 kg/m(2 ) higher BMI was on average associated with about 30 % higher overall mortality ( hazard ratio per 5 kg/m(2 ) [ HR ] 1.29 [ 95 % CI 1.27 - 1.32 ] ) : 40 % for vascular mortality ( HR 1.41 [ 1.37 - 1.45 ] ) ; 60 - 120 % for diabetic , renal , and hepatic mortality ( HRs 2.16 [ 1.89 - 2.46 ] , 1.59 [ 1.27 - 1.99 ] , and 1.82 [ 1.59 - 2.09 ] , respectively ) ; 10 % for neoplastic mortality ( HR 1.10 [ 1.06 - 1.15 ] ) ; and 20 % for respiratory and for all other mortality ( HRs 1.20 [ 1.07 - 1.34 ] and 1.20 [ 1.16 - 1.25 ] , respectively ) . Below the range 22.5 - 25 kg/m(2 ) , BMI was associated inversely with overall mortality , mainly because of strong inverse associations with respiratory disease and lung cancer . These inverse associations were much stronger for smokers than for non-smokers , despite cigarette consumption per smoker varying little with BMI . INTERPRETATION Although other anthropometric measures ( eg , waist circumference , waist-to-hip ratio ) could well add extra information to BMI , and BMI to them , BMI is in itself a strong predictor of overall mortality both above and below the apparent optimum of about 22.5 - 25 kg/m(2 ) . The progressive excess mortality above this range is due mainly to vascular disease and is probably largely causal . At 30 - 35 kg/m(2 ) , median survival is reduced by 2 - 4 years ; at 40 - 45 kg/m(2 ) , it is reduced by 8 - 10 years ( which is comparable with the effects of smoking ) . The definite excess mortality below 22.5 kg/m(2 ) is due mainly to smoking-related diseases , and is not fully explained",
"Background Negative consequences of the obesity epidemic include decreased physical , psychological , and sexual health . Bariatric surgery is a well-tolerated and effective treatment for morbid obesity . This study aim ed to determine the effect of bariatric surgery on health-related quality of life ( HRQOL ) and sexual functioning and to identify potential predictors of this effect . Methods Eighty morbidly obese patients ( 50 women ) completed the study . HRQOL was measured using the Short Form 36 question naire ( SF-36 ) . Sexual functioning was assessed using the Female Sexual Functioning Index ( FSFI ) and the International Index of Erectile Function ( IIEF ) . All participants were evaluated four times as follows : presurgery ( T1 ) , 1 month ( T2 ) , 6 months ( T3 ) , and 1 year ( T4 ) after surgery . Results Body mass index ( BMI ) significantly decreased over time ( p male orgasm , all sexual functioning components as well as all SF-36 sub-scales improved between T1 and T4 . The maximum improvement was observed between T2 and T3 . Baseline HRQOL scores correlated with postoperative improvement in all HRQOL components . BMI improvement was correlated with improvement in role physical , bodily pain , and mental health scores . Baseline total sexual satisfaction score independently predicted total satisfaction improvement in both genders . Conclusions The present findings indicate that bariatric surgery represents an effective obesity treatment , leading to significant BMI reduction and improvement in HRQOL and sexual functioning , especially in the first 6 months postoperatively"
] | 41165ccc-06ff-11f0-808a-c43d1ab1c353 |
Background : Placebo response is high in bipolar disorder trials . This is a challenge for research ers and an enigma for clinicians . This article will attempt to aid in the comprehension of the ethical questions and method ologies related to the use of placebo in bipolar disorder . Methods : A systematic review of the main computerized data bases ( Medline , Embase , Psychlit , Current Contents ) was carried out , using the following key words : placebo , bipolar disorder , mania , depression , clinical trial . Results : Placebo has a very important role in the study of bipolar disorders . From a method ological point of view , and given the limitations of non-inferiority design s , the use of placebo is necessary to evaluate the sensitivity of the study and ensure that the drug under investigation is really effective . For this reason , several procedures may be used to satisfactorily solve the ethical objections . Placebo response in bipolar disorder trials is more likely to occur in patients who are mildly ill , bipolar II , mixed-episode , first-episode , rapid cycling , atypical , non-psychotic , substance abusers and medically ill . The use of concomitant medication such as benzodiazepines , a high frequency of visits , a high number of treatment groups and sites , fixed-dose design s , and the concomitant use of psychotherapy are likely to increase placebo response . Conclusion : The subject of the use of placebo in psychiatric clinical trials leads to very relevant ethical , method ological and clinical dilemmas . Many reasons support the use of placebo in acute bipolar studies , whereas in maintenance the length of the treatment with placebo makes the decision more difficult . Ethical concerns can be addressed through operational definitions of outcome measures , add-on and discontinuation design s , early escape strategies , and processes design ed to make sure that fully informed consent was fairly obtained . There are a number of clinical and method ological variables that are associated with placebo response | [
"OBJECTIVE Administration of placebo can result in a clinical response indistinguishable from that seen with active antidepressant treatment . Functional brain correlates of this phenomenon have not been fully characterized . METHOD Changes in brain glucose metabolism were measured by using positron emission tomography in hospitalized men with unipolar depression who were administered placebo as part of an inpatient imaging study of fluoxetine . Common and unique response effects to administration of placebo or fluoxetine were assessed after a 6-week , double-blind trial . RESULTS Placebo response was associated with regional metabolic increases involving the prefrontal , anterior cingulate , premotor , parietal , posterior insula , and posterior cingulate and metabolic decreases involving the subgenual cingulate , parahippocampus , and thalamus . Regions of change overlapped those seen in responders administered active fluoxetine . Fluoxetine response , however , was associated with additional subcortical and limbic changes in the brainstem , striatum , anterior insula , and hippocampus , sources of efferent input to the response-specific regions identified with both agents . CONCLUSIONS The common pattern of cortical glucose metabolism increases and limbic-paralimbic metabolism decreases in placebo and fluoxetine responders suggests that facilitation of these changes may be necessary for depression remission , regardless of treatment modality . Clinical improvement in the group receiving placebo as part of an inpatient study is consistent with the well-recognized effect that altering the therapeutic environment may significantly contribute to reducing clinical symptoms . The additional subcortical and limbic metabolism decreases seen uniquely in fluoxetine responders may convey additional advantage in maintaining long-term clinical response and in relapse prevention",
"OBJECTIVE For decades , lithium has been prescribed to treat bipolar disorder . Its efficacy has been documented by clinical trials and by data from specialized clinics . An issue of considerable interest is the use of lithium in managed care systems . This project examined the use of lithium and its continuity of use by enrollees of a health maintenance organization ( HMO ) . METHOD In a 6-year longitudinal cohort study , 1,594 lithium users aged 15 years and older who were enrolled in an HMO were followed from 1986 - 1991 . Data were obtained from automated data bases and from medical record review of a r and om 5 % sub sample of the group ( N = 74 ) . RESULTS Bipolar disorder was the most frequent morbidity treated . Eighty-four percent ( N = 62 or 74 ) received services from a psychiatrist . Annual prevalence of lithium use increased over the 6-year period from 1.4 to 2.3 persons per thous and HMO members . Duration of use varied widely with some long-term but many short-term users . Discontinuation of treatment was associated with evaluated rates of psychiatric hospitalization and use of psychiatric emergency services . Lithium users were much more likely to receive a variety of other psychotropic drugs than nonusers of the same sex and age . CONCLUSIONS Lithium use in this population was more often sporadic than continuous . Discontinuation of lithium was associated with psychiatric hospitalization . If lithium is to be a cost-effective treatment for bipolar disorder , managed care systems will need to improve adherence to drug treatment regimens",
"Maintenance studies in bipolar disorder have received increased attention in recent years . The interest is driven by apparent contradictions between results of early placebo-controlled trials of lithium and recent open studies , as well as interest in a new group of drugs with mood-stabilizing properties . The multiple outcome indices that require attention in prophylactic bipolar disorder studies add a dimension not present in acute studies of bipolar disorder . We present the methodology of a recently completed r and omized , double-blind , placebo-controlled , parallel-group comparison of divalproex and lithium . We examine the consequences of salient design features , along with their implication s for future studies . A fundamental conclusion is that such maintenance studies should be design ed and executed to emphasize enrollment of patients with relatively active , severe forms of the illness . This goal is not achieved simply , as inherent features of long-term , placebo-controlled studies drive recruitment and enrollment in the direction of patients with milder forms of bipolar disorder . Attention to the frequency of both manic and depressive episodes and the severity of an index manic episode may aid in the selection of patients most suitable for studies design ed to achieve adequate statistical power",
"OBJECTIVE The primary intent of this study was to compare the efficacy and safety of olanzapine and placebo in the treatment of acute mania . METHOD The design involved a r and om-assignment , double-blind , placebo-controlled parallel group study of 3 weeks ' duration . After a 2- to 4-day screening period , qualified patients were assigned to either olanzapine ( N = 70 ) or placebo ( N = 69 ) . Patients began double-blind therapy with either olanzapine , 10 mg , or placebo given once per day . After the first day of treatment , the daily dose could be adjusted upward or downward , as clinical ly indicated , by one capsule ( olanzapine , 5 mg/day ) within the allowed range of one to four capsules . The primary efficacy measure in the protocol was defined as a change from baseline to endpoint in total score on the Young Mania Rating Scale . Clinical response was defined a priori as a decrease of 50 % or more from baseline in Young Mania Rating Scale total score . RESULTS The olanzapine group experienced significantly greater mean improvement in Young Mania Rating Scale total score than the placebo group . On the basis of the clinical response criteria , significantly more olanzapine-treated patients ( 48.6 % ) responded than those assigned to placebo ( 24.2 % ) . Somnolence , dizziness , dry mouth , and weight gain occurred significantly more often with olanzapine . There were no statistically significant differences between the olanzapine-treated and placebo-treated patients with respect to measures of parkinsonism , akathisia , and dyskinesias . No discontinuations of treatment due to adverse events occurred in the olanzapine treatment group . CONCLUSIONS The results from this study suggest that compared with placebo , olanzapine has superior efficacy for the symptoms of acute mania"
] | 41165d08-06ff-11f0-808a-c43d1ab1c353 |
Request for Clarification : We have with great interest read the recent article “ Can resistance training enhance the rapid force development in unloaded dynamic isoinertial multijoint movements ? A systematic review ” by van Hooren et al. (10).Although the topic is highly relevant to athletes and | [
"PURPOSE To determine whether the magnitude of improvement in athletic performance and the mechanisms driving these adaptations differ in relatively weak individuals exposed to either ballistic power training or heavy strength training . METHODS Relatively weak men ( n = 24 ) who could perform the back squat with proficient technique were r and omized into three groups : strength training ( n = 8 ; ST ) , power training ( n = 8 ; PT ) , or control ( n = 8) . Training involved three sessions per week for 10 wk in which subjects performed back squats with 75%-90 % of one-repetition maximum ( 1RM ; ST ) or maximal-effort jump squats with 0%-30 % 1RM ( PT ) . Jump and sprint performances were assessed as well as measures of the force-velocity relationship , jumping mechanics , muscle architecture , and neural drive . RESULTS Both experimental groups showed significant ( P jump and sprint performances after training with no significant between-group differences evident in either jump ( peak power : ST = 17.7 % + /- 9.3 % , PT = 17.6 % + /- 4.5 % ) or sprint performance ( 40-m sprint : ST = 2.2 % + /- 1.9 % , PT = 3.6 % + /- 2.3 % ) . ST also displayed a significant increase in maximal strength that was significantly greater than the PT group ( squat 1RM : ST = 31.2 % + /- 11.3 % , PT = 4.5 % + /- 7.1 % ) . The mechanisms driving these improvements included significant ( P force-velocity relationship , jump mechanics , muscle architecture , and neural activation that showed a degree of specificity to the different training stimuli . CONCLUSIONS Improvements in athletic performance were similar in relatively weak individuals exposed to either ballistic power training or heavy strength training for 10 wk . These performance improvements were mediated through neuromuscular adaptations specific to the training stimulus . The ability of strength training to render similar short-term improvements in athletic performance as ballistic power training , coupled with the potential long-term benefits of improved maximal strength , makes strength training a more effective training modality for relatively weak individuals"
] | 41165d44-06ff-11f0-808a-c43d1ab1c353 |
Background Multiple studies in various parts of the world have analysed the association of nutritional status on malaria using anthropometric measures , but results differ due to the heterogeneity of the study population , species of the parasite , and other factors involved in the host and parasite relationship . The aim of this study was to perform a systematic review on the inter-relationship of nutritional status based on anthropometry and malarial infection . Methods Two independent review ers accessed the MEDLINE and LILACS data bases using the same search terms related to malaria and anthropometry . Prospect i ve studies associating anthropometry and malaria ( incidence or severity ) were selected . References from the included studies and review s were used to increase the review sensitivity . Data were extracted using a st and ardized form and the quality of the prospect i ve studies was assessed . Selected articles were grouped based on exposures and outcomes . Results The search identified a total of 1688 studies : 1629 from MEDLINE and 59 from LILACS . A total of 23 met the inclusion criteria . Five additional studies were detected by reading the references of the 23 included studies and review s , totaling 28 studies included . The mean sample size was 662.1 people , ranging from 57 to 5620 . The mean follow-up was 365.8 days , ranging from 14 days to 1 year and 9 months , and nine studies did not report the follow-up period . Prospect i ve studies assessing the relationship between malaria and malnutrition were mostly carried out in Africa . Of the 20 studies with malarial outcomes , fifteen had high and five had average quality , with an average score of 80.5 % . Most anthropometric parameters had no association with malaria incidence ( 47/52 ; 90.4 % ) or parasite density ( 20/25 ; 80 % ) . However , the impact of malnutrition was noted in malaria mortality and severity ( 7/17 ; 41.2 % ) . Regarding the effects of malaria on malnutrition , malaria was associated with very few anthropometric parameters ( 8/39 ; 20.6 % ) . Conclusions This systematic review found that most of the evidence associating malaria and malnutrition comes from P. falciparum endemic areas , with a significant heterogeneity in studies ’ design . Apparently malnutrition has not a great impact on malaria morbidity , but could have a negative impact on malaria mortality and severity . Most studies show no association between malaria and subsequent malnutrition in P. falciparum areas . In Plasmodium vivax endemic areas , malaria was associated with malnutrition in children . A discussion among experts in the field is needed to st and ardize future studies to increase external validity and accuracy | [
"BACKGROUND No comprehensive data on the clinical features and the prognosis of cerebral malaria in the South Pacific are available at present . We conducted a prospect i ve study in children with cerebral malaria to assess the case fatality rate ( CFR ) in the region and to identify potential risk factors for death . METHODS We recruited 134 children admitted to the Madang General Hospital between April 1991 and October 1993 with a strictly defined diagnosis of cerebral malaria . Besides clinical examination , we collected a blood sample for parasitological haematological and biochemical assessment . RESULTS The CFR was 11.9 % and the prevalence of residual neurological sequelae at discharge was 1.5 % . The proportion of children presenting with deep coma ( 12 % ) or hypoglycaemia ( 17 % ) was lower in our study than in African ones , where severe complications are more frequent . Also mortality associated with hypoglycaemia on admission was lower . Clinical or laboratory conditions significantly associated with death were deep coma , malarial anaemia and hyperleucocytosis . CONCLUSIONS All conditions associated with deep coma , such as shock , hypoglycaemia and acidosis , should be corrected . Also prompt administration of blood transfusions to patients with anaemia is likely to reduce the occurrence of death in Papua New Guinean children with cerebral malaria",
"BACKGROUND The relation between malnutrition and malaria is controversial . On the one h and , malaria may cause malnutrition , whereas on the other h and , malnutrition itself may modulate susceptibility to the disease . OBJECTIVE The objective was to investigate the association between Plasmodium falciparum malaria and malnutrition in a cohort of Kenyan children . DESIGN The study involved the longitudinal follow-up of children aged 0 - 95 [ corrected ] mo for clinical malaria episodes and anthropometric measurements through 4 cross-sectional surveys . We used Poisson regression analysis to investigate the association between malaria and nutritional status . RESULTS The crude incidence rate ratios ( IRRs ) for malaria during the 6-mo period before assessment in children defined as malnourished on the basis of low height-for-age or low weight-for-age z scores ( ) were 1.17 ( 95 % CI : 0.91 , 1.50 ; P=0.21 ) and 0.94 ( 0.71 , 1.25 ; P=0.67 ) , respectively , which suggests no association between malaria and the subsequent development of protein-energy malnutrition . However , we found that age acted as an effect modifier in the association between malaria episodes and malnutrition on prospect i ve follow-up . The IRR for malaria in children aged 0 - 2 y , who were subsequently characterized as underweight , was 1.65 ( 1.10 , 2.20 ; P=0.01 ) , and a significant overall relation between malaria and stunting was found on regression analysis after adjustment for the interaction with age ( IRR : 1.91 ; 1.01 , 3.58 ; P=0.04 ) . CONCLUSION Although children living on the coast of Kenya continue to experience clinical episodes of uncomplicated malaria throughout the first decade of life , the effect of malaria on nutritional status appears to be greatest during the first 2 y of life",
"BACKGROUND Previous analyses derived the relative risk ( RR ) of dying as a result of low weight-for-age and calculated the proportion of child deaths worldwide attributable to underweight . OBJECTIVES The objectives were to examine whether the risk of dying because of underweight varies by cause of death and to estimate the fraction of deaths by cause attributable to underweight . DESIGN Data were obtained from investigators of 10 cohort studies with both weight-for-age category ( -1 SD ) and cause of death information . All 10 studies contributed information on weight-for-age and risk of diarrhea , pneumonia , and all-cause mortality ; however , only 6 studies contributed information on deaths because of measles , and only 3 studies contributed information on deaths because of malaria or fever . With use of weighted r and om effects models , we related the log mortality rate by cause and anthropometric status in each study to derive cause-specific RRs of dying because of undernutrition . Prevalences of each weight-for-age category were obtained from analyses of 310 national nutrition surveys . With use of the RR and prevalence information , we then calculated the fraction of deaths by cause attributable to undernutrition . RESULTS The RR of mortality because of low weight-for-age was elevated for each cause of death and for all-cause mortality . Overall , 52.5 % of all deaths in young children were attributable to undernutrition , varying from 44.8 % for deaths because of measles to 60.7 % for deaths because of diarrhea . CONCLUSION A significant proportion of deaths in young children worldwide is attributable to low weight-for-age , and efforts to reduce malnutrition should be a policy priority",
"Objective : To examine the relation of circulating appetite neuropeptides , CCK-8 sulphate ( CCK-8s ) and β-endorphin , and the tumour necrosis factor-alpha ( TNF-α ) and soluble TNF receptors ( sTNFR ) to the anorexia and wasting associated with HIV-infection . Design : Cross-sectional analysis . Setting : A university-based HIV/AIDS ambulatory clinic in Madrid , Spain . Participants : Thirty-six r and omly selected AIDS patients without concomitant diseases or secondary infections were classified into two groups : 19 patients with wasting and 17 with normal body weight , and 18 healthy controls . Measurements : Nutritional status was evaluated by anthropometry , laboratory parameters and self-report of appetite . Plasma levels of TNF-α and sTNFR proteins p55 ( sTNFR-p55 ) and p75 ( sTNFR-p75 ) were determined by enzyme immunoassay , whereas CCK-8s and β-endorphin levels were measured by radioimmunoassay . Results : AIDS patients with wasting had significantly higher plasma concentrations of CCK-8s , but lower levels of β-endorphin when compared to well-nourished AIDS patients ( P 0.001 ) . Mean levels of TNF-α , and sTNFR-p55 and sTNFR-p75 were greater in AIDS patients with wasting than in asymptomatic AIDS patients or in controls . No significant association was observed between any of these circulating peptides and the parameters of malnutrition . Conclusions : An activation of the TNF system , together with reciprocal changes in plasma concentrations of two neuropeptides with opposing appetite regulation , that is increased concentrations of CCK-8s but lower levels of β-endorphin , are associated with the presence of HIV wasting . We hypothesize that these changes may contribute to the development of HIV wasting by producing a pathological inhibition of appetite",
"BACKGROUND Children 's development is affected by the interplay of internal and external factors and changes in one factor can precipitate changes in multiple developmental domains . AIMS The aim of this study was to test a theoretical model of children 's development using structural equation modeling . STUDY DESIGN This was design ed as a sub study of a r and omized , placebo-controlled , 2 × 2 factorial trial of the effects of daily supplementation with iron ( 12.5 mg ) + folic acid ( 50 μg ) ( FeFA ) with or without zinc ( 10 mg ) ( Zn ) on child mortality . SUBJECTS Zanzibari children aged 5 - 9 mo ( n = 106 ) and 10 - 14 mo ( n = 141 ) at baseline were included in this sub study . OUTCOME MEASURES Longitudinal data on children 's hemoglobin , growth , malaria infection , motor development , motor activity , and language development and caregiver behavior were used to test the fit of the theoretical model for two age groups and to examine the direct and indirect relationships among the variables in the model . RESULTS The theoretical models were a good fit to the data for both age groups and revealed that FeFA with or without Zn had positive effects on motor development . FeFA alone had negative effects on language development in both age groups and Zn alone had negative effects on language development in children aged 10 - 14 mo . The incidence of malaria had negative effects on the majority of health and development outcomes in children aged 5 - 9 mo , and on motor development and hemoglobin in children aged 10 - 14 mo . CONCLUSIONS These findings illustrate how nutrition and health factors can affect different domains of development and how these changes can precipitate changes in other domains . More work is needed to better underst and the multiple impacts of internal and external factors on children 's development and how changes in developmental domains interact with each other over time to determine children 's overall developmental trajectory . The r and omized , placebo-controlled study was registered as an International St and ard R and omized Controlled Trial , number IS RCT N59549825",
"BACKGROUND Previous studies on the association of malaria and stunted growth delivered inconsistent results . These conflicting results may be due to different levels of confounding and to considerable difficulties in elucidating a causal relationship . R and omized experiments are impractical and previous observational studies have not fully controlled for potential confounding including nutritional deficiencies , breastfeeding habits , other infectious diseases and socioeconomic status . METHODS This study aims to estimate the causal effect between malaria episodes and stunted growth by applying a combination of Mendelian r and omization , using the sickle cell trait , and matching . We demonstrate the method on a cohort of children in the Ashanti Region , Ghana . RESULTS We found that the risk of stunting increases by 0.32 ( P-value : 0.004 , 95 % CI : 0.09 , 1.0 ) for every malaria episode . The risk estimate based on Mendelian r and omization substantially differs from the multiple regression estimate of 0.02 ( P-value : 0.02 , 95 % CI : 0.003 , 0.03 ) . In addition , based on the sensitivity analysis , our results were reasonably insensitive to unmeasured confounders . CONCLUSIONS The method applied in this study indicates a causal relationship between malaria and stunting in young children in an area of high endemicity and demonstrates the usefulness of the sickle cell trait as an instrument for the analysis of conditions that might be causally related to malaria",
"Negative consequences of malaria might account for seasonality in nutritional status in children in the Sahel . We report the impact of a r and omized , double-blind , placebo-controlled trial of seasonal intermittent preventive anti-malarial treatment on growth and nutritional status in 1,063 Senegalese preschool children . A combination of artesunate and sulfadoxine-pyrimethamine was given monthly from September to November . In the intervention arm , mean weight gain was significantly greater ( 122.9 + /- 340 versus 42.9 + /- 344 [ SD ] g/mo , P losses in triceps and subscapular skinfold measurements were less ( -0.39 + /- 1.01 versus -0.66 + /- 1.01 mm/mo , and -0.15 + /- 0.64 versus -0.36 + /- 0.62 mm/mo , respectively , P height increments . The prevalence of wasting increased significantly in the control arm ( 4.6 % before versus 9.5 % after , P nutritional status in areas with seasonal transmission",
"BACKGROUND The mechanisms of severe malarial anemia and cerebral malaria , which are extreme manifestations of Plasmodium falciparum malaria , are not fully understood . METHODS Children aged were studied prospect ively . Children with overlapping severe anemia and cerebral malaria were excluded . RESULTS Low interleukin 10 concentrations had the strongest association with severe anemia ( st and ard β = .61 ; P high tumor necrosis factor α and sFas concentrations , low weight-for-age z scores , presence of stool parasites , and splenomegaly ( st and ard β = .15-.25 ; P ≤ .031 ) ; most of these factors were also associated with lower reticulocytes . Greater parasitemia was associated with higher interleukin 10 and tumor necrosis factor α concentrations , whereas sulfadoxizole/pyrimethamine therapy and lower weight-for-age z scores were associated with lower interleukin 10 levels . Thrombocytopenia and elevated tissue plasminogen activator inhibitor 1 levels had the strongest associations with cerebral malaria ( st and ard β = .37 or .36 ; P ( altered immune responses , poor nutrition , intestinal parasites , and impaired erythropoiesis ) differed from those of cerebral malaria ( thrombocytopenia , herbal medicine , and intravascular hemolysis ) . Improved preventive and therapeutic measures may need to consider these differences",
"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",
"During the Central African ( Sahelian ) drought , attacks of falciparum malaria were common in patients and their relatives shortly after their arrival in a hospital in Eastern Niger . A prospect i ve study of 72 adult patients not admitted for malaria and 109 accompanying relatives was undertaken to investigate this observation . 23 attacks occurred in patients and 51 in relatives , with a peak frequency five days after arrival . On arrival , parasitaemia was low but reached a maximum by five days . Serum-iron and percentage saturation of transferrin were moderately increased initially , rose dramatically within forty-eight hours with near maximum saturation , and were falling by the fifth day . It is suggested that the early hyperferraemia , apparently related to refeeding , led to rapid multiplication of existing parasites and attacks of malaria . The results of experimental malarial infection of Wistar rats , half of which had been given intramuscular iron , supported this hypothesis",
"Although the association between nutritional status and mortality risk is obvious for extreme malnutrition , the issue is not so clear for mild to moderate undernutrition . We have investigated this association in children of 0 - 5 years in the rural area of Bwam and a , Zaire , where an integrated development project , with good medical facilities , has operated for 20 years . A r and om cluster sample of 5167 children was taken ; newborn infants and immigrants were included at six quarterly survey rounds from October , 1989 , until February , 1991 . All surveys included clinical and anthropometric assessment of nutritional status . Deaths were recorded up to April , 1992 ; there were 246 deaths . Marasmus , kwashiorkor , and other causes of death were defined by the verbal autopsy method and checked against medical records kept at the central hospital and the peripheral dispensaries . As expected , we found an increased risk of death in severe malnutrition . When deaths directly attributed to marasmus or kwashiorkor were excluded , mild to moderate stunting or wasting were not associated with higher mortality in the short term ( within 3 months of the previous study round ) or in the long term ( from 3 - 30 months after study entry ) . The commonest causes of death were malaria and anaemia . Extreme marasmus and kwashiorkor caused 16 % of deaths , and are important causes of death even in this favoured area with an integrated development project . Nutritional interventions should be targeted more selectively so that children with moderate malnutrition can be protected from progression to marasmus or kwashiorkor",
"The impacts of acute falciparum malaria on body weight and the host and parasite factors predictive of change in body weight were characterized in 465 prospect ively studied children in an endemic area of southwest Nigeria . Pre-treatment weights were significantly lower than the 14 to 28-day post-treatment weights ( P = 0.0001 ) . In 187 children , fractional fall in body weight ( FFBW ) exceeded 4.9 % . FFBW correlated negatively with age and body weight ( P = 0.014 and 0.0001 , respectively ) , but not with enrolment parasitaemia . In a multiple regression model , an age ≤5 years ( AOR = 2.03 , 95 % CI 1.2–3.2 , P = 0.003 ) , a hematocrit ≤29 % ( AOR = 1.6 , 95 % CI 1.0–2.3 , P = 0.037 ) , and a body weight ≤9.6 kg ( AOR = 5.4 , 95 % CI 1.7–20 , P = 0.003 ) were independent predictors of FFBW ≥5 % at presentation . Children who , after initial clearance , had recurrence of their parasitaemia within 28 days had a significantly higher propensity not to gain weight than children who were aparasitaemic after treatment ( log-rank statistic 6.76 , df = 1 , P = 0.009 ) . These results indicate that acute malaria contribute to sub-optimal growth in young children and may have implication s for malaria control efforts in sub-Saharan Africa ",
"The aim of this study was to analyze factors influencing the growth pattern of children from birth to 18 months . A longitudinal prospect i ve study was conducted in three maternity wards in Southern Benin . Inclusion took place between June 2007 and July 2008 ; children were followed-up until 18 months of age . Height-for-age and weight-for-height Z-scores were computed using the newborn 's anthropometric measurements taken at delivery , every month up to 6 months and then quarterly . Infant and young child feeding ( IYCF ) practice s and malarial morbidity were recorded . Gestational age was estimated using the Ballard method ; William 's sex-specific reference curve of birth weight-for-gestational-age was used to determine intrauterine growth retardation ( IUGR ) . Analyses were performed on 520 children using a linear mixed model . Low birth weight ( coef=-0.43 ; p=0.002 ) , IUGR ( coef=-0.49 ; p maternal short stature ( coef=-0.25 ; p=0.001 ) and maternal low weight status ( coef=-0.19 ; p=0.006 ) were significantly associated with growth impairment . Only LBW ( coef=-0.28 ; p=0.05 ) and maternal low weight status ( coef=-0.23 ; p=0.004 ) were associated with wasting . A good IYCF score was positively associated with weight gain ( coef=0.14 ; p length ( coef=-0.18 ; p Malaria morbidity was not associated with growth . LBW , IUGR and maternal low weight status and height were important determinants of children 's growth . These results reinforce and justify continuing public health initiatives to fight IUGR and LBW and break the intergenerational cycle of malnutrition"
] | 41165d80-06ff-11f0-808a-c43d1ab1c353 |
Bladder pain syndrome/interstitial cystitis ( BPS/IC ) is a chronic disease characterised by persistent irritating micturition symptoms and pain . The objective was to compare the clinical efficacy of currently available products for intravesical therapy of BPS/IC and to assess their pharmacoeconomic impact . A Pubmed / Medline data base search was performed for articles on intravesical therapy for BPS/IC . A total of 345 publications were identified , from which 326 were excluded . Statistical evaluation was performed with effect size ( ES ) assessment of symptom reduction and response rates . The final set of 19 articles on intravesical BPS/IC therapy included 5 prospect i ve controlled trials ( CTs ) , the remaining were classified as uncontrolled clinical studies . The total number of patients included was 801 , 228 of whom had been evaluated in a CT . For CTs , the largest ES for symptom reduction as well as response rate was observed for high molecular weight hyaluronic acid ( HMW-HA ) , with similar findings in two uncontrolled studies with HMW-HA . The number needed to treat to achieve a response to intravesical therapy was 2.67 for intravesical pentosan polysulphate and 1.31 for HMW-HA which were superior to all other instillates . HMW-HA was significantly superior in cost effectiveness and cost efficacy to all other instillation regimes . The present meta- analysis combined medical and pharmacoeconomic aspects and demonstrated an advantage of HMW-HA over other instillation agents ; however , direct comparisons between the different products have not been performed to date in properly design ed controlled studies | [
"Objective . To evaluate changes in bladder capacity and potassium sensitivity after glycosaminoglycan ( GAG ) substitution therapy . Material and methods . The study population comprised two groups of female patients with bladder pain syndrome/interstitial cystitis ( BPS/IC ) : responders ( those with symptom improvement ) and non-responders ( those without symptom improvement ) after a 10-week period of intravesical , episodic , weekly , GAG substitution therapy . A total of 27 volunteers with increased pre-therapeutic potassium sensitivity were enrolled in the study and re-evaluated using the modified comparative potassium test ( maximal bladder capacity with a saline solution versus a 0.2 M KCl solution ) following intravesical GAG substitution therapy . Results . In the 13 responders , the average maximal bladder capacity increased by 17 % with the saline solution and by 101.5 % with the 0.2 M KCl solution . In the 14 non-responders , post-therapeutic average maximal bladder capacity was decreased by 35 % with the saline solution and remained relatively unchanged after instillation with a 0.2 M KCl solution . Conclusion . These data demonstrate that in patients who respond symptomatically to intravesical GAG substitution therapy , cystometric bladder capacity is increased , whereas non-responders experience a decrease in bladder capacity",
"INTRODUCTION It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency , frequency , and pain associated with interstitial cystitis ( IC ) . This combination has also been reported to relieve pain associated with sex in patients with IC . AIM The aim of this study was to corroborate these findings in a multicenter setting . METHODS The study design was a multicenter prospect i ve , double-blind , crossover , placebo-controlled trial . Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria ( excluding cystoscopy ) for IC . Each patient received drug and control , in r and om order , within 48 hours of enrolling in the study . MAIN OUTCOME MEASURES The primary outcome measure was percent change in pain score ( 11-point analog pain scale ) 12 hours after receiving the drug or control . Secondary measures were the global assessment response ( GAR ) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales . RESULTS Eighteen ( 18 ) patients completed the trial . The average reduction of pain over 12 hours was 21 % for control and 42 % for active drug ( P = 0.0363 ) . GAR was 13 % for control and 50 % for drug ( P = 0.0137 ) . Average urgency reduction was 13 % for control and 35 % for drug ( P = 0.0328 ) . CONCLUSIONS The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC . This combination provides significant immediate relief of symptoms for patients with IC",
"The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid ( HA ) 1.6 % and chondroitin sulfate ( CS ) 2.0 % in patients with refractory painful bladder syndrome/interstitial cystitis ( PBS/IC ) and to observe their impact on Quality of Life . Twenty-three women were enrolled . They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months . Mean follow-up after completion of therapy was 5 months . We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency ( p = 0.045 ) , urgency ( p = 0.005 ) , and pain ( p = 0.001 ) . The O’Leary – Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index result ed in a significant improvement in both scores ( p = 0.004 and 0.01 , respectively ) . The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score ( p = 0.001 ) . This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC",
"OBJECTIVE It is not always possible to clearly differentiate the symptoms of overactive bladder and interstitial cystitis . A prospect i ve r and omized study was performed to determine whether instillation of sodium chondroitin sulphate for treatment of interstitial cystitis is also effective in treating overactive bladder . The expected benefit of this therapeutic approach in overactive bladder is based on the assumption that the glycosaminoglycan layer may be damaged in overactive bladder as well . MATERIAL AND METHODS Patients with chronic overactive bladder were r and omized to one of two study groups each including 41 patients . Group A was treated with an anticholinergic agent ( tolterodine ) , group B with sodium chondroitin sulphate ( Uropol S ) . The diagnosis was established on the basis of a gynecologic examination and history , urodynamic testing , introital ultrasound , and cystoscopy . Patients were treated for 12 months . RESULTS An improvement of symptoms was reported by 15/35 ( 43 % ) of the patients in group A ( p = 0.000 ) as compared with 23/32 ( 72 % ) of the patients in group B. The subjective outcome was corroborated by means of urodynamic testing , number of pads used , voiding frequency , and nycturia ( voiding diary ) . Quality of life increased significantly in both groups in the course of treatment but there was no significant difference between both groups . CONCLUSION The results of the study presented here suggest that restoring the glycosaminoglycan layer also improves or cures the symptoms in patients with overactive bladder . Patients clearly benefit from instillation of sodium chondroitin sulphate . These results must be confirmed in larger studies before a wider use of this therapeutic option can be recommended",
"PURPOSE Based on the assumption that interstitial cystitis results from a defective mucous lining of the bladder epithelium , we investigated the activity of hyaluronic acid in the treatment of this disease . Hyaluronic acid is an important glycosaminoglycan present in all connective tissues , including the glycosaminoglycan layer of the vesical mucosa . It exhibits a variety of pharmacological properties that enhance its appeal for the therapy of interstitial cystitis . MATERIAL S AND METHODS A total of 25 patients with characteristic findings of interstitial cystitis refractory to other medical treatments participated in a trial of intravesical hyaluronic acid at a dose of 40 mg . weekly for 4 weeks and then monthly . Response to therapy was evaluated by symptom score , voiding diaries and visual analog scales . RESULTS An initial 56 % positive ( complete plus partial ) response rate at week 4 increased to 71 % by week 12 and response was maintained until week 20 . Beyond week 24 there was a moderate decrease in the effectiveness of the medication . There was no significant toxicity attributable to hyaluronic acid in the bladder . CONCLUSIONS The response of patients with refractory interstitial cystitis to the intravesical administration of hyaluronic acid was gratifying . In the past many therapies for interstitial cystitis which were initially considered promising failed the test of a controlled study . Such a study to determine the activity of hyaluronic acid in patients with interstitial cystitis is currently under way",
"Introduction and hypothesisWe studied the feasibility and efficacy of intravesical instillations with 40 ml chondroitin sulfate 0.2 % solution to prevent or reduce acute radiation cystitis in women undergoing pelvic radiotherapy . Methods In a comparative pilot study in 20 patients , half of the patients received instillations . Instillations ' bother was measured with visual analog scores ( VAS , 0–10 ) ; bladder pain , with VAS ; micturition-related quality of life , with the urogenital distress inventory ( UDI ) . Results One of the instilled patients discontinued the instillations . The first median “ acceptability”-VAS was 0 ( range , 0–3 ) ; the last median was 1 ( range , 0–3 ) . “ Bladder pain”-VAS peaked halfway in the treatment among controls ( median , 1 ; range , 0–5 ) and after treatment in the instilled patients ( median , 1 ; range , 1–3 ) . UDI scores showed over time median follow-up scores at or above median baseline scores in controls and at or below median baseline scores in instilled patients . Conclusion Intravesical instillations with chondroitin sulfate 0.2 % solution may decrease the bother related to bladder symptoms and are well tolerated",
"OBJECTIVES To compare the clinical effectiveness of different regimens of intravesical hyaluronic acid instillation for patients with interstitial cystitis/painful bladder syndrome . METHODS A total of 60 patients ( age 16 - 77 years ) diagnosed with interstitial cystitis/painful bladder syndrome were enrolled in this prospect i ve , r and omized study . A total of 30 patients were assigned to receive four weekly intravesical instillations of 40 mg of hyaluronic acid followed by five monthly instillations ( hyaluronic acid-9 group ) . Another 30 patients received 12 intravesical instillations of 40 mg hyaluronic acid every 2 weeks ( hyaluronic acid-12 group ) . Symptomatic changes after hyaluronic acid treatments were assessed using Interstitial Cystitis Symptom and Problem Indexes , pain visual analog scale , functional bladder capacity , frequency and nocturia in voiding diary , maximum flow rate , voided volume , postvoid residual volume , and Quality of Life Index at 1 , 3 and 6 months . RESULTS Of the 60 patients , 59 were evaluable at the end of the study . The Interstitial Cystitis Symptom Index , Interstitial Cystitis Problem Index and total score , pain visual analog scale , functional bladder capacity , maximum flow rate , and Quality of Life Index improved significantly after 6 months in both groups . The frequency and voided volume improved significantly only in the hyaluronic acid-12 group . However , patients with moderate and marked improvement were clinical ly similar in both groups . The measured variables did not differ between the two groups over the course of the study . CONCLUSION No significant difference was noted in the therapeutic effect between two hyaluronic acid instillation regimens for treatment of interstitial cystitis/painful bladder syndrome patients . Both groups showed significant improvement in symptom scores and Quality of Life Index",
"To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients",
"PURPOSE Increased urothelial permeability has been proposed as a cause of interstitial cystitis ( IC ) . The potassium sensitivity test assesses bladder discomfort after instillation of 0.4 M KCl for identification of increased urothelial permeability . Since exposure to 0.4 M KCl may be extremely painful for patients with IC we investigated a less traumatic alternative . MATERIAL S AND METHODS The study comprised 38 controls and 40 patients with IC . In all subjects cystometry was performed with 0.9 % NaCl followed by 0.2 M KCl , and filling volume at first urge and maximum bladder capacity ( Cmax ) were assessed for both solutions . RESULTS Controls did not show a significant change in Cmax . KCl decreased Cmax in 37 of 40 ( 92 % ) patients with IC with a mean decrease of 30 % . The examination was painless in all controls and in 33 of 40 ( 82 % ) patients with IC , and was moderately painful in 7 . CONCLUSIONS For demonstration of increased potassium sensitivity and diagnosis of IC , comparative assessment of Cmax is a well tolerated alternative to the 0.4 M potassium sensitivity test . Statistical evaluation of these results suggests that a decrease in Cmax greater than 30 % is indicative of IC",
"OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant immediate symptom relief . The difference in the response rates was statistically significant ( P symptom relief from the single instillation , and 16 ( 80 % ) of 20 reported significant sustained symptom relief after 2 weeks of treatment . CONCLUSIONS Intravesical treatment with combined heparin and alkalinized lidocaine immediately reduced the pain and urgency of IC in most patients treated for newly diagnosed IC . Symptom relief lasted beyond the duration of the local anesthetic activity of lidocaine , suggesting the solution suppresses neurologic upregulation . In IC treatment , this new intravesical solution may be helpful in the interval before heparinoid therapy reaches its full effect",
"AIM A retrospective study was performed to investigate whether the improvement of symptoms achieved with 0.2 % sodium chondroitin sulfate in treating overactive bladder ( OAB ) persists after 24 months . MATERIAL S AND METHODS Two years ago , a total of 82 patients with chronic OAB were r and omly assigned to receive either anticholinergic treatment ( Tolterodin ; group A , n = 41 ) or 0.2 % sodium chondroitin sulfate ( Gepan instill ; group B , n = 41 ) . Diagnostic assessment included a gynecological examination and history , urodynamic test-ing , introital ultrasound , and cystoscopy . Duration of treatment was 12 months . The patients underwent repeat follow-up after 24 months and the findings were compared with the results at 12 months . RESULTS In group A , 15 / 35 ( 43 % ) women reported an improvement of symptoms after 12 months as opposed to only 5 / 35 ( 14 % ) after 24 months . In group B , there was an improvement in 23 / 32 ( 72 % ) at 12 months and in 18 / 32 ( 56 % ) after 24 months ( p = 0.001 ) . The subjective results were corroborated by means of urodynamic test-ing , pad counts , voiding frequency and nycturia ( voiding diary ) . CONCLUSION Our findings suggest that instillation treatment with 0.2 % sodium chondroitin sulfate results in a more sustained improvement or cure of the symptoms of overactive bladder due to development of a glycosaminoglycan layer . Long-term results are needed for confirmation",
"Introduction and hypothesisIntravesical instillation of hyaluronic acid ( HA ) may restore the integrity of glycosaminoglycan layer in patients with painful bladder syndrome/interstitial cystitis ( PBS/IC ) , and the benefit may be improved with addition of alkalinized lidocaine ( AL ) . Methods 48 women with severe PBS/IC who failed oral medications were enrolled and divided into one trial and two control groups . The trial group received intravesical 40 mg HA , 10 ml of 2 % lidocaine and 5 ml of 8.4 % sodium bicarbonate on a weekly basis for 8 weeks and then monthly for 4 months with a subsequent follow-up of 24 weeks , while the two control groups received 40 mg HA and mixture of 10 ml of 2 % lidocaine and 5 ml of 8.4%sodium bicarbonate respectively following the same procedure . Response to therapy was evaluated by Global Response Assessment , voids per day , Visual Analogue Scale for pain , frequency and urgency , O’leary-Sant Interstitial Cystitis Symptom Index and Problem Index , cystoscopy and bladder capacity . Results Overall 45 patients finished this study protocol . The HA + AL group and the AL group showed significant improvement at week 2 ( P HA group began to show effect at week 4 ( P no improvement in the AL group at week 24 and these patients quitted the study without follow up . Contrarily , the HA + AL and HA group kept on improving till the end of the study without significant difference between the two groups . Conclusions Intravesical instillation of HA and AL may provide both immediate and sustained relief of symptoms in severe PBS/IC in this preliminary study",
"OBJECTIVES The aim of our study was to test the effect of a more viscous compound than existent hyaluronic acid formulation in helping to restore a defective glycosaminoglycan layer , and therefore in improving Interstitial Cystitis/Painful Bladder Syndrome ( IC/PBS ) symptoms when administered intravesically in IC/PBS patients . METHODS A total of 23 female patients completed the study . Patients received endovesical administration of hyaluronic acid and chondroitin sulfate in normal saline , 40 ml , weekly for 12 weeks and then bi-weekly for 6 months , if there was initial response . RESULTS After 12 weeks treatment both Interstitial Cystitis Symptom and Problem Index ( ICSI/ICPI ) , pelvic pain and Urgency/Frequency Symptom Scale ( PUF ) showed a mean significant improvement , which was maintained thereafter . The average number of voidings and mean voiding volumes revealed significant improvement after the 12 weeks ' treatment period , with a significant reduction and increase , respectively . Mean voiding volume increased from 143 ml to 191 , which apparently was not reflected in a corresponding reduction of number of daily voids ( from 15,5 to 14 ) . VAS values decreased from 5,4 to 3,6 ( pain ) and from 6,0 to 3,5 ( urgency ) after the treatment cycle , showing a significant improvement . CONCLUSIONS In our preliminary experience , the administration of intravesical hyaluronic acid plus chondroitine sulphate appears to be a safe and efficacious method of treatment in IC/PBS",
"OBJECTIVES To evaluate the efficacy of intravesical instillation of hyaluronic acid ( HA ) after hydrodistention for the treatment of patients with interstitial cystitis ( IC ) having small bladder capacity . METHODS A total of 47 patients with IC ( aged 27 - 76 years ) whose functional bladder capacity was less than 200 mL received bladder hydrodistention . Thereafter , 20 patients received intravesical instillation of 40 mg HA weekly in the first month and then monthly in the following 2 months . Sixteen patients received intravesical heparin instead and 11 patients received hydrodistention alone as the control . Mean voids per day , visual analog scale for pain , and functional bladder capacity were measured before hydrodistention and 3 and 6 months after hydrodistention in all 3 groups and 9 months after hydrodistention in HA and heparin groups . RESULTS Two patients in the HA group and 1 in the heparin group failed to complete the treatment . Three months after hydrodistention , there was no improvement in the control group . Six and 9 months after hydrodistention , rate of improvement was significantly higher in the HA group than in the heparin group ( 77.8 % vs 33.3 % , P heparin treatment did not show any improvement . Improvement in voids per day ( -1.8 + /- 2.5 , P visual analog scale ( -0.9 + /- 1.1 , P bladder capacity ( 16 + /- 18 mL , P HA group . CONCLUSIONS Intravesical instillation of HA may obviously prolong the effect of bladder hydrodistention in patients with severe IC . Its effect was better than heparin ",
"Objective . To determine whether intravesical hyaluronic acid is effective in reducing the urinary frequency and pain associated with interstitial cystitis/painful bladder syndrome ( IC/PBS ) . Material and methods . In a prospect i ve , unblinded , uncontrolled pilot study , 20 patients ( age range 34–80 years ) , all suffering from IC/PBS , received weekly bladder instillations of hyaluronic acid for 1 month and monthly instillations for a further 2 months . Patients were then offered further monthly instillations and all were subsequently evaluated after 3 years . Patient outcomes assessed were urinary frequency , use of analgesics and pain . Results . All patients completed the 3 months of hyaluronic acid treatment with mean decreases in nocturia and pain of 40 % and 30 % , respectively , and a decrease in analgesic use . Thirteen patients ( 65 % ) responded to treatment ( responders ) and continued therapy , while seven patients withdrew , six because of a lack of response and one due to cystectomy . In the 13 patients who continued hyaluronic acid instillations , four complete responders ( 30 % ) ceased therapy after a strong positive response ( 36 % , 60 % and 81 % decreases compared to baseline in day-time voids , night-time voids and pain scores , respectively ) which was maintained in the absence of continuous therapy , while after 3 years seven partial responders ( 35 % ) were still on therapy ( 25 % and 43 % decreases compared to baseline in day-time voids and pain scores , respectively ) . Two patients developed other diseases during follow-up and showed no response to long-term therapy . Hyaluronic acid was well tolerated by all patients . Conclusion . Hyaluronic acid safely reduced the pain and , to a lesser degree , the urinary frequency associated with IC",
"Introduction and hypothesisIntravesical instillations of hyaluronic acid ( HA ) and chondroitin sulfate ( CS ) may lead to regeneration of the damaged glycosaminoglycan layer in interstitial cystitis/bladder pain syndrome ( IC/BPS ) . Methods Twenty-two patients with IC/BPS received intravesical instillations ( 40 ml ) of sodium HA 1.6 % and CS 2.0 % in 0.9 % saline solution ( IALURIL ® , IBSA ) once weekly for 8 weeks , then once every 2 weeks for the next 6 months . Results The score for urgency was reduced from 6.5 to 3.6 ( p = 0.0001 ) , with a reduction in pain scores from an average of 5.6 to 3.2 ( p = 0.0001 ) . The average urine volume increased from 129.7 to 162 ml ( p reduction in the number of voids in 24 h , from 14 to 11.6 ( p The IC Symptom and Problem Index decreased from 25.7 to 20.3 ( p ) , and the Pain Urgency Frequency score , from 18.7 to 12.8 ( p < 0.0001 ) . Conclusion The treatment appeared to be effective and well tolerated in IC/BPS in this initial experience",
"To determine whether the potassium sensitivity test ( PST ) can be used to predict the response to treatment with intravesical sodium hyaluronate in patients with interstitial cystitis",
"INTRODUCTION AND OBJECTIVES According to National Institute of Health ( NIH ) criteria , a bladder capacity of less than 350 cc is an automatic exclusion for a diagnosis of Interstitial Cystitis ( IC ) . In the present study , patients , showing symptoms of IC and with bladder capacities of /=350 cc were tested as to their response to a intravesical hyaluronic acid therapy . METHODS The study included 48 patients with clinical symptoms of IC and a positive 0.4 M potassium sensitivity test . Maximum bladder capacity ( C(max ) ) was assessed for the 0.9 % NaCl solution first and then for the 0.2 M KCl solution . After the NaCl cystometry , patients were separated into two groups : Group I with a C(max ) of /=350 cc . Both groups were again separated in two further groups as to the respective percentage reduction of C(max ) with the 0.2 M KCl solution : Group Ia/IIa ( > /=30 % ) and Group Ib/IIb ( hyaluronic acid for 10 consecutive weeks . Pre- and post-treatment bladder symptoms were evaluated through their visual analog scale ( VAS ) scores . RESULTS With the saline solution , 32 patients had a C(max ) of ) of > /=350 cc ( Group II ) . Evaluation of VAS scores confirmed a positive response , i.e. symptom relief , to hyaluronic acid therapy , irrespective of bladder capacity . The improvement was particularly evident in patients with a C(max ) reduction of > /=30 % versus those with a reduction of patients with typical IC symptoms and a cystometric bladder capacity of > /=350 cc , may have increased potassium sensitivity as a sign of IC and show symptom improvement after hyaluronic acid instillation therapy"
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Increased plasma lipid profiles are among the most important risk factors of CHD and stroke . Sesame contains considerable amounts of vitamin E , MUFA , fibre and lignans , which are thought to be associated with its plasma lipid-lowering properties . This study aim ed to systematic ally review the evidence and identify the effects of sesame consumption on blood lipid profiles using a meta- analysis of controlled trials . PubMed , CINAHL and Cochrane Library data bases were search ed ( from 1960 to May 2015 ) . A total of ten controlled trials were identified based on the eligibility criteria . Both the Cochrane Collaboration tool and the Rosendal scale were used to assess the risk of bias of the included studies . The meta- analysis results showed that consumption of sesame did not significantly change the concentrations of total blood cholesterol ( -0·32 mmol/l ; 95 % CI -0·75 , 0·11 ; P=0·14 , I(2)=96 % ) , LDL-cholesterol ( -0·15 mmol/l ; 95 % CI -0·50 , 0·19 ; P=0·39 , I(2)=96 % ) or HDL-cholesterol ( 0·01 mmol/l ; 95 % CI -0·00 , 0·02 ; P=0·16 , I(2)=0 % ) . However , a significant reduction was observed in serum TAG levels ( -0·24 mmol/l ; 95 % CI -0·32 , -0·15 ; P of sesame . It was concluded that sesame consumption can significantly reduce blood TAG levels but there is insufficient evidence to support its hypocholesterolaemic effects . Further studies are required to determine the potential effect of sesame consumption on lipid profiles and cardiovascular risk factors | [
"Sesame ingestion has been shown to improve blood lipids in humans and antioxidative ability in animals . Sesamin , a sesame lignan , was recently reported to be converted by intestinal microflora to enterolactone , a compound with estrogenic activity and also an enterometabolite of flaxseed lignans , which are known to be phytoestrogens . Whether sesame can be a source of phytoestrogens is unknown . This study was design ed to investigate the effect of sesame ingestion on blood sex hormones , lipids , tocopherol , and ex vivo LDL oxidation in postmenopausal women . Twenty-six healthy subjects attended , and 24 completed , this r and omized , placebo-controlled , crossover study . Half of them consumed 50 g sesame seed powder daily for 5 wk , followed by a 3-wk washout period , then a 5-wk 50-g rice powder placebo period . The other half received the 2 supplements in reverse order . After sesame treatment , plasma total cholesterol ( TC ) , LDL-C , the ratio of LDL-C to HDL-C , thiobarbituric acid reactive substances in oxidized LDL , and serum dehydroepi and rosterone sulfate decreased significantly by 5 , 10 , 6 , 23 , and 18 % , respectively . The ratio of alpha- and gamma-tocopherol to TC increased significantly by 18 and 73 % , respectively . All of these variables differed significantly between the 2 treatments . Serum sex hormone-binding globulin and urinary 2-hydroxyestrone ( n = 8) increased significantly by 15 and 72 % , respectively , after sesame treatment , and these concentrations tended to differ ( P = 0.065 and P = 0.090 , respectively ) from those after the placebo treatment . These results suggest that sesame ingestion benefits postmenopausal women by improving blood lipids , antioxidant status , and possibly sex hormone status",
"We studied the effects of dietary intervention with three vegetable oils ( Linola , corn or sesame oil , all good sources of gamma-tocopherol ) on absolute and relative concentrations of alpha- and gamma-tocopherol in human serum . The oils contained only small amounts of linolenic acid but varying amounts of oleic and linoleic acids , and they had different concentrations of alpha-tocopherol . Forty healthy female students ( mean age 26 y ) were r and omly assigned to one of three groups and consumed a diet that contained one of the three oils for 4 wk . Refined oils were distributed as ingredients in specially prepared buns , in margarine or as dressing . Serum tocopherols , serum lipoproteins and plasma malondialdehyde concentrations were measured . The gamma-tocopherol concentrations normalized to serum lipids increased significantly in the corn and sesame oil groups ( P alpha-tocopherol concentrations did not change during the diet period in any of the three groups . Serum cholesterol , serum apolipoprotein B and plasma malondialdehyde concentrations decreased significantly only in the Linola oil group ( P serum gamma-tocopherol concentration in healthy women without affecting the serum alpha-tocopherol concentration",
"Sesamin , one of the lignans contained in sesame , has been considered to have medicinal effects . It has been reported that sesamin suppressed the development of hypertension in rats . In this study , using a double-blind , cross-over , placebo-controlled trial , we investigated the effect of 4-wk administration of sesamin on blood pressure ( BP ) in mildly hypertensive humans . Twenty-five middle-aged subjects with mild hypertension were divided into two groups , matched by age and body mass index . Twelve subjects were allocated to 4-wk intake of capsules with 60 mg sesamin per day and 13 subjects to 4-wk intake of a placebo ( period 1 ) . After a 4-wk washout period , the subjects received the alternative administration for 4 wk ( period 2 ) . BP decreased with statistical significance with the administration of sesamin ( systolic : 137.6+/-2.2 to 134.1+/-1.7 mmHg , p=0.044 , diastolic : 87.7+/-1.3 to 85.8+/-1.0 mmHg , p=0.045 ) , but little changed with the placebo ( systolic : 135.0+/-1.8 to 135.1+/-1.7 mmHg , diastolic : 85.9+/-1.2 to 86.6+/-1.2 mmHg ) . In conclusion , 4-wk administration of 60 mg sesamin significantly decreased BP by an average of 3.5 mmHg systolic BP and 1.9 mmHg diastolic BP . These results suggest that sesamin has an antihypertensive effect in humans . Epidemiological studies suggested that a 2 - 3 mmHg decrease in BP reduces the rate of cardiovascular diseases ; therefore , it is considered that BP reduction achieved by sesamin may be meaningful to prevent cardiovascular diseases",
"BACKGROUND AND AIMS Pre- clinical studies suggest that sesame and its lignans induce beneficial changes in risk factors related to cardiovascular disease and increase the bioavailability of mammalian lignans . However , only very few intervention trials have investigated the potential bioactivities of sesame in humans . We aim ed to investigate the effects of sesame supplementation in humans on blood lipids , blood pressure , systemic oxidative stress , inflammatory biomarkers and mammalian lignan metabolism . METHODS AND RESULTS We conducted a r and omized , placebo-controlled cross-over intervention trial at a university research centre . Overweight or obese men and women ( n=33 ) consumed 25g/d of sesame ( approximately 50mg/d of sesame lignan ) and an iso-caloric placebo matched for macronutrient composition for 5 wks each . Each intervention period was preceded by a 4-wk washout period . Blood lipid profiles , day time ambulatory blood pressure , oxidative stress and inflammatory biomarkers and urinary mammalian lignans were measured before and after each intervention . Results are presented as the effect of sesame supplementation relative to placebo . Urinary excretion of the mammalian lignans , enterolactone and enterodiol , increased by approximately 8-fold ( P Blood lipids and blood pressure were not altered . In addition , markers of systemic inflammation ( C-reactive protein , interleukin-6 , tumor necrosis factor-alpha ) and lipid peroxidation ( F(2)-isoprostanes ) were not affected . CONCLUSION Supplementation with 25g/d of sesame can significantly increase the exposure to mammalian lignans . However , this did not cause any improvement in markers of cardiovascular disease risk in overweight or obese men and women",
"Objective : Rheumatoid arthritis ( RA ) is an inflammatory disease with increased mortality from cardiovascular disease ( CVD ) . Oxidative stress has a critical role in the pathogenesis of RA and CVD . Sesamin , the main lignin constituent of sesame , has several antioxidant and anti-inflammatory effects . This study aim ed to investigate the effects of sesamin supplementation on anthropometric indices , lipid profile , blood pressure , and oxidative stress markers in women with RA . Methods : In this r and omized , double-blind , placebo-controlled clinical trial , 44 patients with RA were r and omly divided into 2 groups ( intervention and control ) . Patients consumed 200 mg/day sesamin supplement and placebo in the intervention and control groups , respectively , for 6 weeks ( spring 2014 ) . At baseline and at the end of the study , anthropometric indices and blood pressure were assessed . Serum concentrations of lipid profile , malondialdehyde ( MDA ) , and total antioxidant capacity ( TAC ) were also determined . Results : At the end of study , sesamin supplementation significantly decreased serum levels of MDA ( p = 0.018 ) and increased TAC and high-density lipoprotein cholesterol ( HDL-C ) levels in patients with RA ( p = 0.020 and p = 0.007 , respectively ) . In the sesamin group , the mean of weight , body mass index , waist-to-hip ratio , body fat , systolic blood pressure , and the concentration of other lipid profiles ( triglycerides , total cholesterol , and low-density lipoprotein cholesterol [ LDL-C ] ) were also significantly decreased at the end of study compared to baseline values ( p 0.05 ) . Conclusion : Sesamin exhibited a protective effect on cardiovascular risk factors in patients with RA . However , further investigation is suggested",
"In this r and omized and placebo-controlled trial , safety and lipid-lowering effect of fish and corn oils rich in polyunsaturated fatty acids compared with sesame oil that is mainly saturated were studied in 60 hemodialysis cases allocated to 4 different treatment groups . Each group ( n = 15 ) received either fish oil ( 1.5 g ) , corn oil ( 4.5 g ) , sesame oil ( 4.5 g ) , or placebo , daily . Serum triglyceride , cholesterol , low density lipoprotein cholesterol ( LDL-c ) , and high density lipoprotein cholesterol ( HDL-c ) were measured before and after 2 months of therapy . Serum HDL-c increased , but LDL-c decreased significantly after fish and corn oil therapy . In addition , serum triglyceride decreased significantly after supplementary fish oil . The ratios of LDL-c to HDL-c , total cholesterol to HDL-c , and triglyceride to HDL-c decreased significantly after fish and corn oil therapy . Sesame oil had no significant effect on the lipid profile of hemodialysis patients . Our results suggest that short-term low-dose supplementary polyunsaturated fatty acids are safe and beneficial for the lipid abnormalities of hemodialysis patients",
"BACKGROUND Data suggest that sesame seeds have properties beneficial to modulating lipid disorders and decreasing cardiovascular disease ( CVD ) risk factors . The aim of this study was to investigate the effects of Ardeh , paste of ground unhulled sesame seeds , on lipid profiles and atherogenic lipid parameters . METHODS This r and omized clinical trial included 41 patients with type 2 diabetes , who were r and omly assigned to one of the two groups : group A ( Ardeh 28 g/d , n = 21 ) and group B ( control , n = 20 ) . After an initial two-week washout period , the patients in group A , replaced a part of their usual breakfast with two tablespoon ( tbsp ) ( ~ 28 g ) Ardeh , while group B patients continued the usual breakfast meal for six weeks ; energy content of both breakfast meals was maintained in the same range . Anthropometric measures , blood pressure , serum levels of total cholesterol ( TC ) , triglycerides ( TG ) , LDL-C , HDL-C , and atherogenic index of plasma ( AIP ; log TG/HDL-C ) , TC/HDL-C ratio , and LDL/HDL-C ratio were determined at baseline and six weeks later . RESULTS After six weeks , there were significant decreases in serum TG ( 15.3 mg/dL ) and AIP ( 39 % ) in group A. Moreover , slight decreases in serum TC , LDL-C , and other atherogenic lipid parameters and a mild increase in HDL-C also were observed during Ardeh supplementation . Anthropometric measures and blood pressure were unchanged during the study period in both groups . CONCLUSION Ardeh could have favorable effects in decreasing CVD risk factors in type 2 diabetics",
"Pre- clinical studies suggest that sesame and its lignans induce beneficial changes in risk factors related to cardiovascular disease . This study was design ed to investigate the effects of sesame on reducing serum lipids and enhancing antioxidant capacity in 38 hyperlipidemic patients who were divided into two groups r and omly . For all individuals along the 60 days of study period , the same drug treatments were considered . Intervention group patients were supposed to eat 40 g white sesame seeds daily , and instead of these calories , 240 kcal was removed from their diet . Anthropometric measurements including height , weight and body mass index ( BMI ) were measured . We assessed lipid profile and oxidative stress indicators such as glutathione peroxidase ( GPX ) , superoxide dismutase ( SOD ) and thiobarbituric acid reactive substances ( TBARS ) before and after the intervention . Significant differences among and between the groups were determined by independent t-test and paired sample t-test using 13th version of statistical package for the social sciences . The results showed that the diet with sesame significantly decreased the levels of serum total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) and TC/HDL-C ratio . Lipid peroxidation ( TBARS ) decreased while the activities of GPX and SOD were increased . There were no significant changes in anthropometric indexes such as weight and BMI after consumption of sesame . The results suggested that sesame seed supplementation decreased serum TC , LDL-C and lipid peroxidation , and increased antioxidant status in hyperlipidemic patients",
"The objective of this study was to investigate the effect of sesame oil in hypertensive diabetics medicated with atenolol ( beta-blocker ) and glibenclamide ( sulfonylurea ) . This open label trial with two intervention periods comprised 22 male and 18 female patients , 45 - 65 years old , with mild to moderate hypertension and diabetes . Sesame oil ( Idhayam Gingelly oil , V.V.V. & Sons , Virudhunagar , Tamilnadu , India ) was supplied to the patients , who were instructed to use it in place of other cooking oils for 45 days . Blood pressure ( BP ) , anthropometric measurements , plasma glucose , glycated hemoglobin ( HbA1c ) , lipid profiles [ total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , and high-density lipoprotein cholesterol , and triglycerides ( TG ) ] , lipid peroxidation [ thiobarbituric acid-reactive substances ( TBARS ) ] , electrolytes ( sodium , potassium , and chloride ) , and enzymic ( superoxide dismutase , glutathione peroxidase , and catalase ) and nonenzymic ( vitamin C , vitamin E , beta-carotene , and reduced glutathione ) antioxidants were measured at baseline and after 45 days of sesame oil substitution . The same patients were then switched over to other oils like palm or groundnut oils as their regular oils at r and om for another 45 days , and the investigations were carried out again at the end . Systolic and diastolic BP decreased remarkably . When oil substitution was withdrawn , BP values rose again . Body weight , body mass index , girth of waist , girth of hip , and waist : hip ratio were reduced upon substitution of sesame oil . Plasma glucose , HbA1c , TC , LDL-C , and TG were decreased . TBARS level was reduced , while the activities of enzymic and the levels of nonenzymic antioxidants were increased . Plasma sodium levels were reduced , while potassium levels were elevated . These results indicate that substitution of sesame oil as the sole edible oil has an additive effect in further lowering BP and plasma glucose in hypertensive diabetics",
"The study was undertaken to investigate the effect of sesame oil in hypertensive patients who were on antihypertensive therapy either with diuretics ( hydrochlorothiazide ) or ß-blockers ( atenolol ) . Thirty-two male and 18 female patients aged 35 to 60 years old were supplied sesame oil ( Idhayam gingelly oil ) and instructed to use it as the only edible oil for 45 days . Blood pressure , anthropometry , lipid profile , lipid peroxidation , and enzymic and non-enzymic antioxidants were measured at baseline and after 45 days of sesame oil substitution . Substitution of sesame oil brought down systolic and diastolic blood pressure to normal . The same patients were asked to withdraw sesame oil consumption for another 45 days , and the measurements were repeated at the end of withdrawal period . Withdrawal of sesame oil substitution brought back the initial blood pressure values . A significant reduction was noted in body weight and body mass index ( BMI ) upon sesame oil substitution . No significant alterations were observed in lipid profile except triglycerides . Plasma levels of sodium reduced while potassium elevated upon the substitution of sesame oil . Lipid peroxidation ( thiobarbituric acid reactive substances [ TBARS ] ) decreased while the activities of superoxide dismutase ( SOD ) , catalase ( CAT ) , and the levels of vitamin C , vitamin E , ß-carotene , and reduced glutathione ( GSH ) were increased . The results suggested that sesame oil as edible oil lowered blood pressure , decreased lipid peroxidation , and increased antioxidant status in hypertensive patients"
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To overcome limitations of minimally invasive surgical ablation as a st and alone procedure in eliminating atrial fibrillation ( AF ) , hybrid approaches incorporating adjunctive endovascular catheter ablation have been proposed in recent years . The endovascular component targets residual conduction gaps and identifies additional electrophysiological targets with the goal of minimizing recurrent atrial arrhythmia . We performed a systematic review of published studies of hybrid AF ablation , analyzing 432 pooled patients ( 19 % paroxysmal , 29 % persistent , 52 % long-st and ing persistent ) treated using three different approaches : A. bilateral thoracoscopy with bipolar radiofrequency ( RF ) clamp-based approach ; B. right thoracoscopic suction monopolar RF catheter-based approach ; and C. subxiphoid posterior pericardioscopic ( " convergent " ) approach . Freedom from recurrence off antiarrhythmic medications at 12 months was seen in 88.1 % [ 133/151 ] for A , 73.4 % [ 47/64 ] for B , and 59.3 % [ 80/135 ] for C , with no significant difference between paroxysmal ( 76.9 % ) and persistent/long-st and ing persistent AF ( 73.4 % ) . Death and major surgical complications were reported in 8.5 % with A , 0 % with B and 8.6 % with C. A critical appraisal of hybrid ablation is presented , drawing from experiences and insights published over the years on catheter ablation of AF , with a discussion of the rationale underlying hybrid ablation , its strengths and limitations , where it may have a unique role in clinical management of patients with AF , which questions remain unanswered and areas for further investigation | [
"BACKGROUND Atrial fibrillation ( AF ) and systolic heart failure ( HF ) frequently coexist . Restoration of sinus rhythm by catheter ablation may result in a variable improvement in left ventricular ( LV ) function . Late-gadolinium enhancement ( LGE ) on cardiac magnetic resonance ( CMR ) imaging identifies irreversible structural change and may predict incomplete recovery of LV function . OBJECTIVE To prospect ively select patients with AF and symptomatic HF but without LV LGE and report the impact of AF ablation on LV function . METHODS Patients with AF and symptomatic HF ( LV ejection fraction electrical cardioversion underwent contrast-enhanced CMR . LGE-negative patients underwent pulmonary vein isolation and left atrial roof line with continued antiarrhythmic medications until follow-up CMR 6 months postablation . Sixteen patients ( aged 52 ± 11 years ; mean AF duration 37 ± 39 months ; left atrial size 44 ± 13 mL/m(2 ) ) underwent AF ablation . RESULTS At 6 months , 15 of the 16 patients maintained sinus rhythm and underwent CMR . LV ejection fraction increased from 40 % ± 10 % at baseline to 60 % ± 6 % ( P .001 ) and LV end-systolic volume index decreased from 52 ± 12 to 36 ± 9 mL/m(2 ) ( P . Left atrial size decreased from 44 ± 13 to 36 ± 11 mL/m(2 ) ( P patients with AF and LV dysfunction in the absence of LGE on CMR , ventricular function normalizes following the restoration of sinus rhythm . CMR may assist in the selection of patients with combined AF and systolic HF most likely to benefit from catheter ablation",
"Background — Catheter ablation ( CA ) and minimally invasive surgical ablation ( SA ) have become accepted therapy for antiarrhythmic drug – refractory atrial fibrillation . This study describes the first r and omized clinical trial comparing their efficacy and safety during a 12-month follow-up . Methods and Results — One hundred twenty-four patients with antiarrhythmic drug – refractory atrial fibrillation with left atrial dilatation and hypertension ( 42 patients , 33 % ) or failed prior CA ( 82 patients , 67 % ) were r and omized to CA ( 63 patients ) or SA ( 61 patients ) . CA consisted of linear antral pulmonary vein isolation and optional additional lines . SA consisted of bipolar radiofrequency isolation of the bilateral pulmonary vein , ganglionated plexi ablation , and left atrial appendage excision with optional additional lines . Follow-up at 6 and 12 months was performed by ECG and 7-day Holter recording . The primary end point , freedom from left atrial arrhythmia > 30 seconds without antiarrhythmic drugs after 12 months , was 36.5 % for CA and 65.6 % for SA ( P=0.0022 ) . There was no difference in effect for subgroups , which was consistent at both sites . The primary safety end point of significant adverse events during the 12-month follow-up was significantly higher for SA than for CA ( n=21 [ 34.4 % ] versus n=10 [ 15.9 % ] ; P=0.027 ) , driven mainly by procedural complications such as pneumothorax , major bleeding , and the need for pacemaker . In the CA group , 1 patient died at 1 month of subarachnoid hemorrhage . Conclusion — In atrial fibrillation patients with dilated left atrium and hypertension or failed prior atrial fibrillation CA , SA is superior to CA in achieving freedom from left atrial arrhythmias after 12 months of follow-up , although the procedural adverse event rate is significantly higher for SA than for CA . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00662701",
"BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study",
"CONTEXT Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation ( AF ) . Pulmonary vein isolation ( PVI ) with radiofrequency ablation may cure AF , obviating the need for antiarrhythmic drugs and anticoagulation . OBJECTIVE To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve r and omized study conducted from December 31 , 2001 , to July 1 , 2002 , of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs . INTERVENTION Patients were r and omized to receive either PVI using radiofrequency ablation ( n=33 ) or antiarrhythmic drug treatment ( n=37 ) , with a 1-year follow-up . MAIN OUTCOME MEASURES Recurrence of AF , hospitalization , and quality of life assessment . RESULTS Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up . At the end of 1-year follow-up , 22 ( 63 % ) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 ( 13 % ) of 32 patients who received PVI ( P Hospitalization during 1-year follow-up occurred in 19 ( 54 % ) of 35 patients in the antiarrhythmic drug group compared with 3 ( 9 % ) of 32 in the PVI group ( P antiarrhythmic drug group , the mean ( SD ) number of AF episodes decreased from 12 ( 7 ) to 6 ( 4 ) , after initiating therapy ( P = .01 ) . At 6-month follow-up , the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey . There were no thromboembolic events in either group . Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 ( 6 % ) of 32 patients in the PVI group . CONCLUSION Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF . Larger studies are needed to confirm its safety and efficacy",
"AIM The aim of this prospect i ve sub study was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation ( AF ) with radiofrequency catheter ablation ( RFA ) compared with antiarrhythmic drugs ( AADs ) as first-line treatment . METHODS AND RESULTS A decision-analytic Markov model , based on MANTRA-PAF ( Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ) study data , was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment . Positive clinical effects were found in the overall population , a gain of an average 0.06 quality -adjusted life years ( QALYs ) to an incremental cost of € 3033 , result ing in an incremental cost-effectiveness ratio of € 50 570/QALY . However , the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients . This implied an incremental cost-effectiveness ratio of € 3434/QALY in ≤50-year-old patients respectively € 108 937/QALY in > 50-year-old patients . CONCLUSION Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF . However , the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain , and in most of these AADs should be attempted before RFA ( MANTRA-PAF Clinical Trials.gov number ; NCT00133211 )",
"Background — The mainstay of treatment for atrial fibrillation ( AF ) remains pharmacological ; however , catheter ablation has increasingly been used over the last decade . The relative merits of each strategy have not been extensively studied . Methods and Results — We conducted a r and omized multicenter comparison of these 2 treatment strategies in patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug . The primary end point was absence of recurrent AF between months 3 and 12 , absence of recurrent AF after up to 3 ablation procedures , or changes in antiarrhythmic drugs during the first 3 months . Ablation consisted of pulmonary vein isolation in all cases , whereas additional extrapulmonary vein lesions were at the discretion of the physician . Crossover was permitted at 3 months in case of failure . Echocardiographic data , symptom score , exercise capacity , quality of life , and AF burden were evaluated at 3 , 6 , and 12 months by the supervising committee . Of 149 eligible patients , 112 ( 18 women [ 16 % ] ; age , 51.1±11.1 years ) were enrolled and r and omized to ablation ( n=53 ) or “ new ” antiarrhythmic drugs alone or in combination ( n=59 ) . Crossover from the antiarrhythmic drugs and ablation groups occurred in 37 ( 63 % ) and 5 patients ( 9 % ) , respectively ( P=0.0001 ) . At the 1-year follow-up , 13 of 55 patients ( 23 % ) and 46 of 52 patients ( 89 % ) had no recurrence of AF in the antiarrhythmic drug and ablation groups , respectively ( P were significantly higher in the ablation group . Conclusion — This r and omized multicenter study demonstrates the superiority of catheter ablation over antiarrhythmic drugs in patients with AF with regard to maintenance of sinus rhythm and improvement in symptoms , exercise capacity , and quality of life",
"INTRODUCTION The purpose of our study was to evaluate the effect of repeated cardioversion with an implantable atrial defibrillator on the clinical outcome of patients with atrial fibrillation . METHODS AND RESULTS The effects of the implantable atrial defibrillator on the total duration of atrial fibrillation , number of atrial fibrillation recurrences , and left atrial size were evaluated prospect ively in 16 patients with atrial fibrillation ( 13 men and 3 women ; mean age 58 + /- 11 years ) . Seven patients had no cardiovascular disease , 5 patients had hypertension , 3 patients had coronary heart disease , and 1 patient had congenital heart disease . Eight patients had paroxysmal atrial fibrillation for a mean duration of 80 + /- 61 months , and eight patients had persistent atrial fibrillation for a mean duration of 68 + /- 119 months . Except for one patient who received digoxin throughout the study , all patients received the same Class I or III antiarrhythmic agent throughout the study . The implantable atrial defibrillator successfully converted 50 ( 93 % ) of 54 spontaneous episodes of atrial fibrillation in 12 patients . During the initial 3 months of clinical follow-up , the atrial defibrillator documented 261 + /- 270 hours of atrial fibrillation compared with 126 + /- 172 hours ( P = 0.01 ) during the subsequent 3 months . The left atrial size decreased from 4.4 + /- 0.7 cm at the time of atrial defibrillator implantation to 4.1 + /- 0.6 cm ( P = 0.02 ) 6 months later . The number of atrial fibrillation recurrences did not change . These findings were observed in the absence of changes in drug therapy . No complications were observed . CONCLUSION Restoration and maintenance of sinus rhythm in patients with atrial fibrillation by repeated cardioversion with an implantable atrial defibrillator was associated with a reduction in the total arrhythmia duration and a reduction in left atrial size . These results suggest that maintenance of sinus rhythm with the atrial defibrillator may reverse the remodeling process associated with atrial fibrillation",
"Background —Atrial fibrillation recurrence after pulmonary vein ( PV ) isolation is associated with PV to left atrium reconduction . We prospect ively studied the use of 2 procedural techniques design ed to facilitate identification of residual gaps within the index ablation line . Methods and Results —After wide circumferential PV isolation , 40 patients received additional ablation targeted at locations of left atrial capture during high-output pacing ( pace-capture group ) , while 40 patients underwent adenosine testing with targeted ablation at sites of dormant conduction ( adenosine group ) . Patients were followed up at 3 , 6 , and 12 months . After PV isolation , high-output pace-capture was documented in 39 PVs ( 25 % ; 50 % of patients ) in the pace-capture group . Dormant conduction was unmasked in 34 PVs ( 22 % ; 53 % of patients ) in the adenosine group . A subset of 25 patients in the pace-capture group underwent adenosine testing without targeted ablation of dormant conduction . In these patients , only 10 out of 86 PVs ( 11.6 % ; 24 % of patients ) demonstrated dormant conduction after the elimination of local pace-capture . At a follow-up of 329±124 days , the single procedure off antiarrhythmic drug freedom from recurrent atrial fibrillation was 67.5 % in the adenosine group and 65.0 % in the pace-capture group ( P=0.814 ) . Procedure duration and fluoroscopy time were significantly longer in the pace-capture group ( P=0.002 and P whereas radiofrequency ablation time was comparable ( P=0.192 ) . Conclusions —The use of high-output pacing post-PV isolation results in a significant reduction in the incidence of dormant conduction with a comparable long-term freedom from recurrent atrial fibrillation ( versus adenosine-guided ablation ) . The use of these approaches requires evaluation in a long-term prospect i ve r and omized study",
"BACKGROUND There have been no studies of atrial diastolic function after catheter ablation of atrial fibrillation ( AF ) . We encountered a few patients with symptomatic left atrial ( LA ) diastolic dysfunction and associated pulmonary hypertension ( PH ) that developed after catheter ablation for atrial fibrillation . Similar findings were described in patients after cardiac surgery and were referred to as the \" stiff left atrial syndrome . \" OBJECTIVE The purpose of this study was to prospect ively quantify the incidence of patients developing PH associated with diastolic hemodynamic abnormalities of the LA after radiofrequency ablation of AF and to identify the possible predictors . METHODS Between January 2009 and July 2010 , data on 1,380 consecutive patients were prospect ively collected . Before ablation and at follow-up , all patients had an echocardiogram to assess for the presence of PH . Patients with no echocardiographic evidence of PH but complaining of unexplained dyspnea with LA diastolic abnormalities were evaluated with right heart catheterization ( RHC ) . Patients were included in the analysis if they developed new or worsening PH postablation with evidence of LA diastolic dysfunction by RHC or direct LA pressure measurement . All patients were evaluated for pulmonary vein stenosis and excluded if this condition was identified . RESULTS The mean age was 62 ± 11 ( 75 % male ) , and nonparoxysmal AF was the predominant arrhythmia ( 71 % ) . New or worsening PH with associated LA diastolic abnormalities was detected in 19 ( 1.4 % ) patients after ablation . The prevalence of PH did not differ between AF types ( P = .612 ) . Compared with patients who did not develop PH , LA scarring ( P diabetes ( P = .026 ) , and obstructive sleep apnea ( OSA ; P = .006 ) were more frequently observed among those who developed PH . In a multivariable logistic model , preprocedure LA size ≤45 mm ( odds ratio [ OR ] = 6.13 ; P = .033 ) , mean LA pressure ( OR 1.14 ; P = .025 ) , severe LA scarring ( OR = 4.4 ; P = .046 ) , diabetes mellitus ( OR = 9.5 ; P = .004 ) , and OSA ( OR = 6.2 ; P = .009 ) were independently associated with the development of PH postablation . CONCLUSIONS After radiofrequency catheter ablation of atrial fibrillation ( RFCAF ) , PH with LA diastolic dysfunction or the so-called stiff LA syndrome is a rare but potentially significant complication of AF ablation . Severe LA scarring , LA ≤45 mm , diabetes mellitus , OSA , and high LA pressure are clinical variables that predict the development of this syndrome . The main clinical findings include dyspnea , congestive heart failure , PH , and large V waves on pulmonary capillary wedge pressure ( PCWP ) or LA pressure tracings in the absence of mitral regurgitation",
"Background —The effect of successful catheter ablation on left ventricular ( LV ) strain in patients with preserved LV systolic function is unknown . The aim of the present study was to assess the long-term effects of catheter ablation for atrial fibrillation ( AF ) on LV strain and strain rate in patients with preserved LV ejection fraction . Methods and Results —In 78 patients undergoing catheter ablation for AF , speckle tracking strain imaging was performed to assess LV strain in 3 directions ( radial , circumferential , and longitudinal ) at baseline and after 12-month follow-up . The study population was divided into 2 groups , according to the maintenance of sinus rhythm ( SR ) during follow-up . After 13.8±4.7 months of follow-up , 54 patients ( 69 % ) were in SR ( SR group ) , whereas 24 patients ( 31 % ) had recurrence of AF ( AF group ) . No significant changes in LV ejection fraction from baseline to follow-up were noted ( 60±7 % versus 59±7 % , P = NS ) . Circumferential strain improved significantly in the SR group ( −18.3±3.2 % versus −20.4±3.8 % , P in LV longitudinal strain and strain rate were noted , whereas in the AF group , LV longitudinal strain and strain rate deteriorated significantly at long-term follow-up . Conclusions —After successful catheter ablation , LV circumferential and longitudinal strain and strain rate improve significantly in patients who maintain SR . In contrast , a decrease in LV longitudinal strain and strain rate is observed in patients with recurrence of AF",
"OBJECTIVES We sought to determine the relationship between atrial fibrillation ( AF ) ablation efficacy , quality of life ( QoL ) , and AF-specific symptoms at 2 years . BACKGROUND Although the primary goal of AF ablation is QoL improvement , this effect has yet to be demonstrated in the long term . METHODS A total of 502 symptomatic AF ablation recipients were prospect ively followed for recurrence , QoL , and AF symptoms . RESULTS In 323 patients with 2 years of follow-up , 72 % achieved AF elimination off antiarrhythmic drugs ( AADs ) , 15 % achieved AF control with AADs , and 13 % had recurrent AF . The physical component summary scores of the Medical Outcomes Study Short Form 36 increased from 58.8 + /- 20.1 to 76.2 + /- 19.2 ( p mental component summary scores of the Short Form 36 increased from 65.3 + /- 18.6 to 79.8 + /- 15.8 ( p QoL improvements were noted across ablation outcomes , including recurrent AF ( change in physical component summary : 12.1 + /- 19.7 and change in mental component summary : 9.7 + /- 17.9 ) , with no significant differences in QoL improvement across 3 ablative efficacy outcomes . However , in 103 patients who completed additional assessment with Mayo AF Symptom Inventories ( on a scale of 0 to 48 ) , those with AF elimination off AADs had a change in AF symptom frequency score of -9.5 + /- 6.3 , which was significantly higher than those with AF controlled with AADs ( -5.6 + /- 3.8 , p = 0.03 ) or those with recurrent AF ( -3.4 + /- 8.4 , p = 0.02 ) . Independent predictors of limited QoL improvement included higher baseline QoL , obesity , and warfarin use at follow-up . CONCLUSIONS AF ablation produces sustained QoL improvement at 2 years in patients with and without recurrence . AF-specific symptom assessment more accurately reflects ablative efficacy",
"Background —Radiofrequency catheter ablation ( RFA ) has emerged as an important treatment strategy for atrial fibrillation ( AF ) . The potential cost-effectiveness of RFA for AF , relative to antiarrhythmic drug ( AAD ) therapy , has not been fully explored from a US perspective . Methods and Results —We constructed a Markov disease simulation model for a hypothetical cohort of patients with drug-refractory paroxysmal AF , treated either with RFA with/without AAD or AAD alone . Costs and quality -adjusted life-years were projected over 5 years . Model inputs were drawn from published clinical trial and registry data , from new registry and trial data analysis , and from data prospect ively collected from patients with AF treated with RFA at our institution . We assumed no benefit from ablation on stroke , heart failure or death , but did estimate changes in quality -adjusted life expectancy using data from several AF cohorts . In the base case scenario , cumulative costs with the RFA and AAD strategies were $ 26 584 and $ 19 898 , respectively . Over 5 years , quality -adjusted life expectancy was 3.51 quality -adjusted life-years with RFA versus 3.38 for the AAD group . The incremental cost-effectiveness ratio for RFA versus AAD was thus $ 51 431 per quality -adjusted life-year . Model results were most sensitive to time horizon , the relative utility weights of successful ablation versus unsuccessful drug therapy , and to the cost of an ablation procedure . Conclusions —RFA with/without AAD for symptomatic , drug-refractory paroxysmal AF appears to be reasonably cost-effective compared with AAD therapy alone from the perspective of the US health care system , based on improved quality of life and avoidance of future health care costs",
"BACKGROUND We conducted a r and omized , controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation . METHODS A total of 146 patients with a mean ( + /-SD ) age of 57+/-9 years who had chronic atrial fibrillation were r and omly assigned to receive amiodarone and undergo two cardioversions during the first three months alone ( the control group ) or in combination with circumferential pulmonary-vein ablation . Cardiac rhythm was assessed with daily telephonic transmissions for one year . The left atrial diameter and the severity of symptoms were assessed at 12 months . RESULTS Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation , ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent . An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year ( P=0.05 ) . Among the 69 patients in the control group , 53 ( 77 percent ) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 ( 4 percent ) were in sinus rhythm without antiarrhythmic-drug therapy or ablation . There were significant decreases in the left atrial diameter ( 12+/-11 percent , P symptom severity score ( 59+/-21 percent , P Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy , cardioversion , or both . The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter",
"BACKGROUND Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia . Gene therapy-dependent modulation of atrial electrophysiology may provide a more specific alternative to pharmacological and ablative treatment strategies . OBJECTIVE We hypothesized that genetic inactivation of atrial repolarizing ether-a-go-go-related gene ( ERG ) K(+ ) currents using a dominant-negative mutant would provide rhythm control in AF . METHODS Ten domestic swine underwent pacemaker implantation and were subjected to atrial burst pacing to induce persistent AF . Animals were then r and omized to receive either AdCERG-G627S to suppress ERG/I(Kr ) currents or green fluorescent protein ( AdGFP ) as control . Adenoviruses were applied using a novel hybrid technique combining atrial virus injection and epicardial electroporation to increase transgene expression . RESULTS In pigs treated with AdCERG-G627S , the onset of persistent AF was prevented ( n = 2 ) or significantly delayed compared with AdGFP controls ( 12 ± 2.1 vs. 6.2 ± 1.3 days ; P . Effective refractory periods were prolonged in the AdCERG-G627S group compared with AdGFP animals ( 221.5 ± 4.7 ms vs. 197.0 ± 4.7 ms ; P ) . Impairment of left ventricular ejection fraction ( LVEF ) during AF was prevented by AdCERG-G627S application ( LVEF(CERG-G627S ) = 62.1 % ± 4.0 % vs. LVEF(GFP ) = 30.3 % ± 9.1 % ; P AdCERG-G627S gene transfer suppresses or delays the onset of persistent AF by prolongation of atrial refractoriness in a porcine model . Targeted gene therapy represents an alternative to pharmacological or ablative treatment of AF",
"BACKGROUND Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure . METHODS In this prospect i ve , multicenter clinical trial , we r and omly assigned patients with symptomatic , drug-resistant atrial fibrillation , an ejection fraction of 40 % or less , and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing . All patients completed the Minnesota Living with Heart Failure question naire ( scores range from 0 to 105 , with a higher score indicating a worse quality of life ) and underwent echocardiography and a 6-minute walk test ( the composite primary end point ) . Over a 6-month period , patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation . RESULTS In all , 41 patients underwent pulmonary-vein isolation , and 40 underwent atrioventricular-node ablation with biventricular pacing ; none were lost to follow-up at 6 months . The composite primary end point favored the group that underwent pulmonary-vein isolation , with an improved question naire score at 6 months ( 60 , vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing ; P 6-minute-walk distance ( 340 m vs. 297 m , P ejection fraction ( 35 % vs. 28 % , P underwent pulmonary-vein isolation , 88 % of patients receiving antiarrhythmic drugs and 71 % of those not receiving such drugs were free of atrial fibrillation at 6 months . In the group that underwent pulmonary-vein isolation , pulmonary-vein stenosis developed in two patients , pericardial effusion in one , and pulmonary edema in another ; in the group that underwent atrioventricular-node ablation with biventricular pacing , lead dislodgment was found in one patient and pneumothorax in another . CONCLUSIONS Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation . ( Clinical Trials.gov number , NCT00599976 .",
"BACKGROUND Catheter ablation is important for treatment of paroxysmal atrial fibrillation ( PAF ) . Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation . OBJECTIVES The study sought to assess the safety and effectiveness of an irrigated , contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF . METHODS A prospect i ve , multicenter , nonr and omized study was conducted . Enrollment criteria included : ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug ( Class I to IV ) . Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint . RESULTS A total of 172 patients were enrolled at 21 sites , where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application . Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade ( n = 4 ) , pericarditis ( n = 3 ) , heart block ( n = 1 , prior to radiofrequency application ) , and vascular access complications ( n = 4 ) . By Kaplan-Meier analyses , 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5 % . The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80 % of the time during therapy , outcomes were 4.25 times more likely to be successful ( p = 0.0054 ; 95 % confidence interval : 1.53 to 11.79 ) . CONCLUSIONS The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF , with no unanticipated device-related adverse events . The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence . Stable CF during radiofrequency application increases the likelihood of 12-month success . ( THERMOCOOL ® SMARTTOUCH ® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation ; NCT01385202 )",
"OBJECTIVES This study sought to compare catheter ablation with rate control for persistent atrial fibrillation ( AF ) in heart failure ( HF ) . BACKGROUND The optimal therapy for AF in HF is unclear . Drug-based rhythm control has not proved clinical ly beneficial . Catheter ablation improves cardiac function in patients with HF , but impact on physiological performance has not been formally evaluated in a r and omized trial . METHODS In a r and omized , open-label , blinded-endpoint clinical trial , adults with symptomatic HF , radionuclide left ventricular ejection fraction ( EF ) ≤35 % , and persistent AF were assigned to undergo catheter ablation or rate control . Primary outcome was 12-month change in peak oxygen consumption . Secondary endpoints were quality of life , B-type natriuretic peptide , 6-min walk distance , and EF . Results were analyzed by intention-to-treat . RESULTS Fifty-two patients ( age 63 ± 9 years , EF 24 ± 8 % ) were r and omized , 26 each to ablation and rate control . At 12 months , 88 % of ablation patients maintained sinus rhythm ( single-procedure success 68 % ) . Under rate control , rate criteria were achieved in 96 % . The primary endpoint , peak oxygen consumption , significantly increased in the ablation arm compared with rate control ( difference + 3.07 ml/kg/min , 95 % confidence interval : 0.56 to 5.59 , p = 0.018 ) . The change was not evident at 3 months ( + 0.79 ml/kg/min , 95 % confidence interval : -1.01 to 2.60 , p = 0.38 ) . Ablation improved Minnesota score ( p = 0.019 ) and B-type natriuretic peptide ( p = 0.045 ) and showed nonsignificant trends toward improved 6-min walk distance ( p = 0.095 ) and EF ( p = 0.055 ) . CONCLUSIONS This first r and omized trial of ablation versus rate control to focus on objective exercise performance in AF and HF shows significant benefit from ablation , a strategy that also improves symptoms and neurohormonal status . The effects develop over 12 months , consistent with progressive amelioration of the HF syndrome . ( A R and omised Trial to Assess Catheter Ablation Versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure ; NCT00878384 )",
"AIMS Real-time measurement of contact force ( CF ) during catheter ablation of atrial fibrillation ( AF ) has been recently suggested to potentially impact procedural outcome . However , the role of CF intensity on mid-term results using the SmartTouch ™ catheter has not been investigated so far . METHODS AND RESULTS Pulmonary vein isolation ( PVI ) using the SmartTouch ™ catheter was performed in 100 eligible patients ( age 62 ± 8 ; 79 % men ) undergoing a first procedure of paroxysmal AF catheter ablation . Continuous CF monitoring during catheter ablation allowed calculation of mean CF per patient . Patients were dichotomized into high CF ( ≥22 g , upper quartile ) and low CF ( st and ardized follow-up programme ( after a 3-month blanking period ) , free from antiarrhythmic therapy , with regular evaluations including 24 h Holter recordings at 1 , 3 , 6 , 9 , 12 , 18 , and 24 months . Atrial fibrillation relapse was defined as any symptomatic or asymptomatic atrial arrhythmia lasting > 30 s. The average CF among all procedures was 19.6 ± 3.7 g. Though complete PVI was eventually achieved in all cases in both groups , success using an exclusively anatomical approach was higher in the high CF group ( 92.0 vs. 72.0 % ; P = 0.04 ) . During a mean follow-up of 19 ± 5 months , a lower incidence of AF relapse was observed in higher CF patients ( 4.0 vs. 20.0 % ; log rank P = 0.04 ) . Pericardial tamponade occurred in one patient in the higher CF group . No thromboembolism or procedure-associated deaths were observed . CONCLUSION Higher values of CF overall during antral PVI appear to be associated with a higher likelihood of sinus rhythm maintenance without significantly increasing the complication rate",
"BACKGROUND The purpose of the present study was to evaluate the effects of the maze procedure on atrial function in patients operated on for atrial fibrillation . The maze procedure is a new surgical intervention that is design ed to restore sinus rhythm and active mechanical atrial contraction as a definitive treatment for patients with atrial fibrillation . METHODS AND RESULTS Doppler echocardiographic analysis of mitral and tricuspid inflow as well as pulmonary venous flow velocity was carried out in 46 patients 8 + /- 7 months after the maze procedure , and results were compared with those obtained from 27 age-matched control subjects . To evaluate atrial contraction , we determined the presence of atrial contribution to ventricular filling at the mitral and tricuspid valve levels and measured the percent atrial filling fractions of the left and right atria . To evaluate atrial compliance , we measured the systolic and the systolic-to-diastolic flow velocity ratios of the pulmonary venous inflow . Results were compared with similar measurements obtained from control subjects . Restoration of active atrial contraction was detected in 40 of the 46 patients ( 87 % ) ; right atrial contraction was noted in 38 patients ( 83 % ) , and left atrial contraction was noted in 28 patients ( 61 % ) . In patients with active atrial contraction , the percent atrial filling fraction of the right atrium was comparable to that of control subjects ( 32 + /- 7 % versus 33 + /- 8 % , P = NS ) , whereas that of the left atrium was smaller ( 20 + /- 5 % versus 36 + /- 7 % , P systolic component ( 17 + /- 4 versus 53 + /- 16 cm/s , P systolic-to-diastolic flow velocity ratio ( 0.3 + /- 0.01 versus 1.1 + /- 0.3 , P velocity integral ratio ( 0.3 + /- 0.01 versus 1.3 + /- 0.4 , P left atrial filling . CONCLUSIONS The maze procedure restores active right atrial contraction and improves left atrial contraction in most patients . Obtained measurements suggest decreased left atrial compliance and reduced left atrial contribution to ventricular filling compared with control subjects . Despite the reduced indexes , qualitative restoration of function in either atria should translate in improved atrioventricular synchrony and reduction in thromboembolic events in patients with chronic or paroxysmal atrial fibrillation",
"INTRODUCTION Atrial fibrillation ( AF ) adversely impacts mortality , stroke , heart failure , and dementia . AF ablation eliminates AF in most patients . We evaluated the long-term impact of AF ablation on mortality , heart failure ( HF ) , stroke , and dementia in a large system-wide patient population . METHODS A total of 4,212 consecutive patients who underwent AF ablation were compared ( 1:4 ) to 16,848 age/gender matched controls with AF ( no ablation ) and 16,848 age/gender matched controls without AF . Patients were enrolled from the large ongoing prospect i ve Intermountain AF study and were followed for at least 3 years . RESULTS Of the 37,908 patients , mean age 65.0 ± 13 years , 5,667 ( 14.9 % ) died , 1,296 ( 3.4 % ) had a stroke , and 1,096 ( 2.9 % ) were hospitalized for HF over > 3 years of follow-up . AF ablation patients were less likely to have diabetes , but were more likely to have hypertension , HF , and significant valvular heart disease . AF ablation patients had a lower risk of death and stroke in comparison to AF patients without ablation . Alzheimer 's dementia occurred in 0.2 % of the AF ablation patients compared to 0.9 % of the AF no ablation patients and 0.5 % of the no AF patients ( P Other forms of dementia were also reduced significantly in those treated with ablation . Compared to patients with no AF , AF ablation patients had similar long-term rates of death , dementia , and stroke . CONCLUSIONS AF ablation patients have a significantly lower risk of death , stroke , and dementia in comparison to AF patients without ablation . AF ablation may eliminate the increased risk of death and stroke associated with AF",
"Background — The Cox-Maze procedure ( CMP ) has achieved high success rates in the therapy of atrial fibrillation ( AF ) while becoming progressively less invasive . This report evaluates our experience with the CMP in the treatment of lone AF over 2 decades and compares the original cut- and -sew CMP-III to the ablation-assisted CMP-IV , which uses bipolar radiofrequency and cryoenergy to create the original lesion pattern . Methods and Results — Data were collected prospect ively on 212 consecutive patients ( mean age , 53.5±10.4 years ; 78 % male ) who underwent a st and -alone CMP from 1992 through 2010 . The median duration of preoperative AF was 6 ( interquartile range , 2.9–11.5 ) years , with 48 % paroxysmal and 52 % persistent or long-st and ing persistent AF . Univariate analysis with preoperative and perioperative variables used as covariates for the CMP-III ( n=112 ) and the CMP-IV ( n=100 ) was performed . Overall , 30-day mortality was 1.4 % , with no intraoperative deaths . Freedom from AF was 93 % , and freedom from AF off antiarrhythmics was 82 % , at a mean follow-up time of 3.6±3.1 years . Freedom from symptomatic AF at 10 years was 85 % . Only 1 late stroke occurred , with 80 % of patients not receiving anticoagulation therapy . The less invasive CMP-IV had significantly shorter cross-clamp times ( 41±13 versus 92±26 minutes ; P success rates , with 90 % freedom from AF and 84 % freedom from AF off antiarrhythmics at 2 years . Conclusions — The CMP , although simplified and shortened by alternative energy sources , has excellent results , even with improved follow-up and stricter definition of failure",
"AIMS Temporary , ablation-mediated effects such as oedema may cause reversible pulmonary vein ( PV ) isolation . To investigate this , point-by-point circumferential ablation was performed to achieve acute electrical PV isolation with an incomplete circumferential ablation line . Then , the impact of this intentional ' visual gap ' ( ViG ) on the conduction properties of the ablation lesion set was assessed with adenosine and pacing manoeuvres . METHODS AND RESULTS Twenty-eight patients undergoing ablation for paroxysmal ( n= 20 ) or persistent atrial fibrillation ( n= 8) were included . Pulmonary vein ( PV ) ablation was performed around ipsilateral vein pairs . Once acute isolation was achieved , ablation was halted and the presence and size of the ViG were calculated . The ViG electrophysiological properties were tested with pace capture along the ViG at 10 mA/2 ms , and assessment for dormant PV conduction with adenosine . Despite electrical isolation , a ViG was present in 75 % ( n= 42/56 ) of vein pairs ( 21 of 28 left PVs and 21 of 28 right PVs ) . There was no difference in the ViG size between the left and right PVs ( 22.1 ± 14.2 and 17.3 ± 11.3 mm , P > 0.05 ) . Dormant PV connections were revealed by adenosine in more than a quarter ( n= 12/42 ) of acutely isolated PV pairs , of which the majority were dependent on conduction through the ViG. CONCLUSIONS Electrical PV isolation can usually be achieved without complete circumferential ablation . However , more than a quarter of these ' isolated ' PVs exhibit dormant conduction-predominantly via the un-ablated ' ViGs ' in the ablation lesion set . These findings support the hypothesis that reversible tissue injury contributes to PV isolation that may be acute but not necessarily durable"
] | 41165e34-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Paleolithic nutrition , which has attracted substantial public attention lately because of its putative health benefits , differs radically from dietary patterns currently recommended in guidelines , particularly in terms of its recommendation to exclude grains , dairy , and nutritional products of industry . OBJECTIVE We evaluated whether a Paleolithic nutritional pattern improves risk factors for chronic disease more than do other dietary interventions . DESIGN We conducted a systematic review of r and omized controlled trials ( RCTs ) that compared the Paleolithic nutritional pattern with any other dietary pattern in participants with one or more of the 5 components of metabolic syndrome . Two review ers independently extracted study data and assessed risk of bias . Outcome data were extracted from the first measurement time point ( ≤6 mo ) . A r and om-effects model was used to estimate the average intervention effect . The quality of the evidence was rated with the use of the Grading of Recommendations Assessment , Development and Evaluation approach . RESULTS Four RCTs that involved 159 participants were included . The 4 control diets were based on distinct national nutrition guidelines but were broadly similar . Paleolithic nutrition result ed in greater short-term improvements than did the control diets ( r and om-effects model ) for waist circumference ( mean difference : -2.38 cm ; 95 % CI : -4.73 , -0.04 cm ) , triglycerides ( -0.40 mmol/L ; 95 % CI : -0.76 , -0.04 mmol/L ) , systolic blood pressure ( -3.64 mm Hg ; 95 % CI : -7.36 , 0.08 mm Hg ) , diastolic blood pressure ( -2.48 mm Hg ; 95 % CI : -4.98 , 0.02 mm Hg ) , HDL cholesterol ( 0.12 mmol/L ; 95 % CI : -0.03 , 0.28 mmol/L ) , and fasting blood sugar ( -0.16 mmol/L ; 95 % CI : -0.44 , 0.11 mmol/L ) . The quality of the evidence for each of the 5 metabolic components was moderate . The home-delivery ( n = 1 ) and dietary recommendation ( n = 3 ) RCTs showed similar effects with the exception of greater improvements in triglycerides relative to the control with the home delivery . None of the RCTs evaluated an improvement in quality of life . CONCLUSIONS The Paleolithic diet result ed in greater short-term improvements in metabolic syndrome components than did guideline -based control diets . The available data warrant additional evaluations of the health benefits of Paleolithic nutrition . This systematic review was registered at PROSPERO ( www.crd.york.ac.uk/ PROSPERO ) as CRD42014015119 | [
"Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240",
"Background / objectives : Formulas developed to estimate diet-dependent net acid excretion ( NAE ) generally agree with measured values for typical Western diets . Whether they can also appropriately predict NAE for ‘ Paleolithic-type ’ ( Paleo ) diets — which contain very high amounts of fruits and vegetables ( F&V ) and concurrent high amounts of protein is unknown . Here , we compare measured NAEs with established NAE estimates in subjects with Type 2 diabetes (T2D).Subjects/ methods : Thirteen subjects with well-controlled T2D were r and omized to either a Paleo or American Diabetes Association ( ADA ) diet for 14 days . Twenty-four hour urine collection s were performed at baseline and end of the diet period , and analyzed for titratable acid , bicarbonate and ammonium to calculate measured NAE . Three formulas for estimating NAE from dietary intake were used ; two ( NAE_diet R or L ) that include dietary mineral intake and sulfate- and organic acid ( OA ) production , and one that is empirically derived ( NAE_diet F ) only considering potassium and protein intake . Results : Measured NAE on the Paleo diet was significantly lower than on the ADA-diet ( + 31±22 vs 112±52 mEq/day , P=0.002 ) . Although all formula estimates showed similar and reasonable correlations ( r=0.52–0.76 ) with measured NAE , each one underestimated measured values . The formula with the best correlation did not contain an estimate of dietary OA production . Conclusions : Paleo-diets are lower in NAE than typical Western diets . However , commonly used formulas clearly underestimate NAE , especially for diets with very high F&V ( as the Paleo diet ) , and in subjects with T2D . This may be due to an inappropriate estimation of proton loads stemming from OAs , underlining the necessity for improved measures of OA-related proton sources",
"Aims /hypothesisMost studies of diet in glucose intolerance and type 2 diabetes have focused on intakes of fat , carbohydrate , fibre , fruits and vegetables . Instead , we aim ed to compare diets that were available during human evolution with more recently introduced ones . Methods Twenty-nine patients with ischaemic heart disease plus either glucose intolerance or type 2 diabetes were r and omised to receive ( 1 ) a Palaeolithic ( ‘ Old Stone Age ’ ) diet ( n = 14 ) , based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; or ( 2 ) a Consensus ( Mediterranean-like ) diet ( n = 15 ) , based on whole grains , low-fat dairy products , vegetables , fruits , fish , oils and margarines . Primary outcome variables were changes in weight , waist circumference and plasma glucose AUC ( AUC Glucose0–120 ) and plasma insulin AUC ( AUC Insulin0–120 ) in OGTTs . Results Over 12 weeks , there was a 26 % decrease of AUC Glucose0–120 ( p = 0.0001 ) in the Palaeolithic group and a 7 % decrease ( p = 0.08 ) in the Consensus group . The larger ( p = 0.001 ) improvement in the Palaeolithic group was independent ( p = 0.0008 ) of change in waist circumference ( −5.6 cm in the Palaeolithic group , −2.9 cm in the Consensus group ; p = 0.03 ) . In the study population as a whole , there was no relationship between change in AUC Glucose0–120 and changes in weight ( r = −0.06 , p = 0.9 ) or waist circumference ( r = 0.01 , p = 1.0 ) . There was a tendency for a larger decrease of AUC Insulin0–120 in the Palaeolithic group , but because of the strong association between change in AUC Insulin0–120 and change in waist circumference ( r = 0.64 , p = 0.0003 ) , this did not remain after multivariate analysis . Conclusions /interpretationA Palaeolithic diet may improve glucose tolerance independently of decreased waist circumference",
"Recent research suggests that traditional grain-based heart-healthy diet recommendations , which replace dietary saturated fat with carbohydrate and reduce total fat intake , may result in unfavorable plasma lipid ratios , with reduced high-density lipoprotein ( HDL ) and an elevation of low-density lipoprotein ( LDL ) and triacylglycerols ( TG ) . The current study tested the hypothesis that a grain-free Paleolithic diet would induce weight loss and improve plasma total cholesterol , HDL , LDL , and TG concentrations in nondiabetic adults with hyperlipidemia to a greater extent than a grain-based heart-healthy diet , based on the recommendations of the American Heart Association . Twenty volunteers ( 10 male and 10 female ) aged 40 to 62 years were selected based on diagnosis of hypercholesterolemia . Volunteers were not taking any cholesterol-lowering medications and adhered to a traditional heart-healthy diet for 4 months , followed by a Paleolithic diet for 4 months . Regression analysis was used to determine whether change in body weight contributed to observed changes in plasma lipid concentrations . Differences in dietary intakes and plasma lipid measures were assessed using repeated- measures analysis of variance . Four months of Paleolithic nutrition significantly lowered ( P mean total cholesterol , LDL , and TG and increased ( P HDL , independent of changes in body weight , relative to both baseline and the traditional heart-healthy diet . Paleolithic nutrition offers promising potential for nutritional management of hyperlipidemia in adults whose lipid profiles have not improved after following more traditional heart-healthy dietary recommendations",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"In a prospect i ve , r and omised single-blinded secondary prevention trial we compared the effect of a Mediterranean alpha-linolenic acid-rich diet to the usual post-infa rct prudent diet . After a first myocardial infa rct ion , patients were r and omly assigned to the experimental ( n = 302 ) or control group ( n = 303 ) . Patients were seen again 8 weeks after r and omisation , and each year for 5 years . The experimental group consumed significantly less lipids , saturated fat , cholesterol , and linoleic acid but more oleic and alpha-linolenic acids confirmed by measurements in plasma . Serum lipids , blood pressure , and body mass index remained similar in the 2 groups . In the experimental group , plasma levels of albumin , vitamin E , and vitamin C were increased , and granulocyte count decreased . After a mean follow up of 27 months , there were 16 cardiac deaths in the control and 3 in the experimental group ; 17 non-fatal myocardial infa rct ion in the control and 5 in the experimental groups : a risk ratio for these two main endpoints combined of 0.27 ( 95 % CI 0.12 - 0.59 , p = 0.001 ) after adjustment for prognostic variables . Overall mortality was 20 in the control , 8 in the experimental group , an adjusted risk ratio of 0.30 ( 95 % CI 0.11 - 0.82 , p = 0.02 ) . An alpha-linolenic acid-rich Mediterranean diet seems to be more efficient than presently used diets in the secondary prevention of coronary events and death"
] | 41165e70-06ff-11f0-808a-c43d1ab1c353 |
At least 20 % of people over the age of 65 suffer from mental disorders . It is anticipated that the number of older Americans with psychiatric disorders will double over the next 30 years . There is , however , substantial unmet need . The recent Surgeon General 's Report on Mental Health , a Report on Mental Health from the Administration on Aging , and an expert consensus statement underscore the need to plan for the challenge of providing services for elderly people with major mental disorders . Among the greatest challenges is the expertise gap that affects clinicians practicing in routine clinical setting s. This gap reflects inadequate training in geriatrics and a failure to incorporate contemporary clinical research findings and known evidence -based practice s ( EBPs ) into usual care . This article provides an overview of the emerging evidence -base supporting the efficacy of empirically-vali date d geriatric mental health interventions for major geriatric mental health disorders , including systematic EBP review s , meta-analytic studies , and expert consensus statements . Caution s and limitations regarding the reliance on r and omized , controlled trials , meta-analyses , and systematic review s also are presented | [
"CONTEXT Elderly patients with major depression are at high risk for recurrence , increased mortality , and chronic disability . OBJECTIVE To determine the efficacy of maintenance nortriptyline hydrochloride and interpersonal psychotherapy ( IPT ) in preventing recurrence of major depressive episodes in patients older than 59 years . DESIGN A 2 x 2 r and omized , double-blind , placebo-controlled clinical trial , stratified by therapist . SETTING University-based psychiatric research clinic . PATIENTS Of a total of 187 patients with recurrent nonpsychotic unipolar major depression ( average age , 67 years ; one third aged > or = 70 years ) recruited through clinical referral and media announcements , 107 were fully recovered after open acute and treatment continuation with nortriptyline and IPT . These patients were r and omly assigned to 1 of 4 maintenance therapy conditions . INTERVENTIONS Monthly medication clinic with nortriptyline hydrochloride ( 80 - 120 ng/mL steady-state levels ) ( n = 24 ) ; medication clinic with placebo ( n = 29 ) ; monthly maintenance IPT with placebo ( n = 21 ) ; and monthly maintenance IPT with nortriptyline ( n = 22 ) . MAIN OUTCOME MEASURE Recurrence of major depressive episode . RESULTS The time to recurrence of a major depressive episode for all 3 active treatments was significantly better than for placebo . Recurrence rates over 3 years were as follows : nortriptyline and IPT , 20 % ( 95 % confidence interval [ CI ] , 4%-36 % ) ; nortriptyline and medication clinic visits , 43 % ( 95 % CI , 25%-61 % ) ; IPT and placebo , 64 % ( 95 % CI , 45%-83 % ) ; and placebo and medication clinic visits , 90 % ( 95 % CI , 79%-100 % ) . Combined treatment with nortriptyline and IPT was superior to IPT and placebo and showed a trend to superior efficacy over nortriptyline monotherapy ( Wald chi2 = 3.56 ; P = .06 ) . Subjects aged 70 years and older had a higher and more rapid rate of recurrence than those aged 60 to 69 years . CONCLUSION In geriatric patients with recurrent major depression , maintenance treatment with nortriptyline or IPT is superior to placebo in preventing or delaying recurrence . Combined treatment using both appears to be the optimal clinical strategy in preserving recovery",
"BACKGROUND There is increasing concern about the quality , reliability , and independence of practice guidelines . Because no information is available on the method ological quality of the guidelines developed by specialty societies , we undertook a survey on those published in peer- review ed journals . METHODS Practice guidelines produced by specialty societies and published in English between January , 1988 , and July , 1998 , where identified through MEDLINE . Their quality was assessed in terms of whether they reported : the type of professionals and stakeholders involved in the development process ; the strategy to identify primary evidence ; and an explicit grading of recommendations according to the quality of supporting evidence . FINDINGS Overall , 431 guidelines were eligible for the study . Most did not meet the criteria : 67 % did not report any description of the type of stakeholders , 88 % gave no information on search es for published studies , and 82 % did not give any explicit grading of the strength of recommendations . There was improvement over time for search es ( from 2 % to 18 % , p explicit grading of evidence ( from 6 % to 27 % , p<0.001 ) . All three criteria for quality were met in only 22 ( 5 % ) guidelines . INTERPRETATION Despite improvement over time , the quality of practice guidelines developed by specialty societies is unsatisfactory . Explicit method ological criteria for the production of guidelines shared among public agencies , scientific societies , and patients ' associations need to be set up . Common st and ards of reporting , following the same principles that led to the CONSORT statement for r and omised clinical trials , should be promoted",
"OBJECTIVE Developing behavioral interventions to improve functioning of older patients with schizophrenia and other chronic psychoses has the potential to significantly increase the patients ' independence and quality of life . METHODS The authors evaluated a psychosocial intervention design ed to improve everyday living skills of middle-aged and older out patients with very chronic psychotic disorders ( mean duration of illness : 21 years ) . Forty patients who resided in board- and -care facilities were r and omly assigned to either a 24-session functional adaptation skills training ( FAST ) group therapy program targeting problem areas identified in previous work as being problematic for this population ( e.g. , using public transportation ) or treatment-as-usual . Almost all the participants also received antipsychotics . RESULTS Compared with the patients r and omized to the treatment-as-usual condition , FAST-treated patients ' performance on everyday living skills improved significantly immediately post-intervention and was still significantly better at a 3-month maintenance follow-up period . There was no significant change in psychopathology . CONCLUSION Results suggest that older patients with longst and ing psychotic disorders may benefit from participation in this skills-training program",
"OBJECTIVES Depression in older patients contributes to personal suffering and family disruption and increases disability , medical morbidity , mortality , suicide risk , and healthcare utilization . The majority of clinical trials of antidepressant treatments are conducted in younger patients . For this reason , clinicians often have to extrapolate from studies in population s that do not present the same problems as older patients . For example , older patients often have serious coexisting medical conditions that may contribute to the depression and complicate the choice of treatment . Older patients as a rule need to be on many medications , some of which may contribute to depression and /or interact with antidepressants . Finally , older adults metabolize medications slowly and are more sensitive to side effects than younger patients . Because of these complexities , we conducted a consensus survey of expert opinion on the pharmacotherapy of depressive disorders in older patients to address clinical questions not definitively answered in the research literature . METHOD After review ing the literature and convening a work group of experts , we prepared a written survey with 64 questions that asked about 857 options . 618 of the options were scored using a modified version of the R AND 9-point scale for rating appropriateness of medical decisions . For the other options , the experts were asked to write in answers ( e.g. , average doses ) or to check a box to indicate their preferred answer . We sent the survey to 50 national experts on geriatric depression , all of whom completed it . Consensus on each option was defined as a nonr and om distribution of scores by chi-square \" goodness-of-fit \" test . We assigned a categorical rank ( first line/preferred choice , second line/alternate choice , third line/usually inappropriate ) to each option based on the 95 % confidence interval around the mean rating . Guideline tables indicating preferred treatment strategies were then developed for key clinical situations . RESULTS The expert panel reached consensus on 89 % of the options rated on the 9-point scale . The experts stress the importance of identifying coexisting medical conditions that may be contributing to the depression or complicate treatment . For unipolar nonpsychotic major depression , the preferred strategy is an antidepressant ( selective serotonin reuptake inhibitor [ SSRI ] or venlafaxine XR preferred ) plus psychotherapy . For unipolar psychotic major depression , the treatment of choice is an antidepressant ( SSRI or venlafaxine XR ) plus one of the newer atypical antipsychotics . Electroconvulsive therapy is also first line . For dysthymic disorder or persistent milder depression , the experts recommend combining an antidepressant ( SSRIs preferred ) and psychotherapy . If the patient has a comorbid medical condition ( e.g. , hypothyroidism ) that is contributing to the depression , the experts recommend treating both the depression and the medical condition from the outset . The SSRIs were the top-rated antidepressants for all types of depression . Among them , the experts gave the highest ratings for efficacy and tolerability to citalopram and sertraline . Paroxetine was another first-line option , and fluoxetine was rated high second line . The preferred psychotherapy techniques for treating depression in older patients are cognitive-behavioral therapy , supportive psychotherapy , problem-solving psychotherapy , and interpersonal psychotherapy . The experts also give strong support to including appropriate psychosocial interventions ( e.g. , psychoeducation , family counseling , visiting nurse services ) in the treatment program . The majority of experts would continue treatment with antidepressant medication for at least 1 year if a patient has had a single episode of severe unipolar major depression , for 1 - 3 years for a patient who has had 2 such episodes , and for longer than 3 years if there is a history of 3 or more episodes . CONCLUSIONS The experts reached a high level of consensus on the appropriateness of including both antidepressant medication , specifically SSRIs , and nonpharmacological modalities in treatment plans for severe depression . Within the limits of expert opinion and with the expectation that future research data will take precedence , these guidelines provide direction for addressing common clinical dilemmas in older individuals . They can be used to inform clinicians and educate patients regarding the relative merits of a variety of interventions . Nonetheless , the guidelines can not address the complexities involved in the care of each individual patient and can be most helpful in the h and s of experienced clinicians",
"OBJECTIVE The authors studied the incidence of tardive dyskinesia in elderly institutionalized patients with dementia being treated with risperidone . METHOD After participating in a 12-week multicenter double-blind study during which they received placebo or one of three doses of risperidone , 330 patients ( mean age=82.5 years ) with Alzheimer 's , vascular , or mixed dementia were enrolled in a 1-year open-label study during which they received flexible doses of risperidone . Persistent emergent tardive dyskinesia was defined according to scores on the dyskinesia subscale of the Extrapyramidal Symptom Rating Scale . RESULTS The mean modal risperidone dose was 0.96 mg/day ( SD=0.53 ) , and the median length of risperidone use was 273 days . The 1-year cumulative incidence of persistent emergent tardive dyskinesia among the 255 patients without dyskinesia at baseline was 2.6 % . Patients with dyskinetic symptoms at baseline experienced significant reductions in the severity of dyskinesia . Patients who received 0.75 - 1.5 mg/day of risperidone showed a significant improvement in psychopathologic symptoms over the 1-year period . CONCLUSIONS Although there was no control group , the observed incidence of persistent tardive dyskinesia with risperidone seemed to be much lower than that seen in elderly patients treated with conventional neuroleptics . The average optimal dose of risperidone in elderly dementia patients was found to be 0.75 - 1.5 mg/day"
] | 41165eac-06ff-11f0-808a-c43d1ab1c353 |
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 yr or 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 74Gy and 78Gy 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 | [
"CRA4504 Background : The impact of radiotherapy on overall survival ( OS ) in men with locally advanced CaP is unclear . The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality . Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. METHODS Patients with T3/T4 ( 1057 ) or T2 , PSA > 40 μ g/l ( 119 ) or T2 PSA > 20 μ g/l and Gleason ≥ 8 ( 25 ) and N0 /NX , M0 prostate adenocarcinoma were r and omized to lifelong ADT ( bilateral orchiectomy or LHRH agonist ) with or without RT ( 65 - 69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes ) . The primary endpoint was OS and secondary endpoints included disease specific survival ( DSS ) , time to disease progression and quality of life . RESULTS 1205 patients were r and omized from 1995 to 2005 , 602 to ADT and 603 to ADT+RT ( well balanced with respect to baseline characteristics ) . A protocol specified second interim analysis on OS was performed in Aug 2009 ( data cut-off Dec 31 2008 ) . The DSMC recommended release of the results to the Trial Committee for publication . The median follow-up is 6.0 years and 320 patients have died ( 175 ADT and 145 ADT+RT ) . 10 % of patients had no follow-up data beyond 2006 . The addition of RT to ADT significantly reduced the risk of death ( hazard ratio [ HR ] 0.77 , 95 % CI 0.61 - 0.98 , p=0.033 ) . 140 patients died of disease and /or treatment ( 89 on ADT and 51 on ADT+RT ) The disease specific survival HR was 0.57 ( 95 % CI 0.41 - 0.81 , p=0.001 ) favoring ADT+RT . The 10 year cumulative disease specific death rates were estimated at 15 % with ADT+ RT and 23 % with ADT alone . Grade ≥2 late GI toxicity rates were similar in both arms ( proctitis , 1.3 % ADT alone , 1.8 % ADT+RT ) . CONCLUSIONS The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach ( ADT+RT ) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity . In view of this data combined modality therapy ( ADT+RT ) should be the st and ard treatment approach for these patients . Supported by NCI-US Grant # 5U10CA077202 - 12 , CCSRI Grant # 15469 . No significant financial relationships to disclose",
"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",
"PURPOSE To report toxicity and preliminary biochemical outcomes with high-dose intensity-modulated radiation therapy ( IMRT ) to a dose of 86.4 Gy for localized prostate cancer . METHODS AND MATERIAL S Between August 1997 and March 2004 , 478 patients were treated with 86.4 Gy using a 5- to 7-field IMRT technique . To adhere to normal tissue constraints , the mean D95 and V100 for the planning target volume were 83 Gy and 87 % , respectively . Toxicity data were scored according to the Common Terminology Criteria for Adverse Events Version 3.0 . Freedom from biochemical relapse was calculated . The median follow-up was 53 months . RESULTS Thirty-seven patients ( 8 % ) experienced acute Grade 2 gastrointestinal ( GI ) toxicity . There was no acute Grade 3 or 4 GI toxicity . One hundred and five patients ( 22 % ) experienced acute Grade 2 genitourinary ( GU ) toxicity and three patients ( 0.6 % ) had Grade 3 GU toxicity . There was no acute Grade 4 GU toxicity . Sixteen patients ( 3 % ) developed late Grade 2 GI toxicity and two patients ( late Grade 3 GI toxicity . Sixty patients ( 13 % ) had late Grade 2 GU toxicity and 12 ( late Grade 3 GU toxicity . The 5-year actuarial PSA relapse-free survival according to the nadir plus 2 ng/mL definition was 98 % , 85 % and 70 % for the low , intermediate , and high risk NCCN prognostic groups . CONCLUSION This report represents the largest data set of patients treated to ultra-high radiation dose levels of 86.4 Gy using IMRT for localized prostate cancer . Our findings indicate that this treatment is well tolerated and the early excellent biochemical control rates are encouraging",
"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 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 .",
"BACKGROUND In 2008 , we reported that radical prostatectomy , as compared with watchful waiting , reduces the rate of death from prostate cancer . After an additional 3 years of follow-up , we now report estimated 15-year results . METHODS From October 1989 through February 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy . Follow-up was complete through December 2009 , with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death . Relative risks , with 95 % confidence intervals , were estimated with the use of a Cox proportional-hazards model . RESULTS During a median of 12.8 years , 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died ( P=0.007 ) . In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting , death was due to prostate cancer . This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6 % and 20.7 % , respectively ( a difference of 6.1 percentage points ; 95 % confidence interval [ CI ] , 0.2 to 12.0 ) , and a relative risk with surgery of 0.62 ( 95 % CI , 0.44 to 0.87 ; P=0.01 ) . The survival benefit was similar before and after 9 years of follow-up , was observed also among men with low-risk prostate cancer , and was confined to men younger than 65 years of age . The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age . Among men who underwent radical prostatectomy , those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth ( relative risk , 6.9 ; 95 % CI , 2.6 to 18.4 ) . CONCLUSIONS Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer . Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment . ( Funded by the Swedish Cancer Society and the National Institutes of Health . )",
"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",
"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",
"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",
"PURPOSE To determine whether a dose of 78 Gy improves outcome compared with a conventional dose of 68 Gy for prostate cancer patients treated with three-dimensional conformal radiotherapy . PATIENTS AND METHODS Between June 1997 and February 2003 , stage T1b-4 prostate cancer patients were enrolled onto a multicenter r and omized trial comparing 68 Gy with 78 Gy . Patients were stratified by institution , age , (neo)adjuvant hormonal therapy ( HT ) , and treatment group . Four treatment groups ( with specific radiation volumes ) were defined based on the probability of seminal vesicle involvement . The primary end point was freedom from failure ( FFF ) . Failure was defined as clinical failure or biochemical failure , according to the American Society of Therapeutic Radiation Oncology definition . Other end points were freedom from clinical failure ( FFCF ) , overall survival ( OS ) , and toxicity . RESULTS Median follow-up time was 51 months . Of the 669 enrolled patients , 664 were included in the analysis . HT was prescribed for 143 patients . FFF was significantly better in the 78-Gy arm compared with the 68-Gy arm ( 5-year FFF rate , 64 % v 54 % , respectively ) , with an adjusted hazard ratio of 0.74 ( P = .02 ) . No significant differences in FFCF or OS were seen between the treatment arms . There was no difference in late genitourinary toxicity of Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer grade 2 or more and a slightly higher nonsignificant incidence of late gastrointestinal toxicity of grade 2 or more . CONCLUSION This multicenter r and omized trial shows a significantly improved FFF in prostate cancer patients treated with a higher dose of radiotherapy",
"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",
"OBJECTIVE EORTC trial 30891 compared immediate versus deferred and rogen-deprivation therapy ( ADT ) in T0 - 4 N0 - 2 M0 prostate cancer ( PCa ) . Many patients r and omly assigned to deferred ADT did not require ADT because they died before becoming symptomatic . The question arises whether serum prostate-specific antigen ( PSA ) levels may be used to decide when to initiate ADT in PCa not suitable for local curative treatment . METHODS PSA data at baseline , PSA doubling time ( PSADT ) in patients receiving no ADT , and time to PSA relapse ( > 2 ng/ml ) in patients whose PSA declined to ADT were analyzed in 939 eligible patients r and omly assigned to immediate ( n=468 ) or deferred ADT ( n=471 ) . RESULTS In both arms , patients with a baseline PSA>50 ng/ml were at a>3.5-fold higher risk to die of PCa than patients with a baseline PSA risk of PCa death was approximately 7.5-fold higher in patients with PSADT12 mo . Time to PSA relapse after response to immediate ADT correlated significantly with baseline PSA , suggesting that baseline PSA may also reflect disease aggressiveness . CONCLUSIONS Patients with a baseline PSA>50 ng/ml and /or a PSADT risk to die from PCa and might have benefited from immediate ADT , whereas patients with a baseline PSA 12 mo ) were likely to die of causes unrelated to PCa , and thus could be spared the burden of immediate ADT",
"PURPOSE This study ( EORTC 30891 ) attempted to demonstrate equivalent overall survival in patients with localized prostate cancer not suitable for local curative treatment treated with immediate or deferred and rogen ablation . PATIENTS AND METHODS We r and omly assigned 985 patients with newly diagnosed prostate cancer T0 - 4 N0 - 2 M0 to receive and rogen deprivation either immediately ( n = 493 ) or on symptomatic disease progression or occurrence of serious complications ( n = 492 ) . RESULTS Baseline characteristics were well balanced in the two groups . Median age was 73 years ( range , 52 to 81 ) . At a median follow-up of 7.8 years , 541 of 985 patients had died , mostly of prostate cancer ( n = 193 ) or cardiovascular disease ( n = 185 ) . The overall survival hazard ratio was 1.25 ( 95 % CI , 1.05 to 1.48 ; noninferiority P > .1 ) favoring immediate treatment , seemingly due to fewer deaths of nonprostatic cancer causes ( P = .06 ) . The time from r and omization to progression of hormone refractory disease did not differ significantly , nor did prostate-cancer specific survival . The median time to the start of deferred treatment after study entry was 7 years . In this group 126 patients ( 25.6 % ) died without ever needing treatment ( 44 % of the deaths in this arm ) . CONCLUSION Immediate and rogen deprivation result ed in a modest but statistically significant increase in overall survival but no significant difference in prostate cancer mortality or symptom-free survival . This must be weighed on an individual basis against the adverse effects of life-long and rogen deprivation , which may be avoided in a substantial number of patients with a deferred treatment policy",
"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 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",
"BACKGROUND The benefit of radical prostatectomy in patients with early prostate cancer has been assessed in only one r and omized trial . In 2005 , we reported that radical prostatectomy improved prostate cancer survival compared with watchful waiting after a median of 8.2 years of follow-up . We now report results after 3 more years of follow-up . METHODS From October 1 , 1989 , through February 28 , 1999 , 695 men with clinical ly localized prostate cancer were r and omly assigned to radical prostatectomy ( n = 347 ) or watchful waiting ( n = 348 ) . Follow-up was complete through December 31 , 2006 , with histopathologic review and blinded evaluation of causes of death . Relative risks ( RRs ) were estimated using the Cox proportional hazards model . Statistical tests were two-sided . RESULTS During a median of 10.8 years of follow-up ( range = 3 weeks to 17.2 years ) , 137 men in the surgery group and 156 in the watchful waiting group died ( P = .09 ) . For 47 of the 347 men ( 13.5 % ) who were r and omly assigned to surgery and 68 of the 348 men ( 19.5 % ) who were not , death was due to prostate cancer . The difference in cumulative incidence of death due to prostate cancer remained stable after about 10 years of follow-up . At 12 years , 12.5 % of the surgery group and 17.9 % of the watchful waiting group had died of prostate cancer ( difference = 5.4 % , 95 % confidence interval [ CI ] = 0.2 to 11.1 % ) , for a relative risk of 0.65 ( 95 % CI = 0.45 to 0.94 ; P = .03 ) . The difference in cumulative incidence of distant metastases did not increase beyond 10 years of follow-up . At 12 years , 19.3 % of men in the surgery group and 26 % of men in the watchful waiting group had been diagnosed with distant metastases ( difference = 6.7 % , 95 % CI = 0.2 to 13.2 % ) , for a relative risk of 0.65 ( 95 % CI = 0.47 to 0.88 ; P = .006 ) . Among men who underwent radical prostatectomy , those with extracapsular tumor growth had 14 times the risk of prostate cancer death as those without it ( RR = 14.2 , 95 % CI = 3.3 to 61.8 ; P Radical prostatectomy reduces prostate cancer mortality and risk of metastases with little or no further increase in benefit 10 or more years after surgery",
"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",
"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 To estimate the benefits of prostate-specific antigen ( PSA ) screening on prostate cancer ( Pca ) metastasis and Pca-specific mortality , we compared two population s with a well-defined difference in intensity of screening . METHODS Between 1997 and 1999 , a total of 11,970 men , aged 55 - 74 years , were included in the intervention arm of the European R and omised Study of Screening for Prostate Cancer ( ERSPC ) section Rotterdam . Control population consisted of 133,287 men , aged 55 - 74 years , between 1998 and 1999 in Northern Irel and ( NI ) . Men were followed for Pca incidence , Pca metastasis and cause of death until 31st December 2006 . RESULTS Median age in both groups was 63 years at study entry ( p=0.184 ) . In Rotterdam 94.2 % of men and in NI 6 % of men underwent PSA testing . In Rotterdam , 1153 men ( 9.6 % ) were diagnosed with Pca with median baseline PSA of 5.1 ng/ml . In NI , 3962 men ( 3.0 % , p relative risk of Pca metastasis during observation in the intervention population compared to control population was 0.47 ( 95 % confidence interval ( CI ) , 0.35 - 0.63 ; p relative risk of Pca-specific mortality was also lower in the intervention population compared to the control population after a median follow-up of 8.5 years : 0.63 ( 95 % CI , 0.45 - 0.88 ; p=0.008 ) ; absolute mortality reduction was 1.8 deaths per 1000 men . CONCLUSIONS A relative reduction in Pca metastasis of 53 % and Pca mortality of 37 % was observed in the intervention population after 8.5 years of observation . The impact of overdiagnosis , quality of life benefits and cost-effectiveness need to be assessed before population -based PSA screening can be recommended"
] | 41165ee8-06ff-11f0-808a-c43d1ab1c353 |
INTRODUCTION Transrectal ultrasound-guided biopsies ( TRUS-gb ) are associated with both mild and serious complications . Prophylactic antibiotics reduce the risk of septicaemia and mortality ; however , no international consensus exists on the timing and duration of antibiotics , including the optimal drug strategy . We review ed the current evidence supporting use of prophylactic antibiotics and the risk of complications following prostate biopsies . METHODS This review was drafted in accordance with the Prisma Guidelines . The PubMed , Embase and Cochrane data bases were search ed . RESULTS A total of 19 eligible trials were identified . One trial demonstrated a significant reduction in the risk of infection after biopsy and reported that oral ciprofloxacin as either a single-dose or a three-day regimen was superior to oral chloramphenicol and norfloxacin . Of three studies investigating the timing of the first dose of antibiotic , one study found that administration 24 h before biopsy versus administration immediately before reduced the relative risk of post-biopsy infection by 55 % . Seven studies compared different duration s of antibiotic prophylaxis . None showed any benefit from continuing prophylaxis beyond a single dose or a one-day regimen . CONCLUSION Evidence supporting a specific antibiotic regimen for TRUS-gb prophylaxis is scarce . Widespread use of fluoroquinolone prophylaxis may be associated with an increase in resistant Escherichia coli strains , posing a potentially major health issue in the future . | [
"OBJECTIVE To compare , prospect ively , 4 different schemes of antibiotic prophylaxis previously to transrectal prostate biopsy . MATERIAL S AND METHODS 257 patients were r and omized in 4 groups : Group I : single dose of ciprofloxacin 2 hours before the procedure ; Group II : ciprofloxacin 3 days ; Group III : chloramphenicol 3 days ; and Group IV : norfloxacin 3 days . The complication rate was assessed in a blind way on the third and on the thirtieth days through a question naire . Groups were compared by the qui-square method and , in small sample s , by the Fisher method , with statistical significance of 95 % . RESULTS Complications index throughout the sample differed between the 4 groups of patients under study , being 3.1 % for group I , 2.1%for group II , 18.3 % for group III and 10.5 % for group IV . Schemes employing ciprofloxacin were statistically superior to those that used norfloxacin or chloramphenicol ( p ciprofloxacin ( p > 0.05 ) . CONCLUSION Schemes using ciprofloxacin presented better results in prophylaxis previously to prostate biopsy . We recommend using a single dose of ciprofloxacin due to its posologic ease and low cost , associated with a therapeutic response equivalent to 3-day regimens",
"Purpose To compare the antibiotic prophylaxis based on quinolone administered orally with a combination of cephalosporin administered periprostatically and a fluoroquinolone orally , in terms of post-prostate bioptic infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy ( TRUS gpb ) . Methods In a prospect i ve , r and omized , double-blind study , 150 consecutive patients were r and omized to receive 10 ml lidocaine 1 % in Group A and ceftriaxone 1 g diluted in a solution of 10 ml of lidocaine 1 % in Group B , before TRUS gpb . All signed the informed consent . The men were asked to grade the pain using a ten points visual analogue scale close after TRUS gpb . In a telephone interview at 3 and 6 days , they were asked about early and late complications , assessing rectal bleeding , urinary retection , fewer , haematuria , urethral bleeding and hematospermia . Results Of the 150 men enrolled , 135 , 70 in Groups A and 65 in Group B , completed the study . Four men ( 5.7 % ) in Group A developed sepsis after TRUS gpb requiring hospital admission and intravenous antibiotic treatment , while none in Group B. Escherichia coli was the only organism isolated . The mean pain score was 2.76 ± 1.69 and 1.73 ± 1.26 for Group A and B , respectively ( p = 0.08 ) . Complications , evaluated at 3 and 6 days after the procedure through a telephone interview , were similar in both Groups . Conclusions The antibiotic prophylaxis based on the combination of ceftriaxone administered periprostatically and ciprofloxacin orally is able to offer a best control on infections caused by fluoroquinolone-resistant E. coli",
"Transrectal biopsy is one of the more popular methods for the diagnosis of prostatic cancer . However , there is disagreement as to whether the use of prophylactic antimicrobials decreases the incidence of fever and urinary tract infections , which may follow this procedure . A prospect i ve r and omized double-blind study involving 63 patients was instituted to determine the efficacy of carbenicillin indanyl sodium in reducing these complications . The protocol consisted of administration of 2 tablets of 4 times daily of a placebo or the treatment drug 24 hours before and after biopsy . Clean catch urine cultures were obtained 24 hours before biopsy and at 48 hours and 2 weeks after the procedure . Blood cultures were performed 15 minutes after biopsy . In addition , clinical parameters were monitored closely in the hospital for 48 hours after biopsy . A total of 48 patients was considered evaluable . Of 23 patients who received the study drug 2 ( 8.6 per cent ) had positive urine cultures at 48 hours compared to 9 of 25 ( 36 per cent ) from the placebo group . A similar result was observed from the 2-week culture data , in which 2 of 23 patients ( 8.6 per cent ) in the treatment group had positive urine cultures as opposed to 5 of 25 ( 20 per cent ) receiving the placebo . Fever occurred in 48 per cent of the placebo and in 17 per cent of the carbenicillin groups . Our data indicate that prophylactic administration of carbenicillin indanyl sodium decreases the complications of fever and urinary tract infections following transrectal biopsy of the prostate",
"BACKGROUND Infection is a serious adverse effect of prostate biopsy ( P-Bx ) , and recent reports suggest an increasing incidence . OBJECTIVE The aim of this multinational multicentre study was to evaluate prospect ively the incidence of infective complications after P-Bx and identify risk factors . DESIGN , SETTING , AND PARTICIPANTS The study was performed as an adjunct to the Global Prevalence Study of Infections in Urology ( GPIU ) during 2010 and 2011 . Men undergoing P-Bx in participating centres during the 2-wk period commencing on the GPIU study census day were eligible . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Baseline data were collected and men were question ed regarding infective complications at 2 wk following their biopsy . The Fisher exact test , Student t test , Mann-Whitney U test , and multivariate regression analysis were used for data analysis . RESULTS AND LIMITATIONS A total of 702 men from 84 GPIU participating centres worldwide were included . Antibiotic prophylaxis was administered prior to biopsy in 98.2 % of men predominantly using a fluoroquinolone ( 92.5 % ) . Outcome data were available for 521 men ( 74 % ) . Symptomatic urinary tract infection ( UTI ) was seen in 27 men ( 5.2 % ) , which was febrile in 18 ( 3.5 % ) and required hospitalisation in 16 ( 3.1 % ) . Multivariate analysis did not identify any patient subgroups at a significantly higher risk of infection after P-Bx . Causative organisms were isolated in 10 cases ( 37 % ) with 6 resistant to fluoroquinolones . The small sample size per participating site and in compared with other studies may have limited the conclusions from our study . CONCLUSIONS Infective complications after transrectal P-Bx are important because of the associated patient morbidity . Despite antibiotic prophylaxis , 5 % of men will experience an infective complication , but none of the possible factors we examined appeared to increase this risk . Our study confirms a high incidence of fluoroquinolone resistance in causative bacteria",
"OBJECTIVE Prostate biopsy is a frequent diagnostic measure to detect prostatic conditions , including primarily prostate cancer . Its performance does not follow a pattern , mainly regarding preparation for the examination through antimicrobial prophylaxis . The aim of this study is to compare the efficiency of short and long term antimicrobial prophylaxis in transrectal ultrasound-guided prostate biopsies . MATERIAL S AND METHODS A clinical study was conducted with a total of 140 patients su bmi tted to prostate biopsy with transrectal ultrasonographic control . Patients were r and omly separated in two groups : Group 1 receiving norfloxacin 400 mg single dose before the procedure and Group 2 receiving norfloxacin 400 mg initiating before the procedure and then bid up to 6 doses . Efficiency control was determined by the incidence of urinary tract infection ( UTI ) and complications in both groups after statistical analysis . RESULTS The incidence of minor complications in our study was 75 % , consistent with data found in the literature . Among the patients with diagnosis of simple UTI , 23 % belonged to Group 1 and 8 % to Group 2 ( p=0.08 ) . Among the patients with complicated UTI , 37 % belonged to Group 1 and none belonged to Group 2 ( p=0.44 ) . CONCLUSIONS Several advances made transrectal ultrasound-guided prostate biopsies a useful and safe diagnostic tool in the workup of urologic patients . There is no optimal prophylactic preparation to the performance of this procedure . Long term antimicrobial prophylaxis presents a trend toward lower incidence of infectious complications",
"Background Transrectal ultrasound-guided prostate biopsies ( TRUSBx ) , in spite of being one of the most frequently performed urological office procedures , are associated with a spectrum of complications , most significantly including infection . The aim of the study is to evaluate the prevalence of fluoroquinolone-resistant bacteria in rectal swabs from our local population prior to TRUSBx and to identify risk factors among a patient population harboring fluoroquinolone-resistant organisms . Methods We prospect ively included 541 men who were su bmi tted for TRUSBx in our center from March 2011 to June 2015 . The indications for TRUSBx were an elevated prostate-specific antigen level and /or abnormal digital rectal exam . All patients were r and omly divided into two groups : Group 1 ( n = 279 cases ) who received st and ard empirical prophylactic antibiotics and Group 2 who received targeted prophylaxis based on a rectal swab culture and susceptibility result . Differences in risk factors between quinolone-resistant and nonresistant patients were compared . Univariate and multivariate analyses were performed to identify independent potential risk factors associated with fluoroquinolone-resistant rectal flora . Results Sixteen out of 271 men developed infectious complications after TRUSBx in the group receiving st and ard empirical prophylaxis ( 5.7 % ) . No men in the group who received targeted prophylactic antibiotic guided by rectal swab developed infectious complications . Among the 262 patients who underwent prebiopsy rectal swab cultures , 76 men ( 29 % ) displayed fluoroquinolone-resistant rectal flora ( 29 % ) . In the multivariate analysis , a history of antibiotic exposure before prostate biopsy was the only independent factor associated with an increased risk of fluoroquinolone resistance . Conclusion Determining the prevalence of fluoroquinolone resistance in rectal flora has important implication s in the selection of targeted prophylactic antibiotic regimens . Antimicrobial profiles guided by rectal swabs may prove useful to optimize prophylaxis prior to TRUSBx ; this strategy is effective at reducing the rates of infectious complications , including sepsis , especially in men at higher risk of infectious complications",
"PURPOSE Prostate biopsy related infectious complications are associated with significant morbidity . The risk of infectious complications in patients with prostate cancer on active surveillance remains under studied . MATERIAL S AND METHODS A total of 591 consecutive men who underwent prostate biopsy were prospect ively enrolled in a study evaluating prostate biopsy related complications between January 2011 and January 2012 . Of these men 403 were previously diagnosed with prostate cancer and were included in this study . They underwent a 14-core transrectal ultrasound guided prostate biopsy as part of an active surveillance regimen . A nurse contacted all men within 14 days of biopsy , and information was collected on potential complications , antibiotics received and bacterial culture results . RESULTS Fourteen patients ( 3.5 % ) had infectious complications including 13 requiring hospitalization . Five patients had positive urine cultures , and fluoroquinolone resistant isolates were identified in 4 patients , including 2 with extended spectrum beta-lactamase producing isolates . We evaluated the impact of risk factors including diabetes , benign prostatic hyperplasia and antibiotic regimen . However , only the number of previous prostate biopsies was significantly associated with an increased risk of infectious complications ( p = 0.041 ) . For every previous biopsy the odds of an infection increased 1.3 times ( OR 1.33 , 95 % CI 1.01 - 1.74 ) . CONCLUSIONS In men with prostate cancer on active surveillance the number of previous prostate biopsies is associated with a significant risk of infectious complications and every previous biopsy increases the risk of infectious complication . Fluoroquinolone resistant and extended spectrum beta-lactamase producing isolates represent the most commonly identified organisms . Men with prostate cancer on active surveillance should be informed of the risks associated with serial repeat prostate biopsies",
"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",
"INTRODUCTION Prostate cancer is the most common form of cancer in Danish men , and the incidence is rising . The diag-nosis is made by transrectal prostate biopsy guided by ultrasound . This procedure has several complications , the most severe being sepsis . In our department , this is sought prevented by administering the prophylactic antibiotics metronidazol and ciprofloxacin . This study examined the rate of sepsis in patients who had the procedure performed at our department . METHODS The electronic patient records of all patients who had transrectal ultrasound of the prostate with biopsies performed at the Department of Urology at Naestved Hospital in the period from 1 May 2009 to 31 May 2011 were examined , and all admissions to our department ( or any department in the same region ) due to sepsis within two weeks of the procedure were registered . RESULTS A total of 438 patients had the procedure performed , some multiple times , which result ed in a total of 511 procedures . In all , four patients were later admitted due to sepsis , corresponding to 0.91 % . Three of the patients had positive blood and urine cultures in which Escherichia coli resistant to ciprofloxacin were found , the last had been prescribed antibiotics by a general practitioner the previous day , and no bacteria could be cultured . CONCLUSION The frequency of sepsis after transrectal needle biopsies from the prostate at our department was found to be below 1 % in this study , which is comparable to international findings . Most of the cases of sepsis were related to ciprofloxacin-resistant bacteria . Further r and omised studies are needed to investigate the ideal prophylactic regime . FUNDING not relevant . TRIAL REGISTRATION not relevant",
"The objective of this study was to assess the value of a urine bacterial culture performed before prostate biopsy . We performed a prospect i ve study on 353 patients who underwent prostate biopsy . All patients had a urine bacterial culture performed before biopsy . We compared the outcomes of patients with bacteriuria ( left untreated ) with those of patients without bacteriuria . Of the 353 men , 12 had a pre-biopsy-positive bacterial culture and underwent prostate biopsy without any infectious complication . Fifteen patients with a negative pre-biopsy culture developed a post-biopsy-positive bacterial culture , but remained asymptomatic without any treatment . Only four men from the group without pre-biopsy bacteriuria developed an infectious complication , requiring 3 weeks of antibiotic therapy . The complication rates were similar for both groups . Our results suggest that routine urine bacterial culture before prostate biopsy is not useful when antibiotic prophylaxis and enema are performed . We do , however , suggest performing a urine bacterial culture before prostate biopsy for patients with a previous history of urinary tract infections",
"Purpose Despite the recent innovations , complications of prostate biopsy can occur . The aim of this study was a prospect i ve monitoring of major septic complications occurring after transrectal prostate biopsy , to describe their causing agents , to report the clinical course of these patients , and to give guidelines based on our personal experience . Methods This prospect i ve study was carried out between January 2009 and September 2010 . Complications were evaluated by telephone interviews . Results Between January 2009 and September 2010 , 447 ( 96.5 % ) completed the telephone interview . Urosepsis occurred in ten patients ( 2.2 % ) and in three cases evolved into septic shock . Of these ten patients , nine had a positive blood culture , of whom eight for Escherichia coli and one for Aeromonas hydrophila , Aeromonas caviae , and Aeromonas sobria . In seven cases , the E. coli isolated were resistant to fluoroquinolone and six produced an extended spectrum beta-lactamase . Six E. coli were classified as multidrug-resistant organisms . Of the 10 patients , one died after the onset of multiorgan failure . For the other nine , the mean time spent in the hospital was 9 days ( range , 6–15 days ) . Conclusions Escherichia coli are developing new drug resistances . Early recognition of patients who harbor MDRO E. coli in their rectum or in the urine could be an important strategy for preventing sepsis . If a patient who has recently undergone transrectal prostate biopsy shows clinical signs of sepsis in the 48 h , a multiresistant E. coli infection must be suspected . The patient must be admitted urgently to the hospital , and carbapenem antibiotic therapy should be started",
"PURPOSE To compare the incidence of infection between a 1 day and a 3 day antibiotic prophylaxis regimen for transrectal ultrasound ( TRUS ) guided prostate biopsy in a prospect i ve , r and omized open-label trial . MATERIAL S AND METHODS TRUS examination was performed in the left lateral decubitus position using a Brüel and Kjaer 7 MHz rectal probe . Biopsies were carried out with an 18 gauge Tru-cut needle fired by the h and -held Biopsy gun . An average of eight core biopsies ( range 6 to 12 ) was taken . From May 15 , 2000 to May 16 , 2001 , 363 patients were enrolled in this study . Patients were r and omized to receive either 1 day or 3 days of fluroquinolone antibiotic prophylaxis , consisting of either ciprofloxacin or levofloxacin orally . Antibiotics were begun at least 1 hour prior to biopsy . Seven days later , telephone follow-up was obtained . RESULTS Two ( 0.55 % ) of the 363 patients , one in each group , had an episode of sepsis . No urinary tract infection was reported . Traumatic complications were only minor and no significant difference was observed between both groups : hematospermia ( p > 0.4 ) , hematuria ( p>0.1 ) and rectorragia ( p>0.2 ) being reported most frequently . CONCLUSION There is no clinical ly nor statistically significant difference between a 1 day and 3 day antibiotic prophylaxis regimen for patients undergoing TRUS guided biopsies",
"OBJECTIVES To assess the efficacy of tosufloxacin as a prophylactic agent for transrectal biopsy of the prostate ( TBP ) , we conducted a r and omized prospect i ve study comparing tosufloxacin versus levofloxacin . METHODS A r and omized prospect i ve study comparing tosufloxacin versus levofloxacin was performed . In group A , 124 patients received 300 mg tosufloxacin tosilate ( including 204 mg tosufloxacin ) twice daily for 2 days , with the initial dose being 2 h prior to biopsy . In group B , 119 patients received 200 mg levofloxacin in the same manner . RESULTS Infectious complications were reported equally in six cases in each group ( 4.8 % in group A and 5.0 % in group B ) . Each group included five cases of acute prostatitis and one of cystitis . Six patients suffering from prostatitis required hospitalization , while those with symptomatic urinary tract infection were treated as out patients . CONCLUSIONS Tosufloxacin was as effective as levofloxacin when administered twice daily for 2 days as prophylaxis for TBP , which suggests that this regimen is useful for reducing the clinical and febrile infection rate following TBP",
"OBJECTIVES To assess the level of infectious complications and the impact of timing of a single , prophylactic , oral dose of ciprofloxacin 750 mg given either 2 hours before or in conjunction with ultrasound-guided core biopsy of the prostate in men without recognised risk factors and to analyse potential risk factors . METHODS All men undergoing prostate biopsy for elevated prostate specific antigen or clinical suspected prostate cancer were enrolled in an open , comparative prospect i ve study . Excluded were men with recognised risk factors for infective complications . Two end points were chosen : febrile genitourinary infection and the results of postbiopsy urine culture . RESULTS A total of 1322 prostate biopsy occasions were made in 1157 men . Twelve ( 0.9 % ) cases of febrile genitourinary infections were recorded , two of which had proven sepsis . Administrating the drug 2 hours before or at the time of biopsy ( p > 0.5 ) showed no statistical difference . Eight of 12 patients were shown to have prebiopsy undisclosed risk factors . Four percent developed postbiopsy , asymptomatic , significant bacteriuria . In addition , three ( 27 % ) men with prebiopsy unrecognised bacteriuria , who were accidentally enrolled , developed febrile genitourinary infection ; one had proven sepsis . CONCLUSIONS A single high-dose of oral ciprofloxacin 750 mg can be administered in direct conjunction with prostate biopsy to men without recognised risk factors , keeping the infection rate at approximately 1 % . Bacteriuria before biopsy is a major risk factor for infective complications . Attention given to recognising individual risk factors would reduce the risk of infection further",
"Objectives To determine the effect of antibiotic prophylaxis on infective complications after transrectal needle biopsy of the prostate",
"OBJECTIVE To determine the prevalence of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae ( PE ) fecal carriage in patients that undergo transrectal ultrasonography-guided biopsy ( TRUSbx ) and its relationship with post-biopsy infections . METHODS A prospect i ve clinical study in 4 different tertiary hospitals between 2008 and 2010 was conducted . Four hundred men with sterile urine who were to undergo a TRUSbx because of the suspicion of prostate cancer were included and followed for 14 days after biopsy . Rectal swab culture specimens were acquired immediately before the procedure . Demographic data , prophylaxis choice , quinolone or any other antibiotic consumption within the past 2 months , history of prostatitis , repeat biopsy , intensive care unit admission , hospitalization , urethral catheterization , diabetes mellitus ( DM ) , and steroid usage were recorded . RESULTS ESBL carriage was detected in 19 % of patients and quinolone use within the last 2 months ; other antibiotic use within the last 2 months and DM were found to be significantly associated ( P Symptomatic urinary tract infection ( UTI ) on the third day after biopsy was seen in 9 % of patients and was associated with fluoroquinolone ( FQ ) consumption before biopsy . Although ESBL-PE carriage was associated with post-biopsy UTI symptoms , it was not found to be associated with post-biopsy symptomatic UTI . Urosepsis was seen in 2 patients ( 0.5 % ) after biopsy , and both the patients were ESBL-PE carriers . CONCLUSION The presence of ESBL-PE was associated with DM and FQ consumption before biopsy . ESBL-PE carriage was associated with a high rate of post-biopsy UTI symptoms requiring further elucidation ; however , it was not associated with microbiologically proven infections . FQ consumption before TRUSbx was also associated with post-biopsy infections",
"OBJECTIVES To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices . METHODS We conducted a prospect i ve , r and omized , double-blind , multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate . Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy . The primary determinant of efficacy was bacteriologic response ( bacteriuria [ more than 10(4 ) colony-forming units (CFU)/mL ] versus no bacteriuria ) at the 9- to 15-day follow-up evaluation . RESULTS Two hundred twenty-seven ( 84 % ) of 269 ciprofloxacin patients and 230 ( 86 % ) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed . Six ciprofloxacin-treated ( 3 % ) and 19 placebo-treated ( 8 % ) patients had bacteriuria ( more than 10(4 ) CFU/mL ) after the procedure ( P = 0.009 ) . Six ciprofloxacin recipients ( 3 % ) and 12 placebo recipients ( 5 % ) had clinical signs and symptoms of a urinary tract infection ( UTI ) ( P = 0.15 ) . In addition , no ciprofloxacin-treated patients compared with 4 placebo-treated patients ( 2 % ) were admitted to the hospital for febrile UTI after the procedure . Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $ 23 per patient for an overall annual savings of $ 68,195 in the five study groups when compared with placebo . CONCLUSIONS Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage . In addition , this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8 % with a clinical rate of UTI of 5 % and a hospitalization rate of 2 %",
"Although the estimate of the incidence of sepsis following transrectal ultrasound-guided prostate biopsy ( TRUSPB ) is low , fluoroquinolone-resistant infections after prostate biopsy are being increasingly noted . This study was aim ed at determining the prevalence of faecal carriage of fluoroquinolone-resistant Escherichia coli strains before TRUSPB and at evaluating potential predisposing risk factors . The incidence of sepsis after prostate biopsy was determined , and our routine practice for antibiotic prophylaxis for TRUSPB was evaluated . A prospect i ve study was conducted in 342 consecutive patients undergoing prostate biopsy between December 2009 and July 2010 . Before TRUSPB , a rectal swab was cultured . The correlation between the presence of fluoroquinolone-resistant strains and plausible risk factors was investigated by the use of a question naire . Of the 236 patients included , 22.0 % ( 52/236 ) harboured ciprofloxacin-resistant E. coli strains . The use of fluoroquinolones in the 6 months before biopsy was associated with an increased risk of faecal carriage of fluoroquinolone-resistant E. coli strains ( p Faecal carriage of fluoroquinolone-resistant E. coli strains was an important risk factor for infectious complications after TRUSPB ( p faecal carriage of fluoroquinolone-resistant E. coli strains ( 22.0 % ) before TRUSPB . The use of fluoroquinolones in the previous 6 months before biopsy is a risk factor for faecal carriage of fluoroquinolone-resistant E. coli strains and for infectious complications after TRUSPB . Hence , the universal administration of fluoroquinolones should be reconsidered",
"OBJECTIVES To evaluate the incidence , and clinical and bacterial features of iatrogenic prostatitis within 1 month after transrectal ultrasound-guided biopsy for detection of prostate cancer . METHODS From January 2006 to December 2009 , 3000 patients underwent a 21-core transrectal ultrasound-guided prostate biopsy at Henri Mondor Hospital ( Créteil , France ) and were prospect ively followed . All patients had a fluoroquinolone antimicrobial prophylaxis for 7 days . The primary study end-point was to evaluate the incidence of iatrogenic acute prostatitis within 1 month after the biopsy . The secondary end-point was to analyze the clinical and the bacterial features of the prostatitis . RESULTS Overall , 20 patients of the entire study population ( 0.67 % ) had an acute bacterial prostatitis within 2.90 ± 1.77 days ( range 1 - 7 days ) after the transrectal ultrasound-guided biopsy . The groups of patients with ( n = 20 ) and without ( n = 2980 ) infection were similar in terms of age , prostate-specific antigen level and prostate volume . Escherichia coli was the only isolated bacteria . The subsequent tests for antibiotic susceptibility showed a 95 % resistance for fluroquinolone and amoxicillin . Resistance to amoxiclav , trimethoprim-sulfamethoxazole , third generation cephalosporin and amikacin was 70 % , 70 % , 25 % and 5 % respectively . No resistance to imipenem was reported . They were all admitted for treatment without the need of intensive care unit referral . Complete recovery was achieved after 21.4 ± 7 days of antibiotic treatment . CONCLUSIONS A fluroquinolone-based regimen still represents an appropriate prophylaxis protocol to minimize the risk of acute prostatitis secondary to prostate biopsy . Patients should be provided the appropriate care soon after the onset of the symptoms . An intravenous third generation cephalosporin or imipenem-based therapy seem to provide satisfying results",
"OBJECTIVES To prospect ively evaluate the efficacy of single dose antibiotic prophylaxis in 12-core transrectal ultrasonography ( TRUS ) guided prostate biopsy . METHODS A total of 400 patients who underwent prostate biopsy with TRUS guidance were included . The patients were prospect ively r and omized in three groups regarding antibiotic prophylaxis . The first group ( 139 patients ) received a single gram of intramuscular ceftriaxone , while the second group ( 131 patients ) had a 3-day course of oral ciprofloxacin . The third group ( 130 patients ) had single oral 500 mg of ciprofloxacin . All patients had urine cultures prior to biopsy and on the second day after biopsy . RESULTS The study groups were compared in terms of the results of urine cultures and clinical parameters . Overall , only seven patients ( 1.8 % of the cases ) had positive urine cultures with no difference between these three groups . Additionally , no significant difference was observed regarding morbidity rates in all groups . Only eight patients ( 2 % ) developed major complications requiring hospitalization . There was no increase in the rate of infectious complications when the biopsy core numbers were increased up to 12 . CONCLUSIONS The current study suggests that a single oral dose of antimicrobial prophylaxis is reasonable in TRUS prostate biopsy even in the case of 12-core sampling"
] | 41165f24-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Despite clear benefits of the Evidence -Based Practice ( EBP ) approach to ensuring quality and consistency of care , its uptake within physiotherapy has been inconsistent . OBJECTIVES Synthesis e the findings of research into EBP barriers , facilitators and interventions in physiotherapy and identify methods of enhancing adoption and implementation . DATA SOURCES Literature concerning physiotherapists ' practice between 2000 and 2012 was systematic ally search ed using : Academic Search Complete , Cumulative Index of Nursing and Allied Health Literature Plus , American Psychological Association data bases , Medline , Journal Storage , and Science Direct . Reference lists were search ed to identify additional studies . STUDY SELECTION Thirty-two studies , focusing either on physiotherapists ' EBP knowledge , attitudes or implementation , or EBP interventions in physiotherapy were included . DATA EXTRACTION AND SYNTHESIS One author undertook all data extraction and a second author review ed to ensure consistency and rigour . Synthesis was organised around the themes of EBP barriers/enablers , attitudes , knowledge/skills , use and interventions . RESULTS Many physiotherapists hold positive attitudes towards EBP . However , this does not necessarily translate into consistent , high- quality EBP . Many barriers to EBP implementation are apparent , including : lack of time and skills , and misperceptions of EBP . LIMITATIONS Only studies published in the English language , in peer- review ed journals were included , thereby introducing possible publication bias . Furthermore , narrative synthesis may be subject to greater confirmation bias . CONCLUSION AND IMPLICATION S There is no " one-size fits all " approach to enhancing EBP implementation ; assessing organisational culture prior to design ing interventions is crucial . Although some interventions appear promising , further research is required to explore the most effective methods of supporting physiotherapists ' adoption of EBP | [
"BACKGROUND AND PURPOSE Physiotherapists ' use of research evidence with clinical decision-making has interested research ers world-wide since 1980 ; however , little is known about such practice s in Australia . The present survey sought information on Australian physiotherapists ' perceptions of the importance of research , and barriers to uptake of evidence in clinical practice , when compared with an international cohort from 2001 . METHOD An Australian-relevant version of an English ( UK ) National Health Service ( NHS ) survey instrument was used to canvass 453 physiotherapists , r and omly selected from the South Australian Physiotherapy Registration Board 2004 - 2005 records . The first survey was mailed in August 2005 , a reminder was sent two weeks later to non-responders and a follow-up survey was sent in April 2006 to non-responders whose addresses had changed since 2005 . RESULTS There was a 51 % response rate . Of the non-responders , 12 % were not contactable at their listed address , highlighting the mobility of Australian physiotherapists . Most respondents had undertaken research as students ( 59.5 % ) or as students and clinicians ( 11.5 % ) . Of these , 37.1 % were encouraged to embark on more research , and 20.5 % were discouraged . The significant predictors of positive perceived importance of research were : previous research experience ; being positive about undertaking further research ; working in hospitals and holding a postgraduate degree . Clinicians working privately were significantly less likely than managers to be positive about research importance . The only significant predictor for not perceiving barriers to uptake of evidence was being positive about undertaking future research . CONCLUSIONS The study identified constraints on uptake of evidence into practice that were related to accessing , reading and interpreting published research , and implementing findings . Found consistently across employment categories were barriers relating to lack of time , uncertainty about what the research reported , scepticism about the value of research and being isolated from peer support and literature sources . The responses indicated a positive shift towards evidence uptake since the 2001 NHS survey , suggesting an influence of increased exposure to information on evidence -based practice . A greater focus on research whilst training , the application of educational strategies for empowerment , better knowledge transfer and upskilling within the workplace , and ensuring dedicated time and organizational support for research activities are indicated",
"Background Many authors , as well as the American Physical Therapy Association , advocate that physical therapists adopt practice patterns based on research evidence , known as evidence -based practice ( EBP ) . At the same time , physical therapists should be capable of integrating EBP within the day-to-day practice of physical therapy . The purpose of this study was to determine the extent to which personal characteristics and the characteristics of the social system in the workplace influence the propensity of physical therapists to adopt EBP . Methods The study used a 69 item mailed self-completion question naire . The question naire had four major sections . The first three sections were each drawn from a different theoretical framework and from different authors ' work . The instrument was developed to capture the propensity of physical therapists to adopt EBP , characteristics of the social system in the workplace of physical therapists , personal characteristics of physical therapists , and selected demographic variables of physical therapists . The eligible population consisted of 3,897 physical therapists licensed by the state of Georgia in the United States of America . A r and om sample of 1320 potential participants was drawn . Results 939 question naires were returned for a response rate of 73 % . 831 of the participants ' question naires were useable and became the basis for the study . There was a moderate association between desire for learning ( r = .36 , r2 = .13 ) , highest degree held ( r = .29 , r2 = .08 ) , practicality ( r = .27 , r2 = .07 ) and nonconformity ( r = .24 , r2 = .06 ) and the propensity to adopt EBP . A negative correlation was found between age , years licensed and percentage of time in direct patient care . The findings demonstrated that the best three variables for predicting the propensity to adopt EBP in physical therapy were : desire for learning , highest degree held , and practicality . Conclusion The study confirms there is no single factor to facilitate research evidence into day-to-day practice . Multiple practice change strategies will be needed to facilitate change in practice",
"Background Training in the five steps of evidence -based practice ( EBP ) has been recommended for inclusion in entry-level health professional training . The effectiveness of EBP education has been explored predominantly in the medical and nursing professions and more commonly in post-graduate than entry-level students . Few studies have investigated longitudinal changes in EBP attitudes and behaviours . This study aim ed to assess the changes in EBP knowledge , attitudes and behaviours in entry-level physiotherapy students transitioning into the workforce . Methods A prospect i ve , observational , longitudinal design was used , with two cohorts . From 2008 , 29 participants were tested in their final year in a physiotherapy program , and after the first and second workforce years . From 2009 , 76 participants were tested in their final entry-level and first workforce years . Participants completed an Evidence -Based Practice Profile question naire ( EBP2 ) , which includes self-report EBP domains [ Relevance , Terminology ( knowledge of EBP concepts ) , Confidence , Practice ( EBP implementation ) , Sympathy ( disposition towards EBP ) ] . Mixed model analysis with sequential Bonferroni adjustment was used to analyse the matched data . Effect sizes ( ES ) ( 95 % CI ) were calculated for all changes . Results Effect sizes of the changes in EBP domains were small ( ES range 0.02 to 0.42 ) . While most changes were not significant there was a consistent pattern of decline in scores for Relevance in the first workforce year ( ES -0.42 to -0.29 ) followed by an improvement in the second year ( ES + 0.27 ) . Scores in Terminology improved ( ES + 0.19 to + 0.26 ) in each of the first two workforce years , while Practice scores declined ( ES -0.23 to -0.19 ) in the first year and improved minimally in the second year ( ES + 0.04 ) . Confidence scores improved during the second workforce year ( ES + 0.27 ) . Scores for Sympathy showed little change . Conclusions During the first two years in the workforce , there was a transitory decline in the self-reported practice and sense of relevance of EBP , despite increases in confidence and knowledge . The pattern of progression of EBP skills beyond these early professional working years is unknown",
"RATIONALE The concept of evidence -based practice ( EBP ) encourages health care professionals to provide the most effective health care , and to be accountable for the interventions they provide . Little work has been undertaken to examine how practically allied health professionals ' encompass EBP and how they perceptive and underst and the concept of EBP . The use of opinion leaders to disseminate new evidence into practice , and thereby encourage the behaviour of health care professionals has been proposed . AIMS The aims of this study were to investigate physiotherapists ' attitudes towards EBP and to examine change in their attitudes following an education package , which utilized local opinion leaders . METHOD Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster r and omized by location of work to two groups . The intervention group received an evidence -based programme on aspects of EBP including literature search ing and critical appraisal . The attention control group received a st and ard in-service training package on the management of common knee pathologies . The physiotherapists ' attitudes towards EBP were measured at baseline ( before r and omization ) and at 3 and 6 months follow-up . RESULTS Physiotherapists reported that they primarily relied on ' courses ' and ' in-service training ' for informing their clinical practice . Most agreed that clinical practice should be based on the best available evidence and that they would change their clinical practice if evidence suggested they should do so . However , many of the physiotherapists reported difficulty in reading journals and could not identify opinion leaders in key areas . In terms of clinical practice , literature , journals and research were ascribed low priority throughout . Differences in attitudes between the intervention and control groups were observed in relation to management support for EBP at 3 and 6 months follow-up . CONCLUSIONS In this study , physiotherapists appeared to be in favour of the idea of EBP , yet they remained reluctant to change their practice . Opinion leaders were not easily identifiable by physiotherapists , suggesting that this method alone may not be an effective method of changing attitudes in clinical practice . The process of changing attitudes in the clinical environment is a complex issue worthy of further research",
"The emphasis of UK Government policy on primary -care-based services has led to more physiotherapists working in the community . The aims of the present study were to identify the perceived professional , educational and personal needs of community physiotherapists , and to determine good practice in meeting these needs . A survey of physiotherapists working in 15 National Health Service community trusts in the West Midl and s was carried out in September 2000 . The survey question naire was developed through focus groups and mailed to a r and om sample of 200 community physiotherapists . The response rate was 67 % , and the median age group of the respondents was 21 - 30 years . The participants worked mainly in ' urban but not inner city ' areas , most commonly in domiciliary ( 31 % , n = 38 ) and general practitioner surgery/health centre ( 26 % , n = 32 ) locations . Fifty-one per cent ( n = 66 ) of respondents had no specific learning objectives for continuing professional development ( CPD ) ; those with such objectives were more positive as to their helpfulness than those without them ( Mann-Whitney U-test z = 2.519 , P = 0.012 ) . Fifty-three per cent ( n = 68 ) also often/very often found it problematic getting cover for their caseloads so that they could take part in CPD activities . Access to library re sources and use of computers were problems , as were confidence in appraising literature and opportunities to discuss research evidence with colleagues . Fifty-nine per cent ( n = 77 ) of respondents indicated that they often/very often felt stressed by the size of their caseloads . Colleague support included mentorship , peer review , journal clubs , clinical interest groups and multidisciplinary in-service training ; respondents with experience of these re sources expressed more positive attitudes to them than those without ( Mann-Whitney U-test z = 2.871 , P problems with safety issues . This study has identified needs that will have an impact on the ability of community physiotherapists to meet the dem and s of clinical governance . National Health Service management at all levels has a responsibility to facilitate the education , training and support of community physiotherapists",
"BACKGROUND AND PURPOSE Little research has been done regarding the attitudes and behaviors of physical therapists relative to the use of evidence in practice . The purpose s of this study were to describe the beliefs , attitudes , knowledge , and behaviors of physical therapist members of the American Physical Therapy Association ( APTA ) as they relate to evidence -based practice ( EBP ) and to generate hypotheses about the relationship between these attributes and personal and practice characteristics of the respondents . METHODS A survey of a r and om sample of physical therapist members of APTA result ed in a 48.8 % return rate and a sample of 488 that was fairly representative of the national membership . Participants completed a question naire design ed to determine beliefs , attitudes , knowledge , and behaviors regarding EBP , as well as demographic information about themselves and their practice setting s. Responses were summarized for each item , and logistic regression analyses were used to examine relationships among variables . RESULTS Respondents agreed that the use of evidence in practice was necessary , that the literature was helpful in their practice s , and that quality of patient care was better when evidence was used . Training , familiarity with and confidence in search strategies , use of data bases , and critical appraisal tended to be associated with younger therapists with fewer years since they were licensed . Seventeen percent of the respondents stated they read fewer than 2 articles in a typical month , and one quarter of the respondents stated they used literature in their clinical decision making less than twice per month . The majority of the respondents had access to online information , although more had access at home than at work . According to the respondents , the primary barrier to implementing EBP was lack of time . DISCUSSION AND CONCLUSION Physical therapists stated they had a positive attitude about EBP and were interested in learning or improving the skills necessary to implement EBP . They noted that they needed to increase the use of evidence in their daily practice",
"OBJECTIVE To measure the impact of a state health department policy to provide allied health professional staff with access to a point-of-care , 24h , online evidence system in terms of awareness , use and clinical impact of the system on clinical practice ; to identify perceived barriers to use , and differences in measures between seven professional groups ( physiotherapists , occupational therapists , speech pathologists , dieticians , clinical psychologists , pharmacists and social workers ) . METHOD A convenience sample of 790 allied health professionals from 65 r and omly selected hospitals in New South Wales , Australia . A self-administered question naire was distributed . Rates of use , frequency and types of re sources accessed were calculated . Comparisons between professional groups were undertaken using Chi-square analyses and t-tests . RESULTS The results showed that 82 % of allied health professionals had heard of the online evidence system , and of those 76 % had used it . Pharmacists had the highest rates of use and social workers the lowest . Of users , 90 % agreed that use of the system had the potential to improve patient care and 45 % reported direct experience of this . Computer skills and easy access were significantly associated with use and frequency of use . Among non-users , lack of specific training in the use of the online evidence system and lack of time were the most frequently reported reasons for not using the system . However , among users there was no relationship between this training and the frequency or effectiveness of use , i.e. the ability to find the information required . CONCLUSIONS Allied health professionals will use an online evidence system when it is provided , however there are marked differences in use by professional groups . General training aim ed at improving computer skills appears more important in encouraging use of an online evidence system , than specific system-based training . Perceptions of organisational and professional support for allied health professionals to use online evidence as a legitimate part of their work play an important role in influencing system use",
"Clinical effectiveness ( CE ) and evidence -based practice ( EBP ) are the cornerstone of modern-day health care . Although many studies have explored attitudes and perceived knowledge of individual professions , few have compared these factors between professional groups , especially in the allied health professions ( AHP ) and health science services ( HSS ) . We report a study comparing the knowledge and practice of 14 different professional groups from the AHP and HSS in terms of EBP and CE . The aim was to highlight any differences between the 14 professional groups along with the needs of the groups . A postal question naire survey was completed by a r and om sample of 1,000 members of AHP and HSS across the United Kingdom . There were significant differences between professional groups with , in general , professionals from the HSS groups rating their knowledge and application of CE and EBP as lower than members of the AHP . Differences were also noted between individual professional groups . For example , podiatrists , radiographers , and orthoptists reported having less knowledge of CE and EBP than physiotherapists , occupational therapists , dietitians , speech and language therapists , and psychologists . Barriers to implementing EBP were similar for all groups , with lack of both time and money cited as the main issues . A number of differences between professions were recorded that highlight the difference in educational and policy approach required for greater uptake of EBP",
"RATIONALE The concept of evidence -based medicine is important in providing efficient health care . The process uses research findings as the basis for clinical decision making . Evidence -based practice helps optimize current health care and enables the practitioners to be suitably accountable for the interventions they provide . Little work has been undertaken to examine how allied health professionals change their clinical practice in light of the latest evidence . The use of opinion leaders to disseminate new evidence around the management of low back pain into practice has been proposed . AIMS The aim of this study was to investigate if physiotherapists ' clinical management of patients with low back pain would change following an evidence -based education package , which utilized local opinion leaders and delivered the best evidence . METHOD Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster r and omized by location of work , to two groups . The intervention group received an evidence -based programme on the management of low back pain , including advice regarding increasing activity levels and return to normal activity and challenging patients ' fears and beliefs about their pain . The control group received a st and ard in-service training package on the management of common knee pathologies . The physiotherapists ' clinical management of patients with low back pain was measured prior to training and 6 months post training . Outcome measures were based on physiotherapists completing ' discharge summary ' question naires , which included information relating to the use and importance of therapies for treating their low back pain patients . RESULTS There were few significant differences in treatment options between the intervention and control groups post training . Whilst there was some indication that physiotherapists were already utilizing aspects of psychosocial management for patients with low back pain , there was little change in what physiotherapists perceived to be important to patient recovery and actual clinical practice following the intervention . CONCLUSIONS Psychosocial factors have been identified as an important factor in the recovery of patients with low back pain . This project incorporated the latest evidence on the management of low back pain and utilized the theory of opinion leaders to disseminate this evidence into clinical practice . Whilst there were some limitations in the overall size of the study , the results help to give an insight into the challenges faced by the health care system and research ers alike to ensure quality evidence is actually utilized by practitioners for the benefits of patient care",
"One of the components of evidence -based practice ( EBP ) is reading the literature . The purpose of this investigation was 1 ) to determine which publications are read most frequently by physical therapists ( PTs ) , 2 ) to identify employment and education characteristics related to reading patterns , and 3 ) to determine how PTs use information gained from reading professional publications . A survey was constructed , pretested , revised , and then mailed to a r and om sample of 1,000 physical therapists , 500 from the general American Physical Therapy Association ( APTA ) membership and 500 from the combined Geriatric and Orthopedic section memberships . The data were analyzed with descriptive statistics . After all mailings , 43.3 % of the sample responded . Of those responding , 66.3 % were employed as clinicians , 14.7 % as clinician-administrators , 6 % as educators , and 4.9 % as administrators . Overall , and for clinicians , the two most frequently read professional publications were non peer- review ed . For clinician groups “ patient management ” was among the top two most selected uses of information from reading professional publications . Educators and those with an advanced doctorate indicated “ class lectures ” as either their second most frequently selected use or tied for first with “ keeping current . ” Only educators and those with or pursuing an advanced doctorate reported using information from reading professional publications for “ research ideas ” or “ research methods ” among their top five uses . Slightly more than 10 % of the respondents cited a peer- review ed published article as having been most influential on their practice . Non peer- review ed professional publications appear to serve as a more frequent source of information for “ patient management ” than do peer- review ed publications . Efforts to increase the use of EBP need to be explored and evaluated for impact on physical therapists ’ practice"
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OBJECTIVE : To systematic ally review the available evidence on the efficacy of walking training associated with virtual reality-based training in patients with stroke . The specific questions were : Is walking training associated with virtual reality-based training effective in increasing walking speed after stroke ? Is this type of intervention more effective in increasing walking speed , than non-virtual reality-based walking interventions ? METHOD : A systematic review with meta- analysis of r and omized clinical trials was conducted . Participants were adults with chronic stroke and the experimental intervention was walking training associated with virtual reality-based training to increase walking speed . The outcome data regarding walking speed were extracted from the eligible trials and were combined using a meta- analysis approach . RESULTS : Seven trials representing eight comparisons were included in this systematic review . Overall , the virtual reality-based training increased walking speed by 0.17 m/s ( IC 95 % 0.08 to 0.26 ) , compared with placebo/nothing or non-walking interventions . In addition , the virtual reality-based training increased walking speed by 0.15 m/s ( IC 95 % 0.05 to 0.24 ) , compared with non-virtual reality walking interventions . CONCLUSIONS : This review provided evidence that walking training associated with virtual reality-based training was effective in increasing walking speed after stroke , and result ed in better results than non-virtual reality interventions | [
"Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke ",
"OBJECTIVE To evaluate gait biomechanics after training with a virtual reality ( VR ) system and to eluci date underlying mechanisms that contributed to the observed functional improvement in gait speed and distance . DESIGN A single blind r and omized control study . SETTING Gait analysis laboratory in a rehabilitation hospital and the community . PARTICIPANTS Fifteen men and three women with hemiparesis caused by stroke . INTERVENTIONS Subjects trained on a six-degree of freedom force-feedback robot interfaced with a VR simulation . Subjects were r and omized to either a VR group ( n=9 ) or non-VR group ( NVR , n=9 ) . Training was performed three times a week for 4 weeks for approximately 1h each visit . MAIN OUTCOME MEASURES Kinematic and kinetic gait parameters . RESULTS Subjects in the VR group demonstrated a significantly larger increase in ankle power generation at push-off as a result of training ( p=0.036 ) . The VR group had greater change in ankle ROM post-training ( 19.5 % ) as compared to the NVR group ( 3.3 % ) . Significant differences were found in knee ROM on the affected side during stance and swing , with greater change in the VR group . No significant changes were observed in kinematics or kinetics of the hip post-training . CONCLUSIONS These findings are encouraging because they support the potential for recovery of force and power of the lower extremity for individuals with chronic hemiparesis . It is likely that the effects of training included improved motor control at the ankle , which enabled the cascade of changes that produced the functional improvements seen after training",
"Background and Purpose — Gait velocity is a powerful indicator of function and prognosis after stroke . Gait velocity can be stratified into clinical ly meaningful functional ambulation classes , such as household ambulation ( limited community ambulation ( 0.4 to 0.8 m/s ) , and full community ambulation ( > 0.8 m/s ) . The purpose of the current study was to determine whether changes in velocity-based community ambulation classification were related to clinical ly meaningful changes in stroke-related function and quality of life . Methods — In subacute stroke survivors with mild to moderate deficits who participated in a r and omized clinical trial of stroke rehabilitation and had a baseline gait velocity of 0.8 m/s or less , we assessed the effect of success versus failure to achieve a transition to the next class on function and quality of life according to domains of the Stroke Impact Scale ( SIS ) . Results — Of 64 eligible participants , 19 were initially household ambulators , and 12 of them ( 68 % ) transitioned to limited community ambulation , whereas of 45 initially limited community ambulators , 17 ( 38 % ) became full community ambulators . Function and quality -of-life SIS scores after treatment were significantly higher among survivors who achieved a favorable transition compared with those who did not . Among household ambulators , those who transitioned to limited or full community ambulation had significantly better SIS scores in mobility ( P=0.0299 ) and participation ( P=0.0277 ) . Among limited community ambulators , those who achieved the transition to full community ambulatory status had significantly better scores in SIS participation ( P=0.0085 ) . Conclusions — A gait velocity gain that results in a transition to a higher class of ambulation results in better function and quality of life , especially for household ambulators . Household ambulators possibly had more severe stroke deficits , reducing the risk of “ ceiling ” effects in SIS-measured activities of daily living and instrumental activities of daily living . Outcome assessment based on transitions within a mobility classification scheme that is rooted in gait velocity yields potentially meaningful indicators of clinical benefit . Outcomes should be selected that are clinical ly meaningful for all levels of severity",
"Background and Purpose — Training of the lower extremity ( LE ) using a robot coupled with virtual environments has shown to transfer to improved overground locomotion . The purpose of this study was to determine whether the transfer of training of LE movements to locomotion was greater using a virtual environment coupled with a robot or with the robot alone . Methods — A single , blind , r and omized clinical trial was conducted . Eighteen individuals poststroke participated in a 4-week training protocol . One group trained with the robot virtual reality ( VR ) system and the other group trained with the robot alone . Outcome measures were temporal features of gait measured in a laboratory setting and the community . Results — Greater changes in velocity and distance walked were demonstrated for the group trained with the robotic device coupled with the VR than training with the robot alone . Similarly , significantly greater improvements in the distance walked and number of steps taken in the community were measured for the group that trained with robot coupled with the VR . These differences were maintained at 3 months ’ follow-up . Conclusions — The study is the first to demonstrate that LE training of individuals with chronic hemiparesis using a robotic device coupled with VR improved walking ability in the laboratory and the community better than robot training alone",
"Background and Purpose — Hemiparesis result ing in functional limitation of an upper extremity is common among stroke survivors . Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery , limited evidence is available on the efficacy of virtual reality for stroke rehabilitation . Methods — In this pilot , r and omized , single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months , we compared the feasibility , safety , and efficacy of virtual reality using the Nintendo Wii gaming system ( VRWii ) versus recreational therapy ( playing cards , bingo , or “ Jenga ” ) among those receiving st and ard rehabilitation to evaluate arm motor improvement . The primary feasibility outcome was the total time receiving the intervention . The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period . Efficacy , a secondary outcome measure , was evaluated with the Wolf Motor Function Test , Box and Block Test , and Stroke Impact Scale at 4 weeks after intervention . Results — Overall , 22 of 110 ( 20 % ) of screened patients were r and omized . The mean age ( range ) was 61.3 ( 41 to 83 ) years . Two participants dropped out after a training session . The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm . The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group ( P=0.75 ) . There were no serious adverse events in any group . Relative to the recreational therapy group , participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds ( Wolf Motor Function Test , 7.4 seconds ; 95 % CI , −14.5 , −0.2 ) after adjustment for age , baseline functional status ( Wolf Motor Function Test ) , and stroke severity . Conclusions — VRWii gaming technology represents a safe , feasible , and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke",
"OBJECTIVES To investigate the effect of Nintendo Wii ™ -based motor cognitive training versus balance exercise therapy on activities of daily living in patients with Parkinson 's disease . DESIGN Parallel , prospect i ve , single-blind , r and omised clinical trial . SETTING Brazilian Parkinson Association . PARTICIPANTS Thirty-two patients with Parkinson 's disease ( Hoehn and Yahr stages 1 and 2 ) . INTERVENTIONS Fourteen training sessions consisting of 30 minutes of stretching , strengthening and axial mobility exercises , plus 30 minutes of balance training . The control group performed balance exercises without feedback or cognitive stimulation , and the experimental group performed 10 Wii Fit ™ games . MAIN OUTCOME MEASURE Section II of the Unified Parkinson 's Disease Rating Scale ( UPDRS-II ) . R AND OMISATION Participants were r and omised into a control group ( n=16 ) and an experimental group ( n=16 ) through blinded drawing of names . STATISTICAL ANALYSIS Repeated- measures analysis of variance ( RM-ANOVA ) . RESULTS Both groups showed improvement in the UPDRS-II with assessment effect ( RM-ANOVA P CONCLUSION Patients with Parkinson 's disease showed improved performance in activities of daily living after 14 sessions of balance training , with no additional advantages associated with the Wii-based motor and cognitive training . Registered on http://www . clinical trials.gov ( identifier : NCT01580787 )",
"Purpose . This study examined the association between impaired physical function and participation in community ambulation following stroke . We hypothesised that participation would be significantly less following stroke , and that physical impairments would be associated with participation . Method . Using a case – control design 30 survivors of stroke aged 45 and older and 30 controls provided health status information and a self-report of participation in community ambulation ( number of trips and walking-related activities ( WRA ) reported prospect ively over a 12-day period ) . The association of physical impairments ( strength , range of motion , sensation , muscle tone , vision , and activity limitations ( gait speed and performance on complex walking tasks ) ) with level of participation was analysed using negative binomial regression and goodness of fit . Results . Participants included 30 individuals with and 30 without stroke , average age 68 years , majority were Caucasian women . Average time since stroke was 40 months . Participation in survivors of stroke was characterised by fewer trips and WRA and lower satisfaction ( p . Usual gait speed , balance , muscle strength and muscle length were impaired ( p number of trips and WRA ( p participation . Conclusions . While individual factors were associated with level of participation , results failed to accurately predict participation in community ambulation following stroke . Other factors , such as depression , cognition and self-efficacy may be stronger determinants of participation",
"Objective : This study examined the effects of treadmill training with optic flow on the functional recovery of balance and gait in stroke patients . Design : R and omized controlled experimental study . Participants : Thirty patients following stroke were divided r and omly into the treadmill with optic flow group ( n = 10 ) , treadmill group ( n = 10 ) and control group ( n = 10 ) . Interventions : The subjects in the experimental group wore a head-mounted display to receive speed-modulated optic flow during treadmill training for 30 minutes , while those in the treadmill group and control group received treadmill training and regular therapy for the same time , three times a week for four weeks . Main measures : The data were collected using timed up- and -go test , functional reach test , 10-m walk test , and six-minute walk test before and after treatment . Results : The timed up- and -go test in the treadmill with optic flow group ( 5.55 ± 2.04 ) improved significantly greater than the treadmill ( 1.50 ± 0.93 ) and control ( 0.40 ± 0.84 ) groups . The functional reach test in the treadmill with optic flow group ( 2.78 ± 1.44 ) was significantly higher than the control group ( 0.20 ± 0.16 ) only . The gait velocity in the treadmill with optic flow group ( 0.21 ± 0.06 ) showed a significant decrease compared to the treadmill ( 0.03 ± 0.02 ) and control ( 0.01 ± 0.02 ) groups . Finally , the six-minute walk test in the treadmill with optic flow group ( 24.49 ± 11.00 ) showed significant improvement compared to the treadmill training ( 4.65 ± 3.25 ) and control ( 1.79 ± 3.08 ) groups . Conclusion : Treadmill using optic flow speed modulation improves the balance and gait significantly in patients with stroke who are able to participate in physical gait training",
"This is a single blind r and omized controlled trial to examine the effect of virtual reality-based training on the community ambulation in individuals with stroke . Twenty subjects with stroke were assigned r and omly to either the control group ( n=9 ) or the experimental group ( n=11 ) . Subjects in the control group received the treadmill training . Subjects in the experimental group underwent the virtual reality-based treadmill training . Walking speed , community walking time , walking ability question naire ( WAQ ) , and activities-specific balance confidence ( ABC ) scale were evaluated . Subjects in the experimental group improved significantly in walking speed , community walking time , and WAQ score at posttraining and 1-month follow-up periods . Their ABC score also significantly increased at posttraining but did not maintain at follow-up period . Regarding the between-group comparisons , the experimental group improved significantly more than control group in walking speed ( P=0.03 ) and community walking time ( P=0.04 ) at posttraining period and in WAQ score ( P=0.03 ) at follow-up period . Our results support the perceived benefits of gait training programs that incorporate virtual reality to augment the community ambulation of individuals with stroke",
"Objective The purpose of this study was to investigate the effectiveness of the virtual walking training program using a real-world video recording on walking balance and spatiotemporal gait parameters in patients with chronic stroke . Design Fourteen patients with chronic stroke were r and omly assigned to either the experimental group ( n = 7 ) or the control group ( n = 7 ) . The subjects in both groups underwent a st and ard rehabilitation program ; in addition , the experimental group participated in the virtual walking training program using a real-world video recording for 30 mins a day , three times a week , for 6 wks , and the control group participated in treadmill gait training for 30 mins a day , three times a week , for 6 wks . Walking balance was measured using the Berg Balance Scale ( BBS ) and the Timed Up and Go test . Gait performance was measured using an electrical walkway system . Results In walking balance , greater improvement on the Berg Balance Scale ( experimental group : 4.14 vs. control group : 1.85 ) and the Timed Up and Go test ( −2.25 vs. −0.94 ) was observed in the experimental group compared with the control group ( P spatiotemporal gait parameters , greater improvement on velocity ( 25.40 vs. 9.74 ) and cadence ( 26.71 vs. 11.11 ) was observed in the experimental group compared with the control group ( P virtual walking training program using a real-world video recording on gait performance . These findings suggest that the virtual walking training program using a real-world video recording may be a valid approach to enhance gait performance in patients with chronic stroke",
"Kim JH , Jang SH , Kim CS , Jung JH , You JH : Use of virtual reality to enhance balance and ambulation in chronic stroke : A double-blind , r and omized controlled study . Objective : To examine an additive effect of virtual reality on balance and gait function in patients with chronic hemiparetic stroke . Design : Twenty-four adults with hemiparetic stroke were r and omly assigned to either an experimental group ( n = 12 ) or a control group . Both groups underwent conventional physical therapy , 40 mins a day , 4 days a week for 4 wks . The experimental group received an additional 30 mins of virtual reality therapy each session . Balance performance was determined by the Balance Performance Monitor and Berg Balance Scale tests . Gait performance was determined by the 10-m walking test and Modified Motor Assessment Scale , and spatiotemporal parameters were obtained using GAITRite . Analysis of variance and correlation statistics were performed at P Berg Balance Scale scores , balance and dynamic balance angles ( ability to control weight shifting ) compared with the controls ( P velocity , Modified Motor Assessment Scale scores , cadence , step time , step length , and stride length ( P dynamic balance angles was correlated with velocity and cadence ( P adults with hemiparetic stroke when added to conventional therapy"
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BACKGROUND Major depressive disorder ( MDD ) is a common condition with a lifetime prevalence of 15 % to 18 % , which leads to considerable suffering and disability . Some antipsychotics have been reported to induce remission in major depression , when added to an antidepressant . OBJECTIVES To evaluate the effects of second-generation antipsychotic ( SGA ) drugs ( alone or augmentation ) compared with placebo or antidepressants for people with MDD or dysthymia . SEARCH STRATEGY The Cochrane Depression , Anxiety and Neurosis Group 's controlled trial registers ( CCDANCTR- Studies and CCDANCTR-References ) were search ed up to 21 July 2010 . The author team ran complementary search es on clinical trials.gov and contacted key authors and drug companies . SELECTION CRITERIA We included all r and omised , double-blind trials comparing oral SGA treatment ( alone or augmentation ) with other forms of pharmaceutical treatment or placebo in people with MDD or dysthymia . DATA COLLECTION AND ANALYSIS We extracted data independently . For dichotomous data we calculated the odds ratio ( OR ) and 95 % confidence interval ( CI ) on an intention-to-treat basis , and for continuous data the mean difference ( MD ) , based on a r and om-effects model . We presented each comparison separately ; we did not perform a pooled data analysis . MAIN RESULTS We included 28 trials with 8487 participants on five SGAs : amisulpride , aripiprazole , olanzapine , quetiapine and risperidone . Three studies ( 1092 participants ) provided data on aripiprazole augmentation in MDD . All efficacy data ( response n = 1092 , three RCTs , OR 0.48 ; 95 % CI 0.37 to 0.63 ) , ( MADRS n = 1077 , three RCTs , MD -3.04 ; 95 % CI -4.09 to -2 ) indicated a benefit for aripiprazole but more side effects ( weight gain , EPS ) .Seven trials ( 1754 participants ) reported data on olanzapine . Compared to placebo fewer people discontinued treatment due to inefficacy ; compared to antidepressants there were no efficacy differences , olanzapine augmentation showed symptom reduction ( MADRS n = 808 , five RCTs , MD -2.84 ; 95 % CI -5.48 to -0.20 ) , but also more weight or prolactin increase . Quetiapine data are based on seven trials ( 3414 participants ) . Compared to placebo , quetiapine monotherapy ( response n = 1342 , three RCTs , OR 0.52 ; 95 % CI 0.41 to 0.66 ) and quetiapine augmentation ( response n = 937 , two RCTs , OR 0.68 ; 95 % CI 0.52 to 0.90 ) showed symptom reduction , but quetiapine induced more sedation . Four trials ( 637 participants ) presented data on risperidone augmentation , response data were better for risperidone ( n = 371 , two RCTs , OR 0.57 ; 95 % CI 0.36 to 0.89 ) but augmentation showed more prolactin increase and weight gain . Five studies ( 1313 participants ) presented data on amisulpride treatment for dysthymia . There were some beneficial effects compared to placebo or antidepressants but tolerability was worse . AUTHORS ' CONCLUSIONS Quetiapine was more effective than placebo treatment . Aripiprazole and quetiapine and partly also olanzapine and risperidone augmentation showed beneficial effects compared to placebo . Some evidence indicated beneficial effects of low-dose amisulpride for dysthymic people . Most SGAs showed worse tolerability | [
"OBJECTIVE To assess the efficacy and safety of aripiprazole versus placebo as adjunctive treatment to st and ard antidepressant therapy ( ADT ) in patients with major depressive disorder ( MDD ) who showed an incomplete response to 1 prospect i ve and 1 to 3 historical courses of ADT within the current episode . METHOD The study comprised a 7- to 28-day screening phase , an 8-week prospect i ve treatment phase , and a 6-week double-blind treatment phase . Patients with DSM-IV-TR-defined MDD were enrolled between June 16 , 2004 , and April 27 , 2006 . During prospect i ve treatment , patients received ADT : escitalopram , fluoxetine , paroxetine controlled-release , sertraline , or venlafaxine extended-release , each with single-blind , adjunctive placebo . Incomplete responders continued ADT and were r and omly assigned to double-blind , adjunctive placebo or adjunctive aripiprazole ( 2 - 15 mg/day with fluoxetine or paroxetine ; 2 - 20 mg/day with all others ) . The primary efficacy endpoint was the mean change from end of prospect i ve treatment to end of double-blind treatment ( week 14 , last observation carried forward ) in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ( analysis of covariance ) . RESULTS A total of 178 patients were r and omly assigned to adjunctive placebo and 184 to adjunctive aripiprazole . Baseline demographics were similar between groups ( mean MADRS total score of 26.0 ) . Mean change in MADRS total score was significantly greater with adjunctive aripiprazole ( -8.8 ) than adjunctive placebo ( -5.8 ; p Adverse events ( AEs ) that occurred in > or = 10 % of patients with adjunctive placebo or adjunctive aripiprazole were akathisia ( 4.5 % vs. 23.1 % ) , headache ( 10.8 % vs. 6.0 % ) , and restlessness ( 3.4 % vs. 14.3 % ) . Discontinuations due to AEs were low with adjunctive placebo ( 1.7 % ) and adjunctive aripiprazole ( 2.2 % ) ; only 1 adjunctive aripiprazole-treated patient discontinued due to akathisia . CONCLUSIONS In patients with MDD who showed an incomplete response to ADT , adjunctive aripiprazole was efficacious and well tolerated . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00095823",
"OBJECTIVE To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate ( quetiapine XR ) as monotherapy treatment for major depressive disorder ( MDD ) . METHOD This 8-week ( 6-week active-treatment , r and omized phase ; 2-week posttreatment drug-discontinuation/tapering phase ) , multicenter , double-blind , r and omized , parallel-group , placebo- and active-controlled , phase 3 study was conducted between April 2006 and May 2007 . In total , 612 patients with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition (DSM-IV)-defined MDD were r and omly assigned to quetiapine XR 150 mg/day or 300 mg/day , duloxetine 60 mg/day ( active control ) , or placebo . The primary endpoint was the change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score . RESULTS At week 6 , both doses of quetiapine XR ( p MADRS total score versus placebo . A significant reduction was seen at week 1 with quetiapine XR 150 mg/day and 300 mg/day versus placebo ( p Response rates ( > or= 50 % reduction in MADRS total score ) at week 6 were significantly higher for both doses of quetiapine XR ( p Remission rates ( MADRS score quetiapine XR 300 mg/day and duloxetine versus placebo ( p Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , and Clinical Global Impressions-Severity of Illness total scores and the proportion of patients with Clinical Global Impressions-Improvement scores of 1 or 2 ( \" much/very much improved \" ) were significantly improved with both doses of quetiapine XR and duloxetine versus placebo . The most common adverse events reported were dry mouth , sedation , and somnolence for quetiapine XR and nausea , headache , dizziness , and dry mouth for duloxetine . CONCLUSION Quetiapine XR monotherapy ( 150 mg/day and 300 mg/day ) is effective , with safety and tolerability consistent with the known profile of quetiapine XR , in the treatment of patients with MDD , with onset of symptom improvement demonstrated at week 1 . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00321490",
"OBJECTIVE Patients ( 30 - 50 % ) with non-psychotic major depression will not respond despite an adequate trial of antidepressant medication . This study evaluated risperidone as an augmenting agent for patients who failed or only partially responded to an adequate trial of an antidepressant medication . METHOD Ninety-seven patients with unipolar non-psychotic major depression who were not responsive to antidepressant monotherapy were r and omized to risperidone ( 0.5 - 3mg/day ) or placebo augmentation in a four-week , double-blind , placebo controlled treatment trial . The primary outcome measure was remission defined by a score of Montgomery-Asberg Depression Rating Scale ( MADRS ) . Secondary outcomes measures were the Hamilton Rating Scale for Depression , the Clinician Global Impression of Severity scale and the overall satisfaction item of the Quality of Life and Enjoyment Question naire . RESULTS Subjects in both treatment groups improved significantly over time . The odds of remitting were significantly better for patients in the risperidone vs. placebo arm ( OR=3.33 , p=.011 ) . At the end of 4 weeks of treatment 52 % of the risperidone augmentation group remitted ( MADRS placebo augmentation group ( CMH(1)=6.48 , p=.011 ) , but the two groups were converging . Patients in the risperidone group also reported significantly more improvement in quality -of-life than patients in the placebo group . There were no between-group differences in the number of adverse events reported , however , weight gain was significantly higher in the group receiving risperidone . CONCLUSION Augmentation of an antidepressant with risperidone for patients with difficult-to-treat depression leads to more rapid response and a higher remission rate and better quality -of-life",
"Based on preliminary evidence of its usefulness in treatment-resistant depression ( TRD ) , an olanzapine/fluoxetine combination ( OFC ) was examined in comparison with olanzapine , fluoxetine , and venlafaxine in a TRD population . In this 12-week double-blind study , 483 subjects with unipolar , nonpsychotic TRD , with historic failure on a selective serotonin reuptake inhibitor ( SSRI ) and prospect i ve failure on open-label venlafaxine , were r and omized to an OFC or to an olanzapine , fluoxetine , or venlafaxine monotherapy group . Venlafaxine was continued r and omly in the double-blind acute phase to explore the benefits of continuation versus switching therapy . The Montgomery-Asberg Depression Rating Scale ( MADRS ) total change score at end point was the primary outcome measure . The OFC group had significantly greater improvement in depressive symptoms by week 1 of treatment ( MADRS mean change = -7.2 , baseline = 29.6 ) , in comparison to olanzapine ( -4.8 , P=.03 ) , fluoxetine ( -4.7 , P=.03 ) , or venlafaxine ( -3.7 , P=.002 ) groups and maintained its statistical separation from all three monotherapy groups through week 6 . At end point , the OFC group was significantly different only from the olanzapine group ( -14.1 vs. -7.7 , P olanzapine and fluoxetine ( but not venlafaxine ) at end point : OFC ( -14.6 ) versus olanzapine ( -9.4 , P fluoxetine ( -10.7 , P=.006 ) versus venlafaxine ( -14.7 , P=.98 ) . The OFC had a safety profile comparable to its component monotherapies ( i.e. , olanzapine and fluoxetine ) , showed a rapid onset of antidepressant effect , and was effective in this TRD sample . At the study end point , OFC , fluoxetine , venlafaxine , and low-dose OFC all appeared to be similarly effective",
"BACKGROUND Evaluate the efficacy and tolerability of extended release quetiapine fumarate ( quetiapine XR ) once-daily monotherapy for patients with major depressive disorder ( MDD ) . METHODS In this 10-week , ( 8-week active treatment phase and 2-week drug-discontinuation/tapering phase ) , multicenter , parallel-group , placebo-controlled , double-blind , r and omized , Phase III study ( D1448C00003 : Opal ) , patients initially received quetiapine XR 150 mg/day or placebo . At Week 2 , inadequate responders ( quetiapine XR or matching placebo for the final 6 weeks . Primary endpoint : change from r and omization to Week 8 in MADRS total score . Secondary endpoints included : MADRS response ( ≥50 % reduction in total score from r and omization ) and changes from r and omization to Week 8 in HAM-D and CGI-S. RESULTS 310 patients were r and omized . At Week 8 , quetiapine XR significantly reduced mean MADRS total score versus placebo ( -16.49 vs -13.10 , respectively ; p score was significantly reduced by quetiapine XR versus placebo at Week 1 ( p rates were significantly greater at Week 8 for quetiapine XR versus placebo ( 61.9 % vs 48.0 % , respectively ; p ) . Significant changes in HAM-D total score and CGI-S were seen at Week 8 for quetiapine XR versus placebo . Withdrawal rates due to AEs were 9.9 % and 2.6 % for quetiapine XR and placebo , respectively . Common AEs ( > 10 % any group during the r and omized phase ) for quetiapine XR and placebo , respectively were dry mouth ( 32.9 % and 6.5 % ) , sedation ( 21.7 % and 1.9 % ) , somnolence ( 20.4 % and 5.2 % ) , and headache ( 10.5 % and 10.3 % ) . LIMITATIONS The study was not design ed to compare quetiapine XR 150 mg/day and 300 mg/day ; it was intended to reflect dose titration that might occur in clinical practice . CONCLUSIONS Quetiapine XR monotherapy is effective in patients with MDD , with symptom improvement seen as early as Week 1 , and tolerability results consistent with the known profile of quetiapine",
"BACKGROUND Due to their favorable side-effect profile , atypical antipsychotic agents offer important therapeutic advantages in mood disorders . Ziprasidone , an atypical antipsychotic agent with strong 5-HT(1A ) agonist activity , may be particularly useful when used in conjunction with st and ard antidepressants in treatment-resistant depression . The purpose of this study is to test this hypothesis in depressed out patients who have not experienced significant clinical improvement following an adequate trial of a selective serotonin reuptake inhibitor ( SSRI ) . METHOD Twenty patients with major depressive disorder ( MDD ) who had failed to experience a clinical response to an adequate trial of an SSRI were treated with open-label ziprasidone in addition to their SSRI for 6 weeks between February 2002 and December 2002 . MDD was diagnosed with the Structured Clinical Interview for DSM-IV Axis I disorders . Clinical response was defined as a 50 % or greater decrease in depressive symptoms during the course of the trial ( baseline to endpoint ) , as measured by the HAM-D-17 total score . RESULTS Thirteen of 20 patients ( 65.0 % ) completed the trial . Using a completer analysis , 8 patients ( 61.5 % ) were classified as responders . An intent-to-treat ( ITT ) analysis result ed in 10 responders ( 50.0 % ) . The overall proportion of remitters was 5 of 13 ( 38.5 % ) using a completer analysis and 5 of 20 ( 25.0 % ) using the ITT analysis . Ziprasidone administration appeared to be safe , with no clinical ly significant QTc prolongation or severe adverse events observed in any of the study participants . CONCLUSION These results suggest a possible augmentation role for ziprasidone when used in conjunction with SSRIs in SSRI-resistant MDD",
"INTRODUCTION Effective management of major depressive disorder ( MDD ) continues to be a challenging task for psychiatrists and primary care physicians . This trial evaluated the efficacy and safety of adjunctive aripiprazole versus antidepressant monotherapy in patients with MDD and independently replicated the positive findings of two similar trials . METHODS Patients ( N=1,147 ) with MDD experiencing a major depressive episode and a history of inadequate response to antidepressant monotherapy were enrolled ( week 0 ) ; 827 received single-blind adjunctive placebo plus open-label antidepressant ( escitalopram , fluoxetine , paroxetine controlled release , sertraline , or venlafaxine extended release ) for 8 weeks to confirm inadequate response to antidepressants ; 349 patients with inadequate response were r and omized ( 1:1 ) to double-blind , adjunctive placebo ( n=172 ) or adjunctive aripiprazole ( n=177 ; 2 - 20 mg/day ) . Primary outcome was the mean change in Montgomery-Asberg Depression Rating Scale ( MADRS ) Total score from baseline ( week 8) to endpoint ( week 14 ) . RESULTS Clinical ly significant improvements in depressive symptoms as assessed by decreases in the MADRS Total score were greater with adjunctive aripiprazole ( -10.1 ) than placebo ( -6.4 ; P Remission rates were greater for adjunctive aripiprazole than for adjunctive placebo ( week 14 , 36.8 % vs 18.9 % ; P Completion rates with adjunctive aripiprazole and placebo were high ( 83 % vs. 87 % ) and discontinuations due to adverse events were low ( 6.2 % vs 1.7 % ) . CONCLUSION For some patients with MDD who do not obtain adequate symptom relief with antidepressant monotherapy , adjunctive therapies can significantly improve depressive symptoms . As reported , adjunctive aripiprazole was associated with a two-fold higher remission rate than adjunctive placebo . This , and previous studies , have shown that discontinuations due to adverse events were low and completion rates were high , and has indicated that both antidepressant and aripiprazole in combination were relatively well-tolerated and safe . This is the third consecutive clinical trial , in the absence of a failed trial , to demonstrate that aripiprazole augmentation to antidepressants is an efficacious and well-tolerated treatment for patients with MDD who do not respond adequately to st and ard antidepressant monotherapy ( Clinical Trials.gov study NCT00105196 )",
"The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas",
"OBJECTIVE Two parallel , 8-week double-blind studies compared olanzapine/fluoxetine combination , olanzapine , and fluoxetine in out patients with treatment-resistant depression ( TRD ) . METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospect i ve failure on fluoxetine . Following an 8-week fluoxetine lead-in , 605 nonresponders with DSM-IV major depressive disorder were r and omly assigned to olanzapine/fluoxetine combination , olanzapine , or fluoxetine . The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale ( MADRS ) . The study was conducted from April 2002 to May 2005 . RESULTS After 8 weeks of double-blind treatment , Study 1 revealed no statistically significant therapy differences in MADRS mean change ( olanzapine/fluoxetine combination : -11.0 , fluoxetine : -9.4 , olanzapine : -10.5 ) . In Study 2 , olanzapine/fluoxetine combination demonstrated significantly greater MADRS improvement ( -14.5 ) than fluoxetine ( -8.6 , p olanzapine ( -7.0 , p olanzapine/ fluoxetine combination ( -12.7 ) versus fluoxetine ( -9.0 , p olanzapine ( -8.8 , p Pooled remission rates were 27 % for olanzapine/ fluoxetine combination , 17 % for fluoxetine , and 15 % for olanzapine . Adverse events were consistent with previous studies . Cholesterol mean change ( mg/dL ) was + 15.1 for olanzapine/ fluoxetine combination , + 0.8 for fluoxetine , and + 2.7 for olanzapine . Mean weight change ( kg ) was + 4.9 for olanzapine/fluoxetine combination , + 0.4 for fluoxetine , and + 5.5 for olanzapine . Nonfasting glucose mean change ( mg/dL ) was + 11.4 for olanzapine/fluoxetine combination , + 4.9 for fluoxetine , and + 9.9 for olanzapine . CONCLUSION Patients with TRD ( defined as treatment failure on 2 antidepressants ) taking olanzapine/fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or fluoxetine in 1 of 2 studies and in the pooled analysis . When considered within the context of all available evidence , olanzapine/fluoxetine combination is an efficacious therapy for patients with TRD . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier : NCT00035321",
"The objective of this study was to investigate whether quetiapine , when compared with placebo , can speed the onset of action and improve the quality of response to fluoxetine treatment in patients suffering from major depressive disorder . A total of 114 patients with major depressive disorder were enrolled in an 8-week treatment study . Patients were initiated on a course of fluoxetine treatment and r and omized to quetiapine or placebo . Quetiapine was flexibly dosed starting at 25 mg to a maximum of 100 mg daily . Mixed-effects regression showed that quetiapine plus fluoxetine did not achieve 50 % reduction in the Montgomery – Åsberg Depression Rating Scale score or improvement in Hamilton Anxiety Scale , Clinical Global Improvement (CGI)-Severity , and CGI-Improvement scores sooner than the fluoxetine plus placebo group ; however both groups improved in all scores over time . Mixed-effects linear regression of insomnia scores showed that the quetiapine plus fluoxetine group improved significantly more rapidly compared with the fluoxetine plus placebo group . The study indicates that quetiapine plus fluoxetine did not achieve a reduction in the Montgomery – Åsberg Depression Rating Scale score or improvement in Hamilton Anxiety Scale or CGI scores from baseline sooner than the fluoxetine plus placebo group . The combination of quetiapine and fluoxetine , however , improved sleep over fluoxetine alone over the first few weeks of treatment",
"Nonresponse to one or more antidepressants is common and an important public health problem . This study evaluated the efficacy and safety of adjunctive aripiprazole or placebo to st and ard antidepressant therapy ( ADT ) in patients with major depressive disorder who showed an inadequate response to at least 1 and up to 3 historical and 1 additional prospect i ve ADT . The study comprised a 7 - 28-day screening , an 8-week prospect i ve treatment , and a 6-week r and omization phase . During prospect i ve treatment , patients experiencing a major depressive episode ( 17-item Hamilton Rating Scale for Depression total score ≥18 ) received single-blind adjunctive placebo plus clinicians ' choice of ADT ( escitalopram , fluoxetine , paroxetine controlled-release , sertraline , or venlafaxine extended-release ) . Subjects with inadequate response were r and omized to adjunctive placebo ( n = 190 ) or adjunctive aripiprazole ( n = 191 ) ( starting dose 5 mg/d , dose adjustments 2 - 20 mg/d , mean end-point dose of 11.0 mg/d ) . The primary efficacy endpoint was the mean change in Montgomery-Åsberg Depression Rating Scale total score from end of prospect i ve treatment phase to end of r and omized treatment phase ( last observation carried forward ) . Mean change in Montgomery-Åsberg Depression Rating Scale total score was significantly greater with adjunctive aripiprazole than placebo ( −8.5 vs −5.7 ; P = 0.001 ) . Remission rates were significantly greater with adjunctive aripiprazole than placebo ( 25.4 % vs 15.2 % ; P = 0.016 ) as were response rates ( 32.4 % vs 17.4 % ; P Adverse events occurring in 10 % of patients or more with adjunctive placebo or aripiprazole were akathisia ( 4.2 % vs 25.9 % ) , headache ( 10.5 % vs 9.0 % ) , and fatigue ( 3.7 % vs 10.1 % ) . Incidence of adverse events leading to discontinuation was low ( adjunctive placebo [ 1.1 % ] vs adjunctive aripiprazole [ 3.7 % ] ) . Aripiprazole is an effective and safe adjunctive therapy as demonstrated in this short-term study for patients who are nonresponsive to st and ard ADT",
"BACKGROUND PRIMARY OBJECTIVE evaluate the efficacy ( time to recurrence of depressive symptoms ) of once daily extended release quetiapine fumarate ( quetiapine XR ) as maintenance monotherapy treatment to prevent relapse for major depressive disorder ( MDD ) . METHODS Time-to-event ( maximum 52 weeks ) , double-blind , multicenter , r and omized withdrawal , placebo-controlled study of quetiapine XR ( 50 - 300 mg/day ) comprising four treatment phases : enrollment ( up to 28 days ) , open-label run-in ( 4 - 8 weeks ) , open-label stabilization ( 12 - 18 weeks ) , and r and omization ( up to 52 weeks ) . Seven hundred and seventy-six patients stabilized on quetiapine XR were eligible for r and omization ( Montgomery-Åsberg Depression Rating Scale [ MADRS ] score ≤12 and Clinical Global Impression-Severity of Illness [ CGI-S ] score ≤3 ) ; 391 received quetiapine XR and 385 received placebo ( same dose as last open-label visit ) . Primary endpoint : time to recurrence of depressive event from r and omization . Secondary outcomes included changes from r and omization in MADRS total , CGI-S , Pittsburgh Sleep Quality Index ( PSQI ) global , and Hamilton Anxiety Rating Scale ( HAM-A ) total scores . Adverse events were recorded throughout . RESULTS Risk of recurrence of depressive event was significantly ( P patients r and omized to continue with quetiapine XR versus patients r and omized to switch to placebo . During the r and omized phase , quetiapine XR maintained improvements in secondary outcomes ( P : MADRS ( 0.15 versus 2.03 ) , CGI-S ( -0.03 versus 0.23 ) ; PSQI global ( 0.06 versus 1.35 ) , and HAM-A total score ( 0.20 versus 1.58 ) , respectively . The most common AEs ( > 10 % any group ) during the r and omized period were headache and insomnia . CONCLUSIONS Quetiapine XR maintenance therapy significantly reduced the risk of a depressive event in patients with MDD stabilized on quetiapine XR , with a safety and tolerability profile consistent with the known profile of quetiapine ",
"OBJECTIVE To determine the efficacy and tolerability of aripiprazole , a dopamine D2 and 5-HT1A receptor partial agonist , as augmentation of antidepressant treatment of partially responding and nonresponding patients with major depressive disorder . METHOD Fifteen patients with major depressive disorder ( diagnosed with a site-generated form described in the text ) and an incomplete response or no response to > or = 8 weeks of antidepressant ( selective serotonin reuptake inhibitor , venlafaxine , or bupropion ) monotherapy were treated with aripiprazole augmentation in an 8-week , open-label study . Data were gathered from July 2003 to March 2004 . RESULTS The mean duration of antidepressant monotherapy at baseline was 43.1 weeks . At baseline , mean Clinical Global Impressions-Severity of Illness scale and Hamilton Rating Scale for Depression ( HAM-D ) scores were 4.3 and 18.9 , respectively . After initiation of aripiprazole augmentation , 6 of 15 patients achieved remission ( HAM-D score remission by study endpoint . Akathisia in 2 patients who withdrew prematurely prompted a reduction in the starting dose of aripiprazole from 10 mg/day to 2.5 mg/day , result ing in a 50 % reduction in attrition due to akathisia ( 2/7 withdrew due to akathisia with the 10-mg starting dose , 1/8 withdrew due to akathisia with the 2.5-mg starting dose ) . Discontinuation rates after 4 weeks of treatment were lower for the 2.5-mg starting dose ( 1/8 patients ) than for the 10-mg starting dose ( 3/7 patients ) . Overall discontinuation rates at endpoint were lower for the 2.5-mg dose ( 3/8 patients ) than the 10-mg dose ( 4/7 patients ) . Response to aripiprazole augmentation did not appear to be related to the antidepressant used at study initiation . CONCLUSION Aripiprazole is an effective augmentation strategy for improving therapeutic response in patients with treatment-resistant major depressive disorder when administered in combination with st and ard antidepressant therapy . Based on this clinical signal , a double-blind , placebo-controlled trial is warranted",
"Amisulpride , a selective antagonist of D2 and D3 dopamine receptors , acts preferentially on presynaptic receptors increasing dopaminergic transmission at low doses . In a multicentre , 6 months , placebo-controlled trial , amisulpride ( 50 mg/daily ) was compared to imipramine ( 100 mg/daily ) in the treatment of patients with DSM-III-R criteria for primary dysthymia , dysthymia with major depression or major depression in partial remission . A total of 219 patients were included . Both analyses ( intention-to-treat and \" per protocol ' analysis ) detected significant differences between groups ( active treatment vs. placebo ) on all main rating scales ( CGI , MADRS , ERD , and SANS ) . The number of patients reporting at least one adverse event was higher in the imipramine group than in the two other , mainly due to anticholinergic effects . Endocrine symptoms were more frequent in female patients treated with amisulpride . These results confirm the interest of a drug acting on dopaminergic transmission such as amisulpride in the treatment of depressed patients",
"OBJECTIVE Treatment-resistant depression is a significant public health concern ; drug switching or augmentation often produce limited results . The authors hypothesized that fluoxetine could be augmented with olanzapine to successfully treat resistant depression . METHOD An 8-week double-blind study was conducted with 28 patients who were diagnosed with recurrent , nonbipolar , treatment-resistant depression without psychotic features . Subjects were r and omly assigned to one of three groups : olanzapine plus placebo , fluoxetine plus placebo , or olanzapine plus fluoxetine . RESULTS Fluoxetine monotherapy produced minimal improvement on various scales that rate severity of depression . The benefits of olanzapine monotherapy were modest . Olanzapine plus fluoxetine produced significantly greater improvement than either monotherapy on one measure and significantly greater improvement than olanzapine monotherapy on the other measures after 1 week . There were no significant differences between treatment groups on extrapyramidal measures nor significant adverse drug interactions . CONCLUSIONS Olanzapine plus fluoxetine demonstrated superior efficacy for treating resistant depression compared to either agent alone",
"Two hundred and fifty patients participated in a 6-month , double-blind study to evaluate safety and e¤cacy of a medium-term treatment with amisulpride 50 mg/day versus amitriptyline 2575 mg/day in dysthymia . Patients in treatment groups ( 165 amisulpride ; 85 amitriptyline ) were well balanced for demographic and baseline characteristics . A total of 139 patients ( 93 amisulpride , 46 amitriptyline ) completed the study with no statistically signifcant di¡erences in reasons for premature termination between the two groups . A tendency towards a higher incidence of treatment-emergent adverse events with amitriptyline was observed ( 73 % versus 64 % amisulpride ) . In the amitriptyline group , a statistically signifcantly higher incidence of central nervous system ( 41 % versus 24 % , p=0.004 ) and autonomic nervous system disorders ( 45 % versus 16 % , p50.0001 ) was reported . Conversely , endocrine disorders were more frequent with amisulpride ( 18 % versus 7 % , p=0.023 ) . E¤cacy was a secondary end-point . Results of the symptom rating scales indicate that both drugs were equally e¡ective : 60 % and 62 % of patients under amisulpride and amitriptyline , respectively , achieved a reduction 550 % of the Montgomery and Asberg Rating Scale total score at end-point . On the item ` global improvement ' of the Clinical Global Impression , 67 % of amisulpride and 68 % of amitriptyline patients were rated as ` very much ' or ` much ' improved . Results of the present study in a large patient population further confrm the safe use of amisulpride in dysthymia and support its administration upon a medium-term treatment period",
"Context Does augmentation with an atypical antipsychotic improve symptoms in patients with major depression that is suboptimally responsive to antidepressant monotherapy ? Contribution This double-blind r and omized trial found that 6 weeks of treatment with risperidone improved symptoms more than placebo in 274 adults with major depression that was suboptimally responsive to antidepressant monotherapy . Risperidone , compared with placebo , result ed in more remissions ( 25 % vs. 11 % ) , as well as more cases of somnolence ( 5 % vs. 2 % ) and dry mouth ( 5 % vs. 1 % ) . Caution The trial duration was short , and 19 % of risperidone recipients did not complete treatment . Implication Risperidone augmentation may improve symptoms in some patients with suboptimal response to antidepressant monotherapy . The Editors Major depressive disorder is the leading cause of disability worldwide ( 1 ) , affecting nearly 121 million people . It is associated with increased overall mortality ( 2 , 3 ) ; premature cardiovascular-related death ( 4 , 5 ) ; and morbidity , including disability , lost productivity , and decreased wages , compared with individuals without depression ( 6 ) . Selective serotonin reuptake inhibitors ( SSRIs ) and serotoninnorepinephrine reuptake inhibitors are generally considered first-line treatments for depression . Despite a sufficient dose and duration of antidepressant treatment , symptoms do not resolve in 30 % to 40 % of patients with major depressive disorder ( 710 ) . Remission , defined as the virtual absence of depressive symptoms , is important because it is associated with improved patient prognosis and functioning relative to response ( generally defined as 50 % reduction in symptoms ) ( 11 , 12 ) . In an effort to improve the therapeutic efficacy of antidepressant monotherapy , several pharmacologic strategies to modulate different or additional neurotransmitters ( 1315 ) are commonly used , despite a paucity of evidence from r and omized clinical trials . These strategies include switching monotherapy within ( 10 , 1618 ) or between antidepressant classes ( 10 , 1921 ) , combination regimens consisting of 2 antidepressants ( 2226 ) , and augmentation of antidepressants with nonst and ard treatmentsfor example , thyroid hormone ( 27 ) ; S-adenosyl-l-methionine ( 28 ) ; lithium ( 29 ) ; cyclooxygenase-2 inhibitors ( 30 ) ; or an atypical antipsychotic ( 3133 ) , such as risperidone . Findings of several open-label studies ( 3135 ) suggest that atypical antipsychotic augmentation provides benefit in major depressive disorder that is suboptimally responsive to antidepressant monotherapy . Risperidone , whose activity includes blockade of certain serotonin and dopamine receptors , is considered an atypical antipsychotic . It is approved in the United States for treatment of bipolar mania and schizophrenia and in other countries for additional uses . The efficacy of risperidone has also been studied for various psychoses and behavioral disorders , including treatment-resistant depression and anxiety spectrum disorders ( 34 , 3639 ) . We hypothesized that low-dose risperidone augmentation would reduce symptoms of major depressive disorder , enhance clinical response and remission rates , and reduce disability and improve quality of life compared with continued antidepressant monotherapy . Preliminary data suggest that persons with a confirmed suboptimal response to previous treatment may respond to risperidone augmentation within 4 to 6 weeks ( 38 ) . We therefore conducted a large , multicenter , double-blind , placebo-controlled trial to assess the clinical efficacy of risperidone augmentation from the clinician and patient perspectives and to evaluate tolerability in patients with major depressive disorder who continue to experience symptoms despite an adequate trial of st and ard antidepressants . Methods Design Consenting persons entered a 4-week prospect i ve open-label run-in period during which they received their current antidepressant monotherapy at the dosages recommended in product labeling , so that we could confirm an insufficient response to st and ard monotherapy . The run-in period was followed by a 6-week double-blind treatment phase ; during this phase , patients who continued to experience depressive symptoms , defined as a Clinical Global ImpressionSeverity of illness ( CGI-S ) score of 4 or greater and a Carroll Depression Scale ( 40 ) score of 20 or greater , were r and omly assigned to receive risperidone augmentation therapy or placebo . A 4-week follow-up phase of open-label risperidone augmentation therapy was available to participants who completed at least 4 weeks of double-blind treatment ( results not shown ) . Setting and Participants Out patients 18 to 65 years of age who had received antidepressant monotherapy for at least 4 weeks and met the Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( 41 ) , criteria for unremitting major depressive disorder ( single or recurrent episodes ) and a CGI-S score of 4 or more ( 42 ) at the start of both the open-label and double-blind phases were eligible . The CGI-S is scored on a scale of increasing intensity from 1 to 7 , with 4 representing moderate illness . We recruited participants by using various methods , including media advertisements , and enrolled persons from 75 public and private primary care ( n= 41 ) and psychiatric ( n= 34 ) centers in the United States between 19 October 2004 and 17 November 2005 . Ethical approval was obtained from the institutional review board of each site , and written informed consent was obtained from all patients . Exclusion criteria were pregnancy ; serious suicidal risk or serious medical or neurologic illness ; active substance or alcohol use disorders ; or current treatment with a tricyclic antidepressant , monoamine oxidase inhibitor , mood stabilizer , antiepileptic , or a central ly acting agent for attention deficit disorder/attention deficit hyperactivity disorder or narcolepsy . R and omization and Interventions Patients who were eligible for r and omization continued their st and ard antidepressant regimen and dosage and were assigned to receive risperidone or placebo . Tablets were identical in appearance . The investigators , study staff , and patients were blinded to the treatment assignment . The r and omization code was central ly generated and administered by a telephone interactive voice response system , was stratified by antidepressant class ( SSRI or non-SSRI ) and center , and occurred in r and om permuted blocks . An independent statistician provided the r and omization codes . The dosing schedule was 0.25 mg for the first 3 days , 0.5 mg on days 4 to 15 , and 1.0 mg on days 16 to 28 . On day 29 , patients with insufficient treatment response in the opinion of the investigator could continue augmentation at the current dosage , have the dosage increased to 2 mg/d , or discontinue double-blind treatment . Concomitant medications were allowed as necessary for medical conditions . Sedative agents ( zolpidem , 2.5 to 10 mg/d , or zaleplon , 5 to 20 mg/d , as needed ) were allowed for insomnia . During double-blind treatment , benztropine mesylate was permitted as needed for potential treatment-emergent motor effects . Measurements and Outcomes At each visit ( end of the open-label phase and weeks 1 , 2 , 4 , and 6 ) , trained personnel administered the grid version of the 17-item Hamilton Rating Scale for Depression ( HRSD-17 ) ( 43 , 44 ) and the CGI-S ( 42 ) , both clinician-rated instruments . Scores on the HRSD-17 range from 0 to 52 ; higher scores indicate more severe depression . Patients also independently rated their response by using the telephone interactive voice response system at baseline and weekly thereafter . Other patient-reported outcomes were scores on 3 vali date d instruments : the Quality of Life Enjoyment and Satisfaction Question naire ( Q-LES-Q ) ( 45 ) , the Patient Global Improvement Scale ( 7-point rating from 1 [ very much improved ] to 7 [ very much worse ] ) , and the Sheehan Disability Scale ( SDS ) . Change in HRSD-17 total score from baseline to study end was the a priori primary efficacy measure . Response ( 50 % reduction in HRSD-17 total score from baseline ) and remission ( HRSD-17 total score 7 ) were assessed at each time point . Secondary measures were changes in the CGI-S , Q-LES-Q , SDS , and Patient Global Improvement Scale scores . Follow-up Patients underwent physical examination , including assessment of vital signs , at regular intervals . Research staff maintained records of trial medication and assessed treatment compliance by matching doses taken with the number of treatment days . To assess adverse effects , patients were interviewed at each study visit with open-ended questions about potential adverse events ; spontaneous reports were also taken into account . All adverse events were recorded , and the investigator assessed each event for severity and relationship to the study drug ( probable , possible , not related ) . Statistical Analysis A sample of 116 patients per group was anticipated to have 90 % power to detect an arbitrary difference in change in mean HRSD-17 total score of 3.0 units , assuming a common SD of 7.0 using a 2-group t test and a 2-sided significance level of 0.05 . We also assumed that approximately 30 % of the participants would not complete double-blind treatment and planned for 332 persons to undergo r and omization . We further assumed that during the open-label run-in phase , 30 % of participants would discontinue the study and 20 % would respond to st and ard antidepressant treatment and therefore be ineligible for r and omization ; thus , we sought 592 persons for the open-label run-in phase . All analyses were performed by using SAS , version 8.2 ( SAS Institute , Cary , North Carolina ) , and statistical analysis personnel were blinded to patient group assignment . Baseline patient characteristics were summarized by using descriptive statistics . Efficacy and safety analyses were based on the intention-to-treat population ( that is , all persons who underwent r and omization and received at least 1 dose of medication in the double-blind phase ) .",
"BACKGROUND The purpose of this study was to provide preliminary data on the effects of paroxetine and amisulpride on depressive dimensions , analyzed by factor analysis , in dysthymic patients . METHODS One hundred and eighteen patients with DSM IV criteria for DD without concurrent major depression were enrolled in this 8-week , open study , and 100 completed it . Symptom dimensions were identified by principal components analysis with the SAS Factor procedure . RESULTS Results of the symptom rating scales indicated that both drugs were equally effective . Response rate was 65 % both in the paroxetine and the amisulpride group and the proportions of patients achieving a final HRSD score MADRS factor analysis identified two factors at baseline : the first corresponding to the global severity of depression and the second to somatic symptoms . After 8 weeks of treatment only one factor could be substantiated . At week 4 both paroxetine and amisulpride produced significant improvements on factor 1 while at week 8 mean changes of factor 1 were greater in the amisulpride-treated patients . LIMITATIONS The main limitation was the open-label design . CONCLUSIONS Both paroxetine and amisulpride appear to be effective in the short-term management of DD , improving its most characteristic symptoms",
"OBJECTIVE This 6-week , r and omized , double-blind study evaluated efficacy and safety of adjunctive extended-release ( XR ) quetiapine in patients with major depressive disorder ( MDD ) and an inadequate response to > or= 1 antidepressant . METHOD Male or female patients aged 18 to 65 years with DSM-IV-TR MDD were r and omly assigned to receive quetiapine XR ( 150 or 300 mg/day ) or placebo adjunctive to continuing antidepressant . Primary endpoint was change from r and omization to week 6 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score . Secondary variables included MADRS response ( > or= 50 % reduction in score from r and omization ) at weeks 1 and 6 , MADRS remission ( Hamilton Rating Scale for Depression and Hamilton Rating Scale for Anxiety total scores . Safety was assessed throughout the study . The study was conducted between May 8 , 2006 , and April 7 , 2007 . RESULTS Four hundred ninety-three patients were r and omly assigned . Mean change from r and omization to week 6 in MADRS score was -15.26 and -14.94 for quetiapine XR 150 mg/day and 300 mg/day , respectively ( both p Quetiapine XR showed separation from placebo in MADRS score from week 1 ( p MADRS response rates were 55.4 % , 57.8 % , and 46.3 % for quetiapine XR 150 mg/day ( p = .107 vs. placebo ) , 300 mg/day ( p MADRS remission rates were 36.1 % ( p Withdrawal rates due to adverse events were 6.6 % , 11.7 % , and 3.7 % with quetiapine XR 150 mg/day , 300 mg/day , and placebo , respectively . The most common adverse events were dry mouth ( 20.4 % , 35.6 % , and 6.8 % ) and somnolence ( 16.8 % , 23.3 % , and 3.1 % ) . CONCLUSIONS Adjunctive quetiapine XR ( 150 mg/day and 300 mg/day ) was effective in patients with MDD who had shown an inadequate response to antidepressant treatment . Significant reduction of depressive symptoms occurred as early as week 1 . Findings were consistent with the known safety and tolerability profile of quetiapine . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00351910",
"In a multicenter , double-blind , parallel group trial , the efficacy of risperidone ( RIS ) was compared with a combination of haloperidol and amitriptyline ( HAL/AMI ) over 6 weeks in patients with coexisting psychotic and depressive symptoms with either a schizoaffective disorder , depressive type , a major depression with psychotic features , or a nonresidual schizophrenia with major depressive symptoms according to DSM-III-R criteria . A total of 123 patients ( 62 RIS ; 61 HAL/AMI ) were included ; the mean daily dosage at endpoint was 6.9 mg RIS versus 9 mg HAL combined with 180 mg AMI . Efficacy results for those 98 patients ( 47 RIS ; 51 HAL/AMI ) who completed at least 3 weeks of double-blind treatment revealed in both treatment groups large reductions in the Positive and Negative Syndrome Scale-derived Brief Psychiatric Rating Scale ( RIS 37 % ; HAL/AMI 51 % ) and the Bech-Rafaelsen Melancholia Scale total scores ( RIS 51 % ; HAL/AMI 70 % ) . The reductions in the Brief Psychiatric Rating Scale and the Bech-Rafaelsen Melancholia Scale scores in the total group were significantly larger in the HAL/AMI group than in the RIS group ( p incidence of extrapyramidal side effects as assessed by the Extrapyramidal Symptom Rating Scale was slightly higher under RIS ( 37 % ) than under HAL/AMI ( 31 % ) . Adverse events were reported by 66 % of RIS and 75 % of HAL/AMI patients . The results of this trial suggest that the therapeutic effect of HAL/AMI is superior to RIS in the total group of patients with combined psychotic and depressive symptoms . However , subgroup differences have to be considered",
"INTRODUCTION Once-daily extended release quetiapine fumarate ( quetiapine XR ) monotherapy was evaluated in major depressive disorder ( MDD ) . METHOD This was an 8-week ( 6-week r and omized-phase ; 2-week drug-discontinuation/tapering phase ) , double-blind , parallel-group , placebo-controlled study . The primary outcome measure was Montgomery-Asberg Depression Rating Scale ( MADRS ) total score r and omization-to-Week 6 change . Other assessment s included the Hamilton Rating Scale for Depression , the Hamilton Rating Scale for Anxiety , and adverse events ( AEs ) . RESULTS 723 patients were r and omized : 182 , 178 , 179 , and 184 to quetiapine XR 50 , 150 , 300 mg/day , and placebo , respectively . At Week 6 , significant reductions occurred in MADRS score with quetiapine XR 50 mg/day ( -13.56 ; P placebo ( -11.07 ) ; at Day 4 , reductions for quetiapine XR ( titrated to 50 or 150 mg/day according to dose group ) versus placebo ( -2.9 ) were : -4.7 ( P MADRS response ( > or=50 % reduction in score ) was 42.7 % ( P quetiapine XR 50 , 150 , and 300 mg/day , respectively ; 30.3 % for placebo . Overall , quetiapine XR 150 mg/day provided consistently more positive secondary efficacy results than 50 mg/day and 300 mg/day versus placebo . The most common AEs in quetiapine XR-treated patients were dry mouth , sedation , somnolence , headache , and dizziness . CONCLUSION In patients with MDD , quetiapine XR monotherapy ( 50/150/300 mg/day ) is effective in reducing depressive symptoms , with improvement from Day 4 onwards . Safety and tolerability were consistent with the known profile of quetiapine",
"Amisulpride ( 50 mg o.d . ) was compared with sertraline ( 50 - 100 mg o.d . ) for 12 weeks in a double-blind , parallel-group study in 313 out patients with dysthymia ( DSM-IV ± episode of major depression ) . Full response rate [ ≥ 50 % decrease in Hamilton Depression Rating Scale ( HAMD ) total score ] was higher with amisulpride after 4 weeks ( 63 % versus 50 % , P 0.009 ) . Time to initial improvement ( ≥ 25 % decrease in HAMD total score ) and to ≥ 50 % HAMD decrease were significantly shorter with amisulpride ( P The improvement in HAMD , Montgomery and Asberg Depression Rating Scale and Social and Occupational Assessment Scale total scores , as well as Clinical Global Impression improvement , was significantly greater with amisulpride after 4 weeks . Both drugs were equally effective at week 12 . The tolerability of both drugs was satisfactory . Amisulpride is significantly more effective than sertraline during the first weeks of treatment in dysthymia",
"AIM Evaluation of the effect of acetyl-L-carnitine ( ALCAR ) vs. amisulpride measured by total Hamilton Depression Rating Scale score ( HAM-D(21 ) ) in patients with pure dysthymia ( DSM IV ) . Two hundred and four patients were r and omised and treated with ALCAR 500 mg b.i.d . or amisulpride 50 mg u.i.d . in a double-blind study , for 12 weeks . RESULTS A solid improvement of HAM-D(21 ) was observed in both treatment groups throughout the study . The results did not disclose statistically significant differences between treatments , although the confidence interval for the non-inferiority of the primary end-point exceeded the pre-established limit of 2 by 0.46 points . According to a non-inferiority margin of 3 ( considered acceptable by recent published data ) the primary end-point could have been fully satisfied . CDRS , MADRS and CGI , employed to further measure the clinical outcome , reported similar results in both treatment groups . The greater tolerability of ALCAR is of clinical relevance considering the chronicity of dysthymia , which often requires prolonged treatment",
"Abstract : The purpose of this study was to compare the efficacy and safety of olanzapine ( OLZ ) monotherapy and an olanzapine/fluoxetine combination ( OFC ) with placebo ( PLA ) for unipolar major depression with psychotic features . Under a single protocol , two 8-week , double-blind trials were conducted at 27 sites . Patients ( n = 124 trial 1 , n = 125 trial 2 ) were r and omized to 1 of 3 treatment groups : OLZ ( 5 to 20 mg/d ) , PLA , or OFC ( olanzapine 5 to 20 mg/d + fluoxetine 20 to 80 mg/d ) . The primary outcome measure was the 24-item Hamilton Depression Rating Scale total score . For trial 1 , endpoint improvement for the OLZ group ( −14.9 ) was not significantly different from the PLA or OFC groups . The OFC group had significantly greater endpoint improvement ( −20.9 ) than the PLA group ( −10.4 , P = 0.001 ) ; this significant difference was present within 7 days of therapy and maintained at every subsequent visit . The OFC group also had significantly higher response rate ( 63.6 % ) than the PLA ( 28.0 % , P = 0.004 ) or OLZ ( 34.9 % , P = 0.027 ) groups . For trial 2 , there were no significant differences among treatment groups on the 24-item Hamilton Depression Rating Scale total scores or response rates . The combination exhibited a comparable safety profile with OLZ monotherapy and no significant increases in extrapyramidal symptoms compared with placebo . Patients with major depression with psychotic features treated with OLZ monotherapy did not demonstrate significant depressive symptom improvement compared with placebo in either trial ; however , an olanzapine/fluoxetine combination was associated with significant improvement compared with placebo in one trial and was well tolerated",
"BACKGROUND This 8-week , double-blind , multicenter study was undertaken to replicate , in a larger sample of patients with treatment-resistant major depressive disorder ( MDD ; DSM-IV criteria ) , the results of a pilot study of the olanzapine/fluoxetine combination . METHOD The study was begun in August 1999 . The primary entry criterion was a history of failure to respond to a selective serotonin reuptake inhibitor ( SSRI ) . Patients ( N = 500 ) who subsequently failed to respond to nortriptyline during an open-label lead-in phase were r and omly assigned to 1 of 4 treatment groups : olanzapine ( 6 - 12 mg/day ) plus fluoxetine ( 25 - 50 mg/day ) combination , olanzapine ( 6 - 12 mg/day ) , fluoxetine ( 25 - 50 mg/day ) , or nortriptyline ( 25 - 175 mg/day ) . The primary outcome measure was baseline-to-endpoint mean change in score on the Montgomery-Asberg Depression Rating Scale ( MADRS ) . RESULTS At the 8-week study endpoint , MADRS total scores decreased by a mean 8.7 points from baseline ( 28.5 ) with the olanzapine/fluoxetine combination , 7.0 points from baseline ( 28.4 ) with olanzapine ( p = .08 ) , 8.5 points from baseline ( 28.4 ) with fluoxetine ( p = .84 ) , and 7.5 points from baseline ( 28.8 ) with nortriptyline ( p = .30 ) , with no significant differences among the therapies . The olanzapine/fluoxetine combination was associated with significantly ( p MADRS scores than olanzapine at weeks 2 , 4 , 6 , and 7 ; than fluoxetine at weeks 2 through 5 ; and than nortriptyline at weeks 1 through 4 . A post hoc analysis of a subgroup of patients who had an SSRI treatment failure during their current MDD episode ( N = 314 ) revealed that the olanzapine/fluoxetine combination group had a significantly ( p = .005 ) greater decrease in MADRS scores than the olanzapine group at endpoint . Safety data for the olanzapine/fluoxetine combination were similar to those for its component monotherapies . CONCLUSIONS The olanzapine/fluoxetine combination did not differ significantly from the other therapies at endpoint , although it demonstrated a more rapid response that was sustained until the end of treatment . The results raised several method ological questions , and recommendations are made regarding the criteria for study entry and r and omization",
"BACKGROUND Many questions remain regarding the use of atypical neuroleptics as antidepressant augmentation agents . To date , there have been no reports in the literature regarding the effectiveness of these drugs when trials of one or more of them have failed previously as antidepressant augmentation . METHOD This retrospective chart review was conducted to determine the effectiveness of olanzapine , risperidone , quetiapine , and ziprasidone when given in a fee-for-service setting as anti-depressant augmentation agents to patients with treatment-resistant , nonpsychotic major depressive disorder ( DSM-IV ) . Prospect i ve ( Global Assessment of Functioning [ GAF ] ) along with retrospective ( Clinical Global Impressions-Improvement [ CGI-I ] and -Severity of Illness scales ) ratings were completed for each patient . Analyses were conducted in an attempt to identify factors that appeared to correlate with response , including order of administration and Thase-Rush staging of treatment resistance . RESULTS In this study of 76 medication trials in 49 patients , the overall response rate based on the CGI-I ratings was 65 % ( 32/49 ) . Individual rates of response were 57 % ( 21/37 ) for olanzapine , 50 % ( 7/14 ) for risperidone , 33 % ( 6/18 ) for quetiapine , and 10 % ( 1/10 ) for ziprasidone . None of the differences between neuroleptics in rates of response were significant . The difference between baseline and final GAF scores was statistically significant only in the olanzapine ( p Rates of discontinuation did not vary significantly between agents , though trends were present . Crossover trials from one atypical neuroleptic to another in the event of nonresponse appeared to be effective . CONCLUSIONS Although limited by its design , this study suggests atypical neuroleptic augmentation of antidepressants may be a viable option in treatment-resistant major depressive disorder",
"In a multicentre , double blind , parallel group study 281 patients with DSM III-R diagnosis of dysthymia or a single episode of major depression in partial remission were r and omised to 3 months of treatment with amisulpride 50 mg/day or fluoxetine 20 mg/day . The baseline Montgomery and Asberg Depression Rating Scale ( MADRS ) total score was reduced by at least 50 % in 74.1 % of patients ( 103/139 ) with amisulpride and 67.4 % ( 87/129 ) with fluoxetine ( P = 0.230 ) . No significant differences between treatment groups were found in the reductions in mean total score with the MADRS , Widlöcher psychomotor retardation scale , Sheehan disability scale , and CGI . Anxiety measured by HAM-A total mean score decreased significantly more with amisulpride ( 63 % ) than with fluoxetine ( 54 % ; P = 0.021 ) . There were 13 dropouts due to adverse events with amisulpride and ten with fluoxetine . The number of patients reporting at least one adverse event was similar in the two groups ( amisulpride 47.5 % ; fluoxetine 40.9 % ) . As expected , in the amisulpride group endocrine-like adverse events in female patients were the most common , while nausea , dyspepsia , anorexia and insomnia occurred more frequently with fluoxetine",
"The efficacy of amisulpride in depressive disorders has been demonstrated in dysthymia and in double depression . Limited data are available in major depression . A r and omized , double-blind , parallel group , multicentre study was set up to compare the efficacy and tolerability of amisulpride ( 50 mg o.d . ) and paroxetine ( 20 mg o.d . ) for 8 weeks in 272 patients with major depression ( DSM-IV and baseline Hamilton Depression Rating Scale ( HAMD ) score ≥18 ) . The study was design ed as a non-inferiority trial based on the proportion of responders ( ≥50 % decrease in HAMD total score ) at end-point , with a maximal allowable difference of 15 % ; secondary end-points included HAMD total and cluster scores , Montgomery and Asberg Depression Rating Scale score and responders rates and Clinical Global Impression improvement . The tolerability evaluation was based on incidence of adverse events and routine laboratory tests . The results did not disclose statistically significant differences between treatments , although the hypothesis of an efficacy difference between the two treatments within the set limit at day 56 could not be accepted . The issue of non-inferiority trials is discussed",
"Amisulpride , a selective antagonist for D2 and D3 dopamine receptors , acts preferentially on presynaptic receptors increasing dopaminergic transmission at low doses . In a multicentre , 3-month , placebo-controlled study , amisulpride ( 50 mg/day ) was compared to amineptine ( 200 mg/day ) in the treatment of primary dysthymia . A total of 323 patients were enrolled . Amisulpride and amineptine were found to be statistically superior to placebo ( p Clinical Global Impression ( item 2 ) : 63 , 64 and 33 % responders , respectively ; improvement of Montgomery-Asberg Depression Rating Scale and Scale for the Assessment of Negative Symptoms scores following amisulpride or amineptine treatment was twice as high as with placebo ( p adverse event profile of amisulpride was similar to that of placebo except for endocrine symptoms in female patients ; amineptine showed mainly events linked to psychic activation ( insomnia , nervousness ) . Results show that amisulpride can improve symptoms of chronic depression in dysthymia",
"This study evaluated once-daily extended-release quetiapine fumarate ( quetiapine XR ) as adjunctive therapy in patients with major depressive disorder ( MDD ) with inadequate response to ongoing antidepressant treatment . In this 8-wk ( 6-wk active treatment/2-wk post-treatment drug-discontinuation/follow-up ) , multicentre , double-blind , placebo-controlled , Phase III study , 446 patients were r and omized to quetiapine XR 150 mg/d , 300 mg/d , or placebo adjunct to ongoing antidepressant treatment . The primary endpoint was the change from r and omization to week 6 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score . At week 6 , MADRS total scores significantly improved with quetiapine XR 300 mg/d vs. placebo ( -14.7 vs. -11.7 , p Quetiapine XR 300 mg/d showed significant improvements vs. placebo for : MADRS total score from week 1 onwards ; MADRS response [ ( > or = 50 % total score reduction ) 58.9 % vs. 46.2 % , p remission [ ( total score Hamilton Depression Rating Scale ( HAMD ) ( -13.53 vs. -10.80 , p Clinical Global Impression-Severity of illness ( CGI-S ) change ( -1.52 vs. -1.23 , p quetiapine XR 150 mg/d , improvements were not significantly different vs. placebo , except for MADRS ( weeks 1 and 2 ) and HAMD ( week 6 ) total scores . Withdrawal rates due to adverse events ( AEs ) were : quetiapine XR 150 mg/d 11.5 % , 300 mg/d 19.5 % , and placebo 0.7 % . The most common AEs ( > 10 % ) with quetiapine XR were dry mouth , somnolence , sedation , dizziness , constipation , nausea , insomnia , headache , and fatigue . In this study , quetiapine XR 300 mg/d as adjunctive therapy in patients with MDD with an inadequate response to ongoing antidepressant treatment was effective at week 6 . However , the difference from placebo for quetiapine XR 150 mg/d at week 6 was not statistically significant . Both doses studied ( 150 and 300 mg/d ) were effective at week 1 and generally well tolerated",
"OBJECTIVE Major depressive disorder ( MDD ) is a severe mental illness with high risk of suicidality . Antidepressant treatment alone is not sufficient for the acute management of risk-taking symptoms of depression . This pilot study was design ed to investigate the efficacy of risperidone augmentation to antidepressants in the acute management of suicidality and other core symptoms in MDD with suicidality . METHOD Twenty-four adult men and women diagnosed with MDD ( DSM-IV ) , having a depressive episode with suicidality despite taking an antidepressant , were enrolled in an 8-week double-blind , placebo-controlled study . Subjects were r and omly assigned to receive risperidone ( 0.25 - 2 mg/day ) or placebo while continuing on their antidepressant therapy . Clinical efficacy in suicidality , depressive symptoms , and impulsivity were assessed after treatment with study drugs for 4 days , weekly for 4 weeks , then every other week for 4 weeks . Adverse events were also recorded at each visit . The study was conducted from June 2004 to April 2007 . RESULTS Risperidone significantly reduced suicidal ideations in MDD patients , and the overall effect of risperidone appeared to be superior to placebo . The effect of risperidone was rapid , with onset at 2 weeks ' treatment , and was sustained along the course of 8 weeks ' treatment . Furthermore , risperidone demonstrated superiority to placebo in improving other symptoms related to suicidality and having better trial completion rate , and the low dose risperidone was well tolerated by subjects in this study . CONCLUSION Data from this pilot study suggest that risperidone is beneficial as an augmenting treatment in MDD patients who have developed high-risk suicidal ideation during a depressive episode . The antisuicidality effect of risperidone is especially valuable in the acute management of severe depressive symptoms . Although the pilot study is limited by small sample size , the promising results warrant further larger scale investigation in the efficacy of atypical antipsychotics in the treatment of severe depression with suicidality . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00167154",
"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",
"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 ( enrollment , 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 Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression ( MD ) with psychotic features . OBJECTIVES To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy ; and to compare response by age . DESIGN Twelve-week , double-blind , r and omized , controlled trial . SETTING Clinical services of 4 academic sites . Patients Two hundred fifty-nine subjects with MD with psychotic features r and omized by age ( or = 60 years ) ( mean [ st and ard deviation ( SD ) ] , 41.3 [ 10.8 ] years in 117 younger adults vs 71.7 [ 7.8 ] years in 142 geriatric participants ) . Intervention Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day . Main Outcome Measure Remission rates of MD with psychotic features . RESULTS Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo ( odds ratio [ OR ] , 1.28 ; 95 % confidence interval [ CI ] , 1.12 - 1.47 ; P in remission at their last assessment compared with 23.9 % of subjects treated with monotherapy ( chi(2)(1 ) = 9.53 , P = .002 ) . Combination therapy was comparably superior in both younger ( OR , 1.25 ; 95 % CI , 1.05 - 1.50 ; P = .02 ) and older ( OR , 1.34 ; 95 % CI , 1.09 - 1.66 ; P = .01 ) adults . Overall , tolerability was comparable across age groups . Both age groups had significant increases in cholesterol and triglyceride concentrations , but statistically significant increases in glucose occurred only in younger adults . Younger adults gained significantly more weight than older subjects ( mean [ SD ] , 6.5 [ 6.6 ] kg vs 3.3 [ 4.9 ] kg , P = .001 ) . CONCLUSIONS Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features . Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00056472"
] | 41165fd8-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE The aim of this study was to review the radiological alignment outcomes of patient Specific ( PS ) cutting blocks and St and ard Instrumentation in Primary Total Knee Arthroplasty . METHODS We hypothesized that the use of PS techniques would significantly improve sagittal , coronal and rotational alignment of the prosthesis on short term . We performed a systematic review and a meta- analysis including all the r and omised controlled trials ( RCT ) using PS and st and ard ( ST ) total knee arthroplasty to date . RESULTS A total of 538 PS TKA and 549 ST TKA were included in the study . Statistical analysis of the outliers for femoral component sagittal , coronal and rotational positioning , tibial component sagittal and coronal positioning and the overall mechanical axis were assessed . We found that there was no significant benefit from using PS instrumentation in primary knee arthroplasty to aid in the positioning of either the tibial or femoral components . Furthermore sagittal plane tibial component positioning was worse in the PS than the traditional ST group . CONCLUSION Our results suggest that at present PS instrumentation is not superior to ST instrumentation in primary total knee arthroplasty . LEVEL OF EVIDENCE Level 1 , Systematic review of therapeutic studies | [
"Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II",
"Background Recently , patient-specific guides ( PSGs ) have been introduced , cl aim ing a significant improvement in accuracy and reproducibility of component positioning in TKA . Despite intensive marketing by the manufacturers , this cl aim has not yet been confirmed in a controlled prospect i ve trial . Questions / purpose sWe ( 1 ) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and ( 2 ) logged the need for applying changes in the suggested position of the PSG . Methods In this r and omized controlled trial , we enrolled 128 patients . In the PSG cohort , surgical navigation was used as an intraoperative control . When the suggested cut deviated more than 3 ° from target , the use of PSG was ab and oned and marked as an outlier . When cranial-caudal position or size was adapted , the PSG was marked as modified . All patients underwent long-leg st and ing radiography and CT scan . Deviation of more than 3 ° from the target in any plane was defined as an outlier . Results The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment ( 25 % versus 28 % ; p = 0.69 ) , femoral coronal alignment ( 7 % versus 14 % ) ( p = 0.24 ) , and femoral axial alignment ( 23 % versus 17 % ; p = 0.50 ) . There were more outliers in tibial coronal ( 15 % versus 3 % ; p = 0.03 ) and sagittal 21 % versus 3 % ; p = 0.002 ) alignment in the PSG group than in the conventional group . PSGs were ab and oned in 14 patients ( 22 % ) and modified in 18 ( 28 % ) . Conclusions PSGs do not improve accuracy in TKA and , in our experience , were somewhat impractical in that the procedure needed to be either modified or ab and oned with some frequency . Level of Evidence Level I , therapeutic study . See instructions for authors for a complete description of levels of evidence",
"BACKGROUND Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty . We report the results of a r and omized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments and those managed with traditional instruments . METHODS The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a r and omized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or st and ard instruments ( twenty-six knees ) . Orientation of the implants was compared by using three-dimensional CT data . RESULTS No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up . The patient-specific tibial cutting block was ab and oned in favor of a st and ard external alignment jig in seven of the twenty-two study knees because of possible malalignment . A detailed analysis of intent-to-treat and per- protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments . The percentage of outliers -- defined as less than -3 ° or more than 3 ° from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks than it was in the control group , in both the intent-to-treat ( 32 % versus 8 % , p = 0.032 ) and the per- protocol ( 47 % versus 6 % , p = 0.0008 ) analysis . CONCLUSIONS There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with st and ard instruments . The group treated with patient-specific cutting blocks had a significantly higher prevalence of malalignment in terms of tibial component slope than the knees treated with st and ard instruments ",
"Purpose This prospect i ve , double-blind , r and omised controlled trial was design ed to address the following research questions : firstly , is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA . Secondly , is there a significant difference in operation time , blood loss and length of hospital stay between the two techniques . We hypothesise that there will be fewer outliers with PSG TKA and that operation time , blood loss and length of hospital stay can be significantly reduced with PSG . Methods A total of 180 patients were r and omised for PSG TKA ( group 1 ) or conventional TKA ( group 2 ) in two centres . Patients were stratified per hospital . Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital , st and ing , long-leg and st and ard lateral radiographs by two independent outcome assessors in both centres . Percentages of outliers ( > 3 ° ) were determined . We compared blood loss , operation time and length of hospital stay . Results There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups . No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers . There was a statistically significant difference in outliers for the femoral component in the sagittal plane , with a higher percentage of outliers in the group 1 ( p = 0.017 ) . No such significant result was found for the tibial component in that plane . All interclass correlation coefficients were good . Blood loss was 100 mL less in group 1 ( p ) . Operation time was 5 min shorter in group 1 ( p 0.001 ) . Length of hospital stay was identical with a mean of 3.6 days ( p = 0.657 ) . Conclusions The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups . A small reduction in operation time and blood loss was found with the PSG system . Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA.Level of evidence",
"The primary purpose of this prospect i ve , r and omized study was to determine if patient-specific instrumentation ( PSI ) for total knee arthroplasty ( TKA ) shortened surgical time . Secondarily the number of instrument trays and alignment were also compared to cases performed with traditional instrumentation ( TI ) . Fifty-two cases ( 26 per group ) were r and omized and videotaped to measure the length of surgery , as well as each individual surgical step . Component alignment and mechanical axis was measured radiographically for each patient . Total surgical time was over 4 minutes shorter for patients in the TI group ( 57.4 minutes vs. 61.8 minutes ; P instrument trays were used in the TI group ( 7.3 vs. 2.5 ; P difference in mechanical alignment between groups on postoperative long alignment radiographs ( P=0.77 ) . In conclusion , PSI did not shorten surgical time or improve alignment compared with TI in this prospect i ve , r and omized trial , but did reduce the required number of trays",
"Purpose The aim of this study was to compare radiological results of total knee arthroplasties ( TKAs ) performed with patient-specific computed tomography (CT)-based instrumentation and conventional technique . The main study hypothesis was that CT-based patient-specific instrumentation ( PSI ) increases the accuracy of TKA . Methods A prospect i ve , r and omized controlled trial was carried out between January and December 2011 . A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and r and omly assigned to an experimental or control group . The experimental group comprised 52 patients operated on with the aid of the Signature ™ CT-based implant positioning system . The control group consisted of 60 patients operated on using conventional instrumentation . The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using st and ing anteroposterior radiographs of the entire lower limb and st and ard lateral radiographs . Results Of the 112 patients initially enrolled for the study , 95 were included in the subsequent analyses . There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning . For this parameter , better results were obtained in the control group , with borderline statistical significance . Conclusions Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation . Further high- quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA . In our opinion , the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method",
"In a prospect i ve r and omized control trial comparing computer-assisted vs conventional total knee arthroplasty , we previously reported that patients with coronal alignment within 3 ° of neutral had superior international knee society and Short-Form 12 ( SF-12 ) physical scores at 6 weeks , 3 months , 6 months , and 12 months after surgery . Computer-assisted total knee arthroplasty achieved greater accuracy in implant alignment , and this correlated with better knee function and quality of life . At 5 years , 90 of 111 patients assessed in our original study were review ed . Coronal alignment within 3 ° of neutral continued to be correlated with superior International Knee Society and SF-12 scores . Coronal alignment greater than 3 ° was associated with a significant decline in SF-12 mental health scores",
"Background Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components . In contrast , the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation . Depending on the manufacturer , patient-specific instrumentation is based on either MRI or CT scans . However , it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery . Questions / purpose sWe compared the accuracy of MRI- and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs . The three approaches also were compared with respect to vali date d outcomes scores and duration of surgery . Methods A r and omized clinical trial was conducted in which 90 patients were enrolled and divided into three groups : CT-based , MRI-based patient-specific instrumentation , and conventional instrumentation . The groups were not different regarding age , male/female sex distribution , and BMI . In all groups , coronal and sagittal alignments were measured on postoperative st and ing long-leg and lateral radiographs . Component rotation was measured on CT scans . Clinical outcomes ( Knee Society and WOMAC scores ) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient . MRI- and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation , the patient-specific instrumentation groups were compared with each other , and all three approaches were compared for clinical outcome measures and duration of surgery . Results Compared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis ( MRI versus conventional , 1.0 ° [ range , 0 ° –4 ° ] versus 4.5 ° [ range , 0 ° –8 ° ] , p p = 0.02 ) , femoral rotation ( MRI versus conventional , 1.0 ° [ range , 0 ° –2 ° ] versus 4.0 ° [ range , 1 ° –7 ° ] , p ) , and tibial slope ( MRI versus conventional , 1.0 ° [ range , 0 ° –2 ° ] versus 3.5 ° [ range , 1 ° –7 ° ] , p MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation ( MRI versus CT , 1.0 ° [ range , 0 ° –4 ° ] versus 3.0 ° [ range , 0 ° –5 ° ] , p = 0.03 ) , while there was no difference in femoral rotation or tibial slope . Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation ( MRI versus conventional , 58 minutes [ range , 53–67 minutes ] versus 76 minutes [ range , 57–83 minutes ] , p the postoperative Knee Society pain and function and WOMAC scores among the groups . Conclusions Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis , differences are only subtle and of question able clinical relevance . Because there are no differences in the long-term clinical outcome or survivorship yet available , the widespread use of this technique can not be recommended . Level of Evidence Level I , therapeutic study . See the Instructions to Authors for a complete description of levels of evidence",
"In this study we r and omised 140 patients who were due to undergo primary total knee arthroplasty ( TKA ) to have the procedure performed using either patient-specific cutting guides ( PSCG ) or conventional instrumentation ( CI ) . The primary outcome measure was the mechanical axis , as measured at three months on a st and ing long-leg radiograph by the hip-knee-ankle ( HKA ) angle . This was undertaken by an independent observer who was blinded to the instrumentation . Secondary outcome measures were component positioning , operating time , Knee Society and Oxford knee scores , blood loss and length of hospital stay . A total of 126 patients ( 67 in the CI group and 59 in the PSCG group ) had complete clinical and radiological data . There were 88 females and 52 males with a mean age of 69.3 years ( 47 to 84 ) and a mean BMI of 28.6 kg/m(2 ) ( 20.2 to 40.8 ) . The mean HKA angle was 178.9 ° ( 172.5 to 183.4 ) in the CI group and 178.2 ° ( 172.4 to 183.4 ) in the PSCG group ( p = 0.34 ) . Outliers were identified in 22 of 67 knees ( 32.8 % ) in the CI group and 19 of 59 knees ( 32.2 % ) in the PSCG group ( p = 0.99 ) . There was no significant difference in the clinical results ( p = 0.95 and 0.59 , respectively ) . Operating time , blood loss and length of hospital stay were not significantly reduced ( p = 0.09 , 0.58 and 0.50 , respectively ) when using PSCG . The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment",
"BACKGROUND The purpose of this study was to assess whether custom cutting blocks improve accuracy of component alignment compared to conventional TKA instrumentation . METHODS Eighty primary TKA patients were enrolled in an open-label r and omized prospect i ve clinical trial and were divided into two groups , 40 custom cutting blocks and 40 conventional TKA instrumentations . The primary outcome was prosthetic alignment with respect to mechanical axis and epicondylar axis . Secondary outcomes included operative time , 24-hour postoperative blood loss and hemoglobin at discharged . RESULTS There were no statistical significant differences in the postoperative mechanical axis between the custom cutting blocks group and conventional TKA group , ( 95 % vs. 87.5 % within 3 ° of neutral mechanical alignment , p=0.192 ) . The average rotational alignment was statistically significantly different in the custom cutting blocks group ( 1.0 ° ±0.6 ° vs. 1.6 ° ±1.8 ° external rotation from epicondylar axis , p in operation time between custom cutting blocks group and conventional group , skin to skin [ 57.5±2.3 min vs. 62.1±1.5 , p proportion of patients with postoperative blood loss within 24 h. CONCLUSIONS Custom cutting blocks technique was a surgical procedure which provided better accuracy in rotational alignment but no statistical differences in mechanical axis , less operative time and reduced blood loss than the conventional TKA instrumentation in the majority of patients",
"Patient-specific cutting guides ( PSCGs ) are design ed to improve the accuracy of alignment of total knee replacement ( TKR ) . We compared the accuracy of limb alignment and component positioning after TKR performed using PSCGs or conventional instrumentation . A total of 80 patients were r and omised to undergo TKR with either of the different forms of instrumentation , and radiological outcomes and peri-operative factors such as operating time were assessed . No significant difference was observed between the groups in terms of tibiofemoral angle or femoral component alignment . Although the tibial component in the PSCGs group was measurably closer to neutral alignment than in the conventional group , the size of the difference was very small ( 89.8 ° ( sd 1.2 ) vs 90.5 ° ( sd 1.6 ) ; p = 0.030 ) . This new technology slightly shortened the bone-cutting time by a mean of 3.6 minutes ( p and the operating time by a mean 5.1 minutes ( p = 0.019 ) , without tangible differences in post-operative blood loss ( p = 0.528 ) or need for blood transfusion ( p = 0.789 ) . This study demonstrated that both PSCGs and conventional instrumentation restore limb alignment and place the components with the similar accuracy . The minimal advantages of PSCGs in terms of consistency of alignment or operative time are unlikely to be clinical ly relevant",
"Background Patient-specific CT-based instrumentation may reduce implant malpositioning and improve alignment in TKA . However , it is not known whether this innovation is an advance that benefits patients . Questions / purpose sWe evaluated ( 1 ) the precision of patient-specific TKA by comparing the incidence of outliers in postoperative alignment between TKAs using patient-specific instruments and TKAs using conventional instruments , and ( 2 ) the reliability of patient-specific instruments by intraoperatively investigating whether the surgery could be completed with patient-specific instruments alone . Methods In this r and omized controlled trial , we compared patient-specific TKA instruments from one manufacturer ( n = 50 ) with conventional TKA instruments ( n = 50 ) . Postoperative hip-knee-ankle angles , femoral component rotation , and coronal and sagittal alignments of each component were measured . The validity of the patient-specific instrument was examined using cross-checking procedures with conventional instruments during the surgeries . When the procedure could not be completed accurately with patient-specific instruments , the procedure was converted to TKA using conventional instruments , and the frequency of this occurrence was tallied . Results Outliers in the hip-knee-ankle angle were comparable between groups ( 12 % in the patient-specific instrument group and 10 % in the conventional instrument group ) . Other parameters such as sagittal alignment and femoral component rotation did not differ in terms of outliers . Patient-specific guides were ab and oned in eight knees ( 16 % ) during the surgery because of malrotation of the femoral components and decreased slope of the tibia . Conclusions Accuracy was comparable between TKAs done with patient-specific instruments and those done with conventional instruments . However , the patient-specific instrument procedures had to be aborted frequently , incurring expenses that did not benefit patients .Level of Evidence Level II , therapeutic study . See Instructions for Authors for a complete description of levels of evidence"
] | 41166014-06ff-11f0-808a-c43d1ab1c353 |
Introduction and hypothesisThe objective of the study was to assess the effectiveness of intravesical treatment for painful bladder syndrome ( PBS ) . Methods A systematic review was performed until December 31 , 2010 . The selection criteria included only r and omized controlled trials of PBS patients who received intravesical treatment . The primary outcomes measures were clinical and urodynamic parameters . Relative risk and mean differences were used for binary and continuous outcomes respectively , with confidence interval of 95 % . Results The search strategy identified 770 ; however , only 28 eligible trials met method ological requirements for complete analysis . Altogether , the review included four treatment modalities : resiniferatoxin , Bacillus Calmette – Guérin ( BCG ) , oxybutynin , and alkalinized lidocaine . Meta- analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory , but no difference in 24-h urinary frequency . Conclusions Meta- analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory , but not in 24-h urinary frequency , with BCG therapy . Further r and omized clinical trials , including trials of more recent drugs , are required for evaluation of intravesical therapies for PBS | [
"To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients",
"OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo . Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects",
"PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive",
"PURPOSE To evaluate the efficacy and safety of intravesical Bacillus Calmette-Gurein injection in the treatment of female patients with interstitial cystitis . MATERIAL S AND METHODS Thirty women meeting the National Institute of Arthritis , Diabetes , digestive and kidney diseases criteria for interstitial cystitis , were r and omized in a double-blinded fashion in two groups each consisted of 15 patients to receive six , weekly instillation of 120 mg BCG vaccine of Iranian Institute of pastor or placebo . Periodic question naires on symptoms of interstitial cystitis , voiding diaries , bladder capacity at first desire to void , and maximum bladder capacity were obtained . Adverse events were closely monitored during the treatment and follow-up phases of the study . Subjective and objective baseline values were compared with the follow-up data . RESULTS With a mean follow-up of 24 ( range 6 to 33 ) months 11 out of 15 ( 73 % ) in BCG group , and 3 out of 15 ( 20 % ) in placebo group responded to the treatment ( p improvement in the symptoms of interstitial cystitis . The global improvement in symptoms and signs of interstitial cystitis was 62 % . Adverse events were similar in both groups , mostly irritative in nature and no significant systemic event was noted . BCG did not worsen interstitial cystitis symptoms . CONCLUSION We concluded that intravesical BCG is safe , effective , available , and inexpensive with relatively durable results in the treatment of interstitial cystitis",
"PURPOSE We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis . MATERIAL S AND METHODS The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis . Patients were treated with gradual intravesical instillation of saline oxybutynin solution ( oxybutynin group ) or gradual filling of simple saline ( control group ) . Evaluation parameters consisted of symptom problem index , voids per day , volume per void , functional bladder capacity , volume at first sensation , cystometric bladder capacity and cystometric volume at first sensation . RESULTS Statistically significant improvement of all evaluated parameters was found in both groups . When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group . CONCLUSIONS Bladder training alone produces a satisfactory result by gradually exp and ing the bladder , and an additional statistically significant improvement is evident with intravesical oxybutynin"
] | 41166050-06ff-11f0-808a-c43d1ab1c353 |
We sought to conduct a systematic review to evaluate the predictors of surgical site infection ( SSI ) after cardiac surgery . We included published , peer- review ed , English- language , retrospective and prospect i ve studies identified in a search of Medline , CINAHL , and PubMed from 2005 and through February 20 , 2012 . The studies involved adults ( age > 18 years ) undergoing cardiac surgery ( defined by ICD-9 codes ) and could be of any study design , in English , published within last 7 years , with data collection taking place in United States within last 10 years . We excluded animal studies , duplicates , summaries , commentaries , editorials , case reports , studies that conducted outside United States , and studies published before last 7 years or studies with data collection take place before last 10 years ( 2002 ) . Three types of predictors emerge : Predictors of general infection post cardiac surgery , predictors of micro-organisms ' specific SSIs and tracheotomy , and allogenic blood transfusion as specific predictors of SSI . Although the review ed articles cover wide range of SSIs predictors , none of these articles investigate preoperative skin preparation , using pre- and postoperative prophylaxes antibiotics , postoperative wound care ( appropriate time for first dressing ) , and patient nutritional status as a predictors of SSIs after cardiac surgery . Investigating these predictors for SSIs will enhance nurses ' underst and ing of the importance of specific types of nutrition in preventing SSIs and enhancing wound healing , implementing a protocol for the wound care postoperatively , and implementing a protocol for the use of prophylactic antibiotics | [
"A prospect i ve open-cohort study was performed in 838 adults undergoing coronary revascularization or valve surgery to define the risk factors for development of surgical site infections . Patients diagnosed with mediastinitis or endocarditis during follow-up were compared with patients with no such infection . After 1 year of follow-up , 22 ( 2.6 % ) patients had developed mediastinitis or endocarditis . No preoperative or intraoperative variables were identified as risk factors . By multivariate analysis of postoperative variables , respiratory insufficiency , microorganisms in blood cultures , and intensive care unit stay were independent risk factors for the development of these complications . The type of antibiotic prophylaxis had no influence on the incidence of organ or space infections after cardiac surgery",
"Abstract Gram-negative bacteria account for up to 35 % of postoperative sternal wound infections ( SWI ) in patients undergoing cardiac surgery . Despite this , risk factors for Gram-negative SWI have not been investigated . The objective of this study was to define risk factors associated with Gram-negative SWI in patients undergoing cardiac surgery . 2590 patients undergoing cardiac surgery between 2002 - 2005 were prospect ively monitored for development of SWI . Patient , operative , and post-operative risk factors were compared among patients that developed Gram-negative SWI and Gram-positive SWI to uninfected controls using univariate and multivariate analysis . A p Surgical site infections developed in 152 ( 5.9 % ) patients . Isolates were recovered from the sternum for 128 ( 5.0 % ) patients , from the leg donor site for 19 ( 0.73 % ) patients , and from the sternum and donor site for 5 ( 0.19 % ) patients . Gram-positive pathogens were isolated from 83 ( 3.3 % ) patients , Gram-negative pathogens from 42 ( 1.6 % ) patients , and mixed pathogens from 27 ( 1.0 % ) patients . Hospital admission greater than 48 hours before surgery ( OR : 2.25 ; 95 % CI : 1.11- 4.58 ) , ventilator-dependency preoperatively ( OR : 5.32 95 % CI : 2.22 - 12.75 ) , and thoracentesis procedure postoperatively ( OR : 3.71 ; 95 % CI : 1.45 - 9.49 ) and diabetes ( OR : 2.04 ; 95 % CI : 1.17 - 3.55 ) were identified as significant risk factors for SWI due to Gram-negative bacteria using multivariate logistic regression . Diabetes , increased age , and peripheral vascular disease were identified as significant risk factors for SWI due to Gram-positive bacteria ( p SWI in cardiac surgery",
"OBJECTIVE To identify risk factors associated with surgical-site infection according to the depth of infection , the cardiac procedure , and the National Nosocomial Infections Surveillance System risk index . DESIGN Prospect i ve survey conducted during a 12-month period . SETTING A 48-bed cardiac surgical department in a teaching hospital . PATIENTS Patients admitted for cardiac surgery between February 2002 and January 2003 . RESULTS Surgical-site infections were diagnosed in 3 % of the patients ( 38 of 1,268 ) . Of the 38 surgical-site infections , 20 were superficial incisional infections and 18 were mediastinitis for incidence rates of 1.6 % and 1.4 % , respectively . Cultures were positive in 28 cases and the most commonly isolated pathogen was Staphylococcus . A National Nosocomial Infections Surveillance System risk index score of 2 or greater was associated with a risk of surgical-site infection ( relative risk , 2.4 ; P Heart transplantation , mechanical circulatory assistance , coronary artery bypass graft with the use of internal mammary artery , and reoperation for cardiac tamponade or pericard effusion were independent risk factors associated with surgical-site infection . CONCLUSIONS Data surveillance using incidence rates stratified by cardiac procedure and type of infection is relevant to improving infection control efforts . Risk factors in patients who developed superficial infection were different from those in patients who developed mediastinitis . Coronary artery bypass graft using internal mammary artery was associated with a high risk of surgical-site infection , and independent factors such as reoperation for cardiac tamponade or pericard effusion increased the risk of infection",
"BACKGROUND Many retrospective studies report increased postoperative infection after allogenic blood transfusion . To investigate this phenomenon , we prospect ively studied 232 patients undergoing cardiac surgery . METHODS Patients were screened daily for evidence of culture positive infections . Wounds were examined daily and defined on the ASEPSIS score . Chest radiographs and white cell counts and differentials were recorded on days 1 , 2 , and 4 . The use of blood products was monitored blindly and independently . Patients were grouped according to transfusion status and compared using chi2 or Fisher 's test . Logistic regression analyses were performed to identify predictors of transfusion and infection . RESULTS Of 232 patients , 116 ( 50 % ) received blood product transfusion . Patients receiving blood had lower preoperative hemoglobin , were older , with a greater proportion of urgent/emergency or revision surgery , and were higher risk . Despite this , there were no differences in the frequency of chest infection ( 20 % versus 15 % , p = 0.38 ) , urinary infection ( 3.5 % versus 5.3 % , p = 0 0.75 ) , wound infection ( 3.5 % versus 8.0 % , p = 0.16 ) , or overall infection ( 28 % versus 30 % , p = 0.89 ) comparing the transfused versus untransfused groups . There was no evidence to suggest that administration of blood products was associated with infection ( odds ratio 0.92 , p = 0.77 ) . CONCLUSIONS The administration of blood per se did not lead to increased postoperative infection . Clinicians should reconsider withholding blood transfusion in patients solely owing to concerns of predisposition to infection",
"BACKGROUND As part of a Food and Drug Administration trial , mitral repairs were performed in 38 patients using the robotic da Vinci surgical system ( Intuitive Surgical , Inc , Mountain View , CA ) . Prospect ively , we evaluated safety and efficacy in performing both simple and complex mitral repairs . METHODS Eligible patients had nonischemic moderate to severe mitral insufficiency . Operative techniques included peripheral cardiopulmonary perfusion , a 4- to 5-cm mini-thoracotomy , transthoracic aortic occlusion , and ante grade blood cardioplegia . Transesophageal echocardiograms were done intraoperatively with three-dimensional reconstructions . Successful repairs were defined as mild or less residual regurgitation . RESULTS Enhanced three-dimensional visualization of mitral leaflets and the subvalvar apparatus allowed safe , dexterous intracardiac tissue manipulation . All patients had successful valve repairs including quadrangular resections , sliding plasties , and edge-to-edge approximations , as well as both chordal transfers and replacements . There were no operative deaths , strokes , or device-related complications . One patient required valve replacement for hemolysis and 1 was reexplored for bleeding . There were no incisional conversions . Both robotic repair and total operating times decreased significantly from 1.9 + /- 0.1 and 5.1 + /- 0.1 hours ( mean + /- st and ard error of the mean ) for the first 19 patients to 1.5 + /- 0.1 ( p = 0.002 ) and 4.4 + /- 0.1 hours ( p = 0.04 ) for the last 19 operations , respectively . Total hospital length of stay for patients was 3.8 + /- 0.6 days . Of all patients , 31 ( 82 % ) had a 4-day or less length of stay . Seven patients ( 18 % ) had stays between 5 and 9 days ( 6.4 + /- 1.0 ) . CONCLUSIONS This study shows that the da Vinci surgical system ( Intuitive Surgical , Inc ) has few limitations in performing complex valve repairs . Articulated wrist-like instruments and three-dimensional visualization enabled precise tissue telemanipulation . Future robotic design advances and adjunctive suture technologies may promote continuing evolution of robotic cardiac operations",
"OBJECTIVE In a prospect i ve phase II Food and Drug Administration trial , robotic mitral valve repairs were performed in 112 patients at 10 centers by using the da Vinci surgical system . The safety of performing valve repairs with computerized telemanipulation was studied . METHODS After institutional review board approval , informed consent was obtained . Patients had moderate to severe mitral regurgitation . Operative technique included peripheral cardiopulmonary bypass , a 4- to 5-cm right minithoracotomy , a transthoracic aortic crossclamp , and ante grade cardioplegia . The successful study end point was grade 0 or 1 mitral regurgitation by transthoracic echocardiography at 1 month after surgery . RESULTS Valve repairs included quadrangular resections , sliding plasties , edge-to-edge approximations , and both chordal transfers and replacements . The average age was 56.4 + /- 0.09 years ( mean + /- SEM ) . There were 77 ( 68.8 % ) men and 35 ( 31.2 % ) women . Valve pathology was myxomatous degeneration in 105 ( 91.1 % ) , and 103 ( 92.0 % ) had type II leaflet prolapse . Leaflet repair times averaged 36.7 + /- 0.2 minutes , with annuloplasty times of 39.6 + /- 0.1 minutes . Total robot , aortic crossclamp , and cardiopulmonary bypass times were 77.9 + /- 0.3 minutes , 2.1 + /- 0.1 hours , and 2.8 + /- 0.1 hours , respectively . On 1-month transthoracic echocardiography , 9 ( 8.0 % ) had grade 2 mitral regurgitation , and 6 ( 5.4 % ) of these had reoperations ( 5 replacements and 1 repair ) . There were no deaths , strokes , or device-related complications . CONCLUSIONS Multiple surgical teams performed robotic mitral valve repairs safely early in development of this procedure , with a reoperation rate of 5.4 % . Advancements in robotic design and adjunctive technologies may help in the evolution of this minimally invasive technique by decreasing operative times"
] | 4116608c-06ff-11f0-808a-c43d1ab1c353 |
& NA ; Objectives To assess diagnostic accuracy of screening tests for pre‐diabetes and efficacy of interventions ( lifestyle or metformin ) in preventing onset of type 2 diabetes in people with pre‐diabetes . Design Systematic review and meta‐ analysis . Data sources and method Medline , Pre Medline , and Embase . Study protocol s and seminal papers were citation‐tracked in Google Scholar to identify definitive trials and additional publications . Data on study design , methods , and findings were extracted onto Excel spreadsheets ; a 20 % sample was checked by a second research er . Data extracted for screening tests included diagnostic accuracy and population prevalence . Two meta‐analyses were performed , one summarising accuracy of screening tests ( with the oral glucose tolerance test as the st and ard ) for identification of pre‐diabetes , and the other assessing relative risk of progression to type 2 diabetes after either lifestyle intervention or treatment with metformin . Eligibility criteria Empirical studies evaluating accuracy of tests for identification of pre‐diabetes . Interventions ( r and omised trials and interventional studies ) with a control group in people identified through screening . No language restrictions . Results 2874 titles were scanned and 148 papers ( covering 138 studies ) review ed in full . The final analysis included 49 studies of screening tests ( five of which were prevalence studies ) and 50 intervention trials . HbA1c had a mean sensitivity of 0.49 ( 95 % confidence interval 0.40 to 0.58 ) and specificity of 0.79 ( 0.73 to 0.84 ) , for identification of pre‐diabetes , though different studies used different cut‐off values . Fasting plasma glucose had a mean sensitivity of 0.25 ( 0.19 to 0.32 ) and specificity of 0.94 ( 0.92 to 0.96 ) . Different measures of glycaemic abnormality identified different sub population s ( for example , 47 % of people with abnormal HbA1c had no other glycaemic abnormality ) . Lifestyle interventions were associated with a 36 % ( 28 % to 43 % ) reduction in relative risk of type 2 diabetes over six months to six years , attenuating to 20 % ( 8 % to 31 % ) at follow‐up in the period after the trails . Conclusions HbA1c is neither sensitive nor specific for detecting pre‐diabetes ; fasting glucose is specific but not sensitive . Interventions in people classified through screening as having pre‐diabetes have some efficacy in preventing or delaying onset of type 2 diabetes in trial population s. As screening is inaccurate , many people will receives an incorrect diagnosis and be referred on for interventions while others will be falsely reassured and not offered the intervention . These findings suggest that “ screen and treat ” policies alone are unlikely to have substantial impact on the worsening epidemic of type 2 diabetes . Registration PROSPERO ( No CRD42016042920 ) | [
"Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir =",
"BACKGROUND Public health decision-making is hampered by inappropriate adherence to underpowered r and omized controlled trials ( RCTs ) which give inconclusive results and lead to decision-makers being loath to recommend interventions with strong theoretical and observational support . METHODS We outline situations in which robust decisions about health interventions can be made without trial evidence . We present a new approach in which theory , causal models and past observations are given proper regard in the decision-making process . RESULTS Using our approach , we provide examples where the use of causal theories and observations in areas , such as salt reduction , smoking cessation and gardening to improve mental health , is sufficient for deciding that such interventions are effective for improving health without needing the support of underpowered RCTs . Particularly where RCT evidence is inconclusive , our approach may provide similar aggregate health outcomes for society for vastly lower cost . CONCLUSIONS When knowledge and theoretical underst and ing are unable sufficiently to reduce doubt about the direction of effect from an intervention , decisions should be made using evidence -based medicine approaches . There are , however , many cases where the combination of robust theory , causal underst and ing and observation are able to provide sufficient evidence of the direction of effect from an intervention that current practice should be altered",
"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",
"Background Type 2 diabetes is a major health problem in many countries including India . Yoga may be an effective type 2 diabetes prevention strategy in India , particularly given its cultural familiarity . Methods This was a parallel , r and omized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes . Primary outcomes included : changes in BMI , waist circumference , fasting blood glucose , postpr and ial blood glucose , insulin , insulin resistance , blood pressure , and cholesterol . We also looked at measures of psychological well-being including changes in depression , anxiety , positive and negative affect and perceived stress . Forty-one participants with elevated fasting blood glucose in Bangalore , India were r and omized to either yoga ( n = 21 ) or a walking control ( n = 20 ) . Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks . R and omization and allocation was performed using computer-generated r and om numbers and group assignments delivered in sealed , opaque envelopes generated by off-site study staff . Data were analyzed based on intention to treat . Results This study was feasible in terms of recruitment , retention and adherence . In addition , yoga participants had significantly greater reductions in weight , waist circumference and BMI versus control ( weight −0.8 ± 2.1 vs. 1.4 ± 3.6 , p = 0.02 ; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2 , p 0.01 ; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6 , p = 0.05 ) . There were no between group differences in fasting blood glucose , postpr and ial blood glucose , insulin resistance or any other factors related to diabetes risk or psychological well-being . There were significant reductions in systolic and diastolic blood pressure , total cholesterol , anxiety , depression , negative affect and perceived stress in both the yoga intervention and walking control over the course of the study . Conclusion Among Indians with elevated fasting blood glucose , we found that participation in an 8-week yoga intervention was feasible and result ed in greater weight loss and reduction in waist circumference when compared to a walking control . Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being . Trial registration Clinical Trials.gov Identified NCT00090506",
"BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values reductions in metabolic indicators and adiposity ",
"The purpose of the present study was to evaluate the impact of a lifestyle intervention programme , combined with a daily low-glycaemic index meal replacement , on body-weight and glycaemic control in subjects with impaired glucose regulation ( IGR ) . Subjects with IGR were r and omly assigned to an intervention group ( n 46 ) and a control group ( n 42 ) . Both groups received health counselling at baseline . The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study , and follow-up visits performed monthly until the end of the 1-year study . Outcome measurements included changes in plasma glucose , glycated Hb ( HbA1c ) , plasma lipids , body weight , blood pressure and body composition ( such as body fat mass and visceral fat area ) . The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group ( -1·8 ( SEM 0·35 ) v. -0·6 ( SEM 0·40 ) 2·5 kg , P decreased 1·24 mmol/l in the intervention group and increased 0·85 mmol/l in the control group ( P 5 kg body-weight loss at 1 year was associated with a decrease of 1·49 mmol/l in 2 h plasma glucose ( P . The incidence of normal glucose regulation ( NGR ) in the two groups was significantly different ( P=0·001 ) . In conclusion , the combination of regular contact , lifestyle advice and meal replacement is beneficial in promoting IGR to NGR",
"Venn diagrams with three curves are used extensively in various medical and scientific disciplines to visualize relationships between data sets and facilitate data analysis . The area of the regions formed by the overlapping curves is often directly proportional to the cardinality of the depicted set relation or any other related quantitative data . Drawing these diagrams manually is difficult and current automatic drawing methods do not always produce appropriate diagrams . Most methods depict the data sets as circles , as they perceptually pop out as complete distinct objects due to their smoothness and regularity . However , circles can not draw accurate diagrams for most 3-set data and so the generated diagrams often have misleading region areas . Other methods use polygons to draw accurate diagrams . However , polygons are non-smooth and non-symmetric , so the curves are not easily distinguishable and the diagrams are difficult to comprehend . Ellipses are more flexible than circles and are similarly smooth , but none of the current automatic drawing methods use ellipses . We present eulerAPE as the first method and software that uses ellipses for automatically drawing accurate area-proportional Venn diagrams for 3-set data . We describe the drawing method adopted by eulerAPE and we discuss our evaluation of the effectiveness of eulerAPE and ellipses for drawing r and om 3-set data . We compare eulerAPE and various other methods that are currently available and we discuss differences between their generated diagrams in terms of accuracy and ease of underst and ing for real world data",
"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",
"AIMS To explore factors influencing post-natal health behaviours following the experience of gestational diabetes , and to elicit women 's views about the feasibility of lifestyle intervention to prevent diabetes during the first 2 years after childbirth . METHODS Qualitative study using semi-structured interviews with women who had gestational diabetes . In phase 1 ( 31 women ) , interviews explored the experience of gestational diabetes , ideas about future risk of diabetes and factors influencing post-natal health-related behaviours . Statements were developed summarizing women 's views of lifestyle change to prevent diabetes . In phase 2 ( 14 women ) , interviews explored how the passage of time had contributed to changes in health behaviour , and the statements were used to develop views about diabetes interventions . RESULTS Women were aware of their risk of developing diabetes , but did not always act on such knowledge . Pregnancy motivated behaviour changes to benefit the unborn child , but after delivery these changes were often not maintained . Tiredness , maternal attachment and childcare dem and s were prominent barriers in the early post-natal months . Later , work , family and child development became more significant barriers . Many women became more receptive to healthy eating messages around the time of weaning . Women were positive about long-term support for self-management to reduce their diabetes risk . CONCLUSIONS There is potential to reduce the risk of Type 2 diabetes post-natally among women with gestational diabetes . Interventions need to be developed that take into account context ual factors and competing dem and s , are flexible and respond to women 's individual circumstances . R and omized trials of such interventions are warranted",
"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 To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus ( GDM ) delivered at the health system level : mailed recommendations ( usual care ) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention . RESEARCH DESIGN AND METHODS This study was a cluster r and omized controlled trial of 44 medical facilities ( including 2,280 women with GDM ) r and omized to intervention or usual care . The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum . Primary outcomes included the following : proportion meeting the postpartum goals of 1 ) reaching pregravid weight if pregravid BMI . RESULTS On average , over the 12-month postpartum period , women in the intervention had significantly higher odds of meeting weight goals than women in usual care ( odds ratio [ OR ] 1.28 [ 95 % CI 1.10 , 1.47 ] ) . The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks ( 25.5 vs. 22.4 % ; OR 1.17 [ 1.01 , 1.36 ] ) and 6 months ( 30.6 vs. 23.9 % ; OR 1.45 [ 1.14 , 1.83 ] ) . Condition differences were reduced at 12 months ( 33.0 vs. 28.0 % ; OR 1.25 [ 0.96 , 1.62 ] ) . At 6 months , women in the intervention retained significantly less weight than women in usual care ( mean 0.39 kg [ SD 5.5 ] vs. 0.95 kg [ 5.5 ] ; mean condition difference −0.64 kg [ 95 % CI −1.13 , −0.14 ] ) and had greater increases in vigorous-intensity physical activity ( mean condition difference 15.4 min/week [ 4.9 , 25.8 ] ) . CONCLUSIONS A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity ",
"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",
"Background Offering the overweight or obese patient the option of choosing from a selection of weight loss diets has not been investigated in type 2 diabetes . The aim of the study was to investigate if the option to choose from , and interchange between a selection of diets ( “ Choice ” ) , as opposed to being prescribed one set diet ( “ No Choice ” ) , improves drop out rates and leads to improved weight loss and cardio-metabolic outcomes . Methods The study was a 12 month , r and omized parallel intervention . A total of 144 volunteers with type 2 diabetes or pre-diabetes and a BMI > 27 were r and omized to “ No Choice ” or “ Choice ” . Those in the No Choice group were placed on a set weight loss diet ( CSIRO ) with no change permitted . Those in the Choice group could choose from , and interchange between , the CSIRO , South Beach or Mediterranean diets . Results There were no differences in attrition rates or weight loss between the “ Choice ” and “ No Choice ” . In a secondary analysis of the intention-to-treat weight loss data with last measured weight carried forward gave a highly significant diet group by time by gender interaction ( p = 0.002 ) with men doing better in the No Choice group overall ( maximum difference “ No Choice “ -2.9 ± 4.6 kg vs. “ Choice”-6.2 kg ± 5.3 kg at 6 months ) and women doing better in the Choice group overall ( maximum difference Choice -3.1 ± 3.7 kg vs. “ No Choice ” -2.0 kg ± 2.6 kg at 6 months ) . Conclusions Men prefer direction in their weight loss advice and do less well with choice . A gender-specific approach is recommended when prescribing weight loss diets . Trial registration anzctr.org.au ACTRN12612000310864",
"Objective To assess effectiveness and implementability of the public health programme Life ! Taking action on diabetes in Australian people at risk of developing type 2 diabetes . Research design and methods Melbourne Diabetes Prevention Study ( MDPS ) was a unique study assessing effectiveness of Life ! that used a r and omized controlled trial design . Intervention participants with AUSDRISK score ≥15 received 1 individual and 5 structured 90 min group sessions . Controls received usual care . Outcome measures were obtained for all participants at baseline and 12 months and , additionally , for intervention participants at 3 months . Per protocol set ( PPS ) and intention to treat ( ITT ) analyses were performed . Results PPS analyses were considered more informative from our study . In PPS analyses , intervention participants significantly improved in weight ( −1.13 kg , p=0.016 ) , waist circumference ( −1.35 cm , p=0.044 ) , systolic ( −5.2 mm Hg , p=0.028 ) and diastolic blood pressure ( −3.2 mm Hg , p=0.030 ) compared with controls . Based on observed weight change , estimated risk of developing diabetes reduced by 9.6 % in the intervention and increased by 3.3 % in control participants . Absolute 5-year cardiovascular disease ( CVD ) risk reduced significantly for intervention participants by 0.97 percentage points from 9.35 % ( 10.4 % relative risk reduction ) . In control participants , the risk increased by 0.11 percentage points ( 1.3 % relative risk increase ) . The net effect for the change in CVD risk was −1.08 percentage points of absolute risk ( p=0.013 ) . Conclusions MDPS effectively reduced the risk of diabetes and CVD , but the intervention effect on weight and waist reduction was modest due to the challenges in recruiting high-risk individuals and the abbreviated intervention",
"OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk ",
"Introduction This study investigated the outcomes and identified influencing factors of intensive integrated intervention over 2 years in Chinese patients with impaired glucose regulation ( IGR ) . Methods Adults in Beijing , China , were screened for IGR using the 75 g oral glucose tolerance test . Participants with IGR received lifestyle and health education ; those who still had IGR after 1 year were r and omly assigned to either a routine care group or to an intensive integrated intervention group . Results Of 2344 adults screened , 463 had IGR . Of these , 210 adults had IGR after 1 year and were therefore recruited and r and omized to an intensive integrated intervention group ( n=106 ) or a control group ( n=104 ) . The percentage of patients who reached the set targets of plasma glucose , blood pressure , body mass index , or triglycerides was significantly higher in the intensive integrated intervention group . None of the patients within the intensive integrated intervention group progressed to diabetes , whereas eight ( 9.3 % ) cases of the control group developed type 2 diabetes mellitus ( T2DM ) . Logistic regression analysis showed that both an increase in waist circumference and systolic blood pressure ( SBP ) were positively correlated with the development of T2DM , whereas improvement in islet beta cell function was negatively correlated with the development of T2DM . Conclusions Intensive integrated intervention may significantly decrease the conversion rate of IGR to T2DM , and increase the conversion ratio to normal glucose tolerance . The increase of waist circumference or SBP and the deterioration of islet beta cell function may be important risk factors for progression from prediabetes to diabetes",
"Introduction Although lifestyle interventions are effective in delaying the onset of diabetes , translating these lessons to routine health care setting s remains a challenge . We investigated the effectiveness of a theory-based , brief , small-group weight loss intervention for diabetes prevention . A secondary purpose was to determine the potential reach of the intervention . Methods A total of 14,379 members of an integrated health care organization newly diagnosed with prediabetes were potentially eligible to participate in this matched cohort longitudinal study . Of this group , 1,030 attended a 90-minute , small-group session that targeted personal action planning for healthful eating , physical activity , and weight management . We accessed electronic medical records to select 1 to 2 controls ( matched on impaired fasting glucose measurement , sex , age , and body mass index ) for each member who attended the small-group session ( n = 760 ) . Weight change , as recorded in the medical record , was the primary outcome . Mixed models analyses were used to adjust for matching variables and covariates and to account for individual r and om effects over time . Results Small-group participants lost significantly more weight than did their matched controls . A significantly higher proportion of small-group participants lost at least 5 % of their body weight compared with controls . Conclusion A brief , small-group weight loss intervention was effective . However , it did not reach broadly into the population that was at risk for diabetes",
"OBJECTIVES To study the effectiveness of yoga intervention on oxidative stress , glycemic status , blood pressure and anthropometry in prediabetes . DESIGN R and omized-controlled trial . PARTICIPANTS Twenty nine prediabetes subjects aged 30 - 75 years . SETTING Yoga was conducted at 4 different community diabetes clinics in Mangalore , India . INTERVENTIONS Participants were r and omized to either 3-month yoga or wait-list control groups . MAIN OUTCOME MEASURES Malondialdehyde , glutathione , vitamin C , vitamin E , superoxide dismutase , plasma glucose , glycated haemoglobin , BMI , waist circumference , waist-to-hip ratio and blood pressure . RESULTS Yoga intervention result ed in a significant decline in malondialdehyde ( p BMI , waist circumference , systolic blood pressure and fasting glucose levels at follow-up . No significant improvement in glycated haemoglobin , waist-to-hip ratio or any of the antioxidants was observed . CONCLUSIONS Yoga intervention may be helpful in control of oxidative stress in prediabetes subjects . Yoga can also be beneficial in reduction in BMI , waist circumference , systolic blood pressure and fasting glucose . Effect of yoga on antioxidant parameters was not evident in this study . The findings of this study need to be confirmed in larger trials involving active control groups",
"OBJECTIVE To determine A1C cut points for glucose intolerance in Asian Indians . RESEARCH DESIGN AND METHODS A total of 2,188 participants without known diabetes were r and omly selected from the Chennai Urban Rural Epidemiology Study . All had fasting plasma glucose ( FPG ) and 2-h postload plasma glucose measurements after a 75-g load and were classified as having impaired fasting glucose ( IFG ) ( American Diabetes Association [ ADA ] criteria , FPG ≥5.5 and . A1C was measured using the Bio-Rad Variant machine . Based on receiver operating characteristic curves , optimum sensitivity and specificity were derived for defining A1C cut points for diabetes , IGT , and IFG . RESULTS Mean ± SD values of A1C among subjects with normal glucose tolerance , IGT , and diabetes were 5.5 ± 0.4 , 5.9 ± 0.6 , and 8.3 ± 2.0 % , respectively ( Ptrend postload plasma glucose , the A1C cut point of 6.1 % had an area under the curve ( AUC ) of 0.941 with 88.0 % sensitivity and 87.9 % specificity . When diabetes was defined as FPG ≥7.0 mmol/l , the A1C cut point was 6.4 % ( AUC = 0.966 , sensitivity 93.3 % , and specificity 92.3 % ) . For IGT , AUC = 0.708 ; for IFG , AUC = 0.632 ( WHO criteria ) and 0.708 ( ADA criteria ) , and the A1C cut point was 5.6 % . CONCLUSIONS In Asian Indians , A1C cut points of 6.1 and 6.4 % defined diabetes by 2-h postload plasma glucose or FPG criteria , respectively . A value of 5.6 % optimally identified IGT or IFG but was < 70 % accurate",
"Objectives To examine the effects of telephone-delivered lifestyle coaching on preventing the development of type 2 diabetes mellitus ( T2DM ) in participants with impaired fasting glucose ( IFG ) . Design Cluster r and omised trial . Setting 40 groups from 17 healthcare divisions in Japan : companies ( 31 ) , communities ( 6 ) and mixed setting s ( 3 ) . Participants Participants aged 20–65 years with fasting plasma glucose ( FPG ) of 5.6–6.9 mmol/L were invited from the 17 healthcare divisions . R and omisation The groups were then r and omly assigned to an intervention or a control arm by independent statisticians according to a computer-generated list . Intervention The intervention arm received a 1-year telephone-delivered intervention provided by three private lifestyle support centres ( at different frequencies : low-frequency ( 3 times ) , middle-frequency ( 6 times ) and high-frequency ( 10 times ) support calls ) . The intervention and control arms both received self-help devices such as a weight scale and pedometer . Outcomes Participants were followed up using data from annual health check-ups and a question naire regarding lifestyle . The primary outcome was the development of T2DM defined as FPG ≥7.0 mmol/L , the diagnosis of diabetes , or use of an antidiabetic drug , confirmed by referring to medical cards . Results Of 14 473 screened individuals , participants were enrolled in either the intervention ( n=1240 ) arm or control ( n=1367 ) arm . Overall , the HR for the development of T2DM in the intervention arm during 5.5 years was 1.00 ( 95 % CI 0.74 to 1.34 ) . In the sub analysis , the HR was 0.59 ( 95 % CI 0.42 to 0.83 ) in the subgroup that received phone calls the most frequently , compared with the control arm . A limitation of the study includes a lack of blinding . Conclusions High-frequency telephone-delivered lifestyle support could effectively prevent T2DM in participants with IFG in a primary healthcare setting , although low-frequency and middle-frequency phone calls did not . Trial registration number This trial has been registered with the University Hospital Medical Information Network ( UMIN000000662 )",
"Background A r and omized control trial was performed to test whether a lifestyle intervention program , carried out in a primary healthcare setting using existing re sources , can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance ( IGT ) . The results of 3 years ' intervention are summarized . Methods Through health checkups in communities and workplaces , 304 middle-aged IGT subjects with a mean body mass index ( BMI ) of 24.5 kg/m2 were recruited and r and omized to the intervention group or control group . The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational material s provided by the study group . Results After 1 year , the intervention had significantly improved body weight ( -1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control ; p = 0.023 ) and daily non-exercise leisure time energy expenditure ( 25 ± 113 vs. -3 ± 98 kcal ; p = 0.045 ) . Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years . The 3-year cumulative incidence tended to be lower in the intervention group ( 14.8 % vs.8.2 % , log-rank test : p = 0.097 ) . In a sub- analysis for the subjects with a BMI > 22.5 kg/m2 , a significant reduction in the cumulative incidence was found ( p = 0.027 ) . Conclusions The present lifestyle intervention program using existing healthcare re sources is beneficial in preventing diabetes in Japanese with IGT . This has important implication s for primary healthcare-based diabetes prevention . Trial registration",
"OBJECTIVE To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance ( IGT ) . RESEARCH DESIGN AND METHODS Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester , U.K. Participants were r and omly assigned to one of three groups . Group 1 received a 3-h group-based structured education program design ed to promote walking activity using personalized steps-per-day goals and pedometers . Group 2 received a 3-h group-based structured education program design ed to promote walking activity using generic time-based goals . Group 3 received a brief information leaflet ( control condition ) . Outcomes included an oral glucose tolerance test , st and ard anthropometric measures , ambulatory activity , and psychological variables . Follow-up was conducted at 3 , 6 , and 12 months . RESULTS A total of 87 individuals ( 66 % male , mean age 65 years ) were included in this study . At 12 months , significant decreases in 2-h postchallenge glucose and fasting glucose of −1.31 mmol/l ( 95 % CI −2.20 to −0.43 ) and −0.32 mmol/l ( −0.59 to −0.03 ) , respectively , were seen in the pedometer group compared with the control group . No significant improvements in glucose control were seen in those given the st and ard education program . CONCLUSIONS This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT . This result is likely to have important implication s for future primary care – based diabetes prevention initiatives",
"We compared the effects of two diets on glycated hemoglobin ( HbA1c ) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes ( HbA1c>6 % ) . We r and omized participants to either a medium carbohydrate , low fat , calorie-restricted , carbohydrate counting diet ( MCCR ) consistent with guidelines from the American Diabetes Association ( n = 18 ) or a very low carbohydrate , high fat , non calorie-restricted diet whose goal was to induce nutritional ketosis ( LCK , n = 16 ) . We excluded participants receiving insulin ; 74 % were taking oral diabetes medications . Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance . At 3 months , mean HbA1c level was unchanged from baseline in the MCCR diet group , while it decreased 0.6 % in the LCK group ; there was a significant between group difference in HbA1c change favoring the LCK group ( −0.6 % , 95 % CI , −1.1 % to −0.03 % , p = 0.04 ) . Forty-four percent of the LCK group discontinued one or more diabetes medications , compared to 11 % of the MCCR group ( p = 0.03 ) ; 31 % discontinued sulfonylureas in the LCK group , compared to 5 % in the MCCR group ( p = 0.05 ) . The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group ( p = 0.09 ) . Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications . This clinical trial was registered with Clinical Trials.gov , number NCT01713764",
"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",
"BACKGROUND Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive . Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification . We aim ed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance . METHODS We did a prospect i ve , parallel-group , r and omised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India . Working Indian men ( aged 35 - 55 years ) with impaired glucose tolerance were r and omly assigned ( 1:1 ) with a computer-generated r and omisation sequence to a mobile phone messaging intervention or st and ard care ( control group ) . Participants in the intervention group received frequent mobile phone messages compared with controls who received st and ard lifestyle modification advice at baseline only . Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators . The primary outcome was incidence of type 2 diabetes , analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00819455 . RESULTS We assessed 8741 participants for eligibility . 537 patients were r and omly assigned to either the mobile phone messaging intervention ( n=271 ) or st and ard care ( n=266 ) . The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 0·64 , 95 % CI 0·45 - 0·92 ; p=0·015 ) . The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6 - 55 ) . One patient in the control group died suddenly at the end of the first year . We recorded no other serious adverse events . INTERPRETATION Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk . FUNDING The UK India Education and Research Initiative , the World Diabetes Foundation",
"Objective : To compare the effects of counseling alone with that of additional participation in supervised training courses on exercise capacity in patients with impaired fasting glucose . Design : R and omized , controlled intervention trial using a nested cohort approach . Setting : Primary care centers in western Austria . Patients : Thirty-six patients with impaired fasting glucose ( 16 males , 20 females ; mean age , 57.5 ± 6.9 years ) . Interventions : Participants of both groups were instructed about the preventive effectiveness of changing their lifestyle , especially losing weight and increasing physical activity . One group had additionally been offered supervised , progressive , individually tailored aerobic exercise programs for 1 hour twice a week . Main Outcome Measures : Changes in the levels of exercise capacity , body mass , and fasting blood glucose . Results : The subjects with supervised exercise participated in this program for 1.8 hours ( ± 0.3 ) per week over 12 months . Supervised exercise was sufficient to maintain exercise capacity , whereas counseling alone was not ( + 4.4 % versus -6.9 % ; P = 0.01 ) . After the 12-month intervention period , body mass was reduced in the supervised exercise group ( -3.0 % ) compared with the counseling alone group ( + 1.0 % ) ( P = 0.03 ) and fasting plasma glucose levels had similarly improved by counseling for adequate lifestyle changes alone ( -8.2 % ) and in combination with supervised exercise ( -6.0 % ) . Conclusion : In contrast to counseling alone , 2 sessions of supervised training per week , besides the self-chosen physical activity and nutritional measures , are sufficient to maintain exercise capacity in patients with impaired fasting glucose",
"I was asked recently to name the single most important intervention to reduce childhood obesity . My weary reply was that the single most important intervention is to underst and that there is no single most important intervention . This was greeted with predictable dismay , and groans of derision from my colleagues , who chided me for imperious ivory-towered idealism . But I st and by my response . Obesity is the outcome of a complex web of social , cultural , environmental , biological and psychological influences . As has recently been described in this journal ( Raine 2012 ) people ’s diets and physical activity exist within an ecological system of human behaviour that requires upstream actions to shift it . The system map produced for the UK Government ’s Foresight report clearly shows how this complex system acts at all levels of society , with numerous linkages and interactions ( Butl and et al. 2007 ; Finegood et al. 2010 ) . But what do we need to do fully to underst and a complex system such as this , and more importantly how do we decide how best to respond to it ? The scientific underpinnings of public health have made huge advances in recent years , building to a large extent on the principles of evidence -based medicine ( EBM ) . But many complex questions about the most effective ways to influence behaviour and improve health are simply not amenable to this kind of assessment . There is a fundamental epistemological difference between the rigorous EBM methods that can differentiate between two treatments , and the kinds of research that are able to identify effective , sustainable approaches within complex adaptive systems . We need to move from evidence to knowledge ( Rayner and Lang 2012 ) , but public health remains largely in thrall to the EBM approach . In obesity , despite the rhetoric of complexity becoming commonplace , there is still a strong intellectual dependence upon systematic review s and other forms of putatively robust and defensible evidence . The concept of complexity in health care , and in public health , has been around for some years now ( Plsek and Greenhalgh 2001 ) , but remains on the margins of the majority of health and policy activity . This may be at least partly because of the inherent challenge of the perspective to a discipline grounded in biomedicine . R and omised controlled trials and meta analyses are the kinds of tools that have successfully dragged us away from the unhelpful biases of expert opinion and led us to disinterested objectivity . But non-linear systems with feedback , interactions , emergence , compensatory behaviours and small effect sizes are not suited to dichotomous hypothesis testing , result ing in few robust studies and often very little to review . The job of public health is not the same as the one we started on a few years ago , and now is the time for some new tools , and new skills to use them . These tools are commonly used in other fields , such as climate change modelling , defence , and business . They involve a significant shift in thinking , from linear cause and effect to non-linear system-wide dynamics , and much greater tolerance of uncertainty and unpredictability . These ways of thinking allow us to conceptualise and respond to systems problems such as obesity in far more effective H. Rutter ( & ) London School of Hygiene and Tropical Medicine , Keppel Street , London WC1E 7HT , UK e-mail : [email protected] Int J Public Health DOI 10.1007/s00038 - 012 - 0385 -",
"AIM To compare American Diabetes Association and International Expert Committee recommended cut-off values of HbA(1c ) for detecting the presence of pre-diabetes against plasma glucose values obtained from oral glucose tolerance tests in Asian Indians . METHODS A cross-sectional r and omly sample d population survey involving 2368 adults , aged ≥ 20 years . HbA(1c ) was measured on a Bio-Rad 10 system in 1972 subjects . RESULTS Of the 1972 subjects studied , 329 were detected to have pre-diabetes based on isolated impaired fasting glucose in 125 subjects ( 6.3 % ) , isolated impaired glucose tolerance in 141 subjects ( 7.1 % ) and the presence of both in 63 subjects ( 3.2 % ) . The HbA(1c ) cut-off of 34 mmol/mol ( 5.7 % ) , as recommended by the American Diabetes Association for detecting the presence of pre-diabetes , showed sensitivity of 62 % , specificity 77 % , with a positive predictive value of 34.7 % , a negative predictive value of 89.5 % and accuracy of 67.8 % ; whereas the HbA(1c ) cut-off recommended by the International Expert Committee of 42 mmol/mol ( 6 % ) had a sensitivity of 36 % , specificity of 90 % , positive predictive value of 42.7 % , negative predictive of 85.4 % and an accuracy of 77 % . However , both these HbA(1c ) cut-offs underdiagnosed the presence of pre-diabetes in 38 and 64 % of these subjects , respectively . CONCLUSIONS The American Diabetes Association and the International Expert Committee recommended HbA(1c ) cut-off values and oral glucose tolerance tests identify different pre-diabetes cohorts . Long-term prospect i ve studies are required to define the usefulness of one over the other",
"AIMS To evaluate the effect of metformin on glucose metabolism , insulin sensitivity and rate of conversion diabetes in people with impaired glucose tolerance ( IGT ) . METHODS Seventy subjects with IGT were r and omized under double-blind conditions to receive either placebo ( n = 37 ) or metformin ( n = 33 ) at a dosage of 250 mg three times daily for a duration of 12 months . Glycaemic control , plasma insulin and other biochemical indexes were assessed before and after 3 , 6 and 12 months . RESULT At 12 months the conversion rate to diabetes was 16.2 % in the placebo group compared to 3.0 % for the metformin group ( P = 0.011 ) . Of subjects treated with metformin for 12 months , 84.9 % became normoglycaemic compared to 51.4 % of those receiving the placebo . Significant improvements in fasting glucose , glucose tolerance and insulin sensitivity were found at 12 months and at intermediate clinic assessment s. CONCLUSIONS Metformin can improve glucose metabolism in IGT patients and may be a treatment option in their management of IGT subjects",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"Gestational diabetes mellitus ( GDM ) is associated with adverse foetal and maternal outcomes , and identifies women at risk of future Type 2 Diabetes Mellitus ( T2DM ) . Breast-feeding may improve postpartum maternal glucose tolerance . We prospect ively examined the prevalence of postpartum dysglycaemia after GDM and examined the effect of lactation on postpartum glucose tolerance . We compared postpartum 75 g oral glucose tolerance test ( OGTT ) results from 300 women with GDM and 220 controls with normal gestational glucose tolerance ( NGT ) . Breast-feeding data was collected at time of OGTT . Postpartum OGTT results were classified as normal [ fasting plasma glucose ( FPG ) impaired fasting glucose ( IFG ) , FPG 5.6 - 6.9 mmol/l ; impaired glucose tolerance ( IGT ) , 2-h glucose 7.8 - 11 mmol/l ; IFG+IGT ; T2DM , FPG > or = 7 mmol/l + /- 2h glucose > or = 11.1 mmol/l ] . 6 ( 2.7 % ) with NGT in pregnancy had postpartum dysglycaemia compared to 57 ( 19 % ) with GDM in index pregnancy ( p T2DM ( OR 2.14 , 95 % CI 1.06 - 4.32 , p = 0.034 ) and gestational insulin use ( OR 2.62 , 95 % CI 1.17 - 5.87 p = 0.019 ) were associated with persistent dysglycaemia . The prevalence of persistent hyperglycaemia was significantly lower in women who breast-fed versus bottle-fed postpartum ( 8.2 % v 18.4 % , p metabolic effects after GDM and should be encouraged",
"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",
"CONTEXT Glycated hemoglobin ( A1C ) has been recommended by the American Diabetes Association for the diagnosis of diabetes and prediabetes . The diagnostic utility of A1C has not been evaluated in Arabs , a population at increased risk for developing diabetes . OBJECTIVE Our objective was to examine the sensitivity and specificity of A1C for the diagnosis of diabetes and prediabetes in Arabs . DESIGN & SETTING In this cross-sectional study , glucose tolerance was classified by the American Diabetes Association diagnostic criteria specified for A1C , fasting plasma glucose , and 75-g oral glucose tolerance test . PARTICIPANTS A population -based representative sample of 482 r and omly selected adult Arabs without known diabetes was studied . MAIN OUTCOME MEASURES Sensitivity , specificity , and area under the receiver operating characteristic curve of A1C diagnostic cutpoints for diabetes and prediabetes were calculated . κ Coefficients were used to test for agreement between A1C categorization and glucose-based diagnoses . RESULTS A1C testing correctly identified 5 % of individuals diagnosed with diabetes by oral glucose tolerance test , 13 % by fasting plasma glucose , and 41 % by both criteria . A1C alone identified 14 % of individuals diagnosed with impaired glucose tolerance , 9 % with impaired fasting glucose , and 33 % with both abnormalities . Sensitivity , specificity , and area under the receiver operating characteristic curve were 19 % ( 16 - 23 % ) , 100 % ( 99 - 100 % ) , and 77 % ( 69 - 85 % ) for diabetes A1C cutpoint and 14 % ( 11 - 17 % ) , 91 % ( 89 - 94 % ) , and 57 % ( 52 - 62 % ) for prediabetes A1C range . A1C cutpoint of 6.2 % for diabetes and 5.1 % for prediabetes yielded the highest accuracy but still missed 73 % of those with diabetes and 31 % with prediabetes . Agreement between A1C and diabetes ( κ = 0.2835 ) or prediabetes ( κ = 0.0530 ) was low . CONCLUSIONS A1C-based criteria yield a high proportion of false-negative tests for diabetes and prediabetes in Arabs . SUMMARY Racial/ethnic differences in A1C performance for diagnosis and prediction of diabetes exist . This paper examines its utility against glucose measurements in an at-risk Arab population",
"The aim of this study is to evaluate the short-term effectiveness of our individual-based counseling program and tools among individuals in ordinary Japanese communities with impaired fasting glucose ( IFG ) and mild type 2 diabetes . A total of 233 eligible participants ( age 30 - 69 years ) in 14 local study centers were r and omly assigned to an intervention group ( INT , N=119 ) and a control group ( CONT , N=114 ) . During the 4-month intervention , the INT received 4 individual counseling sessions and one reminder on life style modification . The CONT received only an explanation of blood test results and general information on diabetes . Baseline characteristics did not differ significantly between groups . Percentages of participants with desirable changes in glycemic level and weight were significantly higher in INT than CONT : fasting plasma glucose reduction of more than 10 mg/dL ( 39 % in INT vs. 26 % in CONT , p=0.045 ) , hemoglobinA1c reduction greater than 0.3 % ( 14 % vs. 4 % , p=0.01 ) , and weight reduction of more than 4 kg ( 13 % vs. 4 % , p=0.025 ) . Decreases in total energy intake and percentage of heavy alcohol drinkers ( more than 46 g/day ) were significantly greater in INT than CONT . The increase in percentages of participants who engaged in leisure time physical activity more than 12 times per month was significantly greater in INT than CONT . Our program result ed in life style modification and glycemic level improvement in the short-term among individuals with IFG and mild type 2 diabetes . Results indicated that the program was sufficiently effective and feasible for implementation in ordinary communities",
"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",
"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",
"OBJECTIVES To determine whether a home-based multicomponent physical activity counseling ( PAC ) intervention is effective in reducing glycemic measures in older out patients with prediabetes mellitus . DESIGN Controlled clinical trial . SETTING Primary care clinics of the Durham Veterans Affairs ( VA ) Medical Center between September 29 , 2008 , and March 25 , 2010 . PARTICIPANTS Three hundred two overweight ( body mass index 25 - 45 kg/m(2 ) ) , older ( 60 - 89 ) out patients with impaired glucose tolerance ( fasting blood glucose 100 - 125 mg/dL , glycosylated hemoglobin ( HbA1c ) to a PAC intervention group ( n = 180 ) or a usual care control group ( n = 122 ) . INTERVENTION A 12-month , home-based multicomponent PAC program including one in-person baseline counseling session , regular telephone counseling , physician endorsement in clinic with monthly automated encouragement , and customized mailed material s. All study participants , including controls , received a consultation in a VA weight management program . MEASUREMENTS The primary outcome was a homeostasis model assessment of insulin resistance ( HOMA-IR ) , calculated from fasting insulin and glucose levels at baseline and 3 and 12 months . HbA1c was the secondary indicator of glycemic control . Other secondary outcomes were anthropometric measures and self-reported physical activity , health-related quality of life , and physical function . RESULTS There were no significant differences between the PAC and control groups over time for any of the glycemic indicators . Both groups had small declines over time of approximately 6 % in fasting blood glucose ( P glycemic indicators remained stable . The declines in glucose were not sufficient to affect the change in HOMA-IR scores due to fluctuations in insulin over time . Endurance physical activity increased significantly in the PAC group ( P physical activity levels but was insufficient to improve glycemic indicators in older out patients with prediabetes mellitus",
"This study was a r and omised control trial with a waiting control group . It was design ed to evaluate the effectiveness of a 6-month , group-based diabetes prevention programme , The Healthy Living Course and assess whether participation in the programme led to changes in modifiable risk factors for type 2 diabetes among an already at-risk pre-diabetic population . Individuals design ated at risk for diabetes by their general practitioners ( GPs ) were screened using an Oral Glucose Tolerance Test . Volunteers ( N = 307 ) with pre-diabetes were assigned to an intervention or wait-control group in the ratio of approximately 2 : 1 . The sample was pre-tested on biochemical , anthropometric and self-report behavioural , cognitive and mood variables and post-tested either at the end of the educational/support-based lifestyle programme or the end of the wait period . The intervention group significantly improved their diabetes knowledge , motivation to change , positive affect , healthy eating and activity levels and showed significantly greater reductions in weight , body mass index , waist circumference , diastolic blood pressure and fasting plasma glucose in comparison with controls . The intervention group also changed their diagnostic status from pre-diabetes to non-diabetes at a greater rate than the wait group ( 43 % vs. 26 % ) who received st and ard care from their GPs",
"Commonly used tests for the diagnosis of diabetes include measurements of fasting plasma glucose levels and the oral glucose tolerance test ( OGTT ) . Recently , a hemoglobin A1C ( A1C ) level of 6.5 % has been included as a criterion for diabetes diagnosis by the American Diabetes Association . We aim ed to determine appropriate A1C cutoff values for identifying patients with diabetes or prediabetes , including impaired glucose tolerance and impaired fasting glucose among Korean adults and to determine whether these cutoffs vary according to age . We recruited 4616 adults without a history of diabetes from 10 university hospitals . A 75-g OGTT and A1C sampling were performed in all examinees . Pointwise area under the receiver operating characteristic curve was used to evaluate the diagnostic accuracy of the A1C cutoff . An A1C threshold of 6.1 % proved to be the optimal limit for diagnosing diabetes , with 63.8 % sensitivity and 88.1 % specificity . The cutoff value increased with age ( 5.9 % in 18 - 39 years , 6.2 % in 40 - 64 years , and 6.4 % in older than 65 years ) and were similar for men and women . An A1C cutoff of 5.7 % had reasonable sensitivity ( 48.6 % ) and specificity ( 65.7 % ) for the identification of prediabetes . Further prospect i ve studies should be carried out to determine whether the application of age-specific diagnostic criteria is appropriate",
"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",
"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",
"BACKGROUND Intensive lifestyle interventions can reduce the incidence of type 2 diabetes in people with impaired glucose tolerance , but how long these benefits extend beyond the period of active intervention , and whether such interventions reduce the risk of cardiovascular disease ( CVD ) and mortality , is unclear . We aim ed to assess whether intensive lifestyle interventions have a long-term effect on the risk of diabetes , diabetes-related macrovascular and microvascular complications , and mortality . METHODS In 1986 , 577 adults with impaired glucose tolerance from 33 clinics in China were r and omly assigned to either the control group or to one of three lifestyle intervention groups ( diet , exercise , or diet plus exercise ) . Active intervention took place over 6 years until 1992 . In 2006 , study participants were followed-up to assess the long-term effect of the interventions . The primary outcomes were diabetes incidence , CVD incidence and mortality , and all-cause mortality . FINDINGS Compared with control participants , those in the combined lifestyle intervention groups had a 51 % lower incidence of diabetes ( hazard rate ratio [ HRR ] 0.49 ; 95 % CI 0.33 - 0.73 ) during the active intervention period and a 43 % lower incidence ( 0.57 ; 0.41 - 0.81 ) over the 20 year period , controlled for age and clustering by clinic . The average annual incidence of diabetes was 7 % for intervention participants versus 11 % in control participants , with 20-year cumulative incidence of 80 % in the intervention groups and 93 % in the control group . Participants in the intervention group spent an average of 3.6 fewer years with diabetes than those in the control group . There was no significant difference between the intervention and control groups in the rate of first CVD events ( HRR 0.98 ; 95 % CI 0.71 - 1.37 ) , CVD mortality ( 0.83 ; 0.48 - 1.40 ) , and all-cause mortality ( 0.96 ; 0.65 - 1.41 ) , but our study had limited statistical power to detect differences for these outcomes . INTERPRETATION Group-based lifestyle interventions over 6 years can prevent or delay diabetes for up to 14 years after the active intervention . However , whether lifestyle intervention also leads to reduced CVD and mortality remains unclear",
"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",
"ISSUE ADDRESSED Substantial numbers of women with past gestational diabetes mellitus ( GDM ) develop type 2 diabetes mellitus ( T2DM ) . In northern New South Wales 23 % of women attending diabetes services between 2007 and 2010 with T2DM previously had GDM . This study investigated whether phone-based lifestyle education using motivational interviewing result ed in positive lifestyle change post GDM for women in a large rural area . METHOD Thirty-eight women were recruited to this pilot study following GDM diagnosis and r and omly allocated to either the control or intervention group . Following baseline assessment , the intervention group received a 6-month phone-based motivational interviewing program , and access to usual care . The control group received usual care only . Measures were collected at baseline ( 6 weeks postnatal ) , and at 6 months follow-up . Outcome measures included body mass index , diet , and physical activity . RESULTS At follow-up , the intervention group compared to the control group significantly reduced total fat intake by -19 g/d ( 95%CI : -37 to -1 ) , total carbohydrate intake by -42 g/d ( 95%CI : -82 to -1 ) , and glycaemic load by -26 units ( 95%CI : -48 to -4 ) . These women also increased leisure physical activity compared to the control group by 11 min/d ( 95%CI : 1 to 22 ) ; no significant change in total physical activity levels occurred . At follow-up , body mass index in the intervention group improved by -1.5 kg/m2 ( 95%CI : -2.8 to -0.1 ) compared to the control group . CONCLUSION The intervention group showed positive trends across lifestyle variables compared to the control group . Further large-scale research on the effectiveness of phone-based lifestyle counselling following GDM is warranted",
"BACKGROUND The susceptibility to type 2 diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem . We assessed a weight control and physical activity intervention in south Asian individuals in the UK . METHODS We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotl and ( UK ) . Between July 1 , 2007 , and Oct 31 , 2009 , we recruited men and women of Indian and Pakistani origin , aged 35 years or older , with waist circumference 90 cm or greater in men or 80 cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test . Families were r and omised ( using a r and om number generator program , with permuted blocks of r and om size , stratified by location [ Edinburgh or Glasgow ] , ethnic group [ Indian or Pakistani ] , and number of participants in the family [ one vs more than one ] ) to intervention or control . Participants in the same family were not r and omised separately . The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period . The primary outcome was weight change at 3 years . Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up . We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years . This trial is registered , number IS RCT N25729565 . FINDINGS Of 1319 people who were screened with an oral glucose tolerance test , 196 ( 15 % ) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial . Participants were in 156 family clusters that were r and omised ( 78 families with 85 participants were allocated to intervention ; 78 families with 86 participants were allocated to control ) . 167 ( 98 % ) participants in 152 families completed the trial . Mean weight loss in the intervention group was 1.13 kg ( SD 4.12 ) , compared with a mean weight gain of 0.51 kg ( 3.65 ) in the control group , an adjusted mean difference of -1.64 kg ( 95 % CI -2.83 to -0.44 ) . INTERPRETATION Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases . FUNDING National Prevention Research Initiative , NHS Research and Development ; NHS National Services Scotl and ; NHS Health Scotl and",
"AIM To determine the independent effects of total and each health professional 's frequency of contacts , on changes in anthropometric measures and physical capacity following a lifestyle intervention offered by a multi-disciplinary team in adults at high risk for type 2 diabetes . MATERIAL S AND METHODS A 12-month lifestyle intervention was performed in 48 adults with prediabetes . Participants were r and omly assigned to either an individual counselling group ( every six weeks)+an optional series of 25 group seminars ( every week ) or to the group seminars only . Physical activity level , energy intake , anthropometric measures , and physical capacity were assessed . RESULTS Total frequency of contacts with any professional was associated with change in body weight , BMI and , waist circumference ( all P ≤.05 ) . However , no frequency of contacts with a specific professional was associated with the studied outcomes , except for changes in physical capacity . The latest was significantly improved in participants who attended at least two group sessions with the kinesiologist ( P=.02 ) . DISCUSSION To improve anthropometric measures , total contact frequency seems to be more important than contact frequency with any specific professionals . However , to improve physical capacity , meeting with a kinesiologist for two or more occasions , in group sessions , seems to be an effective strategy",
"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",
"Diabetes is an “ old disease ” . The first description of diabetes written on papyrus about 3500 years ago is found in the Ebers papyrus , which was discovered in Egypt in 1873 by the German archeologist Georg Ebers . Humans , like most mammals , may develop diabetes , if sufficient environmental exposure to physical inactivity , unhealthy diet and obesity are present . Genetic effects are important for the individual risk of type 2 diabetes ( T2D ) but twin studies have shown that the genetic effects combined explain less than 50 % of the risk of T2D ( 1 ) . Today we know almost 100 susceptibility genes associated with T2D but the relative importance of each of these genes is low ( 2 ) , and together they explain only a small part of the disease risk . Thus , genetic screening can not be used for the prediction of T2D for individuals . On the other h and , healthy lifestyle can also prevent T2D in people who are genetically at high risk , e.g. those with positive family history ( 3 ) . Thus , the importance of lifestyle factors for the development and prevention of T2D is overwhelming . The strongest evidence in medicine is considered to come from r and omized controlled trials ( RCTs ) . They are also important in providing the link to causal inference that in most observational studies can not be derived . At the same time , observational studies are necessary for the identification of factors associated with an increased or decreased risk of a disease , and for generation of hypotheses on potential means for prevention based on modifiable risk factors . Observational studies have by now identified a large number of factors that are associated with the development of T2D or with the protection against it . Most of them are related to physical activity , diet and obesity . It has also been shown unequivocally that exposures ( poor nutrition , infections , smoking , etc . ) during fetal life and early infancy result ing in insufficient development ( often shown as low birth weight ) also predict T2D later in life ( 4 ) . Traditionally , T2D has been considered to be a disease of the elderly . However , with increasing obesity and sedentary lifestyle in children , there are increasing numbers of cases of T2D already occurring at a young age in many population s ( 5 ) . In the past two decades several innovative RCTs have repeatedly shown that interventions on modifiable risk factors can reduce the incidence of diabetes in high-risk groups . The evidence has been summarized in several systematic review s and meta-analyses ( 6,7 ) . There is compelling scientific evidence from RCTs that T2D can be prevented or its onset delayed . The key for prevention is a multimodal package of lifestyle changes that is a sum outcome of dietary and physical activity behaviours . The power of lifestyle was dramatically illustrated by the Finnish Diabetes Prevention Study ( DPS ) that explicitly showed that when the study participants with impaired glucose tolerance reached all five modest lifestyle intervention targets , none of them progressed to T2D ( 8) . Importantly , lifestyle intervention lasting for 3–6 years has been shown to have a carry-over effect on T2D incidence that lasts for several years ; up to 15 in the Finnish Diabetes Prevention Study ( 9 ) and 20 years in the China Da Qing Diabetes Prevention Study ( 10 ) . The observed sustained risk reduction seems to be a result of sustained lifestyle changes , but the legacy effect of improved glycaemia during the early intervention may also have contributed to the long-term effect . The follow-up data from the Chinese study indicate moreover that vascular risks are also reduced by lifestyle management . Several prognostic question naires exist for detecting people at risk of T2D ( 11 ) . One of the screening tools with an adequately high sensitivity and specificity is the Finnish Diabetes Risk Score ( FINDRISC ) developed in Finl and ( 12 ) . The FINDRISC has been successfully implemented in the Finnish primary health care system and used also in many other countries . The FINDRISC was also tested in the Omani population and as a result a slightly modified Omani Diabetes Risk Score was developed ( 13 ) which may be a suitable screening tool for the Arab population s in the Middle East . Lifestyle interventions aim ing at translating evidence from efficacy RCTs on T2D prevention into “ real world ” intervention programmes have also been carried out in various population s. Such data were recently combined in a meta- analysis considering the relationship between intervention effectiveness and adherence to guidelines ( 14 ) . The primary meta- analysis included 22 studies with outcome data for weight loss at 12 months . The pooled result of the direct pairwise meta- analysis shows that",
"AIM To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance ( IGT ) . METHODS Participants with IGT ( n=78 ) , diagnosed on two consecutive oral glucose tolerance tests ( OGTTs ) , were r and omly assigned to a 2-year lifestyle intervention or to a control group . Main outcome measures were changes from baseline in : nutrient intake ; physical activity ; anthropometry , glucose tolerance and insulin sensitivity . Measurements were repeated at 6 , 12 and 24 months follow-up . RESULTS After 24 months follow-up , there was a significant fall in total fat consumption ( difference in change between groups ( Delta intervention-Delta control)= -17.9 , 95 % confidence interval ( CI ) -33.6 to -2.1g/day ) as a result of the intervention . Body mass was significantly lower in the intervention group compared with controls after 6 months ( -1.6 , 95 % CI -2.9 to -0.4 kg ) and 24 months ( -3.3 , 95 % CI -5.7 to -0.89 kg ) . Whole body insulin sensitivity , assessed by the short insulin tolerance test ( ITT ) , improved after 12 months in the intervention group ( 0.52 , 95 % CI 0.15 - 0.89%/min ) . CONCLUSIONS These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study , both of which tested intensive interventions , by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT , without change in other cardiovascular risk factors",
"BACKGROUND Previous studies demonstrated that intensive lifestyle modification can prevent type 2 diabetes mellitus among those with impaired glucose tolerance , but similar beneficial results have not been proved among those with impaired fasting glucose levels . We investigated the efficacy of lifestyle modification on type 2 diabetes incidence among those with impaired fasting glucose levels . METHODS The present study was an unmasked , multicenter , r and omized , controlled trial . A total of 641 overweight Japanese ( aged 30 - 60 years ) with impaired fasting glucose levels were recruited nationwide in Japan and r and omly assigned to a frequent intervention group ( n = 311 ) or a control group ( n = 330 ) . For 36 months after r and omization , the frequent intervention group received individual instructions and follow-up support for lifestyle modification from the medical staff 9 times . The control group received similar individual instructions 4 times at 12-month intervals during the same period . The primary outcome was type 2 diabetes incidence in annual 75-g oral glucose tolerance tests , diagnosed according to World Health Organization criteria . RESULTS There were no significant differences between the allocation groups in baseline characteristics and dropout rates . Estimated cumulative incidences of type 2 diabetes were 12.2 % in the frequent intervention group and 16.6 % in the control group . Overall , the adjusted hazard ratio in the frequent intervention group was 0.56 ( 95 % confidence interval , 0.36 - 0.87 ) . In the post hoc subgroup analyses , the hazard ratio reduced to 0.41 ( 95 % confidence interval , 0.24 - 0.69 ) among participants with impaired glucose tolerance at baseline , and to 0.24 ( 0.12 - 0.48 ) among those with baseline hemoglobin A(1c ) levels of 5.6 % or more ( the Japan Diabetes Society method ) . Such risk reduction was not observed among those with isolated impaired fasting glucose findings or baseline hemoglobin A(1c ) levels of less than 5.6 % . CONCLUSIONS Lifestyle modifications can prevent type 2 diabetes among overweight Japanese with impaired fasting glucose levels . In addition , identifying individuals with more deteriorated glycemic status by using 75-g oral glucose tolerance test findings or , especially , measurement of hemoglobin A(1c ) levels , could enhance the efficacy of lifestyle modifications . TRIAL REGISTRATION umin.ac.jp/ctr Identifier : UMIN000001959",
"BACKGROUND & AIMS Women with prior gestational diabetes mellitus ( GDM ) have a high risk of developing type 2 diabetes mellitus ( DM2 ) in later life . The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders ( impaired fasting glucose , impaired glucose tolerance or DM2 ) in women with prior GDM . METHODS A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were r and omized into two groups : a Mediterranean lifestyle intervention group ( n = 130 ) who underwent an educational program on nutrition and a monitored physical activity program and a control group ( n = 130 ) with a conventional follow-up . A total of 237 women completed the three-year follow-up ( 126 in the intervention group and 111 in the control group ) . Their glucose disorders rates , clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed . RESULTS Less women in the intervention group ( 42.8 % ) developed glucose disorders at the end of the three-year follow-up period compared with the control group ( 56.75 % ) , p rate of glucose disorders with a BMI of less than 27 kg/m(2 ) ( OR 0.28 ; 0.12 - 0.65 ; p low fat intake pattern ( OR 0.30 ; 0.13 - 0.70 ; p saturated fat pattern ( OR 0.30 ; 0.13 - 0.69 ; p healthy fat pattern ( OR 0.34 ; 0.12 - 0.94 ; p Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM . Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders . Current Controlled trials : IS RCT N24165302 . http://www.controlled-trials.com/is rct n/pf/24165302",
"AIMS This study was conducted to compare the effects of two years of lifestyle intervention to no intervention or one year of intervention on diabetes risk factors in male workers with impaired fasting glucose ( IFG ) or diabetes . METHODS We conducted a r and omized lifestyle intervention trial design ed to alter personal lifestyles among 123 industrial male workers ( CG ; control group , n=75 ; OIG ; one-year intervention group , n=23 ; TIG ; two-year intervention group , n=25 ) . The intervention consisted of two parts , the main program ( face-to-face counseling five times/12 weeks ) and a follow-up program ( e-mail counseling ten times/30 weeks ) . Assessment s included biochemical characteristics , anthropometry and nutrient intake at baseline and after two years . RESULTS After two years , systolic blood pressure , HOMA-IR , HDL cholesterol and total energy intake ( p weight , body mass index , waist circumference , blood pressure , fasting plasma glucose ( FPG ) , HbA1c and nutrient intake ( total energy , carbohydrate , protein and sodium ) were significantly decreased ( p level of FPG and HbA1c ( p diabetes risk factors than OIG"
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Background Information on how behavior change strategies have been used to design digital interventions ( DIs ) to improve blood pressure ( BP ) control or medication adherence ( MA ) for patients with hypertension is currently limited . Objective Hypertension is a major modifiable risk factor for cardiovascular diseases and can be controlled with appropriate medication . Many interventions that target MA to improve BP are increasingly using modern digital technologies . This systematic review was conducted to discover how DIs have been design ed to improve MA and BP control among patients with hypertension in the recent 10 years . Results were mapped into a matrix of change objectives using the Intervention Mapping framework to guide future development of technologies to improve MA and BP control . Methods We included all the studies regarding DI development to improve MA or BP control for patients with hypertension published in PubMed from 2008 to 2018 . All the DI components were mapped into a matrix of change objectives using the Intervention Mapping technique by eliciting the key determinant factors ( from patient and health care team and system levels ) and targeted patient behaviors . Results The analysis included 54 eligible studies . The determinants were considered at two levels : patient and health care team and system . The most commonly described determinants at the patient level were lack of education , lack of self-awareness , lack of self-efficacy , and forgetfulness . Clinical inertia and an inadequate health workforce were the most commonly targeted determinants at the health care team and system level . Taking medication , interactive patient-provider communication , self-measurement , and lifestyle management were the most cited patient behaviors at both levels . Most of the DIs did not include support from peers or family members , despite its reported effectiveness and the rate of social media penetration . Conclusions This review highlights the need to design a multifaceted DI that can be personalized according to patient behavior(s ) that need to be changed to overcome the key determinant(s ) of low adherence to medication or uncontrolled BP among patients with hypertension , considering different levels including patient and healthcare team and system involvement | [
"Introduction Self-management of hypertension , including self-monitoring and antihypertensive medication titration , lowers blood pressure ( BP ) at 1 year compared to usual care . The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure ( HOME BP ) intervention for the self-management of hypertension in primary care . Methods and analysis The HOME BP trial will be a r and omised controlled trial comparing BP self-management — consisting of the HOME BP online digital intervention with self-monitoring , lifestyle advice and antihypertensive drug titration — with usual care for people with uncontrolled essential hypertension . Eligible patients will be recruited from primary care and r and omised to usual care or to self-management using HOME BP . The primary outcome will be the difference in mean systolic BP ( mm Hg ) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates . Secondary outcomes ( also adjusted for baseline and covariates where appropriate ) will be differences in mean BP at 6 months and diastolic BP at 12 months ; patient enablement ; quality of life , and economic analyses including all key re sources associated with the intervention and related services , adopting a broad societal perspective to include NHS , social care and patient costs , considered within trial and modelled with a lifetime horizon . Medication beliefs , adherence and changes ; self-efficacy ; perceived side effects and lifestyle changes will be measured for process analyses . Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability , feasibility and adherence . Ethics and dissemination This study has received NHS ethical approval ( REC reference 15/SC/0082 ) . The findings from HOME BP will be disseminated widely through peer- review ed publications , scientific conferences and workshops . If successful , HOME BP will be directly applicable to UK primary care management of hypertension . Trial registration number IS RCT N13790648 ; pre- results",
"BACKGROUND Less than 50 % of patients with hypertensive disease manage to maintain their blood pressure ( BP ) within normal levels . OBJECTIVE The aim of this study is to evaluate whether cloud BP system integrated with computerized physician order entry ( CPOE ) can improve BP management as compared with traditional care . METHODS A r and omized controlled trial done on a r and om sample of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan . Physicians had access to cloud BP data from CPOE . Neither patients nor physicians were blinded to group assignment . The study was conducted over a period of seven months . RESULTS At baseline , the enrollees were 50 % male with a mean ( SD ) age of 58.18 ( 10.83 ) years . The mean sitting BP of both arms was no different . The proportion of patients with BP control at two , four and six months was significantly greater in the intervention group than in the control group . The average capture rates of blood pressure in the intervention group were also significantly higher than the control group in all three check-points . CONCLUSIONS Cloud-based BP system integrated with CPOE at the point of care achieved better BP control compared to traditional care . This system does not require any technical skills and is therefore suitable for every age group . The praise and assurance to the patients from the physicians after review ing the Cloud BP records positively reinforced both BP measuring and medication adherence behaviors",
"Background Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites . While poor adherence is a major contributor to disparities in blood pressure control , data in Latino patients are scant . More importantly , translation of interventions to improve medication adherence in community-based primary care practice s , where the majority of Latino patients receive their care is non-existent . Methods Using a r and omized controlled design , this study evaluates the effectiveness of a culturally tailored , practice -based intervention compared to usual care on medication adherence , among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications . Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script . Patients r and omized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors . Health Coach sessions are held biweekly for the first 3 months ( 6 sessions total ) and then monthly for the remaining 3 months ( 3 sessions total ) . Patients r and omized to the usual care group receive st and ard hypertension treatment recommendations as determined by their primary care providers . The primary outcome is the rate of medication adherence at 6 months . The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months . Discussion If successful , findings from this study will provide salient information on the translation of culturallytailored , evidence -based interventions targeted at medication adherence and blood pressure control into practice -based setting s for this high-risk population .Trial registration NCT01643473 on 16 July 2012",
"BACKGROUND Many dementia and cardiovascular disease ( CVD ) cases in older adults are attributable to modifiable vascular and lifestyle-related risk factors , providing opportunities for prevention . In the Healthy Aging Through Internet Counselling in the Elderly ( HATICE ) r and omized controlled trial , an internet-based multidomain intervention is being tested to improve the cardiovascular risk ( CVR ) profile of older adults . OBJECTIVE To design a multidomain intervention to improve CVR , based on the guidelines for CVR management , and administered through a coach-supported , interactive , platform to over 2500 community-dwellers aged 65 + in three European countries . METHODS A comparative analysis of national and European guidelines for primary and secondary CVD prevention was performed . Results were used to define the content of the intervention . RESULTS The intervention design focused on promoting awareness and self-management of hypertension , dyslipidemia , diabetes mellitus , and overweight , and supporting smoking cessation , physical activity , and healthy diet . Overall , available guidelines lacked specific recommendations for CVR management in older adults . The comparative analysis of the guidelines showed general consistency for lifestyle-related recommendations . Key differences , identified mostly in methods used to assess the overall CVR , did not hamper the intervention design . Minor country-specific adaptations were implemented to maximize the intervention feasibility in each country . CONCLUSION Despite differences in CVR management within the countries considered , it was possible to design and implement the HATICE multidomain intervention . The study can help define preventative strategies for dementia and CVD that are applicable internationally",
"Background : Little is known about the benefits of social networks in the management of patients . Objective : The aim of this study was to compare the effects of self-management ( SM ) education using telephone follow-up and mobile phone-based social networking on SM behaviors among patients with hypertension . Methods : This r and omized clinical trial was conducted with 100 patients . They were r and omly allocated to four groups : ( i ) control , ( ii ) SM training without follow-up , ( iii ) telephone follow-up and ( iv ) smartphone-based social networking follow-up . The hypertension SM behavior question naire was used for data collection before and six weeks after the study . Results : Those patients who underwent SM education training ( with and without follow-up ) had statistically significant differences from those in the control group in terms of SM behaviors ( p no statistically significant difference between different types of follow-up . Conclusion : SM education using telephone follow-up and /or smartphone-based social networking follow-up influenced SM behaviors among patients with hypertension",
"Background Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac , cerebrovascular , and kidney diseases . Reasons for poor disease control include nonadherence , lack of patient engagement , and therapeutic inertia . Objective The aim of this study was to assess the impact on clinic-measured blood pressure ( BP ) and glycated hemoglobin ( HbA1c ) using a digital medicine offering ( DMO ) that measures medication ingestion adherence , physical activity , and rest using digital medicines ( medication taken with ingestible sensor ) , wearable sensor patches , and a mobile device app . Methods Participants with elevated systolic BP ( SBP ≥140 mm Hg ) and HbA1c ( ≥7 % ) failing antihypertensive ( ≥2 medications ) and oral diabetes therapy were enrolled in this three-arm , 12-week , cluster-r and omized study . Participants used DMO ( includes digital medicines , the wearable sensor patch , and the mobile device app ) for 4 or 12 weeks or received usual care based on site r and omization . Providers in the DMO arms could review the DMO data via a Web portal . In all three arms , providers were instructed to make medical decisions ( medication titration , adherence counseling , education , and lifestyle coaching ) on all available clinical information at each visit . Primary outcome was change in SBP at week 4 . Other outcomes included change in SBP and HbA1c at week 12 , and low-density lipoprotein cholesterol ( LDL-C ) and diastolic blood pressure ( DBP ) at weeks 4 and 12 , as well as proportion of patients at BP goal ( Final analysis included 109 participants ( 12 sites ; age : mean 58.7 , SD years ; female : 49.5 % , 54/109 ; Hispanic : 45.9 % , 50/109 ; income ≤ US $ 20,000 : 56.9 % , 62/109 ; and ≤ high school education : 52.3 % , 57/109 ) . The DMO groups had 80 participants ( 7 sites ) and usual care had 29 participants ( 5 sites ) . At week 4 , DMO result ed in a statistically greater SBP reduction than usual care ( mean –21.8 , SE 1.5 mm Hg vs mean –12.7 , SE 2.8 mmHg ; mean difference –9.1 , 95 % CI –14.0 to –3.3 mm Hg ) and maintained a greater reduction at week 12 . The DMO groups had greater reductions in HbA1c , DBP , and LDL-C , and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care . The DMO groups also received more therapeutic interventions than usual care . Medication adherence was ≥80 % while using the DMO . The most common adverse event was a self-limited rash at the wearable sensor site ( 12 % , 10/82 ) . Conclusions For patients failing hypertension and diabetes oral therapy , this DMO , which provides dose-by-dose feedback on medication ingestion adherence , can help lower BP , HbA1c , and LDL-C , and promote patient engagement and provider decision making . Trial Registration Clinical trials.gov NCT02827630 ; https:// clinical trials.gov/show/NCT02827630 ( Archived by WebCite at http://www.webcitation.org/6rL8dW2VF",
"OBJECTIVES The aim was to determine the impact of a telephone counseling service , provided bi-monthly by pharmacist , on patients ' beliefs about antihypertensive medicines and blood pressure ( BP ) control . METHODS Either hypertensive patients were r and omly assigned to a control group ( CG , usual care ) or an intervention group ( IG ) . All patients had BP values registered and filled in the Italian version of the Belief Medicine Question naire ( BMQ ) . After 12 months , patients filled in the BMQ again and had their self-reported BP registered . The intervention consisted of an educational/counseling session based on patients ' needs assessment provided bi-monthly by a pharmacist for one year via telephone . RESULTS 80 CG and 84 IG patients were recruited . After 12 months , there were significant differences between IG and CG for both BMQ 's Necessity and Concern score ( p reduction in BP values in IG ( p BP control by modifying patients ' perception about treatments and involving patients as participants in the management of their health . PRACTICE IMPLICATION S This paper could serve as a guideline for other studies to confirm the effectiveness of this intervention in modifying health behavior , and the role of hospital pharmacist",
"Background Hypertension is a major risk factor for cardiovascular disease , and its control rate has remained low worldwide . Studies have found that telemonitoring blood pressure ( BP ) helped control hypertension in r and omized controlled trials . However , little is known about its effect in a structured primary care model in which primary care physicians ( PCPs ) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions . This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China . Methods / design Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital , Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet . Study subjects are r and omly assigned to three interventional groups : ( 1 ) usual care ; ( 2 ) home-based BP telemonitor with embedded Global System for Mobile Communications ( GSM ) module and unlimited data plan , an app to access personal healthcare record and receive personalized lifestyle coaching contents , and proficiency training of their use ; or ( 3 ) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches . The primary outcome is mean change in systolic blood pressure over a 12-month period . Secondary outcomes are changes of diastolic blood pressure , HbA1C , blood lipids , and medication adherence measured by the eight-item Morisky Medication Adherence Scale . Discussion This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care . Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension . Trial registration Clinical Trials.gov , NCT02919033 . Registered on 23 September 2016",
"Background Only approximately half of patients with hypertension have their blood pressure controlled , due in large part to the tendency of primary care providers ( PCPs ) not to intensify treatment when blood pressure values are elevated . Objective This study tested the effect of an intervention design ed to help patients ask questions at the point of care to encourage PCPs to appropriately intensify blood pressure treatment . Methods PCPs and their patients with hypertension ( N=500 ) were recruited by letter and r and omized into 2 study groups : ( 1 ) intervention condition in which patients used a fully automated website each month to receive tailored messages suggesting questions to ask their PCP to improve blood pressure control , and ( 2 ) control condition in which a similar tool suggested questions to ask about preventive services ( eg , cancer screening ) . The Web-based tool was design ed to be used during each of the 12 study months and before scheduled visits with PCPs . The primary outcome was the percentage of patients in both conditions with controlled blood pressure . Results Of 500 enrolled patients ( intervention condition : n=282 ; control condition : n=218 ) , 418 ( 83.6 % ) completed the 12-month follow-up visit . At baseline , 289 ( 61.5 % ) of participants had controlled blood pressure . Most ( 411/500 , 82.2 % ) participants used the intervention during at least 6 of 12 months and 222 ( 62.5 % ) reported asking questions directly from the Web-based tool . There were no group differences in asking about medication intensification and there were no differences in blood pressure control after 12 months between the intervention condition ( 201/282 , 71.3 % ) and control condition ( 143/218 , 65.6 % ; P=.27 ) groups . More intervention condition participants discussed having a creatinine test ( 92 , 52.6 % vs 49 , 35.5 % ; P=.02 ) and urine protein test ( 81 , 44.8 % vs 21 , 14.6 % ; P discussion s about tetanus and pneumonia vaccines and reported more tetanus ( 30 , 13.8 % vs 15 , 5.3 % ; P=.02 ) and pneumonia ( 25 , 11.5 % vs 16 , 5.7 % ; P=.02 ) vaccinations after 12 months . Conclusions The use of an interactive website design ed to overcome clinical inertia for hypertension care did not lead to improvements in blood pressure control . Participant adherence to the intervention was high . The control intervention led to positive changes in the use of preventive services ( eg , tetanus immunization ) and the intervention condition led to more discussion s of hypertension-relevant tests ( eg , serum creatinine and urine protein ) . By providing patients with individually tailored questions to ask during PCP visits , this study demonstrated that participants were likely to discuss the questions with PCPs . These discussion s did not , however , lead to improvements in blood pressure control . Trial Registration Clinical Trials.gov NCT00377208 ; http:// clinical trials.gov/ct2/show/NCT00377208 ( Archived by WebCite at http://www.webcitation.org/6IqWiPLon )",
"Context — Very few patient-centered , theory-guided programs for medication adherence and blood pressure control have been conducted in kidney transplant recipients . Objective — To evaluate preliminary indications of sustainability of improved blood pressure in kidney transplant recipients 12 months after completion of a 3-month r and omized controlled trial of a mobile health pilot program to improve blood pressure and medication adherence . Participants and Design — A total of 18 of the 19 trial participants were contacted and all consented to inclusion in the retrospective analysis of their medical records showing their clinic-recorded systolic blood pressures at 3 , 6 , and 12 months following participation in the 3-month trial of a medical regimen self-management intervention . Results — A significant group difference in systolic blood pressure was observed longitudinally , indicating that the intervention group , as compared with the st and ard-care group , exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit ( P = .01 ) . At 12-month follow-up , success in establishing and sustaining control of systolic blood pressure ( systolic blood pressure than did patients in the control group 12 months after the trial ended , suggesting that the intervention may have a durable impact on blood pressure control that most likely reflects sustained medication adherence . These findings will aid in the development of an adequately powered r and omized controlled trial to address the sustainable impact of the intervention program on medication adherence and blood pressure control",
"BACKGROUND Web-based self-management programs offer a novel approach for self-insured employers seeking to improve and maintain employee health . METHODS We conducted a 6-month prospect i ve , cluster-r and omized controlled trial design ed to evaluate whether worksite access to an automated , web-based , self-management program result ed in better blood pressure control . The trial was conducted at 6 EMC Corporation worksites in Massachusetts , each of which had at least 600 employees ; 404 EMC employees with pre-hypertension or hypertension participated . Participants at 3 worksites received a home blood pressure cuff that uploaded readings to a Web site where they could view trends and read automated rules-based messages . Participants at 3 worksites received access to an onsite blood pressure cuff . Primary outcome measure was change in systolic blood pressure . Secondary outcome measures were change in diastolic blood pressure , proportion of participants achieving significant changes in systolic and diastolic blood pressure , and subject satisfaction . RESULTS Although the mean change in systolic blood pressure was not significantly different between intervention and control groups ( -1.69 vs. -0.86 mm HG , respectively , P = .49 ) the change in diastolic blood pressure between groups was significant . ( -1.08 vs. = 1.47 mm HG , respectively , P 10-mm Hg decrease in systolic blood pressure or > 5-mm Hg decrease in diastolic blood pressure compared to controls ( 22 % vs 17 % , P = .02 and 29 % vs 16 % , P = .03 , respectively ) . Intervention participants were twice as likely to report starting a new medication ( P = .02 ) and more likely to report improved communication with their doctor ( P = .02 ) . CONCLUSIONS Participation in an automated online self-management program result ed in improved blood pressure among employees with prehypertension or hypertension",
"Introduction There is important evidence on the beneficial effects of treatment of cardiovascular risk factors in terms of morbidity and mortality , but important challenges remain in motivating patients to adhere to their treatment regimen . This study aim ed to describe the effectiveness of a quality improvement intervention that included information and regular encouragement by email or letter on cardiovascular risk factors for patients at high risk for cardiovascular disease . Methods This r and omized single-blind study included patients of both sexes aged between 45 and 80 years old who had increased cardiovascular risk . Patients were r and omly allocated to either a usual care group ( UCG ) or advanced care group ( ACG ) . Patients in the UCG received regular care while patients in the ACG received usual care plus regular information and encouragement on cardiovascular risk factors by email or letter . Visits for both groups were planned at 0 , 3 , and 6 months . The outcome measures were blood pressure , weight , body mass index ( BMI ) , waist circumference ( WC ) , and smoking status . Results Out of 178 eligible patients from one single primary care practice , 55 participated in the study , three of whom dropped out . After 6 months , there was a significant decrease in mean systolic and diastolic blood pressure in the UCG and ACG ( P systolic blood pressure in the UCG . There was also a significant increase in the proportion of patients who met the target values for blood pressure in the UCG and ACG . There was a nonsignificant decrease of the average weight in the ACG , but significantly more patients lost weight in the UCG ( P = 0.02 ) . BMI , WC , and smoking status did not change in either group . Conclusion This study found that there was a significant decrease of systolic and diastolic blood pressure in both study groups . Weight , BMI , WC , and smoking did not improve in either group . Information on cardiovascular risk factors and encouragement by means of letters or email did not provide additional benefits . Thus , effective patient empowerment probably requires more behaviorally sophisticated support to increase self-management , self-efficacy , and self-esteem in patients",
"Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774",
"Background Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes , but delivery on a wide scale and at low cost is challenging . Some trials evaluating clinical interventions using short message service ( SMS ) text-messaging systems have shown important outcomes , although evidence is limited . We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-re source setting . We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care . Methods / design The SMS Text-message Adherence suppoRt trial ( StAR ) is a pragmatic individually r and omised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town , South Africa . The intervention is a structured programme of clinic appointment , medication pick-up reminders , medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages . Usual care is supplemented by infrequent non-hypertension related SMS text-messages . Participants are 1:1:1 individually r and omised , to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender , age , baseline systolic blood pressure , years with hypertension , and previous clinic attendance . The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation . Secondary outcomes include the proportion of patients with 80 % or more of days medication available , proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg , hospital admissions , health status , retention in clinical care , satisfaction with treatment and care , and patient related quality of life . Anonymised demographic data are collected on non- participants . Discussion The StAR trial uses a novel , low cost system based on widely available mobile phone technology to deliver the SMS-based intervention , manage communication with patients , and measure clinical ly relevant outcomes . The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-re source setting .Trial registration",
"Background Active engagement in the management of hypertension is important in improving self-management behaviors and clinical outcomes . Mobile phone technology using wireless monitoring tools are now widely available to help individuals monitor their blood pressure , but little is known about the conditions under which such technology can effect positive behavior changes or clinical outcomes . Objective To study the influence of wireless self-monitoring program and patient activation measures on health behaviors , medication adherence , and blood pressure levels as well as control of blood pressure in hypertensive patients . Methods We examined a subset of 95 hypertensive participants from a 6-month r and omized controlled trial design ed to determine the utility of a wireless self-monitoring program ( n=52 monitoring program , n=43 control ) , which consisted of a blood pressure monitoring device connected with a mobile phone , reminders for self-monitoring , a Web-based disease management program , and a mobile app for monitoring and education , compared with the control group receiving a st and ard disease management program . Study participants provided measures of patient activation , health behaviors including smoking , drinking , and exercise , medication adherence , and blood pressure levels . We assessed the influence of wireless self-monitoring as a moderator of the relationship between patient activation and health behaviors , medication adherence , and control of blood pressure . Results Improvements in patient activation were associated with improvements in cigarette smoking ( beta=−0.46 , P and blood pressure control ( beta=0.04 , P=.02 ) . This relationship was further strengthened in reducing cigarettes ( beta=−0.60 , P ) , alcohol drinking ( beta=−0.26 , P=.01 ) , and systolic ( beta=−0.27 , P=.02 ) and diastolic blood pressure ( beta=−0.34 , P=.007 ) at 6 months among individuals participating in the wireless self-monitoring program . No differences were observed with respect to medication adherence . Conclusions Participation in a wireless self-monitoring program provides individuals motivated to improve their health management with an added benefit above and beyond that of motivation alone . Hypertensive individuals eager to change health behaviors are excellent c and i date s for mobile health self-monitoring .. Trial Registration Clinical Trials.gov NCT01975428 , https:// clinical trials.gov/ct2/show/NCT01975428 ( Archived by WebCite at http://www.webcitation.org/6iSO5OgOG",
"OBJECTIVE We evaluated the role of home monitoring , communication with pharmacists , medication intensification , medication adherence and lifestyle factors in contributing to the effectiveness of an intervention to improve blood pressure control in patients with uncontrolled essential hypertension . METHODS We performed a mediation analysis of a published r and omized trial based on the Chronic Care Model delivered over a secure patient website from June 2005 to December 2007 . Study arms analyzed included usual care with a home blood pressure monitor and usual care with home blood pressure monitor and web-based pharmacist care . Mediator measures included secure messaging and telephone encounters ; home blood pressure monitoring ; medications intensification and adherence and lifestyle factors . Overall fidelity to the Chronic Care Model was assessed with the Patient Assessment of Chronic Care ( PACIC ) instrument . The primary outcome was percent of participants with blood pressure ( BP ) RESULTS At 12 months follow-up , patients in the web-based pharmacist care group were more likely to have BP 140/90 mm Hg ( 55 % ) compared to patients in the group with home blood pressure monitors only ( 37 % ) ( p = 0.001 ) . Home blood pressure monitoring accounted for 30.3 % of the intervention effect , secure electronic messaging accounted for 96 % , and medication intensification for 29.3 % . Medication adherence and self-report of fruit and vegetable intake and weight change were not different between the two study groups . The PACIC score accounted for 22.0 % of the main intervention effect . CONCLUSIONS The effect of web-based pharmacist care on improved blood pressure control was explained in part through a combination of home blood pressure monitoring , secure messaging , and antihypertensive medication intensification",
"BACKGROUND Prehypertension is considered a precursor of stage 1 hypertension and a predictor of excessive cardiovascular risk . We investigated whether pharmacologic treatment of prehypertension prevents or postpones stage 1 hypertension . METHODS Participants with repeated measurements of systolic pressure of 130 to 139 mm Hg and diastolic pressure of 89 mm Hg or lower , or systolic pressure of 139 mm Hg or lower and diastolic pressure of 85 to 89 mm Hg , were r and omly assigned to receive two years of c and esartan ( Atac and , AstraZeneca ) or placebo , followed by two years of placebo for all . When a participant reached the study end point of stage 1 hypertension , treatment with antihypertensive agents was initiated . Both the c and esartan group and the placebo group were instructed to make changes in lifestyle to reduce blood pressure throughout the trial . RESULTS A total of 409 participants were r and omly assigned to c and esartan , and 400 to placebo . Data on 772 participants ( 391 in the c and esartan group and 381 in the placebo group ; mean age , 48.5 years ; 59.6 percent men ) were available for analysis . During the first two years , hypertension developed in 154 participants in the placebo group and 53 of those in the c and esartan group ( relative risk reduction , 66.3 percent ; P hypertension had developed in 240 participants in the placebo group and 208 of those in the c and esartan group ( relative risk reduction , 15.6 percent ; P Serious adverse events occurred in 3.5 percent of the participants assigned to c and esartan and 5.9 percent of those receiving placebo . CONCLUSIONS Over a period of four years , stage 1 hypertension developed in nearly two thirds of patients with untreated prehypertension ( the placebo group ) . Treatment of prehypertension with c and esartan appeared to be well tolerated and reduced the risk of incident hypertension during the study period . Thus , treatment of prehypertension appears to be feasible . ( Clinical Trials.gov number , NCT00227318 . )",
"BACKGROUND Hypertension is a major contributor to the health and economic burden imposed by stroke , heart disease , and renal insufficiency . Antihypertensives can prevent many of the harmful effects of elevated blood pressure , but medication nonadherence is a known barrier to the effectiveness of these treatments . Smartphone-based applications that remind patients to take their medications , provide education , and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing . METHODS / DESIGN The MedISAFE-BP study is a prospect i ve , r and omized control trial design ed to evaluate the impact on blood pressure and medication adherence of an mhealth application ( Medisafe ) . Four hundred thirteen patients with uncontrolled hypertension have been enrolled and r and omized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform . Patients will be followed up for 12 weeks and the trial 's co- primary outcomes will be change in systolic blood pressure and self-reported medication adherence . DISCUSSION The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application 's effect on blood pressure and medication adherence . The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes",
"Background Despite a variety of efficient and cost-effective antihypertensive medication , hypertension remains a serious health and economic burden . High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality . At the same time , Slovakia has alarmingly low patients ’ adherence to medication intake . Studies have shown the efficiency of short messaging service ( SMS ) reminders to improve patients ’ adherence and health outcomes at low costs . Since SMS is popular among Slovaks , this approach may be feasible also in Slovakia . The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the st and ard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients . Methods The SPPA trial is a pragmatic r and omized parallel group ( 1:1 ) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia . Trial pharmacies will be selected from all main regions of Slovakia . Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice . The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale ( MMAS-8 ) and objective pill count rate . Secondary outcomes include : change in the MMAS-8 ; comparison of adherence rates using pill count ; change in systolic blood pressure ; and patient satisfaction . Also , direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out . Discussion The SPPA trial engages community pharmacists and mobile health ( mHealth ) technologies via evidence -based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges : high prevalence of hypertension ; overconsumption of cardiovascular medicines ; low adherence to medication treatment ; and result ing uncontrolled blood pressure . The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients .Trial registration Clinical Trials.gov , NCT03105687 . Registered on 07 March 2017",
"Background Patients with chronic conditions often use complex medical regimens . A nurse‐led strategy to support medication therapy management incorporated into primary care teams may lead to improved use of medications for disease control . Electronic health record ( EHR ) tools may offer a lower‐cost , less intensive approach to improving medication management . Methods and Results The Northwestern and Access Community Health Network Medication Education Study is a health center – level cluster‐r and omized trial being conducted within a network of federally qualified community health centers . Health centers have been enrolled in groups of 3 and r and omized to ( 1 ) usual care , ( 2 ) EHR‐based medication management tools alone , or ( 3 ) EHR tools plus nurse‐led medication therapy management . Patients with uncontrolled hypertension who are prescribed ≥3 medications of any kind are recruited from the centers . EHR tools include a printed medication list to prompt review at each visit and automated plain‐ language medication information within the after‐visit summary to encourage proper medication use . In the nurse‐led intervention , patients receive one‐on‐one counseling about their medication regimens to clarify medication discrepancies and identify drug‐related concerns , safety issues , and nonadherence . Nurses also provide follow‐up telephone calls following new prescriptions and periodically to perform medication review . The primary study outcome is systolic blood pressure after 1 year . Secondary outcomes include measures of underst and ing of dosing instructions , discrepancies between patient‐reported medications and the medical record , adherence , and intervention costs . Conclusions The Northwestern and Access Community Health Network Medication Education Study will assess the effects of 2 approaches to support outpatient medication management among patients with uncontrolled hypertension in federally qualified health center setting s. Clinical Trial Registration URL : clinical trials.gov . Unique identifier : NCT01578577",
"Background Hypertension is one of the most important and well-known risk factors for cardiovascular diseases . Unfortunately , in spite of effective treatments , adherence to the regular use of drugs and other nondrug treatments , such as lifestyle improvement , is often poor . This study evaluates the effectiveness of an educational , supportive intervention – in the form of a Blood Pressure Management Application ( BPMAP ) – on self-management in patients with primary hypertension on controlling the determinant factors of hypertension , and on adherence to treatment . Methods / design A two-arm , parallel- design r and omized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center . One hundred and thirty-two ( 132 ) patients will be r and omly assigned to the intervention and control ( usual method ) groups . The most important inclusion criteria are , having primary hypertension and being pharmacologically treated for it , and not having developed the complications of hypertension , such as myocardial infa rct ion , cerebral stroke and cardiac insufficiency . The participants should be able to read Persian and be able to use the application . The most important outcomes of the study include adherence to treatment , weight control , and regular monitoring of blood pressure which are assessed in the primary assessment ( baseline data question naire ) and again at the 8th and 24th weeks . The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information . Discussion This application has been programmed to reduce many of the nonadherence factors of hypertension treatment . Therefore , the findings may contribute to a rise in adherence to treatment . If proven to have an appropriate impact , it may be extended for use in the national hypertension control plan . Trial registration This study was registered in the Iran R and omized Clinical Trial Center under the number I RCT 2015111712211N2 on 1 January 2016",
"Background : Hypertension frequently accompanies diabetes mellitus , worsening prognosis and complicating medical care for patients . Low medication adherence with multiple medications is a major factor in the inadequate achievement of blood pressure treatment goals . Widespread access to mobile phones offers a new opportunity to communicate with patients and enhance disease self-management . Methods : We recruited 50 high-risk urban patients with hypertension , who are using at least two prescription medications for hypertension , into an open-label trial using medication reminder software on a mobile phone . Medication adherence was assessed by review of pharmacy refill rates before , during , and after availability of the medication reminder software ( pre-activation , activation , and post-activation phase , respectively ) . Results : Forty-eight patients completed the study . All subjects were insured by Medicaid , 96 % were African-American , and the majority had diabetes mellitus . The proportion of days covered for each study phase was as follows : Pre-activation phase = 0.54 , activation phase = 0.58 , and post-activation phase = 0.46 . A significant difference was found between the activation and post-activation phases ( p = .001 ) . The increase in measured adherence between the pre-activation and activation phases approached significance ( p = .057 ) . Forty-six patients completed the pre- and post-Morisky medication adherence survey . The median score rose from 2.0 at baseline to 3.0 at study completion ( p Average blood pressure and level of control during study period improved significantly after initiation of the study and remained improved from baseline through the course of the study . The 48 subjects who completed the study reported a high level of satisfaction with the medication reminder application at the final study visit . Conclusions : A mobile-phone-based automated medication reminder system shows promise in improving medication adherence and blood pressure in high-cardiovascular-risk individuals",
"Background The majority of North American adult females do not meet current physical activity recommendations ( 150 min of moderate-to-vigorous intensity physical activity ( MVPA ) per week accrued in ≥10 min bouts ) ultimately placing themselves at increased risk of morbidity and mortality . Working-age females face particular challenges in meeting physical activity recommendations as they have multiple dem and s , including occupational , family and social dem and s. To develop effective interventions to increase MVPA among working-age females , it is necessary to identify and underst and the strongest modifiable determinants influencing these behaviours . Therefore , the objective of this systematic review is to examine the available evidence to identify intrapersonal , social and environmental determinants of MVPA among working-age females . Methods / Design Six electronic data bases will be search ed to identify all prospect i ve cohort studies that report on intrapersonal , social and /or environmental determinants of MVPA in working-age females . Grey literature sources including theses , published conference abstract s and websites from relevant organizations will also be included . Articles that report on intrapersonal ( e.g. health status , self-efficacy , socio-economic status ( SES ) , stress , depression ) , social environmental ( e.g. crime , safety , area SES , social support , climate and capital , policies ) , and environmental ( e.g. weather , workplace , home , neighbourhood , recreation environment , active transportation ) determinants of MVPA in a working-age ( mean age 18–65 years ) female population will be included . Risk of bias will be assessed within and across all included studies using the Tool to Assess Risk of Bias in Cohort Studies and the Grade s of Recommendation , Assessment , Development and Evaluation approach . Harvest plots will be used to synthesize results across all determinants , and meta-analyses will be conducted where possible among studies with sufficient homogeneity . Discussion This review will provide a comprehensive examination of evidence in this field and will serve to highlight gaps for future research on the determinants of MVPA in working-age females and ultimately inform intervention design . Systematic review registration PROSPERO : CRD42014009750",
"OBJECTIVE Hypertension and other noncommunicable diseases represent a growing threat to low/middle-income countries ( LMICs ) . Mobile health technologies may improve noncommunicable disease outcomes , but LMICs lack re sources to provide these services . We evaluated the efficacy of a cloud computing model using automated self-management calls plus home blood pressure ( BP ) monitoring as a strategy for improving systolic BPs ( SBPs ) and other outcomes of hypertensive patients in two LMICs . SUBJECTS AND METHODS This was a r and omized trial with a 6-week follow-up . Participants with high SBPs ( ≥140 mm Hg if nondiabetic and ≥130 mm Hg if diabetic ) were enrolled from clinics in Honduras and Mexico . Intervention patients received weekly automated monitoring and behavior change telephone calls sent from a server in the United States , plus a home BP monitor . At baseline , control patients received BP results , hypertension information , and usual healthcare . The primary outcome , SBP , was examined for all patients in addition to a preplanned subgroup with low literacy or high hypertension information needs . Secondary outcomes included perceived health status and medication-related problems . RESULTS Of the 200 patients recruited , 181 ( 90 % ) completed follow-up , and 117 of 181 had low literacy or high hypertension information needs . The median annual income was $ 2,900 USD , and average educational attainment was 6.5 years . At follow-up intervention patients ' SBPs decreased 4.2 mm Hg relative to controls ( 95 % confidence interval -9.1 , 0.7 ; p=0.09 ) . In the subgroup with high information needs , intervention patients ' average SBPs decreased 8.8 mm Hg ( -14.2 , -3.4 , p=0.002 ) . Compared with controls , intervention patients at follow-up reported fewer depressive symptoms ( p=0.004 ) , fewer medication problems ( p , better general health ( p , and greater satisfaction with care ( p≤0.004 ) . CONCLUSIONS Automated telephone care management plus home BP monitors can improve outcomes for hypertensive patients in LMICs . A cloud computing model within regional telecommunication centers could make these services available in areas with limited infrastructure for patient-focused informatics support",
"BACKGROUND Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications . Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence , intervene at single points in time , or are imprecisely targeted to patients who may not need adherence assistance . OBJECTIVE To evaluate the effect of a multicomponent , behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes , hypertension , and hyperlipidemia . TRIAL DESIGN The STIC2IT trial is a cluster-r and omized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing , text messaging , mailed progress reports , and video visits . Targeted patients are those who are nonadherent to glucose-lowering , antihypertensive , or statin medications and who also have evidence of poor disease control . The intervention is tailored to patients ' individual health barriers and their level of health activation . We cluster-r and omized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care . STIC2IT has enrolled 4,076 patients who will be followed up for 12months after r and omization . The trial 's primary outcome is medication adherence , assessed using pharmacy cl aims data . Secondary outcomes are disease control and health care re source utilization . CONCLUSION This trial will determine whether a technologically enabled , behaviorally targeted pharmacist-based intervention results in improved adherence and disease control . If effective , this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need",
"Objective The aim of this study was to assess the feasibility and preliminary outcomes of a medication self-management platform for chronically ill patients , Medplan . Methods We performed a 6-month single-arm prospect i ve pre-post intervention study of patients receiving treatment for hypertension and /or dyslipidemia and /or heart failure and /or human immunodeficiency virus infection . During the pre-intervention phase , participants were followed according to their usual care ; during the intervention phase , they used Medplan . We evaluated adherence , health outcomes , healthcare re sources and measured the satisfaction of patients and health care professionals . Results The study population comprised 42 patients . No differences were found in adherence to medication measured by proportion of days covered with medication ( PDC ) . However , when adherence was measured using the SMAQ , the percentage of adherent patients improved during the intervention phase ( p number of days with missed doses decreased ( p Adherence measured using the Medplan app showed poor concordance with PDC . No differences were found in health outcomes or in the use of health care re sources during the study period . The mean satisfaction score for Medplan was 7.2 ± 2.7 out of 10 among patients and 7.3 ± 1.7 among health care professionals . In fact , 71.4 % of participants said they would recommend the app to a friend , and 88.1 % wanted to continue using it . Conclusion The Medplan platform proved to be feasible and was well accepted by its users . However , its impact on adherence differed depending on the assessment method . The lack of effect on PDC is mainly because patients were already good adherers at baseline . The study enabled us to vali date the platform in real patients using many different mobile devices and to identify potential barriers to scaling up the platform",
"Background : Comprehensive programs addressing tailored patient self‐management and pharmacotherapy may reduce barriers to cardiovascular disease ( CVD ) risk reduction . Methods : This is a 2‐arm ( clinical pharmacist specialist – delivered , telehealth intervention and education control ) r and omized controlled trial including Veterans with poorly controlled hypertension and /or hypercholesterolemia . Primary outcome was Framingham CVD risk score at 6 and 12 months , with systolic blood pressure ; diastolic blood pressure ; total cholesterol ; low‐density lipoprotein ; high‐density lipoprotein ; body mass index ; and , for those with diabetes , HbA1c as secondary outcomes . Results : Among 428 Veterans , 50 % were African American , 85 % were men , and 33 % had limited health literacy . Relative to the education control group , the clinical pharmacist specialist – delivered intervention did not show a reduction in CVD risk score at 6 months ( −1.8 , 95 % CI −3.9 to 0.3 ; P = .10 ) or 12 months ( −0.3 , 95 % CI −2.4 to 1.7 ; P = .74 ) . No differences were seen in systolic blood pressure , diastolic blood pressure , or low‐density lipoprotein at 6 or 12 months . We did observe a significant decline in total cholesterol at 6 months ( −7.0 , 95 % CI −13.4 to −0.6 ; P = .03 ) in the intervention relative to education control group . Among patients in the intervention group , 34 % received at least 5 of the 12 planned intervention calls and were considered “ compliers . ” A sensitivity analysis of the “ complier average causal effect ” of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 ( 95 % CI −12.0 to 0.7 ) at 6 months and −1.7 ( 95 % CI −7.6 to 4.8 ) at 12 months . Conclusions : Despite increased access to pharmacist re sources , we did not observe significant improvements in CVD risk for patients r and omized to the intervention compared to education control over 12 months . However , the intervention may have positive impact among those who actively participate , particularly in the short term",
"BACKGROUND R and omized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease ; however , blood pressure remains inadequately treated in most affected individuals . This large gap continues despite the facts that more than 90 % of adults with hypertension have health insurance , and hypertension is the leading cause of visits to the doctor . New approaches are needed to improve hypertension care . OBJECTIVES The Electronic Communications and Home Blood Pressure Monitoring ( e-BP ) study is a three-arm r and omized controlled trial design ed to determine whether care based on the Chronic Care Model and delivered over the Internet improves hypertension care . The primary study outcomes are systolic , diastolic , and blood pressure control ; secondary outcomes are medication adherence , patient self-efficacy , satisfaction and quality of life , and healthcare utilization and costs . METHODS Hypertensive patients receiving care at Group Health medical centers are eligible if they have uncontrolled blood pressure on two screening visits and access to the Web and an e-mail address . Study participants are r and omly assigned to three intervention groups : ( a ) usual care ; ( b ) home blood pressure monitoring receipt and proficiency training on its use and the Group Health secure patient website ( with secure e-mail access to their healthcare provider , access to a shared medical record , prescription refill and other services ) ; or ( c ) this plus pharmacist care management ( collaborative care management between the patient , the pharmacist , and the patient 's physician via a secure patient website and the electronic medical record ) . CONCLUSION We will determine whether a new model of patient-centered care that leverages Web communications , self-monitoring , and collaborative care management improves hypertension control . If this model proves successful and cost-effective , similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension",
"BACKGROUND Clinical inertia , provider failure to appropriately intensify treatment , is a major contributor to uncontrolled blood pressure ( BP ) . Some clinical inertia may result from physician uncertainty over the patient ’s usual BP , adherence , or value of continuing efforts to control BP through lifestyle changes . OBJECTIVE To test the hypothesis that providing physicians with uncertainty reduction tools , including 24-h ambulatory BP monitoring , electronic bottle cap monitoring , and lifestyle assessment and counseling , will lead to improved BP control . DESIGN Cluster r and omized trial with five intervention clinics ( IC ) and five usual care clinics ( UCC ) . SETTING Six public and 4 private primary care clinics . PARTICIPANTS A total of 665 patients ( 63 percent African American ) with uncontrolled hypertension ( BP ≥140 mmHg/90 mmHg or ≥130/80 mmHg if diabetic ) . INTERVENTIONS An order form for uncertainty reduction tools was placed in the IC participants ’ charts before each visit and results fed back to the provider . OUTCOME MEASURES Percent with controlled BP at last visit . Secondary outcome was BP changes from baseline . RESULTS Median follow-up time was 24 months . IC physicians intensified treatment in 81 % of IC patients compared to 67 % in UCC ( p achieved control at the last recorded visit ( p > 0.05 ) . Multi-level mixed effects longitudinal regression modeling of SBP and DBP indicated a significant , non-linear slope difference favoring IC ( p time × group interaction = 0.048 for SBP and p = 0.001 for DBP ) . The model-predicted difference attributable to intervention was −2.8 mmHg for both SBP and DBP by month 24 , and −6.5 mmHg for both SBP and DBP by month 36 . CONCLUSIONS The uncertainty reduction intervention did not achieve the pre-specified dichotomous outcome , but led to lower measured BP in IC patients",
"ABSTRACT BACKGROUND To appropriately manage uncontrolled hypertension , clinicians must decide whether blood pressure ( BP ) is above goal due to a need for additional medication or to medication nonadherence . Yet , clinicians are poor judges of adherence , and uncertainty about adherence may promote inertia with respect to medication modification . OBJECTIVE We aim ed to determine the effect of sharing electronically-measured adherence data with clinicians on the management of uncontrolled hypertension . DESIGN This was a cluster r and omized trial . PARTICIPANTS Twenty-four primary care providers ( 12 intervention , 12 usual care ; cluster units ) and 100 patients with uncontrolled hypertension ( 65 intervention , 35 usual care ) were included in the study . INTERVENTIONS At one visit per patient , clinicians in the intervention group received a report summarizing electronically measured adherence to the BP regimen and recommended clinical actions . Clinicians in the control group did not receive a report . MAIN MEASURES The primary outcome was the proportion of visits with appropriate clinical management ( i.e. , treatment intensification among adherent patients and adherence counseling among nonadherent patients ) . Secondary outcomes included patient-rated quality of care and communication during the visit . KEY RESULTS The proportion of visits with appropriate clinical management was higher in the intervention group than the control group ( 45 out of 65 ; 69 % ) versus ( 12 out of 35 ; 34 % ; p = 0.001 ) . A higher proportion of adherent patients in the intervention group had their regimen intensified ( p = 0.01 ) , and a higher proportion of nonadherent patients in the intervention group received adherence counseling ( p = 0.005 ) . Patients in the intervention group were more likely to give their clinician high ratings on quality of care ( p = 0.05 ) , and on measures of patient-centered ( p = 0.001 ) and collaborative communication ( p = 0.02 ) . CONCLUSIONS Providing clinicians with electronically-measured antihypertensive adherence reports reduces inertia in the management of uncontrolled hypertension . Trial Registration NCT01257347 ; http:// clinical",
"OBJECTIVE To evaluate the feasibility of a web-based coaching programme for vascular risk factor treatment , to describe the patterns of use and to measure changes in risk factors . METHODS Patients with a clinical manifestation of arterial disease and Internet access were asked to participate in the nurse-led Internet-based risk factor management programme . At the first clinic visit , a personalized action plan was made for the treatment of risk factors . Patients were instructed on communication with a specialized nurse through Internet and encouraged to enter self-measured risk factor levels at their personalized website . The nurse practitioner replied on working days and gave feedback , support , and recommendations on lifestyle and medical treatment . After 6 months , risk factors were re-measured . RESULTS Fifty patients participated , 70 % were overweight , 64 % had hypertension , 42 % hyperlipidemia , and 24 % smoked at baseline . During 6 months , the log-in average at the individual website was 35 times per patient ( 1.3 log-ins/week ) ; while the nurse practitioner logged-in at the overall website 23 times/week . The website was hardly used by five patients . Most e-mail messages were sent by patients for hypertension ( 211 times ) and obesity ( 203 times ) , whereas the nurse practitioner sent nearly twice as many e-mail messages for hypertension ( 400 times ) and obesity ( 455 times ) . The level of most risk factors decreased and the fraction of achieved treatment goals increased ( blood pressure from 36 to 58 % , LDL-cholesterol from 58 to 64 % , glucose from 64 to 82 % ) . CONCLUSIONS A web-based vascular risk factor intervention programme is feasible ; it is frequently used by patients and suitable to decrease the level of several risk factors . It has the promise of being an efficacious intervention for risk factor sanitation in patients with symptomatic vascular disease . PRACTICE IMPLICATION S An Internet-based individualised risk management programme could make patients aware of their self-management capability and may contribute to risk factor reduction",
"BACKGROUND Patients ' engagement in mobile health ( m-health ) interventions using interactive voice response ( IVR ) calls is less in low- and middle-income countries ( LMICs ) than in industrialized ones . We conducted a study to determine whether automated telephone feedback to informal caregivers ( \" CarePartners \" ) increased engagement in m-health support among diabetes and hypertension patients in Bolivia . MATERIAL S AND METHODS Patients with diabetes and /or hypertension were identified through ambulatory clinics affiliated with four hospitals . All patients enrolled with a CarePartner . Patients were r and omized to weekly IVR calls including self-management questions and self-care education either alone ( \" st and ard m-health \" ) or with automated feedback about health and self-care needs sent to their CarePartner after each IVR call ( \" m-health+CP \" ) . RESULTS The 72 participants included 39 with diabetes and 53 with hypertension , of whom 19 had ≤6 years of education . After 1,225 patient-weeks of attempted IVR assessment s , the call completion rate was higher among patients r and omized to m-health+CP compared with st and ard m-health ( 62.0 % versus 44.9 % ; p tripled call completion rates among indigenous patients and patients with low literacy ( p M-health+CP patients were more likely to report excellent health via IVR ( adjusted odds ratio [ AOR ] = 2.60 ; 95 % confidence interval [ CI ] , 1.07 , 6.32 ) and less likely to report days in bed due to illness ( AOR = 0.42 ; 95 % CI , 0.19 , 0.91 ) . CONCLUSIONS In this study we found that caregiver feedback increased engagement in m-health and may improve patients ' health status relative to st and ard approaches . M-health+CP represents a scalable strategy for increasing the reach of self-management support in LMICs",
"AIMS The rapidly increasing prevalence of chronic diseases is an important challenge to healthcare systems worldwide . To improve the quality and efficiency of chronic disease care , we investigated the effectiveness and applicability of the Ubiquitous Chronic Disease Care ( UCDC ) system using cellular phones and the internet for overweight patients with both Type 2 diabetes and hypertension . METHODS We conducted a r and omized , controlled clinical trial over 3 months that included 123 patients at a university hospital and a community public health centre . RESULTS After 12 weeks , there were significant improvements in HbA(1c ) in the intervention group ( 7.6 + /- 0.9 % to 7.1 + /- 0.8 % , P systolic and diastolic blood pressure , as well as improvements in total cholesterol , low-density lipoprotein-cholesterol and triglyceride levels in the intervention group . Furthermore , there was a significant increase in adiponectin levels in the intervention group compared with the control group , although high-sensitivity C-reactive protein and interleukin-6 levels did not change in either group . CONCLUSIONS The novel UCDC system presented in this paper improved multiple metabolic parameters simultaneously in overweight patients with both Type 2 diabetes and hypertension",
"BACKGROUND Poor adherence explains poor blood pressure ( BP ) control ; however African Americans suffer worse hypertension-related outcomes . METHODS This r and omized controlled trial evaluated whether a patient education intervention enhanced with positive-affect induction and self-affirmation ( PA ) was more effective than patient education ( PE ) alone in improving medication adherence and BP reduction among 256 hypertensive African Americans followed up in 2 primary care practice s. Patients in both groups received a culturally tailored hypertension self-management workbook , a behavioral contract , and bimonthly telephone calls design ed to help them overcome barriers to medication adherence . Also , patients in the PA group received small gifts and bimonthly telephone calls to help them incorporate positive thoughts into their daily routine and foster self-affirmation . The main outcome measures were medication adherence ( assessed with electronic pill monitors ) and within-patient change in BP from baseline to 12 months . RESULTS The baseline characteristics were similar in both groups : the mean BP was 137/82 mm Hg ; 36 % of the patients had diabetes ; 11 % had stroke ; and 3 % had chronic kidney disease . Based on the intention-to-treat principle , medication adherence at 12 months was higher in the PA group than in the PE group ( 42 % vs 36 % , respectively ; P = .049 ) . The within-group reduction in systolic BP ( 2.14 mm Hg vs 2.18 mm Hg ; P = .98 ) and diastolic BP ( -1.59 mm Hg vs -0.78 mm Hg ; P = .45 ) for the PA group and PE group , respectively , was not significant . CONCLUSIONS A PE intervention enhanced with PA led to significantly higher medication adherence compared with PE alone in hypertensive African Americans . Future studies should assess the cost-effectiveness of integrating such interventions into primary care . Trial Registration clinical trials.gov Identifier : NCT00227175",
"OBJECTIVE To design and investigate a pharmacist-run intervention using low health literacy flashcards and a smartphone-activated quick response ( QR ) barcoded educational flashcard video to increase medication adherence and disease state underst and ing . DESIGN Prospect i ve , matched , quasi-experimental design . SETTING County health system in Dallas , Texas . PARTICIPANTS Sixty-eight primary care patients prescribed targeted heart failure , hypertension , and diabetes medications INTERVENTION : Low health literacy medication and disease specific flashcards , which were also available as QR-coded online videos , were design ed for the intervention patients . The following vali date d health literacy tools were conducted : Newest Vital Sign ( NVS ) , Rapid Estimate of Adult Literacy Medicine-Short Form , and Short Assessment of Health Literacy-50 . MAIN OUTCOME MEASURES The primary outcome was the difference in medication adherence at 180 days after pharmacist intervention compared with the control group , who were matched on the basis of comorbid conditions , targeted medications , and medication class . Medication adherence was measured using a modified Pharmacy Quality Alliance proportion of days covered ( PDC ) calculation . Secondary outcomes included 90-day PDC , improvement of greater than 25 % in baseline PDC , and final PDC greater than 80 % . Linear regression was performed to evaluate the effect of potential confounders on the primary outcome . RESULTS Of the 34 patients receiving the intervention , a majority of patients scored a high possibility of limited health literacy on the NVS tool ( 91.2 % ) . The medication with the least adherence at baseline was metformin , followed by angiotensin-converting enzyme inhibitors and beta blockers . At 180 days after intervention , patients in the intervention group had higher PDCs compared with their matched controls ( 71 % vs. 44 % ; P = 0.0069 ) . CONCLUSION The use of flashcards and QR-coded prescription bottles for medication and disease state education is an innovative way of improving adherence to diabetes , hypertension , and heart failure medications in a low-health literacy patient population",
"Introduction Rising burden of cardiovascular disease ( CVD ) and diabetes is a major challenge to the health system in India . Innovative approaches such as mobile phone technology ( mHealth ) for electronic decision support in delivering evidence -based and integrated care for hypertension , diabetes and comorbid depression have potential to transform the primary healthcare system . Methods and analysis mWellcare trial is a multicentre , cluster r and omised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India . mWellcare system is an And roid-based mobile application design ed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records , sending alerts and reminders for follow-up and adherence to medication . We recruited a total of 3702 participants from 40 Community Health Centres ( CHCs ) , with ≥90 at each of the CHCs in the intervention and control ( enhanced care ) arms . The primary outcome is the difference in mean change ( from baseline to 1 year ) in systolic blood pressure and glycated haemoglobin ( HbA1c ) between the two treatment arms . The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose , total cholesterol , predicted 10-year risk of CVD , depression , smoking behaviour , body mass index and alcohol use between the two treatment arms and cost-effectiveness . Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine . Findings will be disseminated widely through peer- review ed publications , conference presentations and other mechanisms . Trial registration mWellcare trial is registered with Clinical trial.gov ( Registration number NCT02480062 ; Pre- results ) and Clinical Trial Registry of India ( Registration number CTRI/2016/02/006641 ) . The current version of the protocol is Version 2 date d 19 October 2015 and the study sponsor is Public Health Foundation of India , Gurgaon , India ( www.phfi.org )",
"Clinical inertia is a major contributor to poor blood pressure ( BP ) control . The authors tested the effectiveness of an intervention targeting physician , patient , and office system factors with regard to outcomes of clinical inertia and BP control . A total of 591 adult primary care patients with elevated BP ( mean systolic BP ≥ 140 mm Hg or mean diastolic BP ≥ 90 mm Hg ) were r and omized to intervention or usual care . An outreach coordinator raised patient and provider awareness of unmet BP goals , arranged BP-focused primary care clinic visits , and furnished providers with treatment decision support . The intervention reduced clinical inertia ( -29 % vs -11 % , P=.001 ) . Nonetheless , change in BP did not differ between intervention and usual care ( -10.1/-4.1 mm Hg vs -9.1/-4.5 mm Hg , P=.50 and 0.71 for systolic and diastolic BP , respectively ) . Future primary care-focused interventions might benefit from the use of specific medication titration protocol s , treatment adherence support , and more sustained patient follow-up visits",
"Antihypertensive drug adherence ( ADA ) is a mainstay in blood pressure control . Education through mobile phone short message system ( SMS ) text messaging could improve ADA . The authors conducted a r and omized study involving 314 patients with hypertension with Patients were r and omly assigned to receive or not receive SMS related to ADA and healthy lifestyle . Adherence was assessed by the self-reported four-item scale Morisky-Green-Levine question naire at baseline and after 6 months of follow-up , with four of four positive questions classified as good adherence . Group comparison for adherence was performed by means of a logistic regression model , adjusting by baseline adherence , age older than 60 years , and sex . A total of 163 patients were r and omized to receive and 151 to not receive SMS . After 6 months of follow-up , ADA in the non-SMS group decreased from 59.3 % to 51.4 % ( P=.1 ) . By contrast , adherence increased from 49 % to 62.3 % ( P=.01 ) in the SMS group . Text messaging intervention improved ADA ( risk ratio , 1.3 ; 95 % confidence interval , 1.0 - 1.6 [ P text messaging result ed in an increase in reporting ADA in this hypertensive Latino population . This approach could become an effective tool to overcome poor medication adherence in the community",
"Background Multiple r and omized controlled trials ( RCTs ) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease ( CVD ) outcomes . The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management ; however , evaluation of its impact in minority population s is limited . This study intends to provide early evidence of a theory-driven intervention , Tablet-Aided BehavioraL intervention EffecT on Self-management skills ( TABLETS ) , using real-time videoconferencing for education and skills training . We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American ( AA ) population with poorly controlled type 2 diabetes . Methods The study is a two-arm , pilot controlled trial that r and omizes 30 participants to the TABLETS intervention and 30 participants to a usual care group . Blinded outcome assessment s will be completed at baseline , 2.5 months ( immediate post-intervention ) , and 6.5 months ( follow-up ) . The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices , with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention material s via videoconferencing slides and a manual of supplementary material s. The primary outcomes are physical activity , diet , medication adherence , and self-monitoring behavior , whereas the secondary outcomes are HbA1c , low-density lipoprotein cholesterol ( LDL-C ) , BP , CVD risk , and quality of life . Discussion This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven , tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self-management behaviors and quality of life among a high-risk , low-income AA population with an uncontrolled dyad or triad of CVD risk factors ( diabetes with or without hypertension or hyperlipidemia ) . The intervention leverages the use of novel technology for education and skill-building to foster improved diabetes self-management . The findings of this study will inform the process of disseminating the intervention to a broader and larger sample of people and can potentially be refined to align with clinical workflows that target a sub sample of patients with poor diabetes self-management . Trial registration The trial was registered in April 2014 with the United States National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier NCT02128854 ) , available online at : http:// clinical trials.gov/ct2/show/NCT02128854",
"M eeting the complex needs of patients with chronic illness or impairment is the single greatest challenge facing organized medical practice . Usual care is not doing the job ; dozens of surveys and audits have revealed that sizable proportions of chronically ill patients are not receiving effective therapy , have poor disease con- trol , and are unhappy with their care ( 1 ) . Results of r and omized trials also show that effective disease management programs can achieve substantially better outcomes than usual care , the control intervention . These trials , along with the ideas and efforts for improvement discussed in this issue , show that we can improve care and outcomes . As the articles suggest , these improvements will not come easily . If we are to improve care for most patients with chronic illness , the evidence strongly suggests that we reshape our ambulatory care systems for this purpose . Pri- mary care practice was largely design ed to provide ready access and care to patients with acute , varied problems , with an emphasis on triage and patient flow ; short appointments ; diagnosis and treatment of symptoms and signs ; reliance on laborato- ry investigations and prescriptions ; brief , didactic patient education ; and patient- initiated follow-up . Patients and families struggling with chronic illness have differ- ent needs , and these needs are unlikely to be met by an acute care organization and culture . They require planned , regular interactions with their caregivers , with a focus on function and prevention of exacerbations and complications . This interac- tion includes systematic assessment s , attention to treatment guidelines , and behav- iorally sophisticated support for the patient 's role as self-manager . These interactions must be linked through time by clinical ly relevant information systems and continu- ing follow-up initiated by the medical practice . Comprehensive System",
"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",
"Objective To assess whether non- clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies . Design Pragmatic , multicentre , r and omised controlled trial . Setting 42 general practice s in three areas of Engl and . Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20 % or more , no previous cardiovascular event , at least one modifiable risk factor ( systolic blood pressure ≥140 mm Hg , body mass index ≥30 , current smoker ) , and access to a telephone , the internet , and email . Participants were individually allocated to intervention ( n=325 ) or control ( n=316 ) groups using automated r and omisation stratified by site , minimised by practice and baseline risk score . Interventions Intervention was the Healthlines service ( alongside usual care ) , comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software . Advisors facilitated self management by supporting participants to use online re sources to reduce risk factors , and sought to optimise drug use , improve treatment adherence , and encourage healthier lifestyles . The control group comprised usual care alone . Main outcome measures The primary outcome was the proportion of participants responding to treatment , defined as maintaining or reducing their cardiovascular risk after 12 months . Outcomes were collected six and 12 months after r and omisation and analysed masked . Participants were not masked . Results 50 % ( 148/295 ) of participants in the intervention group responded to treatment compared with 43 % ( 124/291 ) in the control group ( adjusted odds ratio 1.3 , 95 % confidence interval 1.0 to 1.9 ; number needed to treat=13 ) ; a difference possibly due to chance ( P=0.08 ) . The intervention was associated with reductions in blood pressure ( difference in mean systolic −2.7 mm Hg ( 95 % confidence interval −4.7 to −0.6 mm Hg ) , mean diastolic −2.8 ( −4.0 to −1.6 mm Hg ) ; weight −1.0 kg ( −1.8 to −0.3 kg ) , and body mass index −0.4 ( −0.6 to −0.1 ) but not cholesterol −0.1 ( −0.2 to 0.0 ) , smoking status ( adjusted odds ratio 0.4 , 0.2 to 1.0 ) , or overall cardiovascular risk as a continuous measure ( −0.4 , −1.2 to 0.3 ) ) . The intervention was associated with improvements in diet , physical activity , drug adherence , and satisfaction with access to care , treatment received , and care coordination . One serious related adverse event occurred , when a participant was admitted to hospital with low blood pressure . Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk , and there was no overall improvement in average risk . The Healthlines service was , however , associated with improvements in some risk behaviours , and in perceptions of support and access to care . Trial registration Current Controlled Trials IS RCT N 27508731",
"This pilot study evaluated a reinforcement intervention to improve adherence to antihypertensive therapy . Twenty-nine participants were r and omized to st and ard care or st and ard care plus financial reinforcement for 12 weeks . Participants in the reinforcement group received a cell phone to self-record videos of adherence , for which they earned rewards . These participants sent videos demonstrating on-time adherence 97.8 % of the time . Pill count adherence differed significantly between the groups during treatment , with 98.8%±1.5 % of pills taken during treatment in the reinforcement condition vs 92.6%±9.2 % in st and ard care ( P P counts correlated significantly ( P with self-reports of adherence , which also differed between groups over time ( P decreased modestly over time in participants overall ( P cellular phone technology and financial reinforcement holds potential to improve 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 Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 )",
"BACKGROUND The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention , patient self-monitoring , and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months . The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone . We examined direct and patient time costs associated with each intervention . METHODS We conducted a prospect i ve economic evaluation alongside a r and omized controlled trial of 636 patients with hypertension participating in the study interventions . Medical costs were estimated using electronic data representing medical services delivered within the health system . Intervention-related costs were derived using information collected during the trial , administrative records , and published unit costs . RESULTS During 24 months , patients incurred a mean of $ 6,965 ( s.d . , $ 22,054 ) in inpatient costs and $ 8,676 ( s.d . , $ 9,368 ) in outpatient costs , with no significant differences among the intervention groups . With base-case assumptions , intervention costs were estimated at $ 90 ( s.d . , $ 2 ) for home blood pressure monitoring , $ 345 ( s.d . , $ 64 ) for the behavioral intervention ( $ 31 per telephone encounter ) , and $ 416 ( s.d . , $ 93 ) for the combined intervention . Patient time costs were estimated at $ 585 ( s.d . , $ 487 ) for home monitoring , $ 55 ( s.d . , $ 16 ) for the behavioral intervention , and $ 741 ( s.d . , $ 529 ) for the combined intervention . CONCLUSIONS Our analysis demonstrated that the interventions are cost-additive to the health-care system in the short term and that patients ' time costs are nontrivial",
"BACKGROUND Many strategies have been evaluated to improve the prevention and control of cardiovascular ( CVD ) risk factors . Nursing telephonic and tele-counseling individualized lifestyle educational programs have been found to improve blood pressure control and adherence to lifestyle recommendation . This study tested the efficacy of a nurse-led reminder program through email ( NRP-e ) to improve CVD risk factors among hypertensive adults . METHODS All participants received usual CVD prevention and a guideline -based educational program . Subjects in the NRP-e group also received weekly email alerts and phone calls from a nurse care manager for 6 months . Emails contained a reminder program on the need for adherence with a healthy lifestyle based upon current guidelines . Follow-up visits were scheduled at 1 , 3 and 6 months after enrollment ; r and omization was made central ly and blood sample s were evaluated into a single laboratory . RESULTS The final sample consisted of 98 ( control ) and 100 ( NRP-e ) subjects ( mean age 59.0 ± 14.5 years ; 51.0 % males ) . After 6 months , the following CVD risk factors significantly improved in both groups : body mass index , alcohol and fruit consumption , cigarette smoking , adherence to therapy hours , systolic and diastolic blood pressure , fasting blood glucose , low-density lipoproteins ( LDL ) and total cholesterol , triglycerides , and physical activity . In the NRP-e group , however , the prevalence of several behaviors or conditions at risk decreased significantly more than in the control group : obesity ( -16 % ) , low fruit consumption ( -24 % ) , uncontrolled hypertension ( -61 % ) , LDL ( -56 % ) , and total cholesterol ( -40 % ) . CONCLUSIONS The NRP-e improved a range of CVD risk factors . The program had low costs , required only an average of < 20 min per day in addition to normal practice , and may deserve further evaluation for the inclusion among existing care management approaches",
"Self-monitoring of blood glucose is an integral part of diabetes care which may be extended to other biometrics . Cellular and short range communication technologies will be important for the routine usage of these systems . However , the issues of follow-up and patient compliance with these emerging systems have not been yet studied evaluated but could be critical to the adoption of these technologies . We evaluated the impact of mobile telemonitoring on the intensification of care on blood pressure control and exposure to hyperglycaemia in patients with diabetes . We r and omised 137 patients with diabetes to either mobile telemonitoring ( n = 3D72 ) or usual care patients ( n = 3D65 ) for 9 months . In this paper we present some of the clinical results with focus on blood pressure control hypertension and highlight some of the technical and compliance issues that were encountered",
"OBJECTIVE Examine the impact of a PACE ( Prepare , Ask , Check , Express ) inspired web-based communication intervention alone or combined with a workshop on reaching treatment goals for patients suffering from chronic diseases ( CDs ) , compared to usual care . METHODS Three arm single-blind RCT in community primary care ( PC ) practice s. PC practitioners ( n=18 ) had a CD patient caseload , and practicing > 5 years . Patients > 40 years old , English speaking , computer literate , not reaching treatment goals for hypertension , type II diabetes , and /or dyslipidemia . INTERVENTIONS ( 1 ) web-intervention and ( 2 ) web intervention and nurse facilitated workshop and ( 3 ) usual care . OUTCOME Proportion of patients meeting all treatment suggested guidelines for the diagnoses they were enrolled for . RESULTS Patients ( n=322 ) were r and omized , and of these 221 returned for follow up . Patients in the web group were 1.42 times more likely to meet targets compared to usual care [ 95 % CI : 1.00 - 2.00 ] , a statistical difference not seen in the combined group . Sensitivity analyses were performed to mitigate bias due to loss to follow up . CONCLUSIONS Training patients in communication skills using a website positively affects reaching treatment goals for hypertensive , diabetic and dyslipidemic patients . PRACTICE IMPLICATION S Web communication interventions are an effective tool that can be used in primary care"
] | 41166104-06ff-11f0-808a-c43d1ab1c353 |
Background Several recent behavioural and behavioural genetic studies have investigated the relationship between attention deficit hyperactivity disorder ( ADHD ) and mathematical ability . The aim of this systematic review was to provide an overview of these studies to date . An emphasis was placed on review ing results that explored the association between mathematics and the two ADHD components of attention and hyperactivity-impulsivity separately . Methods A systematic search of quantitative studies investigating the association between mathematics and ADHD was conducted across five data bases ( PsychINFO , Web of Science , PubMed , EMBASE , and Scopus ) . A total of 30 cross-sectional and four longitudinal studies were included in this review . Results Narrative synthesis of the results was provided using PRISMA guidelines . Taken together , the studies pointed at substantial evidence for a negative association between ADHD symptoms and mathematical ability . This association was particularly marked for the inattentive component of ADHD than for the hyperactive-impulsive component . Evidence from twin studies also showed a significant genetic correlation between mathematics and ADHD , which was greater for the inattentive component of ADHD compared to the hyperactive-impulsive component . Conclusions The differential relationship of the hyperactivity-impulsivity and inattention domains with mathematics emphasises the heterogeneity within the disorder and suggests a partially different aetiology of the two ADHD domains . A better underst and ing of the aetiology of ADHD could help develop more efficient interventions aim ed at the reduction of its symptoms . It could also offer an explanatory framework for shortcomings in achievement and inform the development of non-pharmacological intervention strategies | [
"BACKGROUND Executive function deficits have been reported repeatedly in children with Attention Deficit Hyperactivity Disorder ( ADHD ) . Stimulant medication has been shown to be effective in improving cognitive performance on most executive function tasks , but neuropsychological tests of executive function in this population have yielded inconsistent results . Method ological limitations may explain these inconsistencies . This study aim ed to measure executive function in medicated and non-medicated children with ADHD by using a computerized battery , the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) , which is sensitive to executive function deficits in older patients with frontostriatal neurological impairments . METHODS Executive function was assessed in 30 children with ADHD : 15 were stimulant medication naive and 15 were treated with stimulant medication . These two groups were compared to 15 age , sex and IQ matched controls . RESULTS The unmedicated children with ADHD displayed specific cognitive impairments on executive function tasks of spatial short-term memory , spatial working memory , set-shifting ability and planning ability . Impairments were also seen on spatial recognition memory and delayed matching to sample , while pattern recognition memory remained intact . The medicated children with ADHD were not impaired on any of the above executive function tasks except for deficits in spatial recognition memory . CONCLUSIONS ADHD is associated with deficits in executive function . Stimulant medication is associated with better executive function performance . Prospect i ve follow-up studies are required to examine these effects",
"BACKGROUND Impairments in language and communication are core features of autism spectrum disorders ( ASDs ) . The basis for this association is poorly understood . How early language is related to each of the triad of impairments characteristic of ASDs is also in need of clarification . AIMS This is the first study that aims to determine the extent to which shared genetic and environmental factors underlie the association between early language performance and autistic-like traits ( ALTs ) in middle childhood . METHODS & PROCEDURES Data came from a population -based twin sample ( n = 6087 pairs ) assessed prospect ively at 2 , 3 , 4 and 8 years . ALTs measured by the Childhood Asperger Syndrome Test ( CAST ) at 8 years were investigated in relation to language assessed by the MacArthur Communicative Development Inventory ( CDI ) at 2 , 3 and 4 years . Multivariate model fitting techniques were used to analyse the origins of this association . OUTCOMES & RESULTS Total CAST scores , as well as Social and Communication subscales , at 8 years were weakly but significantly negatively correlated with language ability at 2 , 3 and 4 years . Correlations between language and restrictive and repetitive behaviours and interests ( RRBI ) were not significant . The phenotypic correlations between language and Social and Communication ALTs were almost entirely mediated by shared genetic influences . There were specific genetic influences on early language that were not shared with ALTs , and specific genetic influences on ALTs not shared with earlier language performance . CONCLUSIONS This is the first study to demonstrate shared genetic influences in relation to language performance as an early antecedent of later ALTs . These results support the idea that the triad of core features in ALTs are aetiologically heterogeneous , with early language relating to social and communication impairments but not RRBIs",
"Sixteen children meeting diagnostic criteria for Attention Deficit Disorder with Hyperactivity ( ADD-H ) were tested on methylpheni date ( 0.3 mg/kg ) and placebo on cognitive , learning , academic and behavioral measures in a double-blind study . Assessment s were carried out in the laboratory and in the children 's regular classrooms . Results indicate methylpheni date -induced improvements on a majority of the measures . Drug-induced changes reflected increased output , accuracy and efficiency and improved learning acquisition . There was also evidence of increased effort and self-correcting behaviours . It is argued that review ers have underestimated the potential of stimulants to improve the performance of ADD-H children on academic , learning and cognitive tasks",
"OBJECTIVE The paucity of data concerning the long-term natural history of attention-deficit hyperactivity disorder ( ADHD ) , a common childhood psychiatric disorder , prompted a longitudinal study to investigate the adult sequelae of the childhood disorder . DESIGN Prospect i ve study , follow-up intervals ranging from 13 to 19 years ( mean , 16 years ) , with blind systematic clinical assessment s. SUBJECTS Ninety-one white males ( mean age , 26 years ) , representing 88 % of a cohort systematic ally diagnosed as hyperactive in childhood , and 95 ( 95 % ) of comparison cases of similar race , gender , age , whose teachers had voiced no complaints about their school behavior in childhood . RESULTS Prob and s had significantly higher rates than comparisons of ADHD symptoms ( 11 % vs 1 % ) , antisocial personality disorders ( 18 % vs 2 % ) , and drug abuse disorders ( 16 % vs 4 % ) . Significant comorbidity occurred between antisocial and drug disorders . Educational and occupational achievements were significantly compromised in the prob and s. These disadvantages were independent of psychiatric status . We did not find increased rates of affective or anxiety disorders in the prob and s. CONCLUSIONS Childhood ADHD predicts specific adult psychiatric disorders , namely antisocial and drug abuse disorders . In the adolescent outcome of this cohort , we found that these disturbances were dependent on the continuation of ADHD symptoms . In contrast , in adulthood , antisocial and drug disorders appeared , in part , independent of sustained ADHD . In addition , regardless of psychiatric status , ADHD placed children at relative risk for educational and vocational disadvantage . The results do not support a relationship between childhood ADHD and adult mood or anxiety disorders"
] | 41166140-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND The rising prevalence of autism spectrum disorders ( ASD ) increases the need for evidence -based behavioral treatments to lessen the impact of symptoms on children 's functioning . At present , there are no curative or psychopharmacological therapies to effectively treat all symptoms of the disorder . Early intensive behavioral intervention ( EIBI ) , a treatment based on the principles of applied behavior analysis delivered for multiple years at an intensity of 20 to 40 hours per week , is one of the more well-established treatments for ASD . OBJECTIVES To systematic ally review the evidence for the effectiveness of EIBI in increasing the functional behaviors and skills of young children with ASD . SEARCH METHODS We search ed the following data bases on 22 November 2011 : CENTRAL ( 2011 Issue 4 ) , MEDLINE ( 1948 to November Week 2 , 2011 ) , EMBASE ( 1980 to Week 46 , 2011 ) , PsycINFO ( 1806 to November Week 3 , 2011 ) , CINAHL ( 1937 to current ) , ERIC ( 1966 to current ) , Sociological Abstract s ( 1952 to current ) , Social Science Citation Index ( 1970 to current ) , WorldCat , metaRegister of Controlled Trials , and Networked Digital Library of Theses and Dissertations . We also search ed the reference lists of published papers . SELECTION CRITERIA R and omized control trials ( RCTs ) , quasi-r and omized control trials , or clinical control trials ( CCTs ) in which EIBI was compared to a no-treatment or treatment-as-usual control condition . Participants must have been less than six years of age at treatment onset and assigned to their study condition prior to commencing treatment . DATA COLLECTION AND ANALYSIS Two authors independently selected and appraised studies for inclusion and assessed the risk of bias in each included study . All outcome data were continuous , from which st and ardized mean difference effect sizes with small sample correction were calculated . We conducted r and om-effects meta- analysis where possible , which means we assumed individual studies would provide different estimates of treatment effects . MAIN RESULTS One RCT and four CCTs with a total of 203 participants were included . Reliance on synthesis from four CCTs limits the evidential base and this should be borne in mind when interpreting the results . All studies used a treatment-as-usual comparison group . We synthesized the results of the four CCTs using a r and om-effects model of meta- analysis of the st and ardized mean differences . Positive effects in favor of the EIBI treatment group were found for all outcomes . The mean effect size for adaptive behavior was g = 0.69 ( 95 % CI 0.38 to 1.01 ; P mean effect size for IQ was g = 0.76 ( 95 % CI 0.40 to 1.11 ; P communication and language skills all showed results in favor of EIBI : expressive language g = 0.50 ( 95 % CI 0.05 to 0.95 ; P = 0.03 ) , receptive language g = 0.57 ( 95 % CI 0.20 to 0.94 ; P = .03 ) , and daily communication skills g = 0.74 ( 95 % CI 0.30 to 1.18 ; P = 0.0009 ) . The mean effect size for socialization was g = 0.42 ( 95 % CI 0.11 to 0.73 ; P = 0.0008 ) , and for daily living skills was g = 0.55 ( 95 % CI 0.24 to 0.87 ; P = 0.0005 ) . Additional descriptive analyses of other aspects related to quality of life and psychopathology are presented . However , due to the inclusion of non-r and omized studies , there is a high risk of bias and the overall quality of evidence was rated as ' low ' using the GRADE system , which rates the quality of evidence from meta-analyses to determine recommendations for practice . AUTHORS ' CONCLUSIONS There is some evidence that EIBI is an effective behavioral treatment for some children with ASD . However , the current state of the evidence is limited because of the reliance on data from non-r and omized studies ( CCTs ) due to the lack of RCTs . Additional studies using RCT research design s are needed to make stronger conclusions about the effects of EIBI for children with ASD | [
"This study extends findings on the effects of intensive applied behavior analytic treatment for children with autism who began treatment at a mean age of 5.5 years . The behavioral treatment group ( n = 13 , 8 boys ) was compared to an eclectic treatment group ( n = 12 , 11 boys ) . Assignment to groups was made independently based on the availability of qualified supervisors . Both behavioral and eclectic treatment took place in public kindergartens and elementary schools for typically developing children . At a mean age of 8 years , 2 months , the behavioral treatment group showed larger increases in IQ and adaptive functioning than did the eclectic group . The behavioral treatment group also displayed fewer aberrant behaviors and social problems at follow-up . Results suggest that behavioral treatment was effective for children with autism in the study",
"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"
] | 4116617c-06ff-11f0-808a-c43d1ab1c353 |
ABSTRACT Background : Cocoa and dark chocolate ( DC ) have been reported to be effective for health promotion ; however the exact effect of cocoa/DC on anthropometric measures have not been yet defined . Methods : A comprehensive search to identify r and omized clinical trials investigating the impact of cocoa/DC on body weight , body mass index ( BMI ) and waist circumference ( WC ) was performed up to December 2017 . A meta- analysis of eligible studies was performed using r and om effects model to estimate pooled effect size . Fractional polynominal modeling was used to explore dose-response relationships . Results : A total of 35 RCTs investigated the effects of cocoa/DC on weight , BMI and WC were included . Meta- analysis did not suggest any significant effect of cocoa/DC supplementation on body weight ( −0.108 kg , 95 % CI −0.262 , 0.046 P = 0.168 ) , BMI ( −0.014 kg/m2 95 % CI −0.105 , 0.077 , P : 0.759 , ) and WC ( 0.025 cm 95 % CI −0.083 , 0.129 , P = 0.640 ) . Subgroup analysis revealed that that weight and BMI were reduced with cocoa/DC supplementation ≥ 30 g chocolate per day in trials between 4 - 8 weeks . Cocoa/DC consumption result ed in WC reduction in non-linear fashion ( r = 0.042 , P-nonlinearity = 0.008 ) . Conclusion : Cocoa/DC supplementation does not reduce anthropometric measures significantly . However subgroup analysis regarding dose ( ≥ 30 g/day ) and duration ( between 4 to 8 weeks ) revealed significant reduction of body weight and BMI | [
"AIMS Flavanol-rich chocolate ( FRC ) is beneficial for vascular and platelet function by increasing nitric oxide bioavailability and decreasing oxidative stress . Congestive heart failure ( CHF ) is characterized by impaired endothelial and increased platelet reactivity . As statins are ineffective in CHF , alternative therapies are a clinical need . We therefore investigated whether FRC might improve cardiovascular function in patients with CHF . METHODS AND RESULTS Twenty patients with CHF were enrolled in a double-blind , r and omized placebo-controlled trial , comparing the effect of commercially available FRC with cocoa-liquor-free control chocolate ( CC ) on endothelial and platelet function in the short term ( 2 h after ingestion of a chocolate bar ) and long term ( 4 weeks , two chocolate bars/day ) . Endothelial function was assessed non-invasively by flow-mediated vasodilatation of the brachial artery . Flow-mediated vasodilatation significantly improved from 4.98 ± 1.95 to 5.98 ± 2.32 % ( P = 0.045 and 0.02 for between-group changes ) 2h after intake of FRC to 6.86 ± 1.76 % after 4 weeks of daily intake ( P = 0.03 and 0.004 for between groups ) . No effect on endothelial-independent vasodilatation was observed . Platelet adhesion significantly decreased from 3.9 ± 1.3 to 3.0 ± 1.3 % ( P = 0.03 and 0.05 for between groups ) 2 h after FRC , an effect that was not sustained at 2 and 4 weeks . Cocoa-liquor-free CC had no effect , either on endothelial function or on platelet function . Blood pressure and heart rate did not change in either group . CONCLUSION Flavanol-rich chocolate acutely improves vascular function in patients with CHF . A sustained effect was seen after daily consumption over a 4-week period , even after 12 h abstinence . These beneficial effects were paralleled by an inhibition of platelet function in the presence of FRC only",
"The consumption of cocoa and dark chocolate is associated with a lower risk of CVD , and improvements in endothelial function may mediate this relationship . Less is known about the effects of cocoa/chocolate on the augmentation index ( AI ) , a measure of vascular stiffness and vascular tone in the peripheral arterioles . We enrolled thirty middle-aged , overweight adults in a r and omised , placebo-controlled , 4-week , cross-over study . During the active treatment ( cocoa ) period , the participants consumed 37 g/d of dark chocolate and a sugar-free cocoa beverage ( total cocoa = 22 g/d , total flavanols ( TF ) = 814 mg/d ) . Colour-matched controls included a low-flavanol chocolate bar and a cocoa-free beverage with no added sugar ( TF = 3 mg/d ) . Treatments were matched for total fat , saturated fat , carbohydrates and protein . The cocoa treatment significantly increased the basal diameter and peak diameter of the brachial artery by 6 % ( + 2 mm ) and basal blood flow volume by 22 % . Substantial decreases in the AI , a measure of arterial stiffness , were observed in only women . Flow-mediated dilation and the reactive hyperaemia index remained unchanged . The consumption of cocoa had no effect on fasting blood measures , while the control treatment increased fasting insulin concentration and insulin resistance ( P= 0·01 ) . Fasting blood pressure ( BP ) remained unchanged , although the acute consumption of cocoa increased resting BP by 4 mmHg . In summary , the high-flavanol cocoa and dark chocolate treatment was associated with enhanced vasodilation in both conduit and resistance arteries and was accompanied by significant reductions in arterial stiffness in women",
"Consumption of flavanol-rich dark chocolate ( DC ) has been shown to decrease blood pressure ( BP ) and insulin resistance in healthy subjects , suggesting similar benefits in patients with essential hypertension ( EH ) . Therefore , we tested the effect of DC on 24-hour ambulatory BP , flow-mediated dilation ( FMD ) , and oral glucose tolerance tests ( OGTTs ) in patients with EH . After a 7-day chocolate-free run-in phase , 20 never-treated , grade I patients with EH ( 10 males ; 43.7±7.8 years ) were r and omized to receive either 100 g per day DC ( containing 88 mg flavanols ) or 90 g per day flavanol-free white chocolate ( WC ) in an isocaloric manner for 15 days . After a second 7-day chocolate-free period , patients were crossed over to the other treatment . Noninvasive 24-hour ambulatory BP , FMD , OGTT , serum cholesterol , and markers of vascular inflammation were evaluated at the end of each treatment . The homeostasis model assessment of insulin resistance ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , and insulin sensitivity index ( ISI ) were calculated from OGTT values . Ambulatory BP decreased after DC ( 24-hour systolic BP −11.9±7.7 mm Hg , P WC . DC but not WC decreased HOMA-IR ( P it improved QUICKI , ISI , and FMD . DC also decreased serum LDL cholesterol ( from 3.4±0.5 to 3.0±0.6 mmol/L ; P summary , DC decreased BP and serum LDL cholesterol , improved FMD , and ameliorated insulin sensitivity in hypertensives . These results suggest that , while balancing total calorie intake , flavanols from cocoa products may provide some cardiovascular benefit if included as part of a healthy diet for patients with EH",
"To assess whether antioxidant , anti-inflammatory and other cardio-protective effects attributed to cocoa are achieved when regularly consuming moderate amounts of a flavanol-rich soluble cocoa product , a non-r and omized , controlled , crossover , free-living study was carried out in healthy ( n = 24 ; 25.9 ± 5.6 years ) and moderately hypercholesterolemic ( 200 - 240 mg dL(-1 ) ; n = 20 ; 30.0 ± 10.3 years ) volunteers . Participants consumed two servings per day ( 7.5 g per serving ) of a soluble cocoa product ( providing 45.3 mg flavanols per day ) in milk , which was compared with consuming only milk during a 4 week period . The effects on systolic and diastolic blood pressure and heart rate were determined , as well as on serum lipid and lipoprotein profiles , interleukins (IL)-1β , IL-6 , IL-8 , IL-10 , tumor necrosis factor-α ( TNF-α ) , monocyte chemoattractant protein-1 ( MCP-1 ) , vascular ( VCAM-1 ) and intercellular cell adhesion molecules ( ICAM-1 ) , serum malondialdehyde ( MDA ) , carbonyl groups ( CG ) , ferric reducing/antioxidant power ( FRAP ) , oxygen radical absorbance capacity ( ORAC ) , and free radical scavenging capacity ( ABTS ) . During the study , the volunteers ' diets and physical activity were also evaluated , as well as any changes in weight , skin folds , circumferences and related anthropometric parameters . Cocoa and certain polyphenol-rich fruits and vegetables and their derivatives were restricted . After consuming the cocoa product positive effects were observed such as an increase in serum HDL-C ( p and dietary fiber intake ( p = 0.050 ) , whereas IL-10 decreased ( p = 0.022 ) . Other cardiovascular-related biomarkers and anthropometric parameters were unaffected . We have therefore concluded that regular consumption of this cocoa product in a Spanish-Mediterranean diet may protect against cardiovascular disease in healthy and hypercholesterolemic subjects without producing any weight gain or other anthropometric changes",
"BACKGROUND Legumes have reported benefits in terms of reduced risk for coronary heart disease and of colonic health . A novel legume fiber , cocoa bran , also may have favorable health effects on serum lipid levels , low-density lipoprotein ( LDL ) cholesterol oxidation , and fecal bulk . METHODS Twenty-five healthy normolipidemic subjects ( 13 men and 12 women ) ( mean + /- SEM age , 37 + /- 2 years ; mean + /- SEM body mass index [ calculated as weight in kilograms divided by the square of height in meters ] , 24.6 + /- 0.7 ) ate cocoa-bran and chocolate-flavored low-fiber breakfast cereals for 2-week periods , with 2-week washout , in a double-blind crossover study . The cocoa-bran cereal provided 25.0 g/d of total dietary fiber ( TDF ) . The low-fiber cereal ( 5.6 g/d TDF ) was of similar appearance and energy value . Fasting blood sample s were obtained at the start and end of each period , and 4-day fecal collection s were made from days 11 through 14 . RESULTS High-density lipoprotein ( HDL ) cholesterol level was higher ( 7.6 % + /- 2.9 % ; P = .02 ) and the LDL/HDL cholesterol ratio was lower ( 6.7 % + /- 2.3 % ; P = .007 ) for cocoa-bran compared with low-fiber cereal at 2 weeks . No effect was seen on LDL cholesterol oxidation . Mean fecal output was significantly higher for cocoa-bran than for low-fiber cereal ( 56 + /- 14 g/d ; P cocoa-bran cereal increased fecal bulk similarly to wheat bran and was associated with a reduction in the LDL/HDL cholesterol ratio . In view of the low-fat , high-fiber nature of the material , these results suggest a possible role for this novel fiber source in the diets of normal , hyperlipidemic , and constipated subjects",
"Background : Sleep deprivation is a risk factor for cardiovascular disease . Cocoa flavonoids exert cardiovascular benefits and neuroprotection . Whether chocolate consumption may mitigate detrimental effects of sleep loss on cognitive performance and cardiovascular parameters has never been studied . Aim : We investigated the effects of flavanol-rich chocolate consumption on cognitive skills and cardiovascular parameters after sleep deprivation . Methods : Thirty-two healthy participants underwent two baseline sessions after one night of undisturbed sleep and two experimental sessions after one night of total sleep deprivation . Two hours before each testing session , participants were r and omly assigned to consume high or poor flavanol chocolate bars . During the tests were evaluated , the Psychomotor Vigilance Task and a working memory task , office SBP and DBP , flow-mediated dilation and pulse-wave velocity . Results : Sleep deprivation increased SBP/DBP . SBP/DBP and pulse pressure were lower after flavanol-rich treatment respect to flavanol-poor treatment ( SBP : 116.9 ± 1.6 vs. 120.8 ± 1.9 mmHg , respectively , P = 0.00005 ; DBP : 70.5 ± 1.2 vs. 72.3 ± 1.2 mmHg , respectively , P = 0.01 ; pulse pressure : 46.4 ± 1.3 vs. 48.4 ± 1.5 mmHg , P = 0.004 ) . Sleep deprivation impaired flow-mediated dilation ( 5.5 ± 0.5 vs. 6.5 ± 0.6 % , P = 0.02 ) , flavanol-rich , but not flavanol-poor chocolate counteracted this alteration ( flavanol-rich/flavanol-poor chocolate : 7.0 ± 0.6 vs. 5.0 ± 0.4 % , P = 0.000001 ) . Flavanol-rich chocolate mitigated the pulse-wave velocity increase ( P = 0.001 ) . Flavanol-rich chocolate preserved working memory accuracy in women after sleep deprivation . Flow-mediated dilation correlated with working memory performance accuracy in the sleep condition ( P = 0.04 ) . Conclusion : Flavanol-rich chocolate counteracted vascular impairment after sleep deprivation and restored working memory performance . Improvement in cognitive performance could be because of the effects of cocoa flavonoids on blood pressure and peripheral and central blood flow ",
"Contrary to other long chain saturated fatty acids ( SFA ) , fats high in stearic acid do not raise plasma cholesterol concentrations , however , a slight elevation in inflammatory markers , plasma fibrinogen and interleukin-6 ( IL-6 ) , has been observed in the fasting state . The effect of stearic acid on inflammation in the postpr and ial state has not yet been reported . We conducted a single blind crossover , r and omized , postpr and ial study to compare the effects of a fat load of cocoa butter high in stearic acid and olive oil in ten healthy women . The test meals contained 1 g of fat per kg body weight ( mean 62 g ) . Blood sample s were collected at 0 ( fasting ) , 4 and 6 h. Both diets result ed in a significant increase in serum triacylglycerol ( TAG ) concentration over time ( P = 0.003 ) and a decrease in serum IL-6 concentration after 4 h followed by an increase to post absorptive values after 6 h ( P serum high sensitivity C-reactive protein ( hsCRP ) concentration was not affected . There was no difference between diets in effects on serum TAG , hsCRP and IL-6 concentrations and no association between postpr and ial lipemia and inflammatory markers . High intake of dietary fats increase postpr and ial serum TAG , however , may not affect inflammatory markers postpr and ially . Thus , fat rich in stearic acid does not seem to increase postpr and ial inflammation",
"Numerous studies indicate that polyphenol-rich chocolate reduces fasting blood glucose , blood pressure ( BP ) and total cholesterol in healthy individuals and hypertensives with or without glucose intolerance . The aim of the present study was to investigate the effect of two doses of polyphenol-rich dark chocolate ( DC ) on fasting capillary whole blood glucose , total cholesterol and BP and to examine whether improvements in these parameters are associated with changes in adrenocorticoid excretion in overweight and obese individuals . The study used a r and omised , single-blind , cross-over design where fourteen overweight and obese subjects were r and omised to either take 20 g DC with 500 mg polyphenols then 20 g DC with 1000 mg polyphenols or vice-versa . Participants followed each diet for 2 weeks separated by a 1-week washout period . It was observed that the 500 mg polyphenol dose was equally effective in reducing fasting blood glucose levels , systolic BP ( SBP ) and diastolic BP ( DBP ) as the 1000 mg polyphenol dose suggesting that a saturation effect might occur with increasing dose of polyphenols . There was also a trend towards a reduction in urinary free cortisone levels with both groups although it did not reach statistical significance . No changes in anthropometrical measurements were seen . We suggest that more research is required to investigate the mechanism(s ) by which polyphenol-rich foods influence health",
"This study aim ed to evaluate the postpr and ial effects of high and low glycemic index ( GI ) breakfasts on vascular function . It was a crossover trial that included 40 young healthy adults ( 50 % women ) , aged 20–40 years , who were recruited at primary care setting s. They consumed three experimental breakfasts in r and omized order , each one separated by a 1-week washout period : ( 1 ) control conditions ( only water ) ; ( 2 ) low GI ( LGI ) breakfast ( 29.4 GI and 1489 KJ energy ) ; and ( 3 ) high GI ( HGI ) breakfast ( 64.0 GI and 1318 KJ energy ) . Blood sample s were collected at 60 and 120 min after each breakfast to determine glucose and insulin levels . Vascular parameters were measured at 15 min intervals . Augmentation index ( AIx ) was studied as a primary outcome . Secondary outcomes comprised glucose , insulin , heart rate ( HR ) and pulse pressures ( PPs ) . We found a trend toward increased AIx , HR and PPs for the HGI versus the LGI breakfast . A significant interaction between the type of breakfast consumed and all measured parameters was identified ( p significant for AIx and augmentation pressure only in males ( p breakfast GI could affect postpr and ial vascular responses in young healthy adults",
"Previous studies with plant sterols ( PS ) and cocoa flavanols ( CF ) provide support for their dietary use in maintaining cardiovascular health . This double-blind , placebo-controlled , cross-over study evaluated the efficacy of daily consumption of a cocoa flavanol-containing dark chocolate bar with added PS on serum lipids , blood pressure , and other circulating cardiovascular health markers in a population with elevated serum cholesterol . We recruited 49 adults ( 32 women , 17 men ) with serum total cholesterol concentrations of 5.20 - 7.28 mmol/L and blood pressure of Following a 2-wk lead-in utilizing the AHA style diet , participants were r and omized into 2 groups and instructed to consume 2 cocoa flavanol-containing dark chocolate bars per day with ( 1.1 g sterol esters per bar ) or without PS . Each 419-kJ bar was nutrient-matched and contained approximately 180 mg CF . Participants consumed 1 bar 2 times per day for 4 wk then switched to the other bar for an additional 4 wk . Serum lipids and other cardiovascular markers were measured at baseline and after 4 and 8 wk . Blood pressure was measured every 2 wk . Regular consumption of the PS-containing chocolate bar result ed in reductions of 2.0 and 5.3 % in serum total and LDL cholesterol ( P CF also reduced systolic blood pressure at 8 wk ( -5.8 mm Hg ; P chocolate bars containing PS and CF as part of a low-fat diet may support cardiovascular health by lowering cholesterol and improving blood pressure",
"BACKGROUND Numerous studies indicate that flavanols may exert significant vascular protection because of their antioxidant properties and increased nitric oxide bioavailability . In turn , nitric oxide bioavailability deeply influences insulin-stimulated glucose uptake and vascular tone . Thus , flavanols may also exert positive metabolic and pressor effects . OBJECTIVE The objective was to compare the effects of either dark or white chocolate bars on blood pressure and glucose and insulin responses to an oral-glucose-tolerance test in healthy subjects . DESIGN After a 7-d cocoa-free run-in phase , 15 healthy subjects were r and omly assigned to receive for 15 d either 100 g dark chocolate bars , which contained approximately 500 mg polyphenols , or 90 g white chocolate bars , which presumably contained no polyphenols . Successively , subjects entered a further cocoa-free washout phase of 7 d and then were crossed over to the other condition . Oral-glucose-tolerance tests were performed at the end of each period to calculate the homeostasis model assessment of insulin resistance ( HOMA-IR ) and the quantitative insulin sensitivity check index ( QUICKI ) ; blood pressure was measured daily . RESULTS HOMA-IR was significantly lower after dark than after white chocolate ingestion ( 0.94 + /- 0.42 compared with 1.72 + /- 0.62 ; P QUICKI was significantly higher after dark than after white chocolate ingestion ( 0.398 + /- 0.039 compared with 0356 + /- 0.023 ; P = 0.001 ) . Although within normal values , systolic blood pressure was lower after dark than after white chocolate ingestion ( 107.5 + /- 8.6 compared with 113.9 + /- 8.4 mm Hg ; P Dark , but not white , chocolate decreases blood pressure and improves insulin sensitivity in healthy persons",
"BACKGROUND Cocoa powder is rich in polyphenols such as catechins and procyanidins and has been shown in various models to inhibit LDL oxidation and atherogenesis . OBJECTIVE We examined whether long-term intake of cocoa powder alters plasma lipid profiles in normocholesterolemic and mildly hypercholesterolemic human subjects . DESIGN Twenty-five subjects were r and omly assigned to ingest either 12 g sugar/d ( control group ) or 26 g cocoa powder and 12 g sugar/d ( cocoa group ) for 12 wk . Blood sample s were collected before the study and 12 wk after intake of the test drinks . Plasma lipids , LDL oxidative susceptibility , and urinary oxidative stress markers were measured . RESULTS At 12 wk , we measured a 9 % prolongation from baseline levels in the lag time of LDL oxidation in the cocoa group . This prolongation in the cocoa group was significantly greater than the reduction measured in the control group ( -13 % ) . A significantly greater increase in plasma HDL cholesterol ( 24 % ) was observed in the cocoa group than in the control group ( 5 % ) . A negative correlation was observed between plasma concentrations of HDL cholesterol and oxidized LDL . At 12 wk , there was a 24 % reduction in dityrosine from baseline concentrations in the cocoa group . This reduction in the cocoa group was significantly greater than the reduction in the control group ( -1 % ) . CONCLUSION It is possible that increases in HDL-cholesterol concentrations may contribute to the suppression of LDL oxidation and that polyphenolic substances derived from cocoa powder may contribute to an elevation in HDL cholesterol",
"BACKGROUND In recent years , there has been increased interest in the potential health-related benefits of antioxidant- and phytochemical-rich dark chocolate and cocoa . OBJECTIVE The objective of the study was to examine the short-term ( 6 wk ) effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health in healthy older adults . DESIGN A double-blind , placebo-controlled , fixed-dose , parallel-group clinical trial was used . Participants ( n = 101 ) were r and omly assigned to receive a 37-g dark chocolate bar and 8 ounces ( 237 mL ) of an artificially sweetened cocoa beverage or similar placebo products each day for 6 wk . RESULTS No significant group ( dark chocolate and cocoa or placebo)-by-trial ( baseline , midpoint , and end-of-treatment assessment s ) interactions were found for the neuropsychological , hematological , or blood pressure variables examined . In contrast , the midpoint and end-of-treatment mean pulse rate assessment s in the dark chocolate and cocoa group were significantly higher than those at baseline and significantly higher than the midpoint and end-of-treatment rates in the control group . Results of a follow-up question naire item on the treatment products that participants believed they had consumed during the trial showed that more than half of the participants in both groups correctly identified the products that they had ingested during the experiment . CONCLUSIONS This investigation failed to support the predicted beneficial effects of short-term dark chocolate and cocoa consumption on any of the neuropsychological or cardiovascular health-related variables included in this research . Consumption of dark chocolate and cocoa was , however , associated with significantly higher pulse rates at 3- and 6-wk treatment assessment",
"BACKGROUND Flavonoids may be partly responsible for some health benefits , including antiinflammatory action and a decreased tendency for the blood to clot . An acute dose of flavanols and oligomeric procyanidins from cocoa powder inhibits platelet activation and function over 6 h in humans . OBJECTIVE This study sought to evaluate whether 28 d of supplementation with cocoa flavanols and related procyanidin oligomers would modulate human platelet reactivity and primary hemostasis and reduce oxidative markers in vivo . DESIGN Thirty-two healthy subjects were assigned to consume active ( 234 mg cocoa flavanols and procyanidins/d ) or placebo ( procyanidins/d ) tablets in a blinded parallel- design ed study . Platelet function was determined by measuring platelet aggregation , ATP release , and expression of activation-dependent platelet antigens by using flow cytometry . Plasma was analyzed for oxidation markers and antioxidant status . RESULTS Plasma concentrations of epicatechin and catechin in the active group increased by 81 % and 28 % , respectively , during the intervention period . The active group had significantly lower P selectin expression and significantly lower ADP-induced aggregation and collagen-induced aggregation than did the placebo group . Plasma ascorbic acid concentrations were significantly higher in the active than in the placebo group ( P plasma oxidation markers and antioxidant status did not change in either group . CONCLUSIONS Cocoa flavanol and procyanidin supplementation for 28 d significantly increased plasma epicatechin and catechin concentrations and significantly decreased platelet function . These data support the results of acute studies that used higher doses of cocoa flavanols and procyanidins",
"BACKGROUND Epidemiologic studies have suggested that flavonoid intake plays a critical role in the prevention of coronary heart disease . Because atherosclerosis is considered a low- grade inflammatory disease , some feeding trials have analyzed the effects of cocoa ( an important source of flavonoids ) on inflammatory biomarkers , but the results have been controversial . OBJECTIVE The objective was to evaluate the effects of chronic cocoa consumption on cellular and serum biomarkers related to atherosclerosis in high-risk patients . DESIGN Forty-two high-risk volunteers ( 19 men and 23 women ; mean + /- SD age : 69.7 + /- 11.5 y ) were included in a r and omized crossover feeding trial . All subjects received 40 g cocoa powder with 500 mL skim milk/d ( C+M ) or only 500 mL skim milk/d ( M ) for 4 wk . Before and after each intervention period , cellular and serum inflammatory biomarkers related to atherosclerosis were evaluated . RESULTS Adherence to the dietary protocol was excellent . No significant changes in the expression of adhesion molecules on T lymphocyte surfaces were found between the C+M and M groups . However , in monocytes , the expression of VLA-4 , CD40 , and CD36 was significantly lower ( P = 0.005 , 0.028 , and 0.001 , respectively ) after C+M intake than after M intake . In addition , serum concentrations of the soluble endothelium-derived adhesion molecules P-selectin and intercellular adhesion molecule-1 were significantly lower ( both P = 0.007 ) after C+M intake than after M intake . CONCLUSIONS These results suggest that the intake of cocoa polyphenols may modulate inflammatory mediators in patients at high risk of cardiovascular disease . These antiinflammatory effects may contribute to the overall benefits of cocoa consumption against atherosclerosis . This trial was registered in the Current Controlled Trials at London , International St and ard R and omized Controlled Trial Number , at controlled-trials.com as IS RCT N75176807",
"This study examined the effects of 3 recovery drinks on endurance performance following glycogen-depleting exercise . Nine trained male cyclists performed 3 experimental trials , in a r and omized counter-balanced order , consisting of a glycogen-depleting trial , a 4-h recovery period , and a cycle to exhaustion at 70 % power at maximal oxygen uptake . At 0 and 2 h into the recovery period , participants consumed chocolate milk ( CM ) , a carbohydrate replacement drink ( CR ) , or a fluid replacement drink ( FR ) . Participants cycled 51 % and 43 % longer after ingesting CM ( 32 + /- 11 min ) than after ingesting CR ( 21 + /- 8 min ) or FR ( 23 + /- 8 min ) . CM is an effective recovery aid after prolonged endurance exercise for subsequent exercise at low-moderate intensities",
"Background : Dark chocolate derived from the plant ( Theobroma cacao ) is a rich source of flavonoids . Cardioprotective effects including antioxidant properties , inhibition of platelet activity , and activation of endothelial nitric oxide synthase have been ascribed to the cocoa flavonoids . Objective : To investigate the effects of flavonoid-rich dark chocolate on endothelial function , measures of oxidative stress , blood lipids , and blood pressure in healthy adult subjects . Design : The study was a r and omized , double-blind , placebo-controlled design conducted over a 2 week period in 21 healthy adult subjects . Subjects were r and omly assigned to daily intake of high-flavonoid ( 213 mg procyanidins , 46 mg epicatechin ) or low-flavonoid dark chocolate bars ( 46 g , 1.6 oz ) . Results : High-flavonoid chocolate consumption improved endothelium-dependent flow-mediated dilation ( FMD ) of the brachial artery ( mean change = 1.3 ± 0.7 % ) as compared to low-flavonoid chocolate consumption ( mean change = −0.96 ± 0.5 % ) ( p = 0.024 ) . No significant differences were noted in the resistance to LDL oxidation , total antioxidant capacity , 8-isoprostanes , blood pressure , lipid parameters , body weight or body mass index ( BMI ) between the two groups . Plasma epicatechin concentrations were markedly increased at 2 weeks in the high-flavonoid group ( 204.4 ± 18.5 nmol/L , p ≤ 0.001 ) but not in the low-flavonoid group ( 17.5 ± 9 nmol/L , p = 0.99 ) . Conclusion : Flavonoid-rich dark chocolate improves endothelial function and is associated with an increase in plasma epicatechin concentrations in healthy adults . No changes in oxidative stress measures , lipid profiles , blood pressure , body weight or BMI were seen",
"Flavanol consumption is favorably associated with cognitive function . We tested the hypothesis that dietary flavanols might improve cognitive function in subjects with mild cognitive impairment . We conducted a double-blind , parallel arm study in 90 elderly individuals with mild cognitive impairment r and omized to consume once daily for 8 weeks a drink containing ≈990 mg ( high flavanols ) , ≈520 mg ( intermediate flavanols ) , or ≈45 mg ( low flavanols ) of cocoa flavanols per day . Cognitive function was assessed by Mini Mental State Examination , Trail Making Test A and B , and verbal fluency test . At the end of the follow-up period , Mini Mental State Examination was similar in the 3 treatment groups ( P=0.13 ) . The time required to complete Trail Making Test A and Trail Making Test B was significantly ( P seconds , respectively ) . Similarly , verbal fluency test score was significantly ( P words per 60 seconds ) . Insulin resistance , blood pressure , and lipid peroxidation also decreased among subjects in the high-flavanol and intermediate-flavanol groups . Changes of insulin resistance explained ≈40 % of composite z score variability through the study period ( partial r2=0.4013 ; P dietary intervention study demonstrating that the regular consumption of cocoa flavanols might be effective in improving cognitive function in elderly subjects with mild cognitive impairment . This effect appears mediated in part by an improvement in insulin sensitivity ",
"Background Flavanol-rich chocolate and lycopene-rich tomato extract have attracted interest as potential alternative treatment options for hypertension , a known risk factor for cardiovascular morbidity and mortality . Treatment of prehypertension ( SBP 120–139/DBP 80–89 mmHg ) may forestall progression to hypertension . However , there has been only limited research into non-pharmacological treatment options for prehypertension . We investigated the effect of dark chocolate or tomato extract on blood pressure , and their acceptability as an ongoing treatment option in a prehypertensive population . Methods Our trial consisted of two phases : a r and omised controlled three-group-parallel trial over 12 weeks ( phase 1 ) followed by a crossover of the two active treatment arms over an additional 12-week period ( phase 2 ) . Group 1 received a 50 g daily dose of dark chocolate with 70 % cocoa containing 750 mg polyphenols , group 2 were allocated one tomato extract capsule containing 15 mg lycopene per day , and group 3 received one placebo capsule daily over 8 weeks followed by a 4-week washout period . In phase 2 the active treatment groups were crossed over to receive the alternative treatment . Median blood pressure , weight , and abdominal circumference were measured 4-weekly , and other characteristics including physical activity , general health , energy , mood , and acceptability of treatment were assessed by question naire at 0 , 8 and 20 weeks . We analysed changes over time using a linear mixed model , and one time point differences using Kruskal-Wallis , Fisher's-Exact , or t-tests . Results Thirty-six prehypertensive healthy adult volunteers completed the 6-month trial . Blood pressure changes over time within groups and between groups were not significant and independent of treatment . Weight and other characteristics did not change significantly during the trial . However , a marked difference in acceptability between the two treatment forms ( chocolate or capsule ) was revealed ( p chocolate treatment found it hard to eat 50 g of dark chocolate every day and 20 % considered it an unacceptable long-term treatment option , whereas all participants found it easy and acceptable to take a capsule each day for blood pressure . Conclusion Our study did not find a blood pressure lowering effect of dark chocolate or tomato extract in a prehypertensive population . Practicability of chocolate as a long-term treatment option may be limited . Trial registration http://www.anzctr.org.au Identifier :",
"Background Chocolate is rich in flavonoids that have been shown to be of benefit in disparate conditions including cardiovascular disease and cancer . The effect of polyphenol rich chocolate in subjects with chronic fatigue syndrome ( CFS ) has not been studied previously . Methods We conducted a double blinded , r and omised , clinical pilot crossover study comparing high cocoa liquor/polyphenol rich chocolate ( HCL/PR ) in comparison to simulated iso-calorific chocolate ( cocoa liquor free/low polyphenols(CLF/LP ) ) on fatigue and residual function in subjects with chronic fatigue syndrome . Subjects with CFS having severe fatigue of at least 10 out of 11 on the Chalder Fatigue Scale were enrolled . Subjects had either 8 weeks of intervention in the form of HCL/PR or CLF/LP , with a 2 week wash out period followed by 8 weeks of intervention with the other chocolate . Results Ten subjects were enrolled in the study . The Chalder Fatigue Scale score improved significantly after 8 weeks of the HCL/PR chocolate arm [ median ( range ) Exact Sig . ( 2-tailed ) ] [ 33 ( 25 - 38 ) vs. 21.5 ( 6 - 35 ) 0.01 ] , but that deteriorated significantly when subjects were given simulated iso-calorific chocolate ( CLF/CP ) [ 28.5 ( 17 - 20 ) vs. 34.5 ( 13 - 26 ) 0.03 ] . The residual function , as assessed by the London H and icap scale , also improved significantly after the HCL/PR arm [ 0.49 ( 0.33 - 0.62 ) vs. 0.64 ( 0.44 - 0.83 ) 0.01 ] and deteriorated after iso-calorific chocolate [ 00.44 ( 0.43 - 0.68 ) vs. 0.36 ( 0.33 - 0.62)0.03 ] . Likewise the Hospital Anxiety and Depression score also improved after the HCL/PR arm , but deteriorated after CLF/CP . Mean weight remained unchanged throughout the trial . Conclusion This study suggests that HCL/PR chocolate may improve symptoms in subjects with chronic fatigue syndrome",
"The consumption of a diet rich in certain flavonoids , including the flavanol sub-class , has been associated with a reduced risk for vascular disease . We evaluated the effects of the regular consumption ( 14 d ) of a flavanol-containing milk chocolate ( FCMC ) or cocoa butter chocolate ( CBC ) on variables related to vascular disease risk , oxidative stress and physical activity . Twenty-eight free-living , young ( 18–20 years old ) male soccer players consumed daily 105 g of FCMC ( 168 mg of flavanols ) or CBC ( FCMC was significantly associated with a decrease in diastolic blood pressure ( -5 mm Hg ) , mean blood pressure ( -5 mm Hg ) , plasma cholesterol ( -11 % ) , LDL-cholesterol ( -15 % ) , malondialdehyde ( -12 % ) , urate ( -11 % ) and lactate dehydrogenase ( LDH ) activity ( -11 % ) , and an increase in vitamin E/cholesterol ( + 12 % ) . No relevant changes in these variables were associated with CBC consumption . No changes in the plasma levels of (-)-epicatechin were observed following analysis of fasting blood sample s. In conclusion , FCMC consumption was associated with changes in several variables often associated with cardiovascular health and oxidant stress . The presence of significant quantities of flavanols in FCMC is likely to have been one of the contributing factors to these results",
"Nine male , endurance-trained cyclists performed an interval workout followed by 4 h of recovery , and a subsequent endurance trial to exhaustion at 70 % VO2max , on three separate days . Immediately following the first exercise bout and 2 h of recovery , subjects drank isovolumic amounts of chocolate milk , fluid replacement drink ( FR ) , or carbohydrate replacement drink ( CR ) , in a single-blind , r and omized design . Carbohydrate content was equivalent for chocolate milk and CR . Time to exhaustion ( TTE ) , average heart rate ( HR ) , rating of perceived exertion ( RPE ) , and total work ( WT ) for the endurance exercise were compared between trials . TTE and WT were significantly greater for chocolate milk and FR trials compared to CR trial . The results of this study suggest that chocolate milk is an effective recovery aid between two exhausting exercise bouts",
"BACKGROUND Dark chocolate may have blood pressure-lowering properties . We conducted a prospect i ve r and omized open-label blinded end-point design trial to study a potential dose dependency of the presumed antihypertensive effect of dark chocolate by directly comparing low vs. higher doses of dark chocolate over the course of 3 months . METHODS We enrolled a total of 102 patients with prehypertension/stage 1 hypertension and established cardiovascular end-organ damage or diabetes mellitus . Patients were r and omly assigned to receive either 6 or 25 g/day of flavanol-rich dark chocolate for 3 months . The difference in 24-h mean blood pressure between groups was defined as the primary outcome measure . RESULTS Significant reductions in mean ambulatory 24-h blood pressure were observed between baseline and follow-up in both groups ( 6 g/day : -2.3 mm Hg , 95 % confidence interval -4.1 to -0.4 ; 25 g/day : -1.9 mm Hg , 95 % confidence interval -3.6 to -0.2 ) . There were no significant differences in blood pressure changes between groups . In the higher-dose group , a slight increase in body weight was noted ( 0.8 kg , 95 % confidence interval 0.06 to 1.6 ) . CONCLUSIONS The findings are consistent with the hypothesis that dark chocolate may be associated with a reduction in blood pressure ( BP ) . However , due to the lack of a control group , confounding may be possible and the results should be interpreted with caution",
"BACKGROUND Essential hypertension is characterized by reciprocal relations between endothelial dysfunction and insulin resistance . Cocoa flavanols stimulate production of the vasodilator nitric oxide from vascular endothelium . OBJECTIVE The objective was to test the hypothesis that consumption of cocoa may simultaneously lower blood pressure , improve endothelial dysfunction , and ameliorate insulin resistance in subjects with essential hypertension . DESIGN We conducted a r and omized , placebo-controlled , double-blind , crossover trial of a flavanol-rich cocoa drink ( 150 mL twice a day , approximately 900 mg flavanols/d ) in individuals with essential hypertension ( n = 20 ) . Antihypertensive medications were discontinued before study enrollment . After a 7-d cocoa-free run-in period , cocoa or flavanol-poor placebo ( approximately 28 mg flavanols/d ) treatment for 2 wk was followed by a 1-wk washout and then crossover to the other treatment arm . Blood pressure was measured thrice weekly . At baseline and after each treatment period , we assessed insulin sensitivity ( hyperinsulinemic-isoglycemic glucose clamp ) and insulin-stimulated changes in brachial artery diameter and forearm skeletal muscle capillary recruitment ( Doppler ultrasound with or without microbubble contrast ) . RESULTS Cocoa treatment for 2 wk increased insulin-stimulated changes in brachial artery diameter when compared with placebo [ median percentage increase from baseline ( 25th-75th percentile ) : 8.3 ( 4.2 - 11.3 ) compared with 5.9 ( -0.3 to 9.6 ) ; P cocoa treatment did not significantly reduce blood pressure or improve insulin resistance and had no significant effects on skeletal muscle capillary recruitment , circulating plasma concentrations of adipocytokines , or endothelial adhesion molecules . CONCLUSIONS Daily consumption of flavanol-rich cocoa for 2 wk is not sufficient to reduce blood pressure or improve insulin resistance in human subjects with essential hypertension . This trial was registered at clinical trials.gov as NCT00099476",
"Recent findings indicate an inverse relationship between cardiovascular disease and consumption of flavonoids . We aim ed to identify clinical and vascular parameters of treated hypertensive who present beneficial effects of dark chocolate for one-week period on vascular function . Twenty-one hypertensive subjects , aged 40–65 years , were included in a prospect i ve study with measurement of blood pressure ( BP ) , brachial flow-mediated dilatation ( FMD ) , peripheral arterial tonometry , and central hemodynamic parameters . These tests were repeated after seven days of eating dark chocolate 75 g/day . Patients were divided according to the response in FMD : responders ( n = 12 ) and nonresponders ( n = 9 ) . The responder group presented lower age ( 54 ± 7 versus 61 ± 6 years , P = 0.037 ) , Framingham risk score ( FRS ) ( 2.5 ± 1.8 versus 8.1 ± 5.1 % , P = 0.017 ) , values of peripheral ( 55 ± 9 versus 63 ± 5 mmHg , P = 0.041 ) , and central pulse pressure ( PP ) ( 44 ± 10 versus 54 ± 6 mmHg , P = 0.021 ) . FMD response showed negative correlation with FRS ( r = −0.60 , P = 0.014 ) , baseline FMD ( r = −0.54 , P = 0.011 ) , baseline reactive hyperemia index ( RHI ; r = −0.56 , P = 0.008 ) , and central PP ( r = −0.43 , P = 0.05 ) . However , after linear regression analysis , only FRS and baseline RHI were associated with FMD response . In conclusion , one-week dark chocolate intake significantly improved endothelial function and reduced BP in younger hypertensive with impaired endothelial function in spite of lower cardiovascular risk ",
"AIMS To investigate the association of chocolate consumption with measured blood pressure ( BP ) and the incidence of cardiovascular disease ( CVD ) . METHODS AND RESULTS Dietary intake , including chocolate , and BP were assessed at baseline ( 1994 - 98 ) in 19 357 participants ( aged 35 - 65 years ) free of myocardial infa rct ion ( MI ) and stroke and not using antihypertensive medication of the Potsdam arm of the European Prospect i ve Investigation into Cancer and Nutrition . Incident cases of MI ( n = 166 ) and stroke ( n = 136 ) were identified after a mean follow-up of approximately 8 years . Mean systolic BP was 1.0 mmHg [ 95 % confidence interval ( CI ) -1.6 to -0.4 mmHg ] and mean diastolic BP 0.9 mmHg ( 95 % CI -1.3 to -0.5 mmHg ) lower in the top quartile compared with the bottom quartile of chocolate consumption . The relative risk of the combined outcome of MI and stroke for top vs. bottom quartiles was 0.61 ( 95 % CI 0.44 - 0.87 ; P linear trend = 0.014 ) . Baseline BP explained 12 % of this lower risk ( 95 % CI 3 - 36 % ) . The inverse association was stronger for stroke than for MI . CONCLUSION Chocolate consumption appears to lower CVD risk , in part through reducing BP . The inverse association may be stronger for stroke than for MI . Further research is needed , in particular r and omized trials",
"CONTEXT Regular intake of cocoa-containing foods is linked to lower cardiovascular mortality in observational studies . Short-term interventions of at most 2 weeks indicate that high doses of cocoa can improve endothelial function and reduce blood pressure ( BP ) due to the action of the cocoa polyphenols , but the clinical effect of low habitual cocoa intake on BP and the underlying BP-lowering mechanisms are unclear . OBJECTIVE To determine effects of low doses of polyphenol-rich dark chocolate on BP . DESIGN , SETTING , AND PARTICIPANTS R and omized , controlled , investigator-blinded , parallel-group trial involving 44 adults aged 56 through 73 years ( 24 women , 20 men ) with untreated upper-range prehypertension or stage 1 hypertension without concomitant risk factors . The trial was conducted at a primary care clinic in Germany between January 2005 and December 2006 . INTERVENTION Participants were r and omly assigned to receive for 18 weeks either 6.3 g ( 30 kcal ) per day of dark chocolate containing 30 mg of polyphenols or matching polyphenol-free white chocolate . MAIN OUTCOME MEASURES Primary outcome measure was the change in BP after 18 weeks . Secondary outcome measures were changes in plasma markers of vasodilative nitric oxide ( S-nitrosoglutathione ) and oxidative stress ( 8-isoprostane ) , and bioavailability of cocoa polyphenols . RESULTS From baseline to 18 weeks , dark chocolate intake reduced mean ( SD ) systolic BP by -2.9 ( 1.6 ) mm Hg ( P diastolic BP by -1.9 ( 1.0 ) mm Hg ( P body weight , plasma levels of lipids , glucose , and 8-isoprostane . Hypertension prevalence declined from 86 % to 68 % . The BP decrease was accompanied by a sustained increase of S-nitrosoglutathione by 0.23 ( 0.12 ) nmol/L ( P dark chocolate dose result ed in the appearance of cocoa phenols in plasma . White chocolate intake caused no changes in BP or plasma biomarkers . CONCLUSIONS Data in this relatively small sample of otherwise healthy individuals with above-optimal BP indicate that inclusion of small amounts of polyphenol-rich dark chocolate as part of a usual diet efficiently reduced BP and improved formation of vasodilative nitric oxide . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00421499",
"Background Dietary fibre is both preventive and therapeutic for bowel functional diseases . Soluble cocoa products are good sources of dietary fibre that may be supplemented with this dietary component . This study assessed the effects of regularly consuming two soluble cocoa products ( A and B ) with different non-starch polysaccharides levels ( NSP , 15.1 and 22.0 % w/w , respectively ) on bowel habits using subjective intestinal function and symptom question naires , a daily diary and a faecal marker in healthy individuals . Methods A free-living , two-stage , r and omized , crossover , single-blind intervention was carried out in 44 healthy men and women , between 18 - 55 y old , who had not taken dietary supplements , laxatives , or antibiotics six months before the start of the study . In the four-week-long intervention stages , separated by a three-week-wash-out stage , two servings of A and B , that provided 2.26 vs. 6.60 g/day of NSP respectively , were taken . In each stage , volunteers ' diet was recorded using a 72-h food intake report . Results Regularly consuming cocoa A and B increased fibre intake , although only cocoa B significantly increased fibre intake ( p body weight were observed in either of the 4 week interventions . With cocoa product B , the number of daily bowel movements increased ( p = 0.002 ) , the frequency of having a bowel movement once a day increased ( p = 0.009 ) , the time to have a bowel movement was lower ( p = 0.016 ) as well as the feeling of constipation ( p = 0.046 ) without inducing adverse gastrointestinal symptoms , only flatulence increased ( p = 0.019 ) . Conclusions Regular consumption of the cocoa products increases dietary fibre intake to recommended levels and product B improves bowel habits . The use of both objective and subjective assessment s to evaluate the effects of food on bowel habits is recommended",
"Background Several r and omized clinical trials ( RCTs ) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation ( FMD ) and blood pressure ( BP ) . However , no RCTs have evaluated these outcomes in pregnant women . The objective of this 2-group , parallel , double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP . Methods Forty-four healthy , pregnant women were r and omized to the high-flavanol ( n = 23 ) or low-flavanol ( n = 21 ) chocolate consumption for 12 weeks . At r and omization ( 0 , 60 , 120 and 180 min after a single 40-g dose of chocolate ) , 6 and 12 weeks after daily 20-g chocolate intake , we evaluated plasma concentrations of flavanols and theobromine , as well as the FMD and BP . Results Plasma epicatechin was significantly increased ( p 40-g high-flavanol chocolate compared to low-flavanol chocolate . Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate ( p FMD was not different between the 2 groups at all pre-defined time periods . No other significant within-group or between-group changes were observed . Conclusion These results confirm the feasibility of a large-scale RCT comparing daily consumption of flavanol-rich chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestionTrial registration Clinical Trials.gov Identifier :",
"Objective Habitual chocolate intake was recently found to be associated with lower body weight in three cross-sectional epidemiological studies . Our objective was to assess whether these cross-sectional results hold up in a more rigorous prospect i ve analysis . Methods We used data from the Atherosclerosis Risk in Communities cohort . Usual dietary intake was assessed by question naire at baseline ( 1987–98 ) , and after six years . Participants reported usual chocolate intake as the frequency of eating a 1-oz ( ∼28 g ) serving . Body weight and height were measured at the two visits . Missing data were replaced by multiple imputation . Linear mixed-effects models were used to evaluate cross-sectional and prospect i ve associations between chocolate intake and adiposity . Results Data were from 15,732 and 12,830 participants at the first and second visit , respectively . More frequent chocolate consumption was associated with a significantly greater prospect i ve weight gain over time , in a dose-response manner . For instance , compared to participants who ate a chocolate serving less often than monthly , those who ate it 1–4 times a month and at least weekly experienced an increase in Body Mass Index ( kg/m2 ) of 0.26 ( 95 % CI 0.08 , 0.44 ) and 0.39 ( 0.23 , 0.55 ) , respectively , during the six-year study period . In cross-sectional analyses the frequency of chocolate consumption was inversely associated with body weight . This inverse association was attenuated after excluding participants with preexisting obesity-related illness . Compared to participants without such illness , those with it had higher BMI and reported less frequent chocolate intake , lower caloric intake , and diets richer in fruits and vegetables . They tended to make these dietary changes after becoming ill . Conclusions Our prospect i ve analysis found that a chocolate habit was associated with long-term weight gain , in a dose-response manner . Our cross-sectional finding that chocolate intake was associated with lower body weight did not apply to participants without preexisting serious illness",
"Introduction . The aim of this study was to assess the vascular benefits of dark chocolate in healthy and young individuals . Methods . A r and omized and controlled trial was carried out involving 60 healthy volunteers , r and omized into two groups : control group ( CG ; n = 30 ) and intervention group ( IG ; n = 30 ) . The IG ingested a daily dosage of 10 g of dark chocolate ( > 75 % cocoa ) for a month . Blood pressure ( BP ) , flow-mediated dilation ( FMD ) , arterial stiffness index ( ASI ) , aortic pulse wave velocity ( PWV ) , and pulse wave analysis ( PWA ) were assessed at baseline and one week after the one-month intervention period . Results . Arterial function improved after intervention in the IG , with PWV decreasing from 6.13 ± 0.41 m/s to 5.83 ± 0.53 m/s ( P = 0.02 ) , with no significant differences observed in the CG . A significant decrease in ASI ( 0.16 ± 0.01 to 0.13 ± 0.01 ; P the IG . Endothelial function improved in the IG , with the FMD increasing 9.31 % after the 1-month intervention ( P dark chocolate ( > 75 % cocoa ) during a month significantly improves vascular function in young and healthy individuals",
"BACKGROUND The sensory attributes of foods may have an important influence on intake because of sensory-specific satiety ( SSS ) . Foods with high SSS may aid in body weight maintenance as a result of termination of consumption before metabolic satiety . No studies have investigated whether long-term exposure to a food might change SSS or how this affects food intake . OBJECTIVE The objective was to compare the effects of daily consumption of 3 energy-dense snack foods ( hazelnuts , chocolate , and potato chips ) for 12 wk on SSS and ad libitum intake during a tasting session . DESIGN One hundred eighteen participants took part in this r and omized , controlled , parallel study with 4 arms : control group ( no additional food ) or ∼1100 kJ/d for each snack . SSS , food intake , and body composition were measured at baseline and at week 12 . RESULTS Daily consumption of snacks for 12 wk result ed in a statistically significant reduction in SSS in all 3 snack groups ( P = 0.015 ) . However , no such changes were seen in the control group ( P = 0.608 ) . Ad libitum energy intake increased over the study during the tasting sessions for the snack food across all groups , including the control group ( P = 0.039 ) . Inverse associations were found between baseline SSS and BMI ( P = 0.039 ) , percentage body fat ( P = 0.013 ) , and fat mass ( P = 0.004 ) . CONCLUSION Habitual consumption of a high energy-dense snack food results in a decrease in SSS , which could lead to a higher energy intake of the snack . This trial was registered at www.anzctr.org.au as ACTRN12609000265279",
"BACKGROUND Evidence from clinical studies has suggested that cocoa may increase high-density lipoprotein (HDL)-cholesterol concentrations . However , it is unclear whether this effect is attributable to flavonoids or theobromine , both of which are major cocoa components . OBJECTIVES We investigated whether pure theobromine increases serum HDL cholesterol and whether there is an interaction effect between theobromine and cocoa . DESIGN The study had a 2-center , double-blind , r and omized , placebo-controlled , full factorial parallel design . After a 2-wk run-in period , 152 healthy men and women ( aged 40 - 70 y ) were r and omly allocated to consume one 200-mL drink/d for 4 wk that contained 1 ) cocoa , which naturally provided 150 mg theobromine and 325 mg flavonoids [ cocoa intervention ( CC ) ] , 2 ) 850 mg pure theobromine [ theobromine intervention ( TB ) ] , 3 ) cocoa and added theobromine , which provided 1000 mg theobromine and 325 mg flavonoids [ theobromine and cocoa intervention ( TB+CC ) ] , or 4 ) neither cocoa nor theobromine ( placebo ) . Blood lipids and apolipoproteins were measured at the start and end of interventions . RESULTS In a 2-factor analysis , there was a significant main effect of the TB ( P HDL cholesterol but no significant interaction ( P = 0.3735 ) . The TB increased HDL-cholesterol concentrations by 0.16 mmol/L ( P increasing apolipoprotein A-I ( P apolipoprotein B and LDL-cholesterol concentrations ( P serum HDL-cholesterol concentrations by 0.16 mmol/L. The lack of significant cocoa and interaction effects suggested that theobromine may be the main ingredient responsible for the HDL cholesterol-raising effect . This trial was registered at clinical trials.gov as NCT01481389",
"Purpose To investigate the effect of cocoa powder supplementation on obesity-related inflammation in high fat (HF)-fed obese mice . Methods Male C57BL/6J ( n = 126 ) were fed with either low-fat ( LF , 10 % kcal from fat ) or HF ( 60 % kcal from fat ) diet for 18 weeks . After 8 weeks , mice from HF group were r and omized to HF diet or HF diet supplemented with 8 % cocoa powder ( HF – HFC group ) for 10 weeks . Blood and tissue sample s were collected for biochemical analyses . Results Cocoa powder supplementation significantly reduced the rate of body weight gain ( 15.8 % ) and increased fecal lipid content ( 55.2 % ) compared to HF-fed control mice . Further , cocoa supplementation attenuated insulin resistance , as indicated by improved HOMA-IR , and reduced the severity of obesity-related fatty liver disease ( decreased plasma alanine aminotransferase and liver triglyceride ) compared to HF group . Cocoa supplementation also significantly decreased plasma levels of the pro-inflammatory mediators interleukin-6 ( IL-6 , 30.4 % ) , monocyte chemoattractant protein-1 ( MCP-1 , 25.2 % ) , and increased adiponectin ( 33.7 % ) compared to HF-fed mice . Expression of pro-inflammatory genes ( Il6 , Il12b , Nos2 , and Emr1 ) in the stromal vascular fraction ( SVF ) of the epididymal white adipose tissue ( WAT ) was significantly reduced ( 37–56 % ) in the cocoa-supplemented mice . Conclusions Dietary supplementation with cocoa ameliorates obesity-related inflammation , insulin resistance , and fatty liver disease in HF-fed obese mice , principally through the down-regulation of pro-inflammatory gene expression in WAT . These effects appear to be mediated in part by a modulation of dietary fat absorption and inhibition of macrophage infiltration in WAT",
"AIM to investigate the effect of consumption of dark chocolate 30 g/day for fifteen days on Nitric oxide ( NO ) serum levels and blood pressure in male and female employees with prehypertension . METHODS the study was a parallel r and omized clinical trial . A total of thirty-two subjects was divided into two groups using block r and omization . Sixteen subjects received 30 g/day dark chocolate and dietary counseling ( treatment group ) and the other 16 subjects received white chocolate 25 g/day and dietary counseling ( control group ) for fifteen days . Data collected in this study consisted of age , physical activity , body massa index , intake of energy , intake of sodium , and intake of polyphenol , NO serum levels and blood pressure . The measurement of NO serum levels was done in pre- and after- treatment , while blood pressure was assessed in pre- , during- and after- treatment . Statistical analysis was performed using independent t-test for normal distribution data and Mann-Whitney test for not normal distribution data , with the level of significancy of 5 % . RESULTS after 15 days treatment , NO serum level between treatment and control groups were significantly different 7.70 ± 3.84 vs 1.92(-0.79 ± 17.78 ) ( p=0.001 ) . Both groups had decreased systolic and diastolic blood pressure . Systolic blood pressure was different significantly between groups after treatment 120.64 ± 8.47 vs 131.19 ± 7.45 ( p=0.001 ) , while diastolic blood pressure was not significant 74.14 ± 6.30 vs 77.44 ± 10.29 ( p=0.308 ) . CONCLUSION in prehypertension subjects , dark chocolate 30 g/day increased NOx serum levels and decreased systolic blood pressure after 15 days of treatment",
"OBJECTIVE The formation of reactive oxygen species ( ROS ) contributes to the pathogenesis and progression of several diseases . Polyphenols have been shown to be beneficial against ROS . The aim of this study was to evaluate the effects of a natural antioxidant ice cream on oxidative stress , vascular function , and physical performance . METHODS In this controlled , single-blind , crossover study , 14 healthy individuals were r and omized to consume 100 g of either antioxidant ice cream containing dark cocoa powder and hazelnut and green tea extracts or milk chocolate ice cream ( control ice cream ) . Participants were studied at baseline and 2 h after ingesting ice cream . Serum polyphenols , antioxidant status ( ferric-reducing ability of plasma [ FRAP ] ) , nitric oxide ( NOx ) bioavailability , markers of oxidative stress ( determination of reactive oxygen metabolites [ d-ROMs ] and hydrogen peroxide [ H2O2 ] ) , endothelium function ( flow-mediated dilation [ FMD ] and reactive hyperemia index [ RHI ] ) , and exercise tolerance ( stress test ) were assessed , and the double product was measured . RESULTS Serum polyphenols ( P NOx ( P FRAP ( P FMD ( P and RHI ( P oxidative stress decreased ( d-Roms , P natural ice cream rich in polyphenols acutely improved vascular function and physical performance in healthy individuals through a reduction in oxidative stress",
"BACKGROUND The consumption of dietary antioxidants is considered to be a good strategy against photo-aging . However , the results of previous clinical trials that investigated the effects of oral consumption of high-flavanol cocoa products on skin photo-aging have been contradictory . OBJECTIVE The aim of this study was to investigate whether high-flavanol cocoa supplementation would improve the moderately photo-aged facial skin of female participants , by assessing skin wrinkles and elasticity . METHODS We performed a 24-wk , r and omized , double-blind , placebo-controlled study to evaluate the effects of oral supplementation of cocoa flavanols on cutaneous photo-aging . All participants were moderately photo-aged Korean women with visible facial wrinkles ( age range : 43 - 86 y ) . Participants were r and omly assigned to receive a placebo beverage or cocoa beverage that contained 320 mg total cocoa flavanols/d . We measured wrinkles , skin elasticity , and hydration at baseline and at 12 and 24 wk . The primary endpoint was the mean percentage change in the average roughness value ( Rz ) at 24 wk . RESULTS At 24 wk , the mean percentage change in Rz ( primary endpoint ) was significantly lower in the cocoa group than in the placebo group ( -8.7 percentage points ; 95 % CI : -16.1 , -1.3 percentage points ; P = 0.023 ) . The mean percentage changes in gross elasticity , as determined by a cutometer , also differed between the groups at 12 wk ( 9.1 percentage points ; 95 % CI : 1.5 , 16.7 percentage points ; P = 0.020 ) and 24 wk ( 8.6 percentage points ; 95 % CI : 1.0 , 16.2 percentage points ; P = 0.027 ) . However , there were no significant differences in skin hydration and barrier integrity between the 2 groups . CONCLUSIONS In moderately photo-aged women , regular cocoa flavanol consumption had positive effects on facial wrinkles and elasticity . Cocoa flavanol supplementation may contribute to the prevention of the progression of photo-aging . This trial was registered at clinical trials.gov as NCT02060097",
"OBJECTIVES Our goal was to test feasibility and efficacy of a dietary intervention based on daily intake of flavanol-containing cocoa for improving vascular function of medicated diabetic patients . BACKGROUND Even in fully medicated diabetic patients , overall prognosis is unfavorable due to deteriorated cardiovascular function . Based on epidemiological data , diets rich in flavanols are associated with a reduced cardiovascular risk . METHODS In a feasibility study with 10 diabetic patients , we assessed vascular function as flow-mediated dilation ( FMD ) of the brachial artery , plasma levels of flavanol metabolites , and tolerability after an acute , single-dose ingestion of cocoa , containing increasing concentrations of flavanols ( 75 , 371 , and 963 mg ) . In a subsequent efficacy study , changes in vascular function in 41 medicated diabetic patients were assessed after a 30-day , thrice-daily dietary intervention with either flavanol-rich cocoa ( 321 mg flavanols per dose ) or a nutrient-matched control ( 25 mg flavanols per dose ) . Both studies were undertaken in a r and omized , double-masked fashion . Primary and secondary outcome measures included changes in FMD and plasma flavanol metabolites , respectively . RESULTS A single ingestion of flavanol-containing cocoa was dose-dependently associated with significant acute increases in circulating flavanols and FMD ( at 2 h : from 3.7 + /- 0.2 % to 5.5 + /- 0.4 % , p flavanol-containing cocoa increased baseline FMD by 30 % ( p FMD upon ingestion of flavanol-containing cocoa continued to be manifest throughout the study . Treatment was well tolerated without evidence of tachyphylaxia . Endothelium-independent responses , blood pressure , heart rate , and glycemic control were unaffected . CONCLUSIONS Diets rich in flavanols reverse vascular dysfunction in diabetes , highlighting therapeutic potentials in cardiovascular disease",
"BACKGROUND AND AIMS Epidemiological studies suggest that regular consumption of cocoa-containing products may confer cardiovascular protection , reducing the risk of coronary heart disease ( CHD ) . However , studies on the effects of cocoa on different cardiovascular risk factors are still scarce . The aim of this study was too evaluate the effects of chronic cocoa consumption on lipid profile , oxidized low-density lipoprotein ( oxLDL ) particles and plasma antioxidant vitamin concentrations in high-risk patients . METHODS AND RESULTS Forty-two high-risk volunteers ( 19 men and 23 women , mean age 69.7 ± 11.5 years ) were included in a r and omized , crossover feeding trial . All received 40 g of cocoa powder with 500 mL of skimmed milk/day(C + M ) or only 500 mL/day of skimmed milk ( M ) for 4 weeks in a r and om order . Before and after each intervention period , plasma lipids , oxLDL and antioxidant vitamin concentrations were measured , as well as urinary cocoa polyphenols metabolites derived from phase II and microbial metabolisms . Compared to M , C + M intervention increases HDLc [ 2.67 mg/dL ( 95 % confidence intervals , CI , 0.58 - 4.73 ; P = 0.008 ) ] and decreases oxLDL levels [ -12.3 U/L ( CI,-19.3 to -5.2;P = 0.001 ) ] . No changes between intervention groups were observed in vitamins B1 , B6 , B12 , C and E , or folic acid concentrations . In addition , subjects who showed higher increments in urinary cocoa polyphenol metabolites exhibited significant increases in HDLc and significant decreases in oxLDL levels ( P Consumption of cocoa power with milk modulates the lipid profile in high-risk subjects for CHD . In addition , the relationship observed between the urinary excretion of cocoa polyphenol metabolites and plasma HDLc and oxLDL levels suggests a beneficial role for cocoa polyphenols in lipid metabolism",
"BACKGROUND AND AIMS Cocoa flavanols are recognised by their favourable antioxidant and vascular effects . This study investigates the influence on health of the daily consumption of ready-to-eat meals supplemented with cocoa extract within a hypocaloric diet , on middle-aged overweight/obese subjects . METHODS AND RESULTS Fifty healthy male and female middle-aged volunteers [ 57.26 ± 5.24 years and body mass index ( BMI ) 30.59 ± 2.33 kg/m(2 ) ] were recruited to participate in a 4 week r and omised , parallel and double-blind study . After following 3 days on a low-polyphenol diet , 25 volunteers received meals supplemented with 1.4 g of cocoa extract ( 645.3 mg of polyphenols ) and the other 25 participants received control meals , within a 15 % energy restriction diet . On the 4th week of intervention individuals in both dietary groups improved ( p , showed a higher reduction ( p = 0.030 ) in the cocoa group . Moreover , myeloperoxidase ( MPO ) levels decreased only in the cocoa supplemented group ( p = 0.007 ) . Intercellular Adhesion Molecule-1 ( sICAM-1 ) decreased significantly in both groups , while Vascular Cell Adhesion Molecule-1 ( sVCAM-1 ) did not present differences after the 4 weeks of intervention . Interestingly , cocoa intake showed a different effect by gender , presenting more beneficial effects in men . CONCLUSIONS The consumption of cocoa extract as part of ready-to-eat meals and within a hypocaloric diet improved oxidative status ( oxLDL ) in middle-aged subjects , being most remarkable in males . REGISTRATION NUMBER Registered at www . clinical trials.gov ( NCT01596309 )",
"Reduced-calorie diets are difficult to follow because they often require elimination of certain foods , leading to poor compliance and limited success . However , a low-calorie , nutrient-dense diet has the potential to accommo date a daily snack without exceeding energy requirements , even during weight loss . This pilot study evaluated the effects of a reduced-calorie diet including either a daily dark chocolate snack or a non-chocolate snack on anthropometric and body composition measurements . In a r and omized clinical trial , 26 overweight and obese ( body mass index ≥25 to ≤43 ) premenopausal women were assigned to a reduced-calorie diet that included either a daily dark chocolate snack or non-chocolate snack ( n=13 per group ) for 18 weeks . At baseline and end of study , body weight and waist and hip circumferences were measured along with fat mass , lean mass , and body fat percentage by dual-energy x-ray absorptiometry . Energy and macronutrient intakes were estimated from 4-day food records . Within- and between-group changes from baseline were analyzed using paired t tests and independent t tests , respectively . Women in both snack groups reduced estimated daily energy intake ( P both the dark chocolate snack and non-chocolate snack groups , respectively , experienced decreases ( P in body weight ( -5.1 vs -5.1 kg ) , hip circumference ( -5.8 vs -5.4 cm ) , waist circumference ( -5.7 vs -3.5 cm ) , fat mass ( -3.9 vs -3.6 kg ) , and body fat percentage ( -3.4 % vs -3.1 % ) , with no change in lean mass . Improvements in anthropometric and body composition measurements among overweight and obese premenopausal women can be achieved with a reduced-calorie diet including either a daily dark chocolate snack or non-chocolate snack",
"BACKGROUND Studies of cocoa suggest an array of cardiovascular benefits ; however , the effects of daily intake of sugar-free and sugar-sweetened cocoa beverages on endothelial function ( EF ) have yet to be established . METHODS 44 adults ( BMI 25 - 35 kg/m2 ) participated in a r and omized , controlled , crossover trial . Participants were r and omly assigned to a treatment sequence : sugar-free cocoa beverage , sugar-sweetened cocoa beverage , and sugar-sweetened cocoa-free placebo . Treatments were administered daily for 6 weeks , with a 4-week washout period . RESULTS Cocoa ingestion improved EF measured as flow-mediated dilation ( FMD ) compared to placebo ( sugar-free cocoa : change , 2.4 % [ 95 % CI , 1.5 to 3.2 ] vs. -0.8 % [ 95 % CI , -1.9 to 0.3 ] ; difference , 3.2 % [ 95 % CI , 1.8 to 4.6 ] ; p : change , 1.5 % [ 95 % CI , 0.6 to 2.4 ] vs. -0.8 % [ 95 % CI , -1.9 to 0.3 ] ; difference , 2.3 % [ 95 % CI , 0.9 to 3.7 ] ; p=0.002 ) . The magnitude of improvement in FMD after consumption of sugar-free versus sugar-sweetened cocoa was greater , but not significantly . Other biomarkers of cardiac risk did not change appreciably from baseline . BMI remained stable throughout the study . CONCLUSIONS Daily cocoa ingestion improves EF independently of other biomarkers of cardiac risk , and does not cause weight gain . Sugar-free preparations may further augment endothelial function",
"Epidemiological studies have suggested that the daily intake of flavonoids is associated with a decreased risk of developing cardiovascular disease . Our purpose was to evaluate the effect of the addition of dietary flavonoids ( DF ) to antihypertensive treatment ( AHT ) , based on telmisartan ( Tms ) or captopril ( Cpr ) , on blood pressure ( BP ) , body mass index ( BMI ) , waist/hip ratio , leptin , lipid profile and inflammation in hypertensive young patients . An open‐label , r and omized , controlled trial was performed among 79 patients aged 20–55 years with grade I or grade II systemic arterial hypertension . The subjects were assigned to one of four groups for AHT plus DF during 6 months : Cpr ( n = 14 ) , Cpr + DF ( n = 19 ) , Tms ( n = 25 ) and Tms + DF ( n = 21 ) . DF consisted of dark chocolate , dehydrated red apple and green tea in an infusion to obtain a daily dose of 425.8 ± 13.9 mg epicatechin equivalents . The BP and anthropometric parameters were measured every 2 weeks . Lipid profile , leptin and hsCRP were determined by st and ard methods . The combination AHT‐DF produced an additional and significant reduction in ( i ) SBP/DBP of −5/−4 mmHg , being −7/−5 for Cpr + DF and −4/−3 for Tms + DF ; ( ii ) triglyceride levels ( −30.6 % ) versus AHT alone ( −9.6 % ) ; and ( iii ) leptin : Cpr + DF versus Tms + DF ( p were reduced significantly in all groups independently of the applied treatment . We conclude that the addition of flavonoids to pharmacological antihypertensive therapy shows additional benefits on BP , lipid profile , leptin , obesity and inflammation ",
"OBJECTIVE We tested the hypothesis that a multifaceted 11-wk intervention comprising nutrition , group exercise , and oral care would have a significant influence on nutrition and function in elderly ( > or=65 y ) nursing-home residents . METHODS The study was an 11-wk r and omized controlled intervention study with nutrition ( chocolate and homemade oral supplements ) , group exercise twice a week ( 45 - 60 min , moderate intensity ) , and oral care intervention one to two times a week , with the aim of improving nutritional status and function in elderly nursing-home residents . A follow-up visit was made 4 mo after the end of the intervention . Assessment s were weight , body mass index , dietary intake , h and grip strength , Senior Fitness Test , Berg 's Balance Scale , and the prevalence of plaque . RESULTS A total of 121 subjects ( 61 % ) accepted the invitation and 62 were r and omized to the intervention group . Six of these dropped out during the 11 wk . At the 4-mo follow-up there were 15 deaths in the intervention group and 8 in the control group . The nutrition and exercise were well tolerated . After 11 wk the change in percentage of weight ( P = 0.005 ) , percentage of body mass index ( P = 0.003 ) , energy intake ( P = 0.084 ) , protein intake ( P = 0.012 ) , and Berg 's Balance Scale ( P = 0.004 ) was higher in the intervention group than in the control group . In addition , the percentage of subjects whose functional tests improved was higher in the intervention group . Both groups lost the same percentage of weight after the intervention ( P = 0.908 ) . The total percentage of weight loss from baseline to follow-up was higher in the control group ( P = 0.019 ) . Oral care was not well accepted and the prevalence of plaque did not change . CONCLUSION It is possible to improve nutrition and function in elderly nursing-home residents by means of a multifaceted intervention consisting of chocolate , homemade supplements , group exercise , and oral care",
"Cephalic effects on appetite are mediated by vagal tone and altered gastrointestinal hormones . The objective of this study is to explore the relationship between appetite and levels of gastrointestinal hormones after smelling chocolate and after melt- and -swallow 30 g chocolate ( 1.059 oz , 85 % cocoa , 12.5 g of sugar per 100 g product ) . Twelve female residents ( BMI between 18 and 25 kg/m(2 ) ) all participated in two 60-minute study sessions . In the first session , all 12 women ate chocolate ; for the second session , they were r and omized either to smell chocolate ( n=6 ) or to serve as a control ( no eating or smelling ; n=6 ) . At the start of the sessions , levels of insulin , glucagon-like peptide-1 ( GLP-1 ) and cholecystokinin ( CCK ) , but not glucose , correlated with appetite scored on a visual analogue scale ( VAS ) . In contrast , ghrelin levels correlated inversely with scored appetite . Chocolate eating and smelling both induced a similar appetite suppression with a disappearance of correlations between VAS scores and insulin , GLP-1 and CCK levels . However , while the correlation between VAS score and ghrelin disappeared completely after chocolate eating , it reversed after chocolate smelling , that is , olfactory stimulation with dark chocolate ( 85 % ) result ed in a satiation response that correlated inversely with ghrelin levels",
"BACKGROUND The absorption of cocoa flavanols in the small intestine is limited , and the majority of the flavanols reach the large intestine where they may be metabolized by resident microbiota . OBJECTIVE We assessed the prebiotic potential of cocoa flavanols in a r and omized , double-blind , crossover , controlled intervention study . DESIGN Twenty-two healthy human volunteers were r and omly assigned to either a high-cocoa flavanol ( HCF ) group ( 494 mg cocoa flavanols/d ) or a low-cocoa flavanol ( LCF ) group ( 23 mg cocoa flavanols/d ) for 4 wk . This was followed by a 4-wk washout period before volunteers crossed to the alternant arm . Fecal sample s were recovered before and after each intervention , and bacterial numbers were measured by fluorescence in situ hybridization . A number of other biochemical and physiologic markers were measured . RESULTS Compared with the consumption of the LCF drink , the daily consumption of the HCF drink for 4 wk significantly increased the bifidobacterial ( P lactobacilli ( P clostridia counts ( P plasma triacylglycerol ( P C-reactive protein ( P C-reactive protein concentrations were linked to changes in lactobacilli counts ( P cocoa flavanols can significantly affect the growth of select gut microflora in humans , which suggests the potential prebiotic benefits associated with the dietary inclusion of flavanol-rich foods . This trial was registered at clinical trials.gov as NCT01091922"
] | 411661b8-06ff-11f0-808a-c43d1ab1c353 |
One often alleges that laboratory bond-strength testing can not predict clinical effectiveness of adhesives . Major argument to sustain this cl aim is the wide variation in bond-strength values recorded for one specific adhesive among different research institutes worldwide . The main reason for these inconsistent bond-strength measurements is supposedly the current lack of a st and ard bond-strength testing protocol . This paper ( and presentation ) aim ed to report on an extensive literature review with regard to the different laboratory bond-strength test methods and their data provided , along with a second extensive literature review on clinical effectiveness data of adhesives in terms of retention rates of adhesive Class-V restorations . Combining both systematic review s , we have subsequently search ed for a potential relationship between bond-strength data and clinical outcomes | [
"PURPOSE The purpose of this prospect i ve r and omized controlled clinical study was to evaluate the clinical performance of a \" mild \" two-step self-etching adhesive , Clearfil SE , in Class V restorations after 5 years of clinical functioning . MATERIAL S AND METHODS Twenty-nine patients received two or four restorations following two r and omly assigned experimental protocol s : ( 1 ) a mild self-etching adhesive ( Clearfil SE , Kuraray ) was applied following manufacturer 's instructions on both enamel and dentin ( C-SE non-etch ) ; ( 2 ) similar application of Clearfil SE , but including prior selective acid-etching of the enamel cavity margins with 40 % phosphoric acid ( C-SE etch ) . Clearfil AP-X ( Kuraray ) was used as the restorative composite for all 100 restorations . The clinical effectiveness was recorded in terms of retention , marginal integrity , marginal discoloration , caries recurrence , postoperative sensitivity , and preservation of tooth vitality after 5 years of clinical service . The hypothesis tested was that selective acid etching of enamel with phosphoric acid improved retention , marginal integrity , and clinical microleakage of Class V restorations . RESULTS Only one restoration of the C-SE non-etch group was lost at the 5-year recall . All other restorations were clinical ly acceptable . Marginal integrity deteriorated with time in both groups . The number of restorations with defect-free margins was significantly lower in the C-SE non-etch group ( p = 0.0043 ) . This latter group presented significantly more small incisal marginal defects on the enamel side ( p = 0.0169 ) . Superficial marginal discoloration increased in both groups , but was more pronounced in the C-SE non-etch group and was related to the higher frequency of small incisal marginal defects . CONCLUSION The clinical effectiveness of the two-step self-etching adhesive Clearfil SE remained excellent after 5 years of clinical service . Additional etching of the enamel cavity margins result ed in an improved marginal adaptation on the enamel side ; however , this was not critical for the overall clinical performance of the restorations",
"PURPOSE The purpose of this study was to examine the sensitivity of the microtensile bond strength ( muTBS ) to changes in the specimen design using three different dentin bonding systems , utilizing both experimental and finite element analysis ( FEA ) . MATERIAL S AND METHODS Freshly extracted bovine central incisors were r and omly divided into 9 experimental groups . Flat dentin surfaces were exposed and polished with 600-grit SiC papers . The dentin bonding agents ( DBA ) Adper Prompt L-Pop , Adper Scotchbond 1XT , and Adper Scotchbond Multi- Purpose Plus were bonded to the dentin surface . A 5- to 6-mm-thick layer of resin composite Filtek Supreme was built up incrementally . For each DBA , after 24 h in water , the bonded specimens were sectioned vertically into slabs of stick- , dumbbell- and hourglass-shaped specimens ( n = 30 ) . The muTBS test was performed at a crosshead speed of 0.5 mm/min and the fracture surfaces were examined under optical microscopy and SEM . FEA models of the three design s were developed using the TOMECH program and viewed using FEMSYS visualization software . RESULTS One-way ANOVA , Tukey 's and Kaplan-Meier tests revealed no significant differences between the bond strengths for the three design s for the same dentin bonding agent ( p > 0.05 ) . However , there were significant differences between the three adhesive systems when using one specimen design . FEA results showed no major differences between the three design s in the maximum stress within the adhesive layer , although the stress distributions for the hourglass shape followed a different pattern . CONCLUSIONS The three different specimen design s had no influence on the bond strength to dentin within one adhesive system . FEA predictions are consistent with the results of the experiments",
"This study evaluated the clinical performance of a self-etching adhesive for resin composites over one year . Thirty pairs of restorations of Pertac II , using the adhesive Prompt L-Pop , were placed in caries-free cervical erosion/abfraction lesions without tooth preparation . One of each pair was cured using \" soft-start \" polymerization , while the other was polymerized with high-intensity halogen light . Restorations were clinical ly evaluated at baseline , six and 12 months using modified Ryge/USPHS criteria . Although no significant difference ( p>0.05 ) was observed between the curing methods , adhesive performance was poor , with a 35 % loss of restorations overall",
"OBJECTIVES To evaluate the push-out bond strength and the sealing ability of five adhesive cements routinely used for fiber-post bonding . METHODS Fifty extracted single-rooted teeth were r and omly divided in five groups and restored using Parapost FiberLux and the following luting agents : Panavia 21 ( PAN ) , Clearfil Esthetic Cement ( CLF ) , Variolink II ( VAR ) , RelyX Unicem ( UNI ) and experimental GC self-adhesive cement ( EGC ) . After 1 week of water storage at 37 degrees C , three sections ( coronal , middle and apical ) of 2 mm thickness were prepared from each specimen . Sealing ability was quantified with a fluid-filtration system ( Flodec ) during 10 min , after which the push-out bond strength was immediately measured . Data were analyzed with ANOVA ( push-out ) and Kruskal-Wallis ( sealing ability ) . RESULTS The push-out bond strength and sealing ability were not significantly different among the coronal , middle and apical sections for each luting agent . The highest push-out bond strength was measured for CLF ( 14.60+/-3.63 MPa ) , which was not significantly different from PAN ( 12.57+/-2.45 MPa ) , but significantly higher than VAR ( 11.09+/-4.09 MPa ) , UNI ( 11.29+/-4.31 MPa ) and EGC ( 7.65+/-4.79 MPa ) . When evaluating the sealing ability , significant differences were not found among PAN , CLF and VAR , and between UNI and EGC . The latter luting agents scored significantly lower than the former ones . The push-out bond strength was correlated to the sealing ability ( p self-etching MDP-based cements presented the highest push-out bond strength . Although the bonding effectiveness of self-adhesive cements appears promising , their interaction with root dentin might be too weak to minimize microleakage at the post-cement-dentin interface",
"OBJECTIVES We examined the correlation between the quantitative margin analysis of two laboratory test methods ( Berlin , Zurich ) and the clinical outcome in Class V restorations . METHODS Prospect i ve clinical studies with an observation period of at least 18 months were search ed in the literature , for which laboratory data were also available . The clinical outcome variables were retention loss , marginal discoloration , detectable margins and secondary caries . Forty-four clinical studies matched the inclusion criteria , including 34 adhesive systems for which laboratory data were also present . For both laboratory test methods and the clinical studies , an index was formulated to better compare the in vitro and in vivo results . Linear mixed models which included a r and om study effect were calculated . As most clinical data were available for 12 and 24 months , the main analysis was restricted to these recall intervals . RESULTS The comparative analysis revealed a weak correlation between the clinical index and both in vitro indices . The correlation was statistically significant for the Berlin method but not for the Zurich method and only present if studies were compared which used the same composite in the in vitro and in vivo study . When defining specific cut-off values , the prognosis for the good clinical performance of an adhesive system based on in vitro results was 78 % ( Berlin ) or 100 % ( Zurich ) . For poor performance it was 67 % and 60 % , respectively . No correlation was found between both in vitro methods . SIGNIFICANCE The surrogate parameter \" marginal adaptation \" of restorations placed in extracted teeth has a mediocre value to predict the clinical performance of an adhesive system in cervical cavities . The composite is an important factor for a successful prediction . The comparison between in vitro/in vivo is sometimes hampered by the great variability of clinical results on the same adhesive system",
"A 2-year r and omized , controlled prospect i ve study evaluated the clinical effectiveness of a one-step self-etch adhesive and a “ gold-st and ard ” three-step etch- and -rinse adhesive in non-carious Class-V lesions . The None hypothesis tested was that the one-step self-etch adhesive does perform clinical ly equally well as the three-step etch- and -rinse adhesive . A total of 161 lesions in 26 patients were restored with Clearfil AP-X ( Kuraray ) . The restorations were bonded either with the “ all-in-one ” adhesive Clearfil S3 Bond ( Kuraray ) or with the three-step etch- and -rinse adhesive Optibond FL ( Kerr ) . The restorations were evaluated at baseline and after 6 months , 1 and 2 years , regarding their retention , marginal adapation , marginal discoloration , caries occurrence , preservation of tooth vitality and post-operative sensivity . Retention loss , severe marginal defects and /or discoloration that needed intervention ( repair or replacement ) and the occurrence of caries were considered as clinical failures . The recall rate at 2 years was 93.8 % . Only one Clearfil S3 Bond restoration was lost at the 2-year recall . All other restorations were clinical ly acceptable . The number of restorations with defect-free margins decreased severely during the 2-year study period ( to 6.7 % and 25.3 % for Clearfil S3 Bond and Optibond FL , respectively ) . The Clearfil S3 Bond restorations presented significantly more small marginal defects at the enamel side than the Optibond FL restorations ( Clearfil S3 Bond : 93.3 % ; Optibond FL : 73.3 % ; p = 0.000 ) . Superficial marginal discoloration increased in both groups ( to 53.3 % and 36 % for Clearfil S3 Bond and Optibond FL , respectively ) and was also more pronounced in the Clearfil S3 Bond group ( p = 0.007 ) . After 2 years , the simplified one-step self-etch adhesive Clearfil S3 Bond and the three-step etch- and -rinse adhesive Optibond FL were clinical ly equally successful , even though both adhesives were characterized by progressive degradation in marginal integrity . Clearfil S3 Bond exhibited more small enamel marginal defects and superficial marginal discolorations",
"This r and omized clinical trial compared the performance of an all-in-one adhesive ( iBond ) applied in sclerotic and non-sclerotic non-carious cervical lesions with that of a three-step etch-prime-bond adhesive ( Gluma Solid Bond , SB ) . One-hundred and five lesions were r and omly assigned to four groups according to adhesive , sclerosis scale and technique : 1 ) SB applied to lesions with sclerosis scale 1 and 2 ( n=26 ) ; 2 ) iBond applied to lesions with sclerosis scale 1 and 2 ( n=28 ) ; 3 ) iBond applied to lesions with sclerosis scale 3 and 4 ( n=25 ) and 4 ) iBond applied with prior acid-etching to lesions with sclerosis scale 3 and 4 ( n=26 ) . A microfilled composite ( Durafill VS ) was used as the restorative material . The restorations were evaluated for retention , color match , marginal adaptation , anatomic form , cavosurface margin discoloration , secondary caries , pre- and post-operative sensitivity , surface texture and fracture at insertion ( baseline ) , 6 , 18 months and at 3 years using modified USPHS evaluation criteria ( Alfa = excellent ; Bravo= clinical ly acceptable ; Charlie= clinical ly unacceptable ) . There was a high percentage of Bravo scores for marginal adaptation ( 4%-32 % ) and marginal discoloration ( 18%-60 % ) in Groups 2 , 3 and 4 , but all groups had Charlie scores at 6 months and Charlie scores at 18 months for retention and marginal discoloration , respectively . However , it should be noted that 13 % of the restorations in Group 4 were not retained at three years",
"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",
"OBJECTIVES The purpose of this study was to determine the correlation between beams from the same tooth in a microtensile bond strength study and to examine their effect on the interpretation of results . METHODS A flat occlusal dentin surface was exposed using wet 180 , 240 , and 320-grit SiC paper on caries-free human molar teeth . Adhesive was applied followed by 6 mm of composite ( CoreRestore2 ) applied in 2 mm increments . Four adhesives were used : Optibond FL , light-cure , dual-cure , and self-cure Optibond Solo Plus . Nine beams ( 1 mm2 ) were obtained from fifteen teeth for each group , labeled to indicate the orientation of the beams to each other and stored in artificial saliva at 37 degrees C for 1 week or 3 months . Microtensile dentin bond strengths were determined using a non-trimming technique . Statistical comparisons between adhesive-storage combinations were performed using ANOVA . Analyses were performed assuming statistical independence between all beams and then repeated using a r and om tooth effect to account for correlations between beams from the same tooth . RESULTS Significant correlations were found between beams . No pattern was observed in the correlations related to the orientations of the beams to each other . Conclusions regarding statistical significance of comparisons ( at alpha=0.05 ) were sometimes affected by the incorrect assumption of independent beams . The degree of correlation was large enough to severely affect power and sample size calculations . SIGNIFICANCE Analyses of microtensile dentin bond strength studies need to account for correlations between beams to avoid over-stating statistical significance of study results",
"OBJECTIVES Flexure at the tooth cervix has been suggested to dislodge cervical restorations more rapidly . The objective of this r and omized controlled clinical trial was to test the hypothesis that a higher composite flexibility better withst and s tooth flexure stress . METHODS One hundred and forty-two non-carious cervical lesions were restored with composites with contrasting stiffness . Seventy-one patients r and omly received two cervical restorations placed following two out of the three experimental groups : ( 1 ) the three-step etch- and -rinse adhesive Permaquick applied with the stiff micro-hybrid composite Amelogen Hybrid ( PMQ/A-Hy , Ultradent ) , ( 2 ) Permaquick applied with the more flexible micro-filled composite Amelogen Microfill ( PMQ/A-Mi , Ultradent ) , or ( 3 ) the ' golden st and ard ' three-step etch- and -rinse adhesive Optibond FL applied with the micro-hybrid composite Prodigy ( O-FL/Pro , Kerr ) . RESULTS The recall rate at 7 years was 80 % . No statistically significant difference was found for any of the parameters evaluated neither between both adhesives , nor between both composites ( McNemar , p>0.05 ) . Eleven percent of the O-FL/Pro restorations were clinical ly unacceptable due to loss of retention ( 5.5 % ) and severe marginal discoloration ( 5.5 % ) . In the PMQ-group , 22 % of the PMQ/A-Mi restorations ( 8 % loss of retention , 5 % severe enamel margin defects , 3 % severe dentin margin defects , 6 % severe marginal discoloration , 3 % extreme sensitivity ) and 19 % of the PMQ/A-Hy restorations ( 13 % loss of retention , 3 % severe enamel margin defects , 3 % severe marginal discoloration ) needed repair or replacement . SIGNIFICANCE The clinical performance of the three adhesive/composite combinations was good and reliable during the 7-year clinical trial . It was concluded that the composite stiffness does not affect the clinical longevity of cervical composite restorations",
"A 3-yr r and omized , controlled prospect i ve study evaluated the clinical effectiveness of a mild two-step self-etch adhesive , Clearfil SE , in Class-V non-carious lesions . The hypothesis tested was that prior selective etching of enamel with phosphoric acid does not affect the 3-yr clinical performance of this adhesive . A total of 100 lesions in 29 patients were r and omly restored in one or two pairs , according to two experimental protocol s : ( i ) application of Clearfil SE according to the instructions of the manufacturer ( C-SE non-etch ) ; and ( ii ) similar application of Clearfil SE with prior etching of enamel cavity margins with phosphoric acid ( C-SE etch ) . Clearfil AP-X was used as a restorative material . At 3 yr , 90 % of the restorations were examined for retention , marginal integrity , marginal discoloration , caries recurrence , postoperative sensitivity , and preservation of tooth vitality . An excellent retention rate ( 100 % ) was noted after 3 yr of clinical functioning . Only one restoration of the C-SE etch group was clinical ly unacceptable owing to the presence of a severe cervical marginal defect . A pairwise comparison between both groups showed a significant difference only in the number of small marginal defects at the enamel side , which was higher in the C-SE non-etch group . These incisal defects were small and clinical ly irrelevant . Superficial marginal discoloration increased slightly in the C-SE non-etch group and was related to the higher frequency of small incisal marginal defects . In this latter group , localized marginal discoloration was observed significantly more in smokers . In conclusion , the clinical performance of the mild two-step self-etch adhesive , Clearfil SE , remained excellent after 3 yr of clinical functioning . Additional etching of the enamel cavity margins was not critical for its clinical performance",
"This study tested the hypothesis that long-term durability of resin bonds to dentin would directly relate to the nanoleakage of dentin bonding systems . Twenty extracted third molars were ground flat with # 600 grit SIC paper under running water to expose middle dentin . One-Step or Single Bond was applied to the dentin surface according to the manufacturer 's instruction . A crown was built-up with Clearfil AP-X resin composite and the specimens were stored in water for 24 hours at 37 degrees C. The bonded assemblies were cut mesio-distally perpendicular to the interface in approximately 0.7 mm thick slabs and trimmed for microtensile bond strength testing . All slabs were immersed in individual bottles containing 37 degrees C water that was changed daily . Specimens were r and omly assigned to four groups ( one day , three , six and nine months ) , and at the specified time period , the specimens to be tested were r and omly divided into two subgroups for testing : 50 % AgNO3 and the control . In the 50 % AgNO3 subgroup , the slabs were coated with fingernail varnish except for approximately 0.5 mm around the bonded interface and immersed for one hour in 50 % AgNO3 , followed by exposure in a photo developing solution for 12 hours just prior to debonding . The specimens in the control subgroup were soaked in water until they were debonded . Then , all specimens were subjected to microtensile bond testing . Micrographs of the fractured surfaces of the debonded specimens in the AgNO3 subgroup were taken using light microscopy . They were then subjected to image analysis by NIH Image PC ( Scion , Fredrick , MD , USA ) , and the area of silver penetration was quantitated . The fractured surface was further analyzed under the SEM . Bond strength data and the silver penetration areas were subjected to two and three-way ANOVA and Fisher 's PLSD test at the 95 % level of confidence . Regression analysis was used to test the relationship between bond strengths and the silver penetra tion area at each time period . The tensile bond strength of both material s gradually decreased over time . Specimens bonded with One-Step showed less silver nanoleakage at one day compared to three , six and nine months ( p nanoleakage measured at three , six and nine months . In contrast , for specimens bonded with Single Bond , there were no statistically significant differences in the silver nanoleakage among the four time periods tested ( p>0.05 ) . No correlation was observed between bond strength and nanoleakage for either bonding system . Nanoleakage occurred in both adhesive systems , and bond strengths gradually decreased over time . However , there was no correlation between bond strength and nanoleakage for either adhesive system in this study",
"OBJECTIVES The aim of this study was to evaluate the clinical long-term retention to dentin of seven adhesive systems . METHODS A total of 270 Class V restorations of four etch- and -rinse , one self-etch adhesive system and a resin-modified glass ionomer cement were placed in non-carious cervical lesions without intentional enamel involvement . The restorations were evaluated at baseline , 6 , 12 , 18 , and 24 months and then every year during a 13-year follow-up . Dentin bonding efficiency was determined by the percentage of lost restorations . RESULTS During the 13 years , 215 restorations could be evaluated . The cumulative loss rate at 13 years was 53.0 % , with significant different failures rates for the different systems varying between 35.6 and 86.8 % . Four systems fulfilled the ADA 18-month full acceptance retention criteria . Two systems showed at 18 months and earlier high debonding rates . The annual failure rates for the etch- and -rinse systems were Optibond 3.1 % , Permagen 13.0 % , Scotchbond MP 4.8 % , Syntac classic 2.8 % ; for the self-etch system P&S 4.4 % ; and the resin-modified glass ionomer cement Vitremer 2.7 % . CONCLUSION It can be concluded that all systems showed a continuous degradation of the bond with a wide variation , which was independent of the adhesion strategy . Three bonding systems showed a cumulative failure rate after 13 years between 36 and 41 % with the best retention for the resin-modified glass ionomer cement and a four-step etch- and -rinse system",
"This in vitro study compared three different methods to evaluate detectable levels of microleakage in Class II restorations placed with five commercially available packable resin composites : Alert , Glacier , Pyramid , Solitaire 2 and SureFil . A flowable resin composite , Flow-It , was used to line all packable composites . The hybrid resin composite Z100 was also included . The adhesive system used with all groups was Scotchbond Multi Purpose Plus . St and ard Class II cavities were prepared on the mesial ( enamel margins ) and distal ( dentin margins ) sides of the teeth with no communication between them . Based on a power analysis , 180 permanent human molars were r and omly assign to each of six groups with 30 specimens per group . All restorative material s were placed following manufacturers ' recommendations . Following restoration and thermocycling , the specimens were stored at room temperature in solutions of 45Ca , methylene blue and rhodamine B , sequentially . Microleakage was ordinal scored as 1 ( no penetration ) , 2 ( penetration up to one-third of the cervical floor ) , 3 ( penetration beyond one-third of the cervical floor to the axial wall ) and 4 ( penetration along the axial wall ) by two independent evaluators . Analysis of the occlusal surfaces was also accomplished following the same scheme . In this study , tracers/dyes were evaluated for differences in penetration using generalized estimating equation methodology applied to cumulative logistic regression models . The results showed that Rhodamine B detected more microleakage than 45Ca or methylene blue , and 45Ca generally detected more microleakage than methylene blue",
"Laboratory testing of dentin adhesive systems still requires corroboration by long-term clinical trials for their ultimate clinical effectiveness to be vali date d. The objective of this clinical investigation was to evaluate , retrospectively , the clinical effectiveness of earlier-investigated dentin adhesive systems ( Scotchbond , Gluma , Clearf il New Bond , Scotchbond 2 , Tenure , and Tripton ) , and to compare their clinical results with those obtained with four modern total-etch adhesive systems ( Bayer exp . 1 and 2 , Clearfil Liner Bond System , and Scotchbond Multi- Purpose ) . In total , 1177 Class V cervical lesions in the teeth of 346 patients were restored following two cavity design s : In Group A , enamel was neither beveled nor intentionally etched , as per ADA guidelines ; in Group B , adjacent enamel was beveled and conditioned . Clinical retention rates definitely indicated the improved clinical efficacy of the newest dentin adhesives over the earlier systems . With regard to adhesion strategy , adhesive systems that removed the smear layer and concurrently demineralized the dentin surface layer performed clinical ly better than systems that modified the disorderly layer of smear debris without complete removal . Hybridization by resin interdiffusion into the exposed dentinal collagen layer , combined with attachment of resin tags into the opened dentin tubules , appeared to be essential for reliable dentin bonding but might be insufficient by itself . The additional formation of an elastic bonding area as a polymerization shrinkage absorber and the use of a microfine restorative composite apparently guaranteed an efficient clinical result . The perfect one-year retention recorded for Clearfil Liner Bond System and Scotchbond Multi- Purpose must be confirmed at later recalls",
"Cutting procedures conventionally used for microtensile specimens ' preparation induce mechanical stress and attrition , leading to cracks in dental structure . Enamel is mainly affected due to its high module of elasticity and brittleness . As an alternative to the conventional diamond saw , a diamond wire was used for cutting . The two techniques were compared in efficacy in the preparation of two different sample shapes . Forty human molars , flattened in dentin or enamel , were used for sample preparation . After bonding procedures , resin block was built incrementally . Half of the teeth were cut using a diamond disc and the other half using a diamond wire , obtaining slabs and stick-shaped specimens . Slabs were then shaped to obtain hourglass sample s. Five sample s from each subgroup were r and omly selected for Scanning electron microscopy ( SEM ) analysis . Remaining sample s underwent microtensile test and the results were analyzed , including/excluding premature failures ( pf ) , with three-way ANOVA and Tukey test , performed separately , by substrate . On dentin , only the exclusion of pf showed a significant higher bond strength values than when pf were included ( p bond strength ( p incidence of specimens ' cracks and defects when diamond blade was used . Scratches and cracks in the hourglass-shaped specimens were also detected . In both cases , enamel was more affected than dentin",
"The purpose of this double-blind clinical trial was to compare the retention rate in noncarious Class V lesions of two resin-based composite restorative material s with contrasting stiffness . Isolation with retraction cord , pressed paper triangles , and cotton rolls was used to closely mimic the procedures generally used in a practice setting . Thirty pairs of restorations were placed , one using Silux Plus and one using Z100 . The assignment of material was r and omized , and the subjects were unaware of the material used . All restorations were placed with a fourth-generation adhesive liner , Scotchbond Multi- Purpose . Evaluations were performed at baseline , 6 , 12 , 18 , and 24 months by two independent examiners using criteria developed by Cvar and Ryge in a forced consensus model . Examiners were unaware of the restoration 's group identity . No difference between the retention rates for the two groups was found after 24 months , bringing into question the role that a material 's stiffness plays in determining retention in a noncarious Class V lesion",
"PURPOSE To clinical ly evaluate the 3-year performance of a one-bottle dentin adhesive in the restoration of non-carious cervical lesions ( NCCLs ) with resin composite . MATERIAL S AND METHODS 105 NCCLs were restored with either AElite Flow , Bisco Glaze ( both flowable resin-based composites ) or Silux ( a microfilled resin-based composite ) , using One-Step dentin adhesive . The cavities were cleaned with pumice and water slurry , the dentin lightly roughened with a fine diamond bur , and the restorations placed according to the manufacturer 's instructions . Patients were recalled at 6 months , 1 year , 2 years and 3 years , and restoration integrity and marginal discoloration assessed . RESULTS The overall retention rates were : 6 months , 100 % ; 1 year , 95 % ; 2 years , 87 % ; 3 years , 75 % . Marginal discoloration was negligible , and there was no significant difference among the material s , although there was a trend for it to be greater around the Bisco Glaze restorations",
"The bonding performance of current adhesive systems to primary enamel has not been thoroughly research ed . This study compared the micro-shear bond strength of two adhesive systems to primary and permanent tooth enamel . Two commercially available resin adhesives , a self-etching primer system ( Clearfil SE Bond ) and a single-bottle adhesive system ( Single Bond ) used with a total-etch wet bonding technique were tested . A micro-shear bond test was used to examine the adhesive systems on mid-coronal buccal enamel of extracted primary or permanent teeth . In addition , etched enamel surfaces and etched-bonded enamel interfaces were examined using scanning electron microscopy ( SEM ) . No statistically significant differences of shear bond strength values were found between the primary and permanent enamel or the adhesive systems used ( p>0.01 ) . The SEM observations showed that both adhesive systems etched the primary enamel deeper than the permanent enamel , suggesting that the action of acid etch seemed to be more intense on primary enamel than on permanent enamel . Bonding of the adhesive systems to primary enamel was almost identical to permanent enamel",
"PURPOSE To evaluate the clinical effectiveness of a resin-modified glass-ionomer adhesive FujiBond LC ( GC ) in non-carious Class V cervical lesions . METHODS 28 patients and 52 abrasion-erosion lesions were restored using FujiBond LC and a microfilled resin composite in a cavity design with the adjacent enamel margins beveled . Clinical parameters as retention , marginal integrity , clinical microleakage , caries recurrence , esthetics , gingival response , tooth vitality and post-operative sensitivity were evaluated at 6 months , 1 and 2 years . RESULTS A 100 % retention rate was recorded after 2 years of clinical service . However , only 15 % of the restorations showed a perfect marginal adaptation . All marginal defects were small , either located at the incisal or at the cervical margin . The percentage of small marginal defects was obviously higher at the incisal enamel margin than at the cervical dentin margin . At the 2-year recall , half of the restorations exhibited a superficial , localized discoloration at the restoration margin , however none of the restorations showed deep , generalized discoloration . Remaining criteria of clinical effectiveness were rated as excellent",
"PURPOSE The effect of carbamide peroxide concentration and length of exposure on fracture toughness ( KIC ) of existing composite-dentin interfaces was assessed using the notchless triangular prism ( NTP ) specimen KIC test . MATERIAL S AND METHODS Freshly extracted human molars and premolars were wet ground on 600-grit SiC to obtain 4 x 4 x 4 x 4 mm triangular prisms , exposing buccal or lingual dentin . Dentin surfaces were bonded using a resin composite ( Z-250 , 3 M ) and SingleBond dentin bonding system ( 3 M ) to obtain 180 8-mm-long dentin-composite NTP specimens . The bonding system was applied using the \" wet-bonding \" technique . The bonded specimens were r and omly assigned to 20 groups . The effect of exposure to three control solutions ( tap water , Carbopol , and Carbopol-urea ) and to four concentrations ( 11 % , 13 % , 16 % , 21 % ) of carbamide peroxide ( Perfecta , Premier ) was assessed . Testing was conducted after 1 , 2 , and 3 weeks representing a cumulative exposure of 14 , 42 , and 70 h. The maximum force recorded before fracture was used to calculate KIC . The data were statistically analysed using two-factor ANOVA followed by one-way ANOVA and Bonferroni multiple means comparisons . Selected fractured surfaces were characterized using SEM . RESULTS Data analysis revealed that cumulative exposure to bleaching agent for 70 h significantly ( p interfacial KIC , regardless of concentration . For the 16 % and 21 % concentrations , a significant reduction was observed after 42 h. CONCLUSION The results suggest that bleaching could adversely affect the interfacial fracture toughness of dentin-resin composite adhesive interfaces",
"OBJECTIVES This study tested the hypothesis that single-bottle total-etch adhesives are effective in reducing dentine permeability under in vivo conditions . METHODS Crown preparations on vital human teeth were performed under local analgesia as part of the treatment plan for prosthetic rehabilitation . Four single-bottle adhesives ( Single Bond , 3 M ESPE ; Excite DSC , Ivoclar Vivadent ; Prime and Bond NT Dual-Cure , Dentsply DeTrey and One-Step , Bisco Inc. ) were applied to the cut dentine after acid-etching . Polyvinyl siloxane impressions were taken , using an ultra-low viscosity impression material , of the smear layer-covered dentine before applying the adhesives to deep vital dentine , and after adhesive placement . Additional impressions were taken of the adhesive-sealed dentine following the removal of the provisional prostheses after a 7 - 10 day period . Epoxy resin replicas of the crown preparations were examined with scanning electron microscopy to evaluate the extent of dentinal fluid transudation during pre-bonded , immediately bonded and post-bonded periods . RESULTS Dentinal fluid transudation from localised areas that were close to the dental pulp was universally observed from all epoxy resin replicas , irrespective of the adhesive employed . The transudation of dentinal fluid from the control smear layer-covered dentine of each crown preparation was comparatively mild when compared to the extent that was observed after total-etching and application of the single-bottle adhesive . Dentinal fluid droplets were specifically located over the surface of the adhesive layer . Continuous transudation of dentinal fluid occurred even after the removal of the provisional prostheses , and was considerably more profuse in subjects who opted for the fitting of the permanent prostheses without the use of a local anaesthetic solution . CONCLUSION Single-bottle adhesives , because of their lack of a comparatively more hydrophobic bonding resin layer , behave as permeable membranes after polymerisation . They permit the continuous transudation of dentinal fluid and do not provide a hermetic seal in vital deep dentine . Although the relatively slow rate of diffusion of dentinal fluid is unlikely to result in post-operative cold sensitivity , it may interfere with the optimal polymerisation of dual-cured or auto-cured composites or resin cements in both direct and indirect restorations",
"This study evaluated the clinical performance of dentinal adhesives in seven various material /technique combinations . No statistically significant differences were observed among the restorative combinations , or among technique variables after two years in terms of retention , sensitivity or USPHS categories . However , other factors related to tooth flexure -- such as occlusal stress , patient age , restorative material and restoration location -- showed statistically significant associations with retention failures . These results support a tooth flexural theory of restoration retention",
"OBJECTIVES One-step self-etch adhesives are the most recent generation of adhesives introduced onto the market . The objective of this r and omized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a conventional three-step etch&rinse adhesive ( gold st and ard ) . METHODS Fifty-two patients had 267 non-carious cervical lesions restored with Gradia Direct Anterior ( GC ) . These composite restorations were bonded either with the ' all-in-one ' adhesive G-Bond ( GC ) or with the three-step etch&rinse adhesive Optibond FL ( Kerr ) . The restorations were evaluated after 6 and 12 months clinical service regarding their retention , marginal integrity and discoloration , caries occurrence , preservation of tooth vitality and post-operative sensitivity . Retention loss , severe marginal defects and /or discoloration that needed intervention ( repair or replacement ) and the occurrence of caries were considered as clinical failures . A logistic regression analysis with generalized estimating equations was used to account for the clustered data ( multiple restorations per patient ) . RESULTS The recall rate at 1 year was 98 % . The statistical analysis revealed a relatively low patient factor , indicating that supplementary information could be obtained from the additional restorations placed per patient . The retention rate for G-Bond was 98.5 % compared to 99.3 % for Optibond FL , due to the retention loss of two and one restorations , respectively . There were no significant differences between the two adhesives regarding the evaluated parameters except for the presence of small enamel marginal defects with G-Bond . CONCLUSIONS After 12 months , the simplified one-step G-Bond and the three-step Optibond FL were clinical ly equally successful , even though both adhesives were characterized by progressive degradation of marginal adaptation , and G-Bond exhibited more small enamel marginal defects"
] | 411661f4-06ff-11f0-808a-c43d1ab1c353 |
Background The high precision of radiostereometric analysis ( RSA ) has enabled us to predict long-term implant survival with a small sample of patients followed for a relatively short period of time . The purpose of our systematic review was to vali date the predictive value of two-year RSA results on long-term survival of different types of primary total hip arthroplasty stems . Methods We systematic ally review ed literature to determine the maximum total point motion ( MTPM ) , distal migration and rotation of stem design s and correlated these values to survival rates for aseptic loosening of these specific stems in arthroplasty registries . Results We included 32 studies describing migration of 15 different stem design s. The mean MTPM for straight polished cemented stems was 1.35 mm , for other cemented stems 0.83 mm and for other uncemented stems 1.50 mm . No data were available for the uncemented collared stem . Mean distal migration for straight polished cemented stems was 1.24 mm , for other cemented stems 0.26 mm , the uncemented collared stem 0.40 mm and for other uncemented stems 0.66 mm . Internal rotation was presented for 13 stems and all stems rotated into retroversion . All stems showed 10-year survival rates of > 97 % corrected for aseptic loosening . Discussion Reporting RSA results in a universal way including interpretation of outliers could improve the predictive value of RSA , allowing this technique to be an important tool during the phased introduction of new implant design s. However , a quality assessment of the data by an experienced review er is essential | [
"Background Introduction of new bone cements into clinical practice should include radiostereometric studies . Material s and methods A prospect i ve r and omised radiostereometric study was performed , comparing SmartSet HV and Palacos R acrylic bone cements ( without antibiotics ) using third-generation cementing techniques in primary total hip arthroplasty . Thirty-five patients ( 36 hips ) undergoing Charnley total hip arthroplasty were r and omised to receive either of the two cements and were followed with repeated clinical , radiographic and radiostereometric examinations over 24 months . Twenty-seven patients ( 28 hips ) attended 2 years postoperatively . Results The mean distal translation observed was −0.15 mm for SmartSet HV and −0.16 mm for Palacos R. The mean rotation around the longitudinal axis was 0.9 ° for SmartSet HV and 1.2 ° for Palacos R. The Merle d’Aubigne Postel score was the maximum of 18 points for all patients in both groups . Conclusions No statistically significant difference in stem fixation with use of SmartSet HV and Palacos R was found at 2-year follow-up",
"Background and purpose Total hip replacement ( THR ) with a reverse hybrid ( RH ) , a combination of a cemented polyethylene cup and a cementless femoral stem , has been increasingly used in Sc and inavia . In a r and omized trial , we compared an RH THR with a proximal hydroxyapatite- ( HA- ) coated stem to a conventional cemented THR . Both groups received the same polyethylene cup . Patients and methods 51 patients ( 52 hips ) were included . Radiostereometry ( RSA ) and dual-energy X-ray absorptiometry ( DEXA ) were performed postoperatively and after 6 , 12 , and 24 months . 42 patients ( 43 hips ) were followed for 2 years . Results Mean cup rotation around the x-axis was 0.13 ° for the cemented group and –0.24 ° for the RH group ( p = 0.03 ) . Cup migration in the other axes , and stem migration and wear were similar between the 2 study groups . Bone remodeling around the cup was also similar between the groups . Bone loss in Gruen zone 1 was 18 % for the cementless stems , as compared to an increase of 1.4 % for the cemented ones ( p 0.001 ) . Bone loss was similar in the other Gruen zones . Harris hip score and Oxford hip score were similar pre- and postoperatively in the 2 groups . Interpretation In the present study , RH THR with a cementless hydroxyapatite-coated stem and conventional cemented THR did not show any major differences regarding stem migration and bone loss after 2 years of follow-up",
"Background and purpose There is no consensus on the best rehabilitation regime after uncemented total hip arthroplasty . Theoretically , bone ingrowth into the implant should benefit from initial partial weight bearing . We investigated whether the degree of postoperative weight bearing influences the periprosthetic bone mineral density ( BMD ) and /or the stability of the CLS stem . Patients and methods 38 patients received an uncemented CLS stem and were r and omized to either unrestricted postoperative weight bearing or to partial weight bearing for 3 months . Periprosthetic BMD was measured in the 7 Gruen zones with DXA and the stability of the femoral stem was assessed by radiostereometric analysis ( RSA ) after surgery and at 3 , 12 , 24 , and 60 months . Results Periprosthetic BMD was not influenced by the type of postoperative weight bearing . BMD was reduced by 8–15 % in all Gruen zones at 3 months . Restoration toward initial BMD was observed in all zones except in zone 7 ( calcar region ) , where BMD was reduced by 22 % at 5 years . Immediate weight bearing after surgery had no influence on the stability of the CLS stem , as assessed by RSA . Interpretation Immediate full weight bearing after uncemented total hip arthroplasty is safe . There is no difference in the periprosthetic BMD or in stability of the stem as measured by RSA compared to partial weight bearing for 3 months . BMD is reduced by more than 20 % in the calcar region around a CLS stem after 5 years",
"Background Due to its collarless , double-tapered polished design , the Exeter femoral stem is known to migrate distally in the first 5 years after implantation . However , its long-term migration pattern has not been investigated . Patients and methods 39 consecutive patients ( 41 total hip arthroplasties ) received a cemented Exeter stem and had prospect i ve clinical and RSA follow-up . Patients were evaluated postoperatively at 6 , 12 , 26 , and 52 weeks , and annually thereafter . Short-term results have been reported . In this study , the mean length of follow-up was 9.4 years ( SD 3.2 years ) . No patients were lost to follow-up . 15 patients died during follow-up . Results No stems were revised . In 4 stems , fractures of the cement mantle were noted within the first 3 postoperative years . In 3 stems , this result ed in a complete circumferential cement mantle discontinuity . For the 37 well-performing stems , continuous but small migration was measured between 2 and 12 years of follow-up . Continued subsidence of 0.08 mm/year ( 95 % CI : 0.05–0.12 , p continued rotation in retroversion of 0.07 ° /year ( 95 % CI : 0.02–0.12 , p = 0.01 ) . At 10 years of follow-up , mean subsidence was 2.1 ( SD 1.2 ) mm and mean retroversion was 1.8 ° ( SD 2.0 ) . Two-thirds of this occurred during the first 2 postoperative years . In the 3 stems with a complete circumferential cement fracture , a sudden and disproportionately high increase in subsidence was measured in the time period of occurrence . Interpretation The Exeter femoral stem continues to migrate during the first decade after implantation . Absolute stability is not required for good long-term survival if this is compatible with the design of the implant",
"Background The surface texture , localization , and magnitude of the surface material applied to the femoral stem can facilitate bone ingrowth and influence the survival of total hip arthroplasties . Clinical and radiographic studies have shown superior bone ingrowth in proximally porous-coated stems with a diaphyseal grit-blasted surface in comparison to a smooth diaphyseal surface . Surface textures — especially porous surface material —have been suggested to have a sealing effect against migration of polyethylene debris along the implant-bone interface and to reduce the inflammatory response , leading to a prolonged implant survival . Patients and methods Between 2004 and 2006 , we conducted a r and omized , controlled trial ( RCT ) involving 50 patients with non-inflammatory arthritis . They received either a distally tapered , extended coated stem or a straight , proximally coated stem . During surgery , tantalum markers were inserted into the greater and lesser trochanter . Implant migration was evaluated at 3 , 12 , and 24 months postoperatively by radiostereometric analysis . The primary endpoint was stem migration 2 years after surgery . Results All femoral components in both groups showed pronounced distal translation , with the highest rate of translation occurring between 0 and 3 months . After 2 years , the mean distal translation was 2.67 ( 95 % CI : –3.93 to –1.42 ) mm for the tapered , extended coated stem and 1.80 ( –2.45 to –1.15 ) mm for the straight , proximally coated stem . Half of the tapered , extended coated stems and two-thirds of the straight , proximally coated stems had migrated more than 1 mm . No difference between the 2 stems could be seen with regard to translation or rotation at any time point . After 2 years , 2 hips have been reoperated due to mechanical loosening of the stem . Interpretation An excessive amount of migration of both stem types was seen 2 years postoperatively . It is of vital importance to follow this patient cohort since radiostereometric analysis is known to be predictive of late implant failure , especially in this study where pronounced early migration was observed . We recommend longer follow-up of both stem types",
"A novel low-stiffness extensively porous-coated total hip femoral component was design ed to achieve stable skeletal fixation , structural durability , and reduced periprosthetic femoral stress shielding . In short- to intermediate-term clinical review , this implant achieved secure biologic fixation and preserved periprosthetic bone . We retrospectively review ed all 102 prospect ively followed patients ( 106 implants ) with this implant to document the longer-term implant survivorship , clinical function , fixation quality , and periprosthetic bone preservation . Ninety-seven patients with 101 implants had current followup or were followed to patient death ( range , 1–14 years ; average , 10 years ) . Eighty-six living patients were followed for an average implant survivorship of 10 years . There were no known femoral implant removals . The average Harris hip score at 10-year followup was 98 . Radiographs demonstrated secure implant fixation and maintenance of periprosthetic bone . These data suggest this implant design provided long-term function characterized by extensive fixation , structural durability , and radiographic appearance of maintained periprosthetic cortical thickness and density . Level of Evidence : Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"This was a safety study where the hypothesis was that the newer- design CPCS femoral stem would demonstrate similar early clinical results and micromovement to the well-established Exeter stem . Both are collarless , tapered , polished cemented stems , the only difference being a slight lateral to medial taper with the CPCS stem . A total of 34 patients were enrolled in a single-blinded r and omised controlled trial in which 17 patients received a dedicated radiostereometric CPCS stem and 17 a radiostereometric Exeter stem . No difference was found in any of the outcome measures pre-operatively or post-operatively between groups . At two years , the mean subsidence for the CPCS stem was nearly half that seen for the Exeter stem ( 0.77 mm ( -0.943 to 1.77 ) and 1.25 mm ( 0.719 to 1.625 ) , respectively ; p = 0.032 ) . In contrast , the mean internal rotation of the CPCS stem was approximately twice that of the Exeter ( 1.61 degrees ( -1.07 degrees to 4.33 degrees ) and 0.59 degrees ( 0.97 degrees to 1.64 degrees ) , respectively ; p = 0.048 ) . Other migration patterns were not significantly different between the stems . The subtle differences in design s may explain the different patterns of migration . Comparable migration with the Exeter stem suggests that the CPCS design will perform well in the long term",
"Forty-two patients ( younger than 65 years ) with osteoarthritis were operated on with an uncemented CLS stem and r and omized to early unrestricted weight bearing combined with intensive physiotherapy or to partial weight bearing combined with self-training . Radiostereometric analysis showed 1.2 ( + 0.11 to -6.76 ) mm subsidence of the stem at 24 months in both groups . There was no significant difference in the migration pattern between the unrestricted and partial weight bearing groups . Actual loading on the operated leg , measured with the F-scan system , did not influence the migration of the stem . There was a strong correlation between the average subsidence at 3 and 24 months ( r = 0.96 ) . Early full weight bearing and active rehabilitation can be used for the uncemented CLS stem without increased risk of early loosening",
"Background We developed a total hip system using osseointegration guidelines , a metaphyseal-loading proximal femoral replacement in the retained neck and a dual-geometry titanium shell in the acetabulum . Patients and methods A r and omized controlled clinical trial was undertaken in 52 patients ( 53 hips ) , using the cemented Spectron stem and cementless Harris-Galante II cup as control implants ( 24 patients in experimental group , 29 control patients ) . Clinical measures of Harris Hip Score ( HHS ) , pain score and radiostereometric analysis ( RSA ) at regular intervals for up to three years were used to monitor progress . Results No statistically significant differences were found in HHS and pain score ; the stability of the cementless experimental implant was also comparable to that of the cemented controls by RSA . 3 revisions were required for migration in the experimental group and 1 was required for component dislocation in the control group . Interpretation Our findings indicate the practicality of osseointegration of titanium implants , but suggest that current performance is inadequate for clinical introduction . However , the stable fixation achieved in the retained neck in the majority of patients is indicative of osseointegration . This finding will encourage technical and design improvements for enhancement of clinical osseointegration and should also encourage further study . Periprosthetic osteolysis might be avoided by the establishment and maintenance of direct implant-bone connection : “ osseointegration ”",
" Thirty-eight patients ( 40 hips ) r and omly received either an uncemented fully porous-coated composite stem ( Epoch ; Zimmer , Warsaw , Ind ) or an uncemented proximally porous-coated solid stem ( Anatomic ; Zimmer ) . Patients were followed up for 7 years using radiostereometry , dual-energy x-ray absorptiometry , conventional radiography , the Harris Hip Score , and a pain question naire . Both stem design s achieved excellent outcome for fixation ( stem subsidence and stem rotations close to zero ) and clinical outcome , without any difference between the 2 groups ( P > .12 ) . Median wear rates were low despite use of conventionally gamma-sterilized polyethylene . No stem was radiographically loose on the postoperative radiographs . The low-modulus composite stem had positive effects on early proximal bone remodeling in Gruen regions 1 , 2 , 6 , and 7 ( P bone-sparing effect persisted in only the calcar region ( Gruen region 7 )",
"We performed a r and omised , radiostereometric study comparing two different bone cements , one of which has been sparsely clinical ly documented . R and omisation of 60 total hip replacements ( 57 patients ) into two groups of 30 was undertaken . All the patients were operated on using a cemented Charnley total hip replacement , the only difference between groups being the bone cement used to secure the femoral component . The two cements used were Palamed G and Palacos R with gentamicin . The patients were followed up with repeated clinical and radiostereometric examinations for two years to assess the micromovement of the femoral component and the clinical outcome . The mean subsidence was 0.18 mm and 0.21 mm , and the mean internal rotation was 1.7 degrees and 2.0 degrees at two years for the Palamed G and Palacos R with gentamicin bone cements , respectively . We found no statistically significant differences between the groups . Micromovement occurred between the femoral component and the cement , while the cement mantle was stable inside the bone . The Harris hip score improved from a mean of 38 points ( 14 to 54 ) and 36 ( 10 to 57 ) pre-operatively to a mean of 92 ( 77 to 100 ) and 91 ( 63 to 100 ) at two years in the Palamed G and Palacos R groups , respectively . No differences were found between the groups . Both bone cements provided good initial fixation of the femoral component and good clinical results at two years",
"40 patients with primary arthrosis were r and omized to receive either a cemented SHP ( Scientific Hip Prosthesis ) or Lubinus SP2 prosthesis . At 2 years radiostereometric measurements showed increased proximal migration ( 0.4/0.2 mm ; p = 0.02 ) and more proximal wear ( 0.3/0.1 mm , p = 0.01 ) of the SHP socket . The SHP stem also subsided ( -O.6/-0.1 mm , p rotated more into retroversion ( 2.6/0.3 degrees ) than did the SP2 design . This subsidence mainly occurred inside the cement mantle in 17 of 18 cases ( 13 SHP , 4 SP2 ) , where this type of motion could be measured . The changes in bone mineral density evaluated with DEXA and the clinical results did not differ between the 2 groups . The subsidence of the SHP stem is the most pronounced so far recorded with radiostereometry in stems without a completely polished surface . This subsidence and the rotational instability imply a substantial risk of abrasive wear and increased stresses in the cement mantle",
" A prospect i ve cohort of 30 patients undergoing primary total hip arthroplasty for treatment of osteoarthritis was enrolled in a study to characterize the migration behavior of a clinical ly successful cementless stem . At 6 years , the mean subsidence of the stem was 0.63 mm ( range , -0.33 to 3.68 mm ) ; the mean rotation into retroversion was 1.41 ° ( range , -1.33 ° to 7.48 ° ) . No stems had additional subsidence of more than 0.25 mm between 6 months and 6 years . The result ant mean subsidence between 2 and 6 years was 0.03 mm , which is below the limit measurable by radiostereometric analysis . The data demonstrate that subsidence of this cementless stem occurs within the first 6 months , after which there is persistent stabilization",
" Bone cement with reduced amount of monomer and low curing temperature may improve implant fixation due to reduced toxicity . We analyzed the mechanical , chemical and thermal properties of such a cement ( Cemex Rx ) using Palacos R as control . The in vivo performance of the 2 cements was also evaluated in a prospect i ve r and omized study of 47 hips , where either of the cement types was used to fixate Lubinus SP2 prostheses with the stem made of titanium alloy . Cemex Rx had a reduced tensile strength , probably because this cement was manually mixed , as recommended by the manufacturer . A st and ardized laboratory test showed lower curing temperature for Cemex , but measurements at 37 ° and with prechilled Palacos R and Cemex Rx , as in clinical work , showed no difference . In the clinical study radiostereometric measurements of cup and stem migration showed similar values in the 2 groups up to 5 years after the operation . The cement mantle was stable in both groups , but the stems migrated similarly inside the cement mantle regardless of the type of cement used . Proximal wear was low ( 0.04 - 0.05 mm/year ) and tended to be lower in the Cemex group ( p = 0.02 ) . Aluminum and vanadium levels in serum increased 5 years after the operation , but no difference was noted between the 2 groups . Collagen markers ( PICP , ICTP ) showed similar increases in bone turnover 6 weeks and 6 months after operation in both groups",
"We have evaluated the difference in the migration patterns over two years of two cementless stems in a r and omised , controlled trial using radiostereophotogrammetric analysis ( RSA ) . The implants studied were the Furlong HAC stem , which has good long-term results and the Furlong Active stem , which is a modified version of the former design ed to minimise stress concentrations between the implant and bone , and thus to improve fixation . A total of 23 Furlong HAC and 20 Furlong Active stems were implanted in 43 patients . RSA examinations were carried out immediately post-operatively and at six , 12 and 24 months post-operatively . The subsidence during the first year in the Furlong HAC stem , was approximately one-third that of the Furlong Active stem , the measured mean subsidence of the femoral head at six months being 0.27 mm ( 95 % confidence interval ( CI ) 0.03 to 0.51 ) and 0.99 mm ( 95 % CI 0.38 to 1.60 ) , respectively ( p = 0.03 ) . One Active stem continued to subside during the second year . All hips , regardless of the type of stem were clinical ly successful as judged by the Oxford hip score and a derived pain score without any distinction between the two types of stem . The initial stability of the Furlong Active stem was not as good as the established stem which might compromise osseo-integration to the detriment of long-term success . The changes in the geometry of the stem , to minimise stress have affected the attainment of initial stability",
"In this issue of Spine , a novel method for managing chronic discogenic low back pain with a thermal intradiscal catheter is reported . This study raises some general questions regarding the introduction of new treatment techniques and devices . Decisions about medical treatment should be based on a careful appraisal of the best evidence available . A step-wise introduction is necessary to increase the use of evidence -based decision making in the implementation of new surgical techniques and implants while exposing as few patients as possible to the potential risk of failure . The development of the total hip arthroplasty procedure , for example , could have been different if the introduction of new devices and techniques had been done more carefully and performed in a step-wise manner . Inferior properties could have been revealed earlier , thus reducing the number of failures and allowing for necessary improvements . It is also desirable , therefore , that members of this profession agree on a st and ardized way to introduce new surgical techniques and implants in the field of spinal disorders . Based on the results of Swedish reports and practice , the following schedule for step-wise clinical introduction of new implants is suggested ( Figure 1 ) : The initial step is a pre clinical testing and is beyond the scope of this discussion . The first clinical step is the open prospect i ve and preferably r and omized trial that includes a minimum of patients but yields a relevant evaluation . The strict rules of prospect i ve , r and omized trials should be adhered to . In this first clinical phase , methods associated with high accuracy , such as radiostereometric analysis ( RSA ) , are required . Within 6 to 24 months , this method has the potential to identify implants/ methods that provide inferior fixation and increased polyethylene wear . Results from this first step determine whether further clinical evaluation is worthwhile . It should be noted and stressed that all types of complications can not be predicted and that further follow-up study is necessary . If favorable results are obtained in the first step , the second step , a multicenter trial exposing the new procedure to a broader aspect in the orthopedic community , can be initiated . In the first step , there is a risk for susceptibility and performance bias because the inventors themselves often perform this introductory investigation . The protocol in the multicenter trial must be prepared carefully and agreed on by all participating inventors . A sufficient number of patients should be included to allow adequate statistical analysis . The ultimate goal for step two is to make even the multicenter trial r and omized by using well-documented methods /implants as the gold st and ard . The final step in the evaluation , step three , is to include a continuous control group by using register studies based on large cohorts to reveal early or unusual and potential clinical catastrophic complications . In a rather small and closed community such as Sweden , the register should be nationwide and include all units in a specific field . When applying the principles for step-wise introduction to the investigation of chronic discogenic low back pain with a thermal intradiscalcatheterbySaal and Saal , oneobserves that the current study falls between the pre clinical step and step one . The lack of r and omization toward either conservative or surgical intervention is a definite limitation of the study , and before this method is introduced to a larger study group , a r and omized trial must be considered . A multicenter trial exposing the new procedure to a broader aspect of the orthopedic community is recommended before using it in general orthopedic practice . The length of the follow-up period was very short in this study , and no long-term clinical conclusions can be drawn based on the results",
"Eighty patients ( 84 hips ) r and omly received an anteverted cobalt-chromium stem ( Lubinus SP2 ; Waldemar Link , Hamburg , Germany ) with matte , polymethyl methacrylate-coated , or polished surface ( uncollared ) . Radiostereometry was used to study migration and wear ; and the bone mineral density was studied with dual-energy x-ray absorptiometry at 6 months , 1 year , 2 years , and 5 years . The polished stems had subsided 0.1 to 0.2 mm more at 6 months and 0.3 to 0.4 mm more at 5 years than the matte and precoated versions ( P rotations of the stem and the migration and wear of the cemented cup did not differ between the 3 groups . After 1 and 2 years , the polished stems had lost significantly less bone mineral in Gruen zones 1 , 2 , 6 , and 7 ( P = .004 to .03 ) ; but this difference had disappeared after 5 years . The period of improved bone remodeling around the polished version coincided with the early period of increased subsidence , suggesting that stem motions inside the mantle result ed in a favorable loading of the proximal femur . Our observations suggest that alternative shapes could be possible on future polished femoral stem design ",
"Roentgen stereophotogrammetry was used to measure the migration of the centre of the femoral head in 84 cemented Lubinus SP I hip arthroplasties ( 58 primary operations , 26 revisions ) . Four to seven years later , seven femoral components had been revised because of painful loosening . These implants showed greater subsidence , medial migration and posterior migration during the first two postoperative years than did the hips which had not been revised . Six months after operation , subsidence of more than 0.33 mm combined with a total migration of more than 0.85 mm predicted an increased risk of subsequent revision ; the amount of subsidence at two years was an even better predictor . The probability of revision was greater than 50 % if the subsidence at two years was 1.2 mm or more",
"The custom made Unique stem is design ed to fit closely to the metaphyseal region of the femur in order to obtain maximum mechanical stability and optimal load transfer . Thirty-seven patients ( 38 hips ) with non-inflammatory arthritis were r and omized to the uncemented custom made Unique stem or the Elite Plus stem inserted with cement . The patients have been followed clinical ly as well as with radiostereometry ( RSA ) and Dual-energy X-ray Absorptiometry ( DXA ) for 2 years . After 2 years the RSA result showed minimal translation and rotation for the Unique stem while the Elite Plus rotated slightly ( mean 1.05 degrees ) into retroversion . Compared to previous studies the Elite Plus was as stable as the Charnley prosthesis . The DXA results showed a significantly higher proximal and total ( 10 % for the Unique versus 5 % for Elite ) bone loss for the Unique stem compared to the Elite Plus . Thus the optimal proximal press-fit of the custom made stem did secure a stable fixation , but did not decrease the proximal bone loss"
] | 41166230-06ff-11f0-808a-c43d1ab1c353 |
Purpose The actual effects of l-carnitine administration on leptin serum level is inconsistent . In order to assess the efficacy of l-carnitine supplementation on serum leptin we conducted a meta- analysis of r and omized controlled trials ( RCTs ) . Methods Seven studies with 325 cases and 330 controls were included . The pooled weighted mean difference ( WMD ) was calculated by r and om-effects model . The heterogeneity across studies was evaluated by using Cochrane ’s Q and I2 tests . In addition , we carried out the metaninf comm and to test the effect of each individual study on the overall result . Results l-carnitine supplementation seemed to have no significant effect on serum leptin concentrations ( WMD : −0.565 ng/mL ; 95 % CI : −2.417 to 1.287 , p = 0.550 ) . However , between- study heterogeneity was higher across all studies ( I2 = 84.3 % , p l-carnitine dosage ( g ) ( reduction in serum leptin concentration was observed with a daily dose of ≥ 2 mg l-carnitine ( WMD : −2.742 ng/mL ; 95 % CI : −3.039 to −2.444 , p diabetic patients ( WMD : −2.946 ng/mL ; 95 % CI : −3.254 to −2.638 , p Conclusion l-carnitine consumption does not reduce serum leptin significantly . However , a significant effect on leptin was observed in diabetic patients and patients who received doses more than 3 mg per day in the course of < 12 weeks | [
"Insulin resistance , a key component of the metabolic syndrome , is a risk factor for diabetes mellitus and cardiovascular disease . Acetyl-l-carnitine infusion acutely ameliorated insulin sensitivity in type 2 diabetics with insulin resistance . In this sequential off-on-off pilot study , we prospect ively evaluated the effects of 24-week oral acetyl-l-carnitine ( 1 g twice daily ) therapy on the glucose disposal rate ( GDR ) , assessed by hyperinsulinemic euglycemic clamps , and components of the metabolic syndrome in nondiabetic subjects at increased cardiovascular risk a priori segregated into 2 groups with GDR ≤7.9 ( n=16 ) or > 7.9 ( n=16 ) mg/kg per minute , respectively . Baseline GDR and systolic blood pressure were negatively correlated ( n=32 ; P=0.001 ; r=−0.545 ) , and patients with GDR ≤7.9 mg/kg per minute had higher systolic/diastolic blood pressure than those with higher GDR . Acetyl-l-carnitine increased GDR from 4.89±1.47 to 6.72±3.12 mg/kg per minute ( P=0.003 , Bonferroni-adjusted ) and improved glucose tolerance in patients with GDR ≤7.9 mg/kg per minute , whereas it had no effects in those with higher GDRs . Changes in GDR were significantly different between groups ( P=0.017 , ANCOVA ) . Systolic blood pressure decreased from 144.0±13.6 to 135.1±8.4 mm Hg and from 130.8±12.4 to 123.8±10.8 mm Hg in the lower and higher GDR groups , respectively ( P weeks posttreatment . Total and high molecular weight adiponectin levels followed specular trends . Diastolic blood pressure significantly decreased only in those with higher GDRs . Treatment was well tolerated in all of the patients . Acetyl-l-carnitine safely ameliorated arterial hypertension , insulin resistance , impaired glucose tolerance , and hypoadiponectinemia in subjects at increased cardiovascular risk . Whether these effects may translate into long-term cardioprotection is worth investigating",
"L-Carnitine ( L-C ) transports fatty acids into mitochondria for oxidation and is marketed as a weight loss supplement . In a double-blind investigation to test the weight loss efficacy of L-C , 36 moderately overweight premenopausal women were pair matched on Body Mass Index ( BMI ) and r and omly assigned to two groups ( N = 18 ) . For 8 weeks the L-C group ingested 2 g twice daily of L-C , while the placebo ( P ) group ingested the same amount of lactose . All subjects walked for 30 min ( 60 - 70 % maximum heart rate ) 4 days/week . Body composition , resting energy expenditure ( REE ) and substrate utilization were estimated before and after treatment . For the subjects who completed the study ( 15 P , 13 L-C ) , no significant changes in mean total body mass ( TBM ) , fat mass FM , and resting lipid utilization occurred over time , nor were there any significant differences between groups for any variable . Conversely REE increased significantly for all subjects , but no between group differences existed . Five of the L-C group experienced nausea or diarrhea and consequently did not complete the study . Eight weeks of L-C ingestion and walking did not significantly alter the TBM or FM of overweight women , thereby casting doubt on the efficacy of L-C supplementation for weight loss",
"BACKGROUND AND OBJECTIVE Molecular mechanisms of most anti-obesity drugs are remained to be clear . MicroRNAs that are noncoding RNA molecules supposed to regulate biological processes concomitant to obesity and have attracted a lot of attention to themselves . The miR-27a and miR-143 expression levels in obese and non-obese rats during weight changes and L-carnitine ( LC ) effects on them was investigated in this study . MATERIAL S AND METHODS In the present study 12 male Wistar rats were r and omly divided into normal fat diet and high fat diet groups to develop obesity . After 8 weeks rats were weighted and half of diet induced obese rats were r and omly selected to receive 200 mg LC kg -1 b.wt . for 4 weeks . At the end epididymal fat was isolated to investigate expression level of microRNAs by real-time PCR . RESULTS After 12 weeks , high fat diet in comparison with normal fat diet mediated significant decrease and increase in expression levels of miR-27a and miR-143 , respectively . These changes were modified in groups , which had received LC in a 4 weeks period . Furthermore , rats in this group gained less weight . CONCLUSION Findings of this study suggest that the changes of microRNAs expression probably play a role in pathogenesis of obesity , might be modulated by means of dietary agents and supplements and modify weight gain trend",
"BACKGROUND A previous study has demonstrated that L-carnitine reduces plasma lipoprotein(a ) ( Lp[a ] ) levels in patients with hypercholesterolemia . OBJECTIVE To test a tolerable Lp(a)-reducing agent in diabetic patients , we assessed the effect of a dietary supplementation of L-carnitine on plasma lipid levels , particularly Lp(a ) , of patients with type 2 diabetes mellitus ( DM ) and hypercholesterolemia . METHODS In this 6-month , r and omized , double-masked , placebo-controlled clinical trial , patients were enrolled , assessed , and followed up at the Diabetic and Metabolic Diseases Center of the Department of Internal Medicine and Therapeutics at the University of Pavia , Pavia , Italy . All study patients had newly diagnosed type 2 DM that was managed through dietary restriction alone throughout the study , as well as hypercholesterolemia . Patients were r and omized to 1 of 2 groups . One group received L-carnitine , one 1-g tablet BID . The other group received a corresponding placebo . We assessed body mass index , fasting plasma glucose , postpr and ial plasma glucose , glycosylated hemoglobin , fasting plasma insulin , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , apolipoprotein ( apo ) A-I , apo B , and Lp(a ) at baseline and at 1 , 3 , and 6 months of treatment . RESULTS This study included 94 patients . The treatment group included 24 men and 22 women ( mean [ SD ] age , 52 [ 6 ] years ) . The placebo group included 23 men and 25 women ( mean [ SD ] age , 50 [ 7 ] years ) . The baseline characteristics of the groups did not differ significantly . The mean ( SD ) body weight , height , and body mass index were 78.2 ( 5.8 ) kg , 1.70 ( 0.04 ) m , and 27.3 ( 2.5 ) kg/m(2 ) , respectively , in the L-carnitine group and 77.6 ( 6.4 ) kg , 1.71 ( 0.05 ) m , and 26.8 ( 2.2 ) kg/m(2 ) , respectively , in the placebo group . In the treatment group , Lp(a ) was significantly reduced at 3 and 6 months compared with baseline ( P Lp(a ) value in patients taking L-carnitine compared with those taking placebo . Between-group differences in other variables did not reach a level of significance at months 3 and 6 . No drug-related adverse events were reported or observed . CONCLUSION In this preliminary study , after 3 and 6 months , L-carnitine significantly lowered the plasma Lp(a ) level compared with placebo in selected hypercholesterolemic patients with newly diagnosed type 2 DM",
"The aim of the study was to evaluate the effects of 12-month treatment with sibutramine plus L-carnitine compared with sibutramine alone on body weight , glycemic control , insulin resistance , and inflammatory state in type 2 diabetes mellitus patients . Two hundred fifty-four patients with uncontrolled type 2 diabetes mellitus ( glycated hemoglobin [ HbA(1c ) ] > 8.0 % ) in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and r and omized to take sibutramine 10 mg plus L-carnitine 2 g or sibutramine 10 mg in monotherapy . We evaluated at baseline and after 3 , 6 , 9 , and 12 months these parameters : body weight , body mass index , HbA(1c ) , fasting plasma glucose , postpr and ial plasma glucose , fasting plasma insulin , homeostasis model assessment of insulin resistance index , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , leptin , tumor necrosis factor-α , adiponectin , vaspin , and high-sensitivity C-reactive protein . Sibutramine plus L-carnitine gave a faster improvement of fasting plasma glucose , postpr and ial plasma glucose , lipid profile , leptin , tumor necrosis factor-α , and high-sensitivity C-reactive protein compared with sibutramine alone . Furthermore , there was a better improvement of body weight , HbA(1c ) , fasting plasma insulin , homeostasis model assessment of insulin resistance index , vaspin , and adiponectin with sibutramine plus L-carnitine compared with sibutramine alone . Sibutramine plus L-carnitine gave a better and faster improvement of all the analyzed parameters compared with sibutramine alone without giving any severe adverse effect",
"To evaluate the effects of 1-year treatment with orlistat plus L-carnitine compared to orlistat alone on body weight , glycemic and lipid control , and inflammatory parameters in obese type 2 diabetic patients . Two hundred and fifty-eight patients with uncontrolled type 2 diabetes mellitus ( T2DM ) [ glycated hemoglobin ( HbA(1c ) ) > 8.0 % ] in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and r and omized to take orlistat 120 mg three times a day plus L-carnitine 2 g one time a day or orlistat 120 mg three times a day . We evaluated the following parameters at baseline and after 3 , 6 , 9 , and 12 months : body weight , body mass index ( BMI ) , glycated hemoglobin ( HbA(1c ) ) , fasting plasma glucose ( FPG ) , postpr and ial plasma glucose ( PPG ) , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , total cholesterol ( TC ) , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides ( Tg ) , adiponectin ( ADN ) , leptin , tumor necrosis factor-α ( TNF-α ) , vaspin , and high-sensitivity C-reactive protein ( Hs-CRP ) . We observed a better decrease in body weight , glycemic profile , HOMA-IR , LDL-C , and ADN and a faster improvement in FPI , TC , Tg , leptin , TNF-α , Hs-CRP with orlistat plus L-carnitine compared to orlistat alone . We also recorded an improvement in vaspin with orlistat plus l-carnitine not reached with orlistat alone . Orlistat plus L-carnitine gave a better improvement in body weight , glycemic and lipid profile compared to orlistat alone ; furthermore , a faster and better improvement in inflammatory parameters was observed with orlistat plus L-carnitine compared to orlistat alone",
"INTRODUCTION Carnitine supplementation may improve the general health and quality of life of hemodialysis patients by improving adipokines levels . The aim of the study was to investigate the effects of L-carnitine supplementation on leptin levels , adiponectin levels , and body weight of hemodialysis patients . MATERIAL S AND METHODS Fifty hemodialysis patients were r and omly divided into the carnitine group , who received oral L-carnitine , 1 g/L for 3 months , and the control group . Anthropometric measurements and serum levels of adipokines were measured at baseline and at the end of the intervention . RESULTS Forty-two participants completed the study . Serum leptin concentrations decreased after 12 weeks of the intervention in both groups , but these changes were not significant . The mean change of leptin concentration were , -1.7 ± 19.0 µg/mL and -7.1 ± 20.0 µg/mL in the carnitine group and the control group , respectively ( P = .39 ) . The mean adiponectin levels at baseline and after the intervention were 8.6 ± 11.19 µg/mL and 9.8 ± 4.1 µg/mL in the carnitine group ( P = .67 ) and 5.0 ± 2.5 µg/mL and 11.2 ± 5.4 µg/mL in the control group , respectively ( P increased significantly in the control group only . The decrease in body mass index was not significant . CONCLUSIONS This study showed that a daily supplementation of 1000 mg oral syrup of L-carnitine for 12 weeks did not affect leptin and adiponectin levels or the body weight or body mass index of hemodialysis patients",
"The purpose of this investigation was to examine the effects of ingestion of L-CARNIPURE ( L-carnitine L-tartrate [ LCLT ] ) on alterations in a complete blood cell profile and in circulating metabolic enzymes . Using a balanced , placebo ( P ) , cross-over design ( 1 week washout ) , 10 healthy , active men volunteered and acted as their own control taking either a P or LCLT supplement ( 3 gday−1 ) for 3 weeks . Postabsorptive morning blood sample s were obtained both before and after 21 days of P and LCLT supplementation . Serum sample s were analyzed for clinical chemistries including a complete chemistry panel with markers of liver and renal function along with various minerals and electrolytes . In addition , whole blood was analyzed for a complete blood count with differential . It was determined that there were no statistically significant differences between the LCLT and the placebo conditions for any of the variables examined . The results of this study suggest that LCLT , when used as a dietary supplement , has no adverse effects on metabolic and hemato-logical safety variables in normally healthy en",
"Chronic hemodialysis ( HD ) patients frequently encounter carnitine depletion , elevated adipose tissue-derived hormones/cytokines , that may contribute to accelerated arteriosclerosis . 10 non-diabetic HD patients were studied over 28 weeks . In the 12 weeks treatment period 1 g L-carnitine was given iv after each HD session . Measurements of plasma free- and acylcarnitines , insulin , leptin , adiponectin , resistin and ghrelin were performed at baseline , at weeks 2 , 4 , 8 , 12 ( treatment period ) and at weeks 24 - 28 ( post-treatment period ) . L-carnitine supplementation result ed in progressive increase of free- and acylcarnitine levels . Plasma levels of insulin , resistin , leptin and ghrelin remained at the already elevated baseline values . L-carnitine therapy induced a significant increase in plasma adiponectin from 20.2 ± 12.7 μg/ml ( baseline ) to 32.7 ± 20.2 μg/ml in week 2 ( p period . Plasma insulin levels correlated positively with leptin ( r = 0.525 , p p levels correlated inversely with leptin ( r = -0.255 , p . Plasma levels of adipokines and related hormones are greatly elevated in patients on regular HD . L-carnitine administration further augmented the plasma levels of protective adiponectin , therefore it may have a role in preventing cardiovascular complications of uremia"
] | 4116626c-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer . METHODS American Society of Clinical Oncology convened an Expert Panel of medical oncology , radiation oncology , surgical oncology , gastroenterology , palliative care , and advocacy experts and conducted a systematic review of the literature from January 2002 to June 2015 . Outcomes included overall survival , disease-free survival , progression-free survival , and adverse events . RESULTS Twenty-six r and omized controlled trials met the systematic review criteria . RECOMMENDATIONS A multiphase computed tomography scan of the chest , abdomen , and pelvis should be performed . Baseline performance status and comorbidity profile should be evaluated . The goals of care , patient preferences , psychological status , support systems , and symptoms should guide decisions for treatments . A palliative care referral should occur at first visit . Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile . There is no clear evidence to support one regimen over another . The gemcitabine-based combinations and treatments recommended in the metastatic setting ( eg , fluorouracil , leucovorin , irinotecan , and oxaliplatin and gemcitabine plus nanoparticle albumin-bound paclitaxel ) have not been evaluated in r and omized controlled trials involving locally advanced , unresectable pancreatic cancer . If there is local disease progression after induction chemotherapy , without metastasis , then radiation therapy or stereotactic body radiotherapy may be offered also with an Eastern Cooperative Oncology Group performance status ≤ 2 and an adequate comorbidity profile . If there is stable disease after 6 months of induction chemotherapy but unacceptable toxicities , radiation therapy may be offered as an alternative . Patients with disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline . Follow-up visits every 3 to 4 months are recommended . Additional information is available at www.asco.org/ guidelines /LAPC and www.asco.org/ guidelines /MetPC and www.asco.org/ guidelines wiki | [
"PURPOSE This Phase II trial evaluated the toxicity , local control , and overall survival in patients treated with sequential gemcitabine and linear accelerator-based single-fraction stereotactic body radiotherapy ( SBRT ) . METHODS AND MATERIAL S Twenty patients with locally advanced , nonmetastatic pancreatic adenocarcinoma were enrolled on this prospect i ve single-institution , institutional review board-approved study . Gemcitabine was administered on Days 1 , 8 , and 15 , and SBRT on Day 29 . Gemcitabine was restarted on Day 43 and continued for 3 - 5 cycles . SBRT of 25 Gy in a single fraction was delivered to the internal target volume with a 2- 3-mm margin using a nine-field intensity-modulated radiotherapy technique . Respiratory gating was used to account for breathing motion . Follow-up evaluations occurred at 4 - 6 weeks , 10 - 12 weeks , and every 3 months after SBRT . RESULTS All patients completed SBRT and a median of five cycles of chemotherapy . Follow-up for the 2 remaining alive patients was 25.1 and 36.4 months . No acute Grade 3 or greater nonhematologic toxicity was observed . Late Grade 3 or greater toxicities occurred in 1 patient ( 5 % ) and consisted of a duodenal perforation ( G4 ) . Three patients ( 15 % ) developed ulcers ( G2 ) that were medically managed . Overall , median survival was 11.8 months , with 1-year survival of 50 % and 2-year survival of 20 % . Using serial computed tomography , the freedom from local progression was 94 % at 1 year . CONCLUSION Linear accelerator-delivered SBRT with sequential gemcitabine result ed in excellent local control of locally advanced pancreatic cancer . Future studies will address strategies for reducing long-term duodenal toxicity associated with SBRT",
"PURPOSE This phase III trial compared the efficacy and safety of gemcitabine ( Gem ) plus capecitabine ( GemCap ) versus single-agent Gem in advanced/metastatic pancreatic cancer . PATIENTS AND METHODS Patients were r and omly assigned to receive GemCap ( oral capecitabine 650 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks ) or Gem ( 1,000 mg/m2 by 30-minute infusion weekly for 7 weeks , followed by a 1-week break , and then weekly for 3 weeks every 4 weeks ) . Patients were stratified according to center , Karnofsky performance score ( KPS ) , presence of pain , and disease extent . RESULTS A total of 319 patients were enrolled between June 2001 and June 2004 . Median overall survival ( OS ) time , the primary end point , was 8.4 and 7.2 months in the GemCap and Gem arms , respectively ( P = .234 ) . Post hoc analysis in patients with good KPS ( score of 90 to 100 ) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm ( 10.1 v 7.4 months , respectively ; P = .014 ) . The overall frequency of grade 3 or 4 adverse events was similar in each arm . Neutropenia was the most frequent grade 3 or 4 adverse event in both arms . CONCLUSION GemCap failed to improve OS at a statistically significant level compared with st and ard Gem treatment . The safety of GemCap and Gem was similar . In the subgroup of patients with good performance status , median OS was improved significantly . GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status",
"CONTEXT Sympathectomy is currently used as the fourth step of the modified World Health Organization ( WHO ) analgesic ladder . Sympathectomy can be performed early , before the second step on the ladder . OBJECTIVES We hypothesized that early sympathectomy would reduce pain and opioid consumption and improve quality of life . METHODS One hundred nine patients , with inoperable abdominal or pelvic cancer , reporting visceral pain of 40 - 70 on a visual analogue scale and taking nonopioid analgesics were allocated r and omly into two groups : either blocks were performed before Step 2 of the WHO ladder , then analgesics were managed according to the ladder ( Group I ) or analgesics were given according to the WHO ladder , and blocks were performed as the fourth step after failure of strong opioids to control pain ( Group II ) . Visual analogue scale scores , responder analysis , daily opioid consumption , related side effects , and quality of life were assessed . RESULTS Responders were significantly higher in Group I ( P Opioid consumption significantly decreased in Group I ( P . The number of patients who had a good analgesic response on tramadol significantly increased in Group I during the first five months ( P European Organization for Research and Treatment of Cancer Quality of Life Question naire-Core 30 global quality -of-life subscale scores revealed significant improvement until the fifth month in Group I ( P Sympathectomy before Step 2 on the WHO analgesic ladder seems to lead to better pain control , less opioid consumption , and better quality of life in cancer patients",
"Purpose Chemoradiation therapy ( CRT ) for patients with locally advanced pancreatic cancer ( LAPC ) provides survival benefits but may result in considerable toxicity . Health-related quality of life ( HRQL ) measurements during CRT have not been widely reported . This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer ( SCALOP ) trial , including validation of the QLQ-PAN26 tool in CRT . Methods and Material s Patients with locally advanced , inoperable , nonmetastatic carcinoma of the pancreas were eligible . Following 12 weeks of induction gemcitabine plus capecitabine ( GEMCAP ) chemotherapy , patients with stable and responding disease were r and omized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT . HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( EORTC QLQ-C30 ) and the EORTC Pancreatic Cancer module ( PAN26 ) . Results A total of 114 patients from 28 UK centers were registered and 74 patients r and omized . There was improvement in the majority of HRQL scales during induction chemotherapy . Patients with significant deterioration in fatigue , appetite loss , and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT . Differences in changes in HRQL scores between trial arms rarely reached statistical significance ; however , where they did , they favored capecitabine therapy . PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity . Conclusions Although there is deterioration in HRQL following CRT , this resolves within 3 weeks . HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation . The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT",
"Summary Background In the UK , chemotherapy is the st and ard treatment for inoperable , locally advanced , non-metastatic pancreatic cancer . Chemoradiotherapy is also an acceptable treatment option , for which gemcitabine , fluorouracil , or capecitabine can be used as concurrent chemotherapy agents . We aim ed to assess the activity , safety , and feasibility of both gemcitabine-based and capecitabine-based chemoradiotherapy after induction chemotherapy for patients with locally advanced pancreatic cancer . Methods In this open-label , r and omised , two-arm , phase 2 trial , patients aged 18 years or older with histologically proven , locally advanced pancreatic cancer ( with a tumour diameter of 7 cm or less ) were recruited from 28 UK centres between Dec 24 , 2009 and Oct 25 , 2011 . After 12 weeks of induction gemcitabine and capecitabine chemotherapy ( three cycles of gemcitabine [ 1000 mg/m2 on days 1 , 8 , 15 of a 28-day cycle ] and capecitabine [ 830 mg/m2 twice daily on days 1–21 of a 28-day cycle ] ) , patients with stable or responding disease , tumour diameter of 6 cm or less , and WHO performance status 0–1 were r and omly assigned to receive a further cycle of gemcitabine and capecitabine chemotherapy followed by either gemcitabine ( 300 mg/m2 once per week ) or capecitabine ( 830 mg/m2 twice daily , Monday to Friday only ) , both in combination with radiation ( 50·4 Gy in 28 fractions ) . R and omisation ( 1:1 ) was done via a central computerised system and used stratified minimisation . The primary endpoint was 9-month progression-free survival , analysed by intention to treat including only those patients with valid CT assessment s. This trial is registered with IS RCT N , number 96169987 . Findings 114 patients were registered and 74 were r and omly allocated ( 38 to the gemcitabine group and 36 to the capecitabine group ) . After 9 months , 22 of 35 assessable patients ( 62·9 % , 80 % CI 50·6–73·9 ) in the capecitabine group and 18 of 35 assessable patients ( 51·4 % , 39·4–63·4 ) in the gemcitabine group had not progressed . Median overall survival was 15·2 months ( 95 % CI 13·9–19·2 ) in the capecitabine group and 13·4 months ( 95 % CI 11·0–15·7 ) in the gemcitabine group ( adjusted hazard ratio [ HR ] 0·39 , 95 % CI 0·18–0·81 ; p=0·012 ) . 12-month overall survival was 79·2 % ( 95 % CI 61·1–89·5 ) in the capecitabine group and 64·2 ( 95 % CI 46·4–77·5 ) in the gemcitabine group . Median progression-free survival was 12·0 months ( 95 % CI 10·2–14·6 ) in the capecitabine group and 10·4 months ( 95 % CI 8·9–12·5 ) in the gemcitabine group ( adjusted HR 0·60 , 95 % CI 0·32–1·12 ; p=0·11 ) . Eight patients in the capecitabine group had an objective response at 26 weeks , as did seven in the gemcitabine group . More patients in the gemcitabine group than in the capecitabine group had grade 3–4 haematological toxic effects ( seven [ 18 % ] vs none , p=0·008 ) and non-haematological toxic effects ( ten [ 26 % ] vs four [ 12 % ] , p=0·12 ) during chemoradiation treatment ; the most frequent events were leucopenia , neutropenia , and fatigue . Two patients in the capecitabine group progressed during the fourth cycle of induction chemotherapy . Of the 34 patients in the capecitabine group who received chemoradiotherapy , 25 ( 74 % ) received the full protocol dose of radiotherapy , compared with 26 ( 68 % ) of 38 patients in the gemcitabine group . Quality -of-life scores were not significantly different between the treatment groups . Interpretation Our results suggest that a capecitabine-based regimen might be preferable to a gemcitabine-based regimen in the context of consolidation chemoradiotherapy after a course of induction chemotherapy for locally advanced pancreatic cancer . However , these findings should be interpreted with caution because the difference in the primary endpoint was non-significant and the number of patients in the trial was small . Funding Cancer Research UK",
"PURPOSE This phase II trial was design ed to assess the efficacy and safety of cetuximab , gemcitabine , and oxaliplatin followed by cetuximab , capecitabine , and radiation therapy in locally advanced pancreatic cancer ( LAPC ) . PATIENTS AND METHODS Treatment-naive eligible patients ( n = 69 ) received intravenous gemcitabine ( 1,000 mg/m(2 ) ) and oxaliplatin ( 100 mg/m(2 ) ) every 2 weeks for four doses , followed by radiation ( 50.4 Gy to the gross tumor only ) with concurrent capecitabine ( 825 mg/m(2 ) twice daily on radiation treatment days ) . Cetuximab ( 500 mg/m(2 ) ) was started on day 1 of chemotherapy and was continued every 2 weeks during chemotherapy and chemoradiotherapy . Diagnostic cytology specimens were immunostained for Smad4(Dpc4 ) expression . RESULTS Median overall survival time was 19.2 months ( 95 % CI , 14.2 to 24.2 months ) , and 1-year , 2-year , and 4-year actuarial overall survival rates were 66.0 % , 25.02 % , and 11.3 % , respectively . Acneiform rash correlated with improved survival ( P = .001 ) , but initial CA19 - 9 , borderline resectable initial stage , and surgical resection ( n = 7 ) did not . The 1-year and 2-year radiographic local progression rates were 22.8 % and 61.0 % , respectively . The worst acute toxic effects were GI toxicity ( 32 % and 10 % for grade s 2 and 3 , respectively ) ; fatigue ( 26 % and 6 % for grade s 2 and 3 , respectively ) ; sensory neuropathy ( 9 % and 1 % for grade s 2 and 3 , respectively ) ; and acneiform rash ( 54 % and 3 % for grade s 2 and 3 , respectively ) . Smad4(Dpc4 ) expression correlated with a local rather than a distant dominant pattern of disease progression ( P = .016 ) . CONCLUSION This regimen appears effective and has acceptable toxicity . The primary end point ( 1-year overall survival rate > 45 % ) was met , with encouraging survival duration . Smad4(Dpc4 ) immunostaining correlated with the pattern of disease progression . Prospect i ve validation of Smad4(Dpc4 ) expression in cytology specimens as a predictive biomarker is warranted and may lead to personalized treatment strategies for patients with localized pancreatic cancer",
"PURPOSE To determine the feasibility and toxicity of delivering stereotactic radiosurgery to patients with locally advanced pancreatic cancer . METHODS AND MATERIAL S Patients with Eastern Cooperative Oncology Group performance status were enrolled on this Phase I dose escalation study . Patients received a single fraction of radiosurgery consisting of either 15 Gy , 20 Gy , or 25 Gy to the primary tumor . Acute gastrointestinal toxicity was scored according to the Radiation Therapy Oncology Group criteria . Response to treatment was determined by serial high-resolution computed tomography scanning . RESULTS Fifteen patients were treated at 3 dose levels ( 3 patients received 15 Gy , 5 patients received 20 Gy , and 7 patients received 25 Gy ) . At these doses , no Grade 3 or higher acute gastrointestinal toxicity was observed . This trial was stopped before any dose-limiting toxicity was reached , because the clinical objective of local control was achieved in all 6 evaluable patients treated at 25 Gy . CONCLUSIONS It is feasible to deliver stereotactic radiosurgery to patients with locally advanced pancreatic cancer . The recommended dose to achieve local control without significant acute gastrointestinal toxicity is 25 Gy",
"BACKGROUND In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group , as compared with 3.7 months in the gemcitabine group ( hazard ratio for disease progression or death , 0.69 ; 95 % CI , 0.58 to 0.82 ; P response rate according to independent review was 23 % versus 7 % in the two groups ( P adverse events of grade 3 or higher were neutropenia ( 38 % in the nab-paclitaxel-gemcitabine group vs. 27 % in the gemcitabine group ) , fatigue ( 17 % vs. 7 % ) , and neuropathy ( 17 % vs. 1 % ) . Febrile neutropenia occurred in 3 % versus 1 % of the patients in the two groups . In the nab-paclitaxel-gemcitabine group , neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days . CONCLUSIONS In patients with metastatic pancreatic adenocarcinoma , nab-paclitaxel plus gemcitabine significantly improved overall survival , progression-free survival , and response rate , but rates of peripheral neuropathy and myelosuppression were increased . ( Funded by Celgene ; Clinical Trials.gov number , NCT00844649 . )",
"PURPOSE Fractionated radiotherapy and chemotherapy for locally advanced pancreatic cancer achieves only modest local control . This prospect i ve trial evaluated the efficacy of a single fraction of 25 Gy stereotactic body radiotherapy ( SBRT ) delivered between Cycle 1 and 2 of gemcitabine chemotherapy . METHODS AND MATERIAL S A total of 16 patients with locally advanced , nonmetastatic , pancreatic adenocarcinoma received gemcitabine with SBRT delivered 2 weeks after completion of the first cycle . Gemcitabine was resumed 2 weeks after SBRT and was continued until progression or dose-limiting toxicity . The gross tumor volume , with a 2 - 3-mm margin , was treated in a single 25-Gy fraction by Cyberknife . Patients were evaluated at 4 - 6 weeks , 10 - 12 weeks , and every 3 months after SBRT . RESULTS All 16 patients completed SBRT . A median of four cycles ( range one to nine ) of chemotherapy was delivered . Three patients ( 19 % ) developed local disease progression at 14 , 16 , and 21 months after SBRT . The median survival was 11.4 months , with 50 % of patients alive at 1 year . Patients with normal carbohydrate antigen (CA)19 - 9 levels either at diagnosis or after Cyberknife SBRT had longer survival ( p Acute gastrointestinal toxicity was mild , with 2 cases of Grade 2 ( 13 % ) and 1 of Grade 3 ( 6 % ) toxicity . Late gastrointestinal toxicity was more common , with five ulcers ( Grade 2 ) , one duodenal stenosis ( Grade 3 ) , and one duodenal perforation ( Grade 4 ) . A trend toward increased duodenal volumes radiated was observed in those experiencing late effects ( p = 0.13 ) . CONCLUSION SBRT with gemcitabine result ed in comparable survival to conventional chemoradiotherapy and good local control . However , the rate of duodenal ulcer development was significant",
"CONTEXT Pancreatic cancer is an aggressive tumor associated with high mortality . Optimal pain control may improve quality of life ( QOL ) for these patients . OBJECTIVE To test the hypothesis that neurolytic celiac plexus block ( NCPB ) vs opioids alone improves pain relief , QOL , and survival in patients with unresectable pancreatic cancer . DESIGN , SETTING , AND PATIENTS Double-blind , r and omized clinical trial conducted at Mayo Clinic , Rochester , Minn. Enrolled ( October 1997 and January 2001 ) were 100 eligible patients with unresectable pancreatic cancer experiencing pain . Patients were followed up for at least 1 year or until death . INTERVENTION Patients were r and omly assigned to receive either NCPB or systemic analgesic therapy alone with a sham injection . All patients could receive additional opioids managed by a clinician blinded to the treatment assignment . MAIN OUTCOME MEASURES Pain intensity ( 0 - 10 numerical rating scale ) , QOL , opioid consumption and related adverse effects , and survival time were assessed weekly by a blinded observer . RESULTS Mean ( SD ) baseline pain was 4.4 ( 1.7 ) for NCPB vs 4.1 ( 1.8 ) for opioids alone . The first week after r and omization , pain intensity and QOL scores were improved ( pain intensity , P pain for the NCPB group ( P = .005 ) . From repeated measures analysis , pain was also lower for NCPB over time ( P = .01 ) . However , opioid consumption ( P = .93 ) , frequency of opioid adverse effects ( all P>.10 ) , and QOL ( P = .46 ) were not significantly different between groups . In the first 6 weeks , fewer NCPB patients reported moderate or severe pain ( pain intensity rating of > or = 5/10 ) vs opioid-only patients ( 14 % vs 40 % , P = .005 ) . At 1 year , 16 % of NCPB patients and 6 % of opioid-only patients were alive . However , survival did not differ significantly between groups ( P = .26 , proportional hazards regression ) . CONCLUSION Although NCPB improves pain relief in patients with pancreatic cancer vs optimized systemic analgesic therapy alone , it does not affect QOL or survival",
"Purpose : Hemostatic activation is common in pancreatic cancer and may be linked to angiogenesis and venous thromboembolism . We investigated expression of tissue factor ( TF ) , the prime initiator of coagulation , in noninvasive and invasive pancreatic neoplasia . We correlated TF expression with vascular endothelial growth factor ( VEGF ) expression , microvessel density , and venous thromboembolism in resected pancreatic cancer . Experimental Design : Tissue cores from a tri-institutional retrospective series of patients were used to build tissue microarrays . TF expression was grade d semiquantitatively using immunohistochemistry in normal pancreas ( n = 10 ) , intraductal papillary mucinous neoplasms ( n = 70 ) , pancreatic intraepithelial neoplasia ( n = 40 ) , and resected or metastatic pancreatic adenocarcinomas ( n = 130 ) . Results : TF expression was observed in a majority of noninvasive and invasive pancreatic neoplasia , including 77 % of pancreatic intraepithelial neoplasias , 91 % of intraductal papillary mucinous neoplasms , and 89 % of pancreatic cancers , but not in normal pancreas . Sixty-six of 122 resected pancreatic cancers ( 54 % ) were found to have high TF expression ( defined as grade ≥2 , the median score ) . Carcinomas with high TF expression were more likely to also express VEGF ( 80 % versus 27 % with low TF expression , P higher median MVD ( 8 versus 5 per tissue core with low TF expression , P = 0.01 ) . Pancreatic cancer patients with high TF expression had a venous thromboembolism rate of 26.3 % compared with 4.5 % in patients with low TF expression ( P = 0.04 ) . Conclusions : TF expression occurs early in pancreatic neoplastic transformation and is associated with VEGF expression , increased microvessel density , and possibly clinical venous thromboembolism in pancreatic cancer . Prospect i ve studies evaluating the role of TF in pancreatic cancer outcomes are warranted",
"This phase 2 multi‐institutional study was design ed to determine whether gemcitabine ( GEM ) with fractionated stereotactic body radiotherapy ( SBRT ) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer ( LAPC )",
"Purpose To evaluate the impact of a multidisciplinary clinic on the clinical care recommendations of patients with pancreatic cancer compared with the recommendations the patients received prior to review by the multidisciplinary tumor board . Methods The records of 203 consecutive patients referred to the Johns Hopkins pancreatic multidisciplinary clinic were prospect ively collected from November 2006 to October 2007 . Cross-sectional imaging , pathology , and medical history were evaluated by a panel of medical/radiation oncologists , surgical oncologists , pathologists , diagnostic radiologists , and geneticists . Alterations in treatment recommendations between the outside institution and the multidisciplinary clinic were recorded and compared . Results On presentation , the outside computed tomography ( CT ) report described locally advanced/unresectable disease ( 34.9 % ) , metastatic disease ( 17.7 % ) , and locally advanced disease with metastasis ( 1.1 % ) . On review of su bmi tted imaging and imaging performed at Hopkins , 38 out of 203 ( 18.7 % ) patients had a change in the status of their clinical stage . Review of the histological slides by dedicated pancreatic pathologists result ed in changes in the interpretation for 7 of 203 patients ( 3.4 % ) . Overall , 48 out of 203 ( 23.6 % ) patients had a change in their recommended management based on clinical review of their case by the multidisciplinary tumor board . Enrollment into the National Familial Pancreas Tumor Registry increased from 52 out of 106 ( 49.2 % ) patients in 2005 to 158 out of 203 ( 77.8 % ) with initiation of the multidisciplinary clinic . Conclusion The single-day pancreatic multidisciplinary clinic provided a comprehensive and coordinated evaluation of patients that led to changes in therapeutic recommendations in close to one-quarter of patients",
"PURPOSE To compare clinical benefit response ( CBR ) and quality of life ( QOL ) in patients receiving gemcitabine ( Gem ) plus capecitabine ( Cap ) versus single-agent Gem for advanced/metastatic pancreatic cancer . PATIENTS AND METHODS Patients were r and omly assigned to receive GemCap ( oral Cap 650 mg/m(2 ) twice daily on days 1 through 14 plus Gem 1,000 mg/m(2 ) in a 30-minute infusion on days 1 and 8 every 3 weeks ) or Gem ( 1,000 mg/m(2 ) in a 30-minute infusion weekly for 7 weeks , followed by a 1-week break , and then weekly for 3 weeks every 4 weeks ) for 24 weeks or until progression . CBR criteria and QOL indicators were assessed over this period . CBR was defined as improvement from baseline for > or= 4 consecutive weeks in pain ( pain intensity or analgesic consumption ) and Karnofsky performance status , stability in one but improvement in the other , or stability in pain and performance status but improvement in weight . RESULTS Of 319 patients , 19 % treated with GemCap and 20 % treated with Gem experienced a CBR , with a median duration of 9.5 and 6.5 weeks , respectively ( P GemCap and 60 % treated with Gem had no CBR ( remaining patients were not assessable ) . There was no treatment difference in QOL ( n = 311 ) . QOL indicators were improving under chemotherapy ( P time to failure , with a worsening 1 to 2 months before treatment failure ( all P CBR or QOL between GemCap and Gem . Regardless of their initial condition , some patients experience an improvement in QOL on chemotherapy , followed by a worsening before treatment failure",
"PURPOSE The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine ( GEM ) compared with GEM alone in patients with localized unresectable pancreatic cancer . PATIENTS AND METHODS Patients with localized unresectable adenocarcinoma of the pancreas were r and omly assigned to receive GEM alone ( at 1,000 mg/m(2)/wk for weeks 1 to 6 , followed by 1 week rest , then for 3 of 4 weeks ) or GEM ( 600 mg/m(2)/wk for weeks 1 to 5 , then 4 weeks later 1,000 mg/m(2 ) for 3 of 4 weeks ) plus radiotherapy ( starting on day 1 , 1.8 Gy/Fx for total of 50.4 Gy ) . Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary question naire was also performed . RESULTS Of 74 patients entered on trial and r and omly assigned to receive GEM alone ( arm A ; n = 37 ) or GEM plus radiation ( arm B ; n = 34 ) , patients in arm B had greater incidence of grade s 4 and 5 toxicities ( 41 % v 9 % ) , but grade s 3 and 4 toxicities combined were similar ( 77 % in A v 79 % in B ) . No statistical differences were seen in quality of life measurements at 6 , 15 to 16 , and 36 weeks . The primary end point was survival , which was 9.2 months ( 95 % CI , 7.9 to 11.4 months ) and 11.1 months ( 95 % CI , 7.6 to 15.5 months ) for arms A and B , respectively ( one-sided P = .017 by stratified log-rank test ) . CONCLUSION This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer , with acceptable toxicity",
"PURPOSE The combination of gemcitabine plus bevacizumab produced a 21 % response rate and a median survival of 8.8 months in a multicenter phase II trial in patients with metastatic pancreatic cancer . These encouraging data led Cancer and Leukemia Group B ( CALGB ) to conduct a double-blind , placebo-controlled , r and omized phase III trial of gemcitabine/bevacizumab versus gemcitabine/placebo in advanced pancreatic cancer patients . PATIENTS AND METHODS Eligible patients had no prior therapy for advanced disease , Eastern Cooperative Oncology Group ( ECOG ) performance status 0 to 2 , no tumor invasion of adjacent organs , and no increased bleeding risk . The primary end point was overall survival . Patients were stratified by performance status , extent of disease , and prior radiotherapy . Patients received gemcitabine at 1,000 mg/m(2 ) over 30 minutes on days 1 , 8 , and 15 every 28 days and bevacizumab at 10 mg/kg or placebo on days 1 and 15 every 28 days . RESULTS Between June 2004 and April 2006 , 602 patients were enrolled onto the study and 535 were treated . Median overall survival was 5.8 months for gemcitabine/bevacizumab and 5.9 months for gemcitabine/placebo ( P = .95 ) . Median progression-free survival was 3.8 and 2.9 months , respectively ( P = .07 ) . Overall response rates were 13 % and 10 % , respectively . Patients with a performance status of 0 , 1 , and 2 survived a median of 7.9 , 4.8 , and 2.4 months , respectively . The only statistically significant differences in grade s 3 and 4 toxicity occurred for hypertension ( 10 % v 3 % ; P proteinuria ( 5 % v 1 % ; P = .002 ) ; venous thrombosis grade > or = 3 was equivalent in both arms ( 14 % and 15 % , respectively ) . CONCLUSION The addition of bevacizumab to gemcitabine does not improve survival in advanced pancreatic cancer patients",
"PURPOSE Gemcitabine is generally considered to constitute first-line therapy for pancreatic cancer . To determine whether the addition of fluorouracil ( 5-FU ) improves on the results from single-agent gemcitabine , the Eastern Cooperative Oncology Group ( ECOG ) compared gemcitabine plus bolus 5-FU with gemcitabine alone for patients with advanced pancreatic carcinoma . PATIENTS AND METHODS This trial involved patients with biopsy-proven , advanced carcinoma of the pancreas not amenable to surgical resection . Patients were r and omized to receive either gemcitabine alone ( 1,000 mg/m(2)/wk ) weekly for 3 weeks of every 4 or to receive gemcitabine ( 1,000 mg/m(2)/wk ) followed by 5-FU ( 600 mg/m(2)/wk ) weekly on the same schedule . The primary end point of the trial was survival , with secondary end points of time to progression and response rate . RESULTS Of 327 patients enrolled over 18 months , 322 were eligible . Overall , the median survival was 5.4 months for gemcitabine alone and 6.7 months for gemcitabine plus 5-FU ( P = .09 ) . Progression-free survival for gemcitabine alone was 2.2 months , compared with 3.4 months for gemcitabine plus 5-FU ( P = .022 ) . Objective responses were uncommon and were observed in only 5.6 % of patients treated with gemcitabine and 6.9 % of patients treated with gemcitabine plus 5-FU . Most toxicities were hematologic or gastrointestinal ; no significant differences were noted between the two treatment arms . CONCLUSION 5-FU , administered in conjunction with gemcitabine , did not improve the median survival of patients with advanced pancreatic carcinoma compared with single-agent gemcitabine . Further studies with other combinations of gemcitabine and 5-FU are not compelling , and clinical trial re sources should address other combinations and novel agents",
"BACKGROUND Annualised figures show an up to 7-fold higher incidence of vascular thromboembolism ( VTE ) in patients with advanced pancreatic cancer ( APC ) compared to other common malignancies . Concurrent VTE has been shown to confer a worse overall prognosis in APC . METHODS One hundred and twenty three APC patients were r and omised to receive either gemcitabine 1000 mg/m(2 ) or the same with weight-adjusted dalteparin ( WAD ) for 12 weeks . Primary end-point was the reduction of all-type VTE during the study period . NCT00462852 , IS RCT N : 76464767 . FINDINGS The incidence of all-type VTE during the WAD treatment period ( risk ratio (RR)of 0.145 , 95 % confidence interval ( CI ) ( 0.035 - 0.612 ) and an 85 % risk reduction . All-type VTE throughout the whole follow-up period was reduced from 28 % to 12 % ( p = 0.039 ) , RR = 0.419 , 95 % CI ( 0.187 - 0.935 ) and a 58 % risk reduction . Lethal VTE was seen only in the control arm , 8.3 % compared to 0 % ( p = 0.057 ) , RR = 0.092 , 95 % CI ( 0.005 - 1.635 ) . INTERPRETATION Weight adjusted dalteparin used as primary prophylaxis for 12 weeks is safe and produces a highly significant reduction of all-type VTE during the prophylaxis period . The benefit is maintained after dalteparin withdrawal although decreases with time",
"PURPOSE Patients with advanced pancreas cancer present with disease that is poorly responsive to conventional therapies . Pre clinical and early clinical evidence has supported targeting the epidermal growth factor receptor ( EGFR ) signaling pathway in patients with pancreas cancer . This trial was conducted to evaluate the contribution of an EGFR-targeted agent to st and ard gemcitabine therapy . Cetuximab is a monoclonal antibody against the lig and -binding domain of the receptor . PATIENTS AND METHODS Patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma were r and omly assigned to receive gemcitabine alone or gemcitabine plus cetuximab . The primary end point was overall survival . Secondary end points included progression-free survival , time to treatment failure , objective response , and toxicity . RESULTS A total of 745 eligible patients were accrued . No significant difference was seen between the two arms of the study with respect to the median survival time ( 6.3 months for the gemcitabine plus cetuximab arm v 5.9 months for the gemcitabine alone arm ; hazard ratio = 1.06 ; 95 % CI , 0.91 to 1.23 ; P = .23 , one-sided ) . Objective responses and progression-free survival were similar in both arms of the study . Although time to treatment failure was longer in patients on gemcitabine plus cetuximab ( P = .006 ) , the difference in length of treatment was only 2 weeks longer in the combination arm . Among patients who were studied for tumoral EGFR expression , 90 % were positive , with no treatment benefit detected in this patient subset . CONCLUSION In patients with advanced pancreas cancer , the anti-EGFR monoclonal antibody cetuximab did not improve the outcome compared with patients treated with gemcitabine alone . Alternate targets other than EGFR should be evaluated for new drug development",
"PURPOSE TNFerade biologic is a novel means of delivering tumor necrosis factor alpha to tumor cells by gene transfer . We herein report final results of the largest r and omized phase III trial performed to date among patients with locally advanced pancreatic cancer ( LAPC ) and the first to test gene transfer against this malignancy . PATIENTS AND METHODS In all , 304 patients were r and omly assigned 2:1 to st and ard of care plus TNFerade ( SOC + TNFerade ) versus st and ard of care alone ( SOC ) . SOC consisted of 50.4 Gy in 28 fractions with concurrent fluorouracil ( 200 mg/m(2 ) per day continuous infusion ) . TNFerade was injected intratumorally before the first fraction of radiotherapy each week at a dose of 4 × 10(11 ) particle units by using either a percutaneous transabdominal or an endoscopic ultrasound approach . Four weeks after chemoradiotherapy , patients began gemcitabine ( 1,000 mg/m(2 ) intravenously ) with or without erlotinib ( 100 to 150 mg per day orally ) until progression or toxicity . RESULTS The analysis included 187 patients r and omly assigned to SOC + TNFerade and 90 to SOC by using a modified intention-to-treat approach . Median follow-up was 9.1 months ( range , 0.1 to 50.5 months ) . Median survival was 10.0 months for patients in both the SOC + TNFerade and SOC arms ( hazard ratio [ HR ] , 0.90 ; 95 % CI , 0.66 to 1.22 ; P = .26 ) . Median progression-free survival ( PFS ) was 6.8 months for SOC + TNFerade versus 7.0 months for SOC ( HR , 0.96 ; 95 % CI , 0.69 to 1.32 ; P = .51 ) . Among patients treated on the SOC + TNFerade arm , multivariate analysis showed that TNFerade injection by an endoscopic ultrasound-guided transgastric/transduodenal approach rather than a percutaneous transabdominal approach was a risk factor for inferior PFS ( HR , 2.08 ; 95 % CI , 1.06 to 4.06 ; P = .032 ) . The patients in the SOC + TNFerade arm experienced more grade 1 to 2 fever and chills than those in the SOC arm ( P similar rates of grade 3 to 4 toxicities ( all P > .05 ) . CONCLUSION SOC + TNFerade is safe but not effective for prolonging survival in patients with LAPC",
"Abstract : A r and omized , controlled trial was conducted to clarify the effect of novel radiosensitizer , PR-350 , accompanied by intraoperative radiology ( IOR ) on locally advanced pancreatic cancer . Between July 1999 and March 2002 , 48 patients were enrolled in this clinical trial and received either PR-350 or placebo . Any differences between the PR-350 group ( n = 22 ) and control group ( n = 25 ) were not statically significant . All patients were evaluated , and none of them showed toxicity , with the exception of 1 patient from the control group , and the PR-350 compound was considered to be safe . The efficacy of IOR with PR-350 was evaluated using CT examination . The committee responsible for evaluating efficacy reported that 47.4 % of the PR-350 group showed the effective response , compared with 21.7 % of the control group ( P = 0.1067 , Fisher analysis ) . At 6 months following treatment , the tumor mass reduction rate in the PR-350 group was significantly improved ( P = 0.0274 ) . By the time of the last follow-up in July 2003 , 17 PR-350 patients and 24 control patients group had died of the disease . The median survival period of the PR-350 group was thus 318.5 days and that of the control group is 303.0 days . One-year survival rates of the PR-350 group and control group were 36.4 % and 32.0 % , respectively . Although the PR-350 group did not demonstrate significantly better survival than the control group , 4 of 22 PR-350 patients were still living more than 2 years after the end of the trial , compared with only 1 of 25 patients from the control group . The mechanism of this increased therapeutic response to radiotherapy using PR-350 must be clarified to establish more effective strategy for pancreatic cancer treatment",
"To date , only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer . Within a r and omized phase III trial , 281 treatment-naive patients were r and omly assigned between capecitabine ( 2000 mg/m2/day , for 14 days , once every 3 weeks ) plus erlotinib ( 150 mg/day , arm A ) and gemcitabine ( 1000 mg/m2 as a 30-min infusion ) plus erlotinib ( 150 mg/day , arm B ) . In case of treatment failure , patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib . The primary study endpoint was the time to treatment failure of second-line therapy ( TTF2 ) . This interim analysis of toxicity contains safety data from the first 127 r and omized patients . During first-line therapy , patients received a median number of three treatment cycles ( range 0–13 ) in both the arms . Regarding chemotherapy , a treatment delay was observed in 12 % of the cycles in arm A and in 22 % of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27 % of treatment cycles , respectively . Erlotinib dose reductions were performed in 6 and 11 % of all cycles . Grade 3/4 hematological toxicity was 3/4 toxicities in arms A and B were diarrhea ( 9 vs. 7 % ) , skin rash ( 4 vs. 12 % ) , and h and –foot syndrome ( 7 vs. 0 % ) . No treatment-related death was observed . In conclusion , this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine",
"PURPOSE Most patients with advanced pancreas cancer experience pain and must limit their daily activities because of tumor-related symptoms . To date , no treatment has had a significant impact on the disease . In early studies with gemcitabine , patients with pancreas cancer experienced an improvement in disease-related symptoms . Based on those findings , a definitive trial was performed to assess the effectiveness of gemcitabine in patients with newly diagnosed advanced pancreas cancer . PATIENTS AND METHODS One hundred twenty-six patients with advanced symptomatic pancreas cancer completed a lead-in period to characterize and stabilize pain and were r and omized to receive either gemcitabine 1,000 mg/m2 weekly x 7 followed by 1 week of rest , then weekly x 3 every 4 weeks thereafter ( 63 patients ) , or to fluorouracil ( 5-FU ) 600 mg/m2 once weekly ( 63 patients ) . The primary efficacy measure was clinical benefit response , which was a composite of measurements of pain ( analgesic consumption and pain intensity ) , Karnofsky performance status , and weight . Clinical benefit required a sustained ( > or = 4 weeks ) improvement in at least one parameter without worsening in any others . Other measures of efficacy included response rate , time to progressive disease , and survival . RESULTS Clinical benefit response was experienced by 23.8 % of gemcitabine-treated patients compared with 4.8 % of 5-FU-treated patients ( P = .0022 ) . The median survival duration s were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients , respectively ( P = .0025 ) . The survival rate at 12 months was 18 % for gemcitabine patients and 2 % for 5-FU patients . Treatment was well tolerated . CONCLUSION This study demonstrates that gemcitabine is more effective than 5-FU in alleviation of some disease-related symptoms in patients with advanced , symptomatic pancreas cancer . Gemcitabine also confers a modest survival advantage over treatment with 5-FU",
"PURPOSE Development of new and expensive drugs with activity against pancreatic cancer has made economic considerations more relevant to treatment decision-making for advanced disease . Economic modeling can be used to explore the potential of such novel therapies and to inform clinical trial design . METHODS AND MATERIAL S We developed a Markov model to evaluate the cost-effectiveness of radiation plus fluorouracil ( RT-FU ) relative to no treatment in elderly patients with locally advanced pancreatic cancer ( LAPC ) and to determine the economic potential of radiation plus gemcitabine ( RT-GEM ) , a novel regimen for this disease . We used the SEER-Medicare data base to estimate effectiveness and costs supplemented by data from the literature where necessary . RESULTS Relative to no treatment , RT-FU was associated with a cost-effectiveness ratio ( ICER ) of $ 68,724/QALY in the base case analysis . Compared with RT-FU , the ICER for RT-GEM was below $ 100,000/QALY when the risk of dying with the new regimen was 1,000 subjects would be necessary to demonstrate this level of efficacy in a r and omized trial . The ICER of RT-GEM was most sensitive to utility values , and , at lower efficacy levels , to costs of gemcitabine and treatment-related toxicity . CONCLUSIONS In elderly patients with LAPC , RT-FU is a cost-effective alternative to no treatment . The novel regimen of RT-GEM is likely to be cost-effective at any clinical ly meaningful benefit , but quality -of-life issues , drug acquisition , and toxicity-related costs may be relevant , especially at lower efficacy levels",
"BACKGROUND Sorafenib is an oral anticancer agent targeting Ras-dependent signaling and angiogenic pathways . A phase I trial demonstrated that the combination of gemcitabine and sorafenib was well tolerated and had activity in advanced pancreatic cancer ( APC ) patients . The BAYPAN study was a multicentric , placebo-controlled , double-blind , r and omized phase III trial comparing gemcitabine/sorafenib and gemcitabine/placebo in the treatment of APC . PATIENTS AND METHODS The patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma , no prior therapy for advanced disease and a performance status of zero to two . The primary end point was progression-free survival ( PFS ) . The patients received gemcitabine 1000 mg/m(2 ) i.v . , weekly seven times followed by 1 rest week , then weekly three times every 4 weeks plus sorafenib 200 mg or placebo , two tablets p.o . , twice daily continuously . RESULTS Between December 2006 and September 2009 , 104 patients were enrolled on the study ( 52 pts in each arm ) and 102 patients were treated . The median and the 6-month PFS were 5.7 months and 48 % for gemcitabine/placebo and 3.8 months and 33 % for gemcitabine/sorafenib ( P = 0.902 , stratified log-rank test ) , respectively . The median overall survivals were 9.2 and 8 months , respectively ( P = 0.231 , log-rank test ) . The overall response rates were similar ( 19 and 23 % , respectively ) . CONCLUSION The addition of sorafenib to gemcitabine does not improve PFS in APC patients",
"Background Stereotactic body radiation therapy ( SBRT ) is a promising option for patients with pancreatic cancer ( PCA ) ; however , limited data support its efficacy . This study review s our institutional experience of SBRT in the treatment of locally advanced ( LAPC ) and borderline resectable ( BRPC ) PCA . Methods Charts of all PCA patients receiving SBRT at our institution from 2010 to 2014 were review ed . Most patients received pre-SBRT chemotherapy . Primary endpoints included overall survival ( OS ) and local progression-free survival ( LPFS ) . Patients received a total dose of 25–33 Gy in five fractions . Results A total of 88 patients were included in the analysis , 74 with LAPC and 14 with BRPC . The median age at diagnosis was 67.2 years , and median follow-up from date of diagnosis for LAPC and BRPC patients was 14.5 and 10.3 months , respectively . Median OS from date of diagnosis was 18.4 months ( LAPC , 18.4 mo ; BRPC , 14.4 mo ) and median PFS was 9.8 months ( 95 % CI 8.0–12.3 ) . Acute toxicity was minimal with only three patients ( 3.4 % ) experiencing acute grade ≥3 toxicity . Late grade ≥2 gastrointestinal toxicity was seen in five patients ( 5.7 % ) . Of the 19 patients ( 21.6 % ) who underwent surgery , 79 % were LAPC patients and 84 % had margin-negative resections . Conclusions Chemotherapy followed by SBRT in patients with LAPC and BRPC result ed in minimal acute and late toxicity . A large proportion of patients underwent surgical resection despite limited radiographic response to therapy . Further refinements in the integration of chemotherapy , SBRT , and surgery might offer additional advancements toward optimizing patient outcomes",
"PURPOSE To compare protracted venous infusion ( PVI ) fluorouracil ( 5-FU ) with PVI 5-FU plus mitomycin ( MMC ) in patients with advanced pancreatic cancer in a multicenter , prospect ively r and omized study . PATIENTS AND METHODS Two hundred eight patients were r and omized to PVI 5-FU ( 300 mg/m(2)/d for a maximum of 24 weeks ) or PVI 5-FU plus MMC ( 7 mg/m(2 ) every 6 weeks for four courses ) . The major end points were tumor response , survival , toxicity , and quality of life ( QOL ) . RESULTS The two treatment groups were balanced for baseline demographic factors , and 62 % had metastatic disease . The overall response rate was 8.4 % ( 95 % confidence interval [ CI ] ) 3.2 % to 13.7 % for patients treated with PVI 5-FU alone compared with 17.6 % ; 95 % CI 10.3 % to 25.1 % for PVI 5-FU plus MMC ( P = .04 ) . Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC ( P = .14 ) . Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC ( P = .34 ) . Toxicities in both arms were mild . There was an increased incidence of neutropenia in the 5-FU plus MMC arm ( P infection were seen . No patients developed hemolytic uremic syndrome . Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC , although there was no statistically significant difference in QOL between arms . CONCLUSION PVI 5-FU plus MMC result ed in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer , but this did not translate into a survival advantage . These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer",
"PURPOSE To determine the efficacy and tolerability of gemcitabine (GEM)-concurrent chemoradiotherapy ( CCRT ) vs. 5-fluorouracil ( 5-FU ) CCRT for locally advanced pancreatic cancer . METHODS AND MATERIAL S Thirty-four patients with locally advanced pancreatic cancer were studied . Eighteen patients were r and omized to receive GEM CCRT ( 600 mg/m(2)/wk for 6 weeks ) and 16 patients to receive bolus 5-FU CCRT ( 500 mg/m(2)/d for 3 days repeated every 2 weeks for 6 weeks ) . All patients were to receive 3D-CRT 50.4 - 61.2 Gy at 1.8-Gy/d fractions and GEM ( 1000 mg/m(2 ) weekly for 3 weeks repeated every 4 weeks ) after RT . RESULTS The median survival and median time to progression were 14.5 months and 7.1 months for the GEM CCRT group and 6.7 months and 2.7 months for the 5-FU CCRT group ( p = 0.027 and p = 0.019 , respectively ) . The quality -adjusted life month survival time was 11.2 + /- 0.5 months for GEM CCRT and 6.0 + /- 0.3 months for 5-FU CCRT patients ( p response rate was 50 % ( four complete responses and five partial responses ) for GEM CCRT and 13 % ( two partial responses ) for 5-FU CCRT ( p = 0.005 ) . Pain control was 39 % for GEM CCRT and 6 % for 5-FU CCRT ( p = 0.043 ) . Grade 3 - 4 neutropenia ( 34 % vs. 19 % ) , thrombocytopenia ( 0 % vs. 7 % ) , nausea ( 33 % vs. 31 % ) , vomiting ( 17 % vs. 19 % ) , hospitalization days per month of survival ( 7.4 + /- 1.7 days vs. 8.0 + /- 1.3 days ) , and full dose of RT received ( 78 % vs. 75 % ) were not significantly different between the GEM CCRT and 5-FU CCRT patients . CONCLUSION GEM CCRT appears more effective than 5-FU CCRT for locally advanced pancreatic cancer and has comparable tolerability",
"Objective : To prospect ively evaluate the additional value of geriatric assessment ( GA ) for predicting surgical outcomes in a cohort of older patients undergoing a pancreaticoduodenectomy ( PD ) for pancreatic tumors . Background : Older patients are less often referred for possible PD . St and ard preoperative assessment s may underestimate the likelihood of significant adverse outcomes . The prospect i ve utility of vali date d GA has not been studied in this group . Methods : PD-eligible patients were enrolled in a prospect i ve outcome study . St and ard preoperative assessment s were recorded . Elements of vali date d GA were also measured , including components of Fried 's model of frailty , the Vulnerable Elders Survey ( VES-13 ) , and the Short Physical Performance Battery ( SPPB ) . All postoperative adverse events were recorded , systematic ally review ed , and grade d using the Clavien-Dindo system by a surgeon blinded to the GA results . Multivariate regression analyses were conducted . Results : Seventy-six older patients underwent a PD . Significant unrecognized vulnerability was identified at the baseline : Fried 's “ exhaustion ” ( 37.3 % ) , SPPB 3 ( 15.4 % ) . Within 30 days of PD , 46 % experienced a severe complication ( Clavien-Dindo grade ≥III ) . In regression analyses controlling for age , the body mass index , the American Society of Anesthesiologists score , and comorbidity burden , Fried 's “ exhaustion ” predicted major complications [ odds ratio ( OR ) = 4.06 ; P = 0.01 ] , longer hospital stays ( & bgr ; = 0.27 ; P = 0.02 ) , and surgical intensive care unit admissions ( OR = 4.30 ; P = 0.01 ) . Both SPPB ( OR = 0.61 ; P = 0.04 ) and older age predicted discharge to a rehabilitation facility ( OR = 1.1 ; P lower likelihood of hospital readmission ( OR = 0.94 ; P = 0.02 ) . Conclusions : Controlling for st and ard preoperative assessment s , worse scores on GA prospect ively and independently predicted important adverse outcomes . Geriatric assessment may help identify older patients at high risk for complications from PD",
"Background —Impeded flow of pancreatic juice due to mechanical obstruction of the pancreatic duct in patients with cancer of the pancreatic head region causes exocrine pancreatic insufficiency with steatorrhoea and creatorrhoea . This may contribute to the profound weight loss that often occurs in these patients . Aims —To investigate whether pancreatic enzyme replacement therapy prevents this weight loss . Patients —Twenty one patients with unresectable cancer of the pancreatic head region with suspected pancreatic duct obstruction , a biliary endoprosthesis in situ , and a Karnofsky performance status greater than 60 . Methods —R and omised double blind trial of eight weeks with either placebo or high dose enteric coated pancreatin enzyme supplementation . All patients received dietary counselling . Results —The mean difference in the percentage change of body weight was 4.9 % ( p=0.02 , 95 % confidence interval for the difference : 0.9 to 8.9 ) . Patients on pancreatic enzymes gained 1.2 % ( 0.7 kg ) body weight whereas patients on placebo lost 3.7 % ( 2.2 kg ) . The fat absorption coefficient in patients on pancreatic enzymes improved by 12 % whereas in placebo patients it dropped by 8 % ( p=0.13 , 95 % confidence interval for the difference : –6 to 45 ) . The daily total energy intake was 8.42 MJ in patients on pancreatic enzymes and 6.66 MJ in placebo patients ( p=0.04 , 95 % confidence interval for the difference : 0.08 to 3.44 ) . Conclusions —Weight loss in patients with unresectable cancer of the pancreatic head region and occlusion of the pancreatic duct can be prevented , at least for the period immediately after insertion of a biliary endoprosthesis , by high dose enteric coated pancreatin enzyme supplementation in combination with dietary counselling ",
"BACKGROUND AND PURPOSE The majority of patients with pancreatic cancer have advanced disease at the time of diagnosis and are not amenable for surgery . Stereotactic radiotherapy ( SRT ) may be an alternative treatment for patients with locally advanced disease . The effect of SRT was investigated in the present phase-II trial . PATIENTS AND METHODS Twenty-two patients with locally advanced and surgically non-resectable , histological proven pancreatic carcinoma were included into the trial . The patients were immobilized by the Elekta stereotactic body frame ( SBF ) or a custom made body frame . SRT was given on st and ard LINAC with st and ard multi-leaf collimator . Central dose was 15 Gyx3 within 5 - 10 days . RESULTS Evaluation of response was found to be very difficult due to radiation and tumour related tissue reaction . Only two patients ( 9 % ) were found to have a partial response ( PR ) , the remaining had no change ( NC ) or progression ( PD ) after treatment . Six patients had local tumour progression , but only one patient had an isolated local failure without simultaneous distant metastasis . Median time to local or distant progression was 4.8 months . Median survival time was 5.7 months and only 5 % were alive 1 year after treatment . Acute toxicity reported 14 days after treatment was pronounced . There was a significant deterioration of performance status ( P=0.008 ) , more nausea ( P=0.001 ) and more pain ( P=0.008 ) after 14 days compared with base-line . However , 8 of 12 patients ( 66 % ) improved in performance status , scored less nausea , pain , or needed less analgesic drugs at 3 months after treatment . Four patients suffered from severe mucositis or ulceration of the stomach or duodenum and one of the patients had a non-fatal ulcer perforation of the stomach . CONCLUSIONS SRT was associated with poor outcome , unacceptable toxicity and question able palliative effect and can not be recommended for patients with advanced pancreatic carcinoma",
"PURPOSE The median survival time of patients with locally advanced adenocarcinoma of the pancreas is 8 - 10 months . Radiation therapy has been used to improve local control and palliate symptoms . This r and omized study was undertaken to determine whether the addition of 5-fluorouracil ( 5-FU ) and mitomycin-C ( MMC ) to radiation therapy improves outcome in this patient population . PATIENTS AND METHODS One hundred fourteen patients were r and omized to receive 59.4 Gy external beam radiotherapy in 1.8 Gy fractions alone or in combination with 5-FU ( 1,000 mg/m2/day for 4 days by continuous infusion Days 2 - 5 and 28 - 31 ) and MMC ( 10 mg/m2 on Day 2 ) . RESULTS One hundred four patients were evaluable for efficacy . Hematologic and nonhematologic toxicities were more common in the combination arm . The response rates were 6 % in the radiation therapy arm and 9 % in the combination arm . There were no differences in median disease-free survival time ( DFS ) or overall survival time ( OS ) between the combination and radiation therapy alone arms : 5.1 vs. 5.0 months , respectively , for DFS ( p = 0.19 ) and 8.4 vs. 7.1 months , respectively , for OS ( p = 0.16 ) . CONCLUSION The addition of 5-FU and MMC to radiotherapy increased toxicity without improving DFS or OS in patients with locally advanced pancreatic cancer . Alternative drugs for radiosensitization may improve outcome",
"PURPOSE Single-agent gemcitabine became st and ard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil . The Gruppo Italiano Pancreas 1 r and omized phase III trial aim ed to compare gemcitabine plus cisplatin versus gemcitabine alone ( Clinical Trials.gov ID NCT00813696 ) . PATIENTS AND METHODS Patients with locally advanced or metastatic pancreatic cancer , age 18 to 75 years , and Karnofsky performance status ( KPS ) > or = 50 , were r and omly assigned to receive gemcitabine ( arm A ) or gemcitabine plus cisplatin ( arm B ) . Arm A : gemcitabine 1,000 mg/m(2 ) weekly for 7 weeks , and , after a 1-week rest , on days 1 , 8 , and 15 every 4 weeks . Arm B : cisplatin 25 mg/m(2 ) added weekly to gemcitabine , except cycle 1 day 22 . Primary end point was overall survival . To have 8 % power of detecting a 0.74 hazard ratio ( HR ) of death , with bilateral alpha .05 , 355 events were needed and 400 patients planned . RESULTS Four hundred patients were enrolled ( arm A : 199 ; arm B : 201 ) . Median age was 63 , 59 % were male , 84 % had stage IV , and 83 % had KPS > or = 80 . Median overall survival was 8.3 months versus 7.2 months in arm A and B , respectively ( HR , 1.10 ; 95 % CI , 0.89 to 1.35 ; P = .38 ) . Median progression-free survival was 3.9 months versus 3.8 months in arm A and B , respectively ( HR , 0.97 ; 95 % CI , 0.80 to 1.19 ; P = .80 ) . The objective response rate was 10.1 % in A and 12.9 % in B ( P = .37 ) . Clinical benefit was experienced by 23.0 % in A and 15.1 % in B ( P = .057 ) . Combination therapy produced more hematologic toxicity , without relevant differences in nonhematologic toxicity . CONCLUSION The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer",
"PURPOSE To compare the effectiveness and tolerability of gemcitabine plus cisplatin with single-agent gemcitabine as first-line chemotherapy for locally advanced or metastatic pancreatic cancer . PATIENTS AND METHODS Patients with advanced adenocarcinoma of the pancreas were r and omly assigned to receive either gemcitabine 1,000 mg/m2 and cisplatin 50 mg/m2 given on days 1 and 15 of a 4-week cycle ( GemCis arm ) or gemcitabine alone at a dose of 1,000 mg/m2 on days 1 , 8 , and 15 of a 4-week regimen ( Gem arm ) . The primary end point was overall survival ; secondary end points were progression-free survival , response rate , safety , and quality of life . RESULTS One hundred ninety-five patients were enrolled and showed baseline characteristics well balanced between treatment arms . Combination treatment in the GemCis arm was associated with a prolonged median progression-free survival ( 5.3 months v 3.1 months ; hazard ratio [ HR ] = 0.75 ; P = .053 ) . Also , median overall survival was superior for patients treated in the GemCis arm as compared with the Gem arm ( 7.5 v 6.0 months ) , an advantage which did not , however , reach statistical significance ( HR = 0.80 ; P = .15 ) . Tumor response rates were comparable between treatment arms ( 10.2 % v 8.2 % ) . The rate of stable disease was , however , greater in the combination arm ( 60.2 % v 40.2 % ; P Grade 3 to 4 hematologic toxicity did not exceed 15 % in both treatment arms . CONCLUSION These results support the efficacy and safety of an every-2-weeks treatment with gemcitabine plus cisplatin . Median overall survival and progression-free survival were more favorable in the combination arm as compared with gemcitabine alone , although the difference did not attain statistical significance",
"BACKGROUND The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer ( LAPC ) is uncertain . PATIENTS AND METHODS One hundred and nineteen patients with LAPC , World Health Organization performance status of zero to two were r and omly assigned to either the induction CHRT group ( 60 Gy , 2 Gy/fraction ; concomitant 5-fluorouracil infusion , 300 mg/m(2)/day , days 1 - 5 for 6 weeks ; cisplatin , 20 mg/m(2)/day , days 1 - 5 during weeks 1 and 5 ) or the induction gemcitabine group ( GEM : 1000 mg/m(2 ) weekly for 7 weeks ) . Maintenance gemcitabine ( 1000 mg/m(2 ) weekly , 3/4 weeks ) was given in both arms until disease progression or toxicity . RESULTS Overall survival was shorter in the CHRT than in GEM arm [ median survival 8.6 ( 99 % confidence interval 7.1 - 11.4 ) and 13 months ( 8.7 - 18.1 ) , P = 0.03 ] . One-year survival was , respectively , 32 % and 53 % . These results were confirmed in a per- protocol analysis for patients who received 75 % or more of the planned dose of radiotherapy . More overall grade s 3 - 4 toxic effects were recorded in the CHRT arm , both during induction ( 36 versus 22 % ) and maintenance ( 32 versus 18 % ) . CONCLUSION This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone",
"Objective AIO-PK0104 investigated two treatment strategies in advanced pancreatic cancer ( PC ) : a reference sequence of gemcitabine/erlotinib followed by 2nd-line capecitabine was compared with a reverse experimental sequence of capecitabine/erlotinib followed by gemcitabine . Methods 281 patients with PC were r and omly assigned to 1st-line treatment with either gemcitabine plus erlotinib or capecitabine plus erlotinib . In case of treatment failure ( eg , disease progression or toxicity ) , patients were allocated to 2nd-line treatment with the comparator cytostatic drug without erlotinib . The primary study endpoint was time to treatment failure ( TTF ) after 1st- and 2nd-line therapy ( TTF2 ; non-inferiority design ) . KRAS exon 2 mutations were analysed in archival tumour tissue from 173 of the r and omised patients . Results Of the 274 eligible patients , 43 had locally advanced and 231 had metastatic disease ; 140 ( 51 % ) received 2nd-line chemotherapy . Median TTF2 was estimated with 4.2 months in both arms ; median overall survival was 6.2 months with gemcitabine/erlotinib followed by capecitabine and 6.9 months with capecitabine/erlotinib followed by gemcitabine , respectively ( HR 1.02 , p=0.90 ) . TTF for 1st-line therapy ( TTF1 ) was significantly prolonged with gemcitabine/erlotinib compared to capecitabine/erlotinib ( 3.2 vs 2.2 months ; HR 0.69 , p=0.0034 ) . Skin rash was associated with both TTF2 ( rash grade 0/1/2–4:2.9/4.3/6.7 months , p survival ( 3.4/7.0/9.6 months , p safe and manageable toxicity profile during 1st- and 2nd-line therapy . A KRAS wild-type status ( 52/173 patients , 30 % ) was associated with an improved overall survival ( HR 1.68 , p=0.005 ) . Conclusion Both treatment strategies are feasible and demonstrated comparable efficacy ; KRAS may serve as biomarker in patients with advanced PC treated with erlotinib . Trial registration number This study was registered at Clinical Trials.gov , number NCT00440167 . Significance of this study What is already known on this subject ? Gemcitabine-based chemotherapy remains an international st and ard of care for patients with non-resectable , advanced pancreatic cancer ( PC ) . Anti-EGFR treatment with the tyrosine kinase inhibitor erlotinib , as well as chemotherapy intensification by application of the FOLFIRINOX regimen , both significantly improved overall survival in r and omised phase 3 trials . The optimal ( sequential ) regimen for the use of gemcitabine , erlotinib and the oral fluoropyrimidine capecitabine remains unclear in advanced PC . Molecular predictors for the efficacy of anti-EGFR treatments in PC have not been defined up to now . What are the new findings ? The sequential use of gemcitabine , erlotinib and capecitabine is safe and equally effective in PC ; gemcitabine appears to be more effective in 1st- and 2nd-line therapy than capecitabine and therefore remains the preferred combination partner for erlotinib . Skin rash is strongly correlated with efficacy outcome measures in PC patients treated with erlotinib . KRAS wild-type status appears to be associated with improved overall survival in patients treated with erlotinib in this AIO study . Significance of this study How might it impact on clinical practice in the foreseeable future ? The benefit of adding erlotinib to chemotherapy is restricted to patients that experience skin rash during treatment ; non-rash patients are characterised by a very poor outcome and need to be offered novel treatment strategies . Second-line salvage chemotherapy is effective and safe in selected PC patients . KRAS could serve as the first biomarker for improved survival in erlotinib-treated patients ; the predictive value of KRAS for erlotinib efficacy remains to be defined prospect ively"
] | 411662a8-06ff-11f0-808a-c43d1ab1c353 |
Mobility is critical in maintaining independence in older adults . This study aims to systematic ally review the scientific literature to identify measures of mobility limitation for community-dwelling older adults . A systematic search of PubMed , CINAHL , and psycINFO , using the search terms " mobility limitation " , " mobility disability " , and " mobility difficulty " yielded 1,847 articles from 1990 to 2012 ; a final selection of 103 articles was used for the present manuscript . Tools to measure mobility were found to be either self-report or performance-based instruments . Commonly measured constructs of mobility included walking , climbing stairs , and lower extremity function . There was heterogeneity in ways of defining and measuring mobility limitation in older adults living in the community . Given the lack of consistency in assessment tools for mobility , a clear underst and ing and st and ardization of instruments are required for comparison across studies and for better underst and ing indicators and outcomes of mobility limitation in community-dwelling older adults | [
"BACKGROUND A major obstacle to screening for early mobility disability ( ie , mobility difficulty ) , a major public health concern , is the lack of a method that identifies those who are at high risk . The goal of this study was to develop easy-to-use clinical nomograms for estimation of the probability of incident mobility difficulty . METHODS We conducted a population -based prospect i ve study using data from 266 high physically and cognitively functioning older women , aged 70 to 80 years , who were free of mobility disability at the baseline evaluation of the Women 's Health and Aging Study II . The outcome measure was incident mobility disability within 18 months , defined as self-reported difficulty walking 0.8 km , climbing 10 steps , or transferring from or into a car or bus . Logistic regression and receiver operating characteristic curve analyses were used for evaluation of the optimal combination of self-reported and performance-based mobility measures . Bootstrap sampling and estimation was used for validation . RESULTS Predictive nomograms were developed based on a final model that included 3 simple-to-obtain measures of pre clinical disability : self-report of modification in mobility tasks without having difficulty with them , one-leg stance balance , and time to walk 1 m at a usual pace . Final model accuracy ( as estimated by the area under the receiver operating characteristic curve ) was 73 % ( SE = 0.04 ) . Validation analysis confirmed the high accuracy of these nomograms . CONCLUSIONS An original tool was developed for assessment of the risk of mobility difficulty in older women that can be used to assist physicians and research ers in deciding which women to target for preventive interventions",
"OBJECTIVES To vali date self-reported pre clinical mobility limitation concept and self-report assessment method against muscle power and walking speed , and to study the predictive validity of pre clinical mobility limitation with respect to future risk of manifest mobility limitation . DESIGN Observational prospect i ve cohort study and cross-sectional analysis . SETTING Research laboratory and community . PARTICIPANTS A total of 632 community-living ( age range , 75 - 81 y ) women and men took part in the baseline assessment s and 302 persons in the semi-annual interviews on mobility limitation over 2 years . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Walking speed , muscle power , and self-reported pre clinical and manifest mobility limitation . Pre clinical mobility limitation was defined as self-reported tiredness or modification of task performance without task difficulty . At baseline , 4 subgroups were created according to self-reported pre clinical mobility limitation in any of 3 mobility tasks ( walking 2 km , walking 0.5 km , climbing up stairs ) : no limitation , pre clinical limitation , and minor and major manifest limitation . RESULTS At baseline , participants with pre clinical mobility limitation showed intermediate levels of walking speed and muscle power , compared with those with no limitation or manifest mobility limitation . Participants reporting baseline pre clinical mobility limitation had 3- to 6-fold higher age- and sex-adjusted risk of progressing to major manifest mobility limitation during the 2-year follow-up compared with participants with no limitation at baseline , whereas the risk among those with minor limitation at baseline was 14- to 18-fold higher compared with those with no limitation . CONCLUSIONS The self-report assessment tool proved to be a valid measure to capture the early signs of disability and may serve as an inexpensive tool for identifying those nondisabled persons at high risk for future disability",
"OBJECTIVES To identify levels of knee extensor strength that are associated with high and low risk of incident severe mobility limitation ( SML ) in initially well-functioning older adults . DESIGN Prospect i ve cohort study . SETTING University clinic center . PARTICIPANTS One thous and three hundred fifty-five men and 1,429 women ( aged 73.6+/-2.85 ) who reported no mobility limitation . MEASUREMENTS Unilateral knee extensor isokinetic strength of participants was obtained . Participants were followed over a median of 5.90 years for the onset of SML , defined as two consecutive reports of a lot of difficulty or inability to walk one-quarter of a mile or climb 10 steps . Deciles of knee extension strength relative to body weight were evaluated to identify cutpoints most predictive of incident SML . Cutpoints were then compared with prevalence of having slow gait speed ( knee extension strength cutpoints were found . High and low risk of SML corresponded to less than 1.13 newton-meters (Nm)/kg ( 1st decile ) and more than 1.71 Nm/kg ( 6th decile ) in men and less than 1.01 Nm/kg ( 3rd decile ) and more than 1.34 Nm/kg ( 7th decile ) in women , respectively . Moderate risk was defined as being between the low- and high-risk cutpoints . Individuals with knee extension strength in the high- and moderate-risk categories were more likely to have a gait speed less than 1.22 m/s ( hazard ratio (HR)=7.00 , 95 % confidence interval (CI)=5.47 - 8.96 and HR=2.14 7.00 , 95 % CI=1.73 - 2.64 , respectively ) and had a higher risk of death ( HR=1.77 , 95 % CI=1.41 - 2.23 and HR=1.51 , 95 % CI=1.24 - 1.84 , respectively ) than individuals in the low-risk category . Adjustment for demographic factors , health behaviors , and medical conditions did not alter these associations . CONCLUSION Knee extensor strength cutpoints provide objective markers to identify initially well-functioning older adults at high and low risk of future mobility limitation",
"Background Interventions that enhance mobility in frail older people are needed to maintain health and independence , yet definitive evidence of effective interventions is lacking . Our objective was to assess the impact of a multifactorial intervention on mobility-related disability in frail older people . Methods We conducted a r and omised , controlled trial with 241 frail community-dwelling older people in Sydney , Australia . Participants were classified as frail using the Cardiovascular Health Study definition , did not have severe cognitive impairment and were recently discharged from an aged care and rehabilitation service . The experimental group received a 12 month multifactorial , interdisciplinary intervention targeting identified frailty components . Two physiotherapists delivered a home exercise program targeting mobility , and coordinated management of psychological and medical conditions with other health professionals . The control group received usual care . Disability in the mobility domain was measured at baseline and at 3 and 12 months using the International Classification of Functioning , Disability and Health framework . Participation ( involvement in life situations ) was assessed using the Life Space Assessment and the Goal Attainment Scale . Activity ( execution of mobility tasks ) was measured using the 4-metre walk and self-report measures . Results The mean age of participants was 83.3 years ( SD : 5.9 years ) . Of the participants recruited , 216 ( 90 % ) were followed-up at 12 months . At this time point , the intervention group had significantly better scores than the control group on the Goal Attainment Scale ( odds ratio 2.1 ; 95 % confidence interval ( CI ) 1.3 to 3.3 , P = 0.004 ) and Life Space Assessment ( 4.68 points , 95 % CI 1.4 to 9.9 , P = 0.005 ) . There was no difference between groups on the global measure of participation or satisfaction with ability to get out of the house . At the activity level , the intervention group walked 0.05 m/s faster over 4 m ( 95 % CI 0.0004 to 0.1 , P = 0.048 ) than the control group , and scored higher on the Activity Measure for Post Acute Care ( P mobility-related disability in frail older people . The benefit was evident at both the participation and activity levels of mobility-related disability . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ANZCTRN12608000507381",
"OBJECTIVE To examine changes in functional status over time by age , gender , and ethnicity in a representative sample of older persons . DESIGN Six-year prospect i ve cohort study . SETTING Alameda County , California . PARTICIPANTS 508 persons 65 years old and older at baseline in 1984 . MAIN OUTCOME MEASURES Activities of daily living ( ADL ) dependence , mobility impairment , and functioning on an 18-item scale . RESULTS The prevalence of ADL dependence and mobility impairment at baseline increased with age , while function decreased . Particularly striking differences occurred for those 80 and older . Changes in function over the 6-year follow-up showed a similar pattern . While death rates for males were higher , females had poorer initial functioning , and surviving females declined more than surviving males . The incidence of ADL dependence and mobility impairment during follow-up was similar for males and females , although females survived longer with incident disability than did males . Blacks had poorer baseline functioning , more ADL dependence and mobility impairment , and declined more than non-Blacks during follow-up . Some of the baseline difference in function between Blacks and non-Blacks was due to higher rates of chronic illness and co-morbidity . In spite of the general downward trend in functioning over the 6 years , 13 % of the males and 20 % of the females improved . CONCLUSION Age-related changes in function for older persons are complex and result in much heterogeneity . Clarifying the reasons for such heterogeneity is an important and challenging area of research",
"Background and aims : Prospect i ve studies on the simultaneous effects of multiple determinants on objective ly assessed mobility are few . The aim of this study was to analyse mobility performance , its stability and sensory , psychomotor and musculoskeletal determinants in an older population from age 75 to age 80 . Methods : Sixty-three men and 121 women aged 75 participated at baseline and , five years later , in the follow-up phase of this population -based prospect i ve study . Maximal walking speed and step-mounting height were assessed at baseline and follow-up . Maximal isometric knee extension strength , st and ing balance on force platform , reaction time , visual acuity and limitations in range of motion ( ROM ) of hips and knees were assessed at baseline . Structural equation modeling was used to analyse the associations . Results : The stability of mobility performance from baseline to the five-year follow-up was high ( coefficient 0.80 in men , 0.78 in women ) . In men , knee extension strength , st and ing balance , ROM limitations and visual acuity explained 69 % of the variation in mobility performance at baseline and , indirectly , 59 % of that variation at follow-up . Among women , knee extension strength , st and ing balance , visual acuity and reaction time explained 52 % of the variation of mobility performance at baseline and , indirectly , 30 % at the five-year follow-up . Conclusions : Results indicate that the predictive effects of sensory , psychomotor and musculoskeletal functions on mobility performance extend over five years in older people . In seeking to prevent mobility limitations , vision , reaction time and lower extremity ROM need to be targeted , in addition to muscle strength and balance",
"BACKGROUND in the primary prevention of disability among older adults it might be useful to identify individuals at high risk for functional decline before it occurs . OBJECTIVE to examine whether tiredness in daily activities is an independent determinant of onset of mobility disability at 1 1/2-year follow-up among non-disabled older men and women . DESIGN a prospect i ve study with 1 1/2-year follow-up . SETTING 34 communities in four counties in Denmark . SUBJECTS 1396 older non-disabled adults ( 74 - 75 and 80 years old ) living in 17 of the participating communities . METHODS question naire surveys at baseline and at 1 1/2-year follow-up . Tiredness in daily activities was measured by questions about tiredness in six mobility activities . Onset of mobility disability was measured as onset of need for help in one to six mobility activities . RESULTS men and women who felt tired in their daily activities at baseline had a higher risk of onset of mobility disability at 1 1/2-year follow-up , when adjusted by the covariates . In addition , low social participation , poor psychological function , and physical inactivity were independent risk factors of onset of mobility disability among men , and home help , low sense of coherence and physical inactivity were independent risk factors of onset of mobility disability among women . CONCLUSION older people who complain about tiredness are at higher risk of becoming disabled than others . This highlights the need for alertness and management of this early sign of functional decline in a preventive perspective",
"BACKGROUND numerous tests have been suggested as fall risk indicators . However , the validity of these assessment s has not been demonstrated in large representative sample s of community-dwelling older people . OBJECTIVE the objective of this study was to examine the comparative ability and clinical utility of eight mobility tests for predicting multiple falls in older community-dwelling people . METHODS design -- prospect i ve cohort study ; subjects--362 subjects aged 74 - 98 years ; measurements --the sit-to-st and test with one and five repetitions , the pick-up-weight test , the half-turn test , the alternate-step test ( AST ) , the six-metre-walk test ( SMWT ) and stair ascent and descent tasks . Falls were monitored for 1 year with fall calendars . RESULTS in the 12-month follow-up period , 80 subjects ( 22.1 % ) suffered two or more falls . Multiple fallers performed significantly worse than non-multiple fallers in the sit-to-st and test with five repetitions ( STS-5 ) , the AST , the half-turn test , the SMWT and the stair-descent test . When dichotomised using cut-off points from receiver-operated characteristics ( ROC ) curve analyses , these tests demonstrated reasonable sensitivity and specificity in identifying multiple fallers . A principal components analysis identified only one factor underlying the mobility tests . Poor performances in two mobility tests , however , increased the risk of multiple falls more than poor performance in one test alone ( ORs = 3.66 , 95 % CI = 1.44 , 9.27 and 1.61 , 95 % CI = 0.62 , 4.16 respectively ) . CONCLUSIONS the mobility tests appear to be measuring a similar ' mobility ' construct . Based on feasibility and predictive validity , the AST , STS-5 and SMWTs were the best tests",
"Background We investigated if personal socioeconomic position ( SEP ) factors and neighborhood characteristics were associated with incident mobility impairment in the elderly . Methods We used data from the Cardiovascular Health Study , a longitudinal , population -based examination of coronary heart disease and stroke among persons aged 65 and older in the United States . Results Among 3,684 persons without baseline mobility impairment , lower baseline SEP was associated with increased risk of incident mobility disability during the 10-year follow-up period , although the strengths of these associations varied by socioeconomic indicator and race/sex group . Conclusion Among independent-living elderly , SEP affected development of mobility impairment into later life . Particular effort should be made to prevent or delay its onset among the elderly with low income , education , and /or who live in economically disadvantaged neighborhoods ",
"BACKGROUND Identifying mobility disability risk factors may facilitate development of interventions promoting functional independence in older persons . We tested the hypothesis that musculoskeletal pain is associated with first occurrence of severe mobility disability . METHODS In a prospect i ve observational study at 40 community-based sites , 759 older Catholic clergy in the Rush Religious Orders Study without baseline dementia , stroke , Parkinson 's disease , or severe performance-based mobility disability ( defined as gait speed less than or equal to 0.4 m/s ) and at least one follow-up mobility evaluation were evaluated over a mean of 8.5 ( SD = 3.8 ) years . All participants were queried about musculoskeletal pain in the year before baseline and underwent annual assessment of mobility . RESULTS Using a proportional hazards model adjusted for age , sex , and education , the hazard for incident severe mobility disability was greater for participants reporting pain in the year before baseline ( odds ratio = 1.47 , 95 % confidence interval = 1.17 - 1.85 ) . Results were unchanged after adjusting for self-reported mobility disability , gait speed , depressive symptoms , body mass index , physical activity , chronic medical conditions , and analgesic use . Compared with no report of musculoskeletal pain , musculoskeletal pain in one or two areas was associated with a 30 % greater hazard for incident disability ( odds ratio = 1.31 , 95 % confidence interval = 1.00 - 1.70 ) . Musculoskeletal pain in three or more areas was associated with an 80 % greater hazard for incident disability ( odds ratio = 1.80 , 95 % confidence interval = 1.31 - 2.47 ) . In participants without baseline self-reported mobility disability ( n = 486 ) , musculoskeletal pain was associated with greater hazard for incident self-reported mobility disability ( odds ratio = 1.38 , 95 % confidence interval = 1.11 - 1.73 ) . CONCLUSION In older persons , musculoskeletal pain is associated with incident mobility disability",
"We examined whether adherence to a Mediterranean-style diet has positive effects on mobility assessed over a 9-year follow-up in a representative sample of older adults . This research is part of the InCHIANTI Study , a prospect i ve population -based study of older persons in Tuscany , Italy . The sample for this analysis included 935 women and men aged 65 years and older . Adherence to the Mediterranean diet was assessed at baseline by the st and ard 10-unit Mediterranean diet score ( MDS ) . Lower extremity function was measured at baseline , and at the 3- , 6- and 9-year follow-up visits using the short physical performance battery ( SPPB ) . At baseline , higher adherence to Mediterranean diet was associated with better lower body performance . Participants with higher adherence experienced less decline in SPPB score , which was of 0.9 points higher ( p mobility disability at baseline , those with higher adherence had a lower risk ( HR=0.71 , 95 % CI=0.51 - 0.98 , p=0.04 ) of developing new mobility disability . High adherence to a Mediterranean-style diet is associated with a slower decline of mobility over time in community-dwelling older persons . If replicated , this observation is highly relevant in terms of public health",
"OBJECTIVES To test the hypothesis that , in older persons , sense of personal mastery , defined as the extent to which one regards one 's life chance as being under one 's own control , predicts change in lower extremity performance during a 6-year follow-up . DESIGN Prospect i ve cohort study . SETTING Community based . PARTICIPANTS Six hundred twenty-six participants aged 65 and older . MEASUREMENTS Personal mastery was assessed at baseline using Pearlin 's mastery scale . Lower extremity performance was measured at baseline and at 6-year follow-up using the Short Physical Performance Battery ( SPPB ) of lower extremity function . RESULTS Higher sense of mastery was associated with a significantly less-steep decline in lower extremity performance . Participants in the two lowest quartiles of personal mastery had , respectively , a 2.6 ( 95 % confidence interval (CI)=1.4 - 5.1 , P=.01 ) and 3.2 ( 95 % CI=1.6 - 6.6 , P=.002 ) higher risk of experiencing a substantial decline ( > or =3 points ) in SPPB scores after 6 years as those in the highest quartile . CONCLUSIONS Older individuals with poor sense of personal mastery are at high risk of accelerated lower extremity physical function decline . Whether interventions aim ed at improving personal mastery may prevent disability remains unknown",
"OBJECTIVES To identify factors that predicted incident use of assistive walking devices ( AWDs ) and to explore whether AWD use was associated with changes in osteoarthritis of the knee . DESIGN Prospect i ve cohort study . SETTING Community . PARTICIPANTS Older adults ( N=2639 ) in the Health , Aging and Body Composition ( Health ABC ) Study including a subset of 874 patients with prevalent knee pain . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Incident use of AWDs , mean Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain scores , and the frequency of joint space narrowing on knee radiographs over a 3-year time period . RESULTS AWD use was initiated by 9 % of the entire Health ABC cohort and 12 % of the knee pain subset . Factors that predicted use in both groups were age ≥73 ( entire cohort : odds ratio [OR]=2.07 ; 95 % confidence interval [ CI ] , 1.43 - 3.01 ; knee pain subset : OR=1.87 ; 95 % CI , 1.16 - 3.03 ) , black race ( entire cohort : OR=2.95 ; 95 % CI , 2.09 - 4.16 ; knee pain subset : OR=3.21 ; 95 % CI , 2.01 - 5.11 ) , and lower balance ratios ( entire cohort : OR=3.18 ; 95 % CI , 2.21 - 4.59 ; knee pain subset : OR=3.77 ; 95 % CI , 2.34 - 6.07 ) . Mean WOMAC pain scores decreased slightly over time in both AWD and non-AWD users . Twenty percent of non-AWD users and 28 % of AWD users had radiographic progression in joint space narrowing of the tibiofemoral joint in at least 1 knee . Fourteen percent of non-AWD users and 12 % of AWD users had radiographic progression in joint space narrowing in the patellofemoral joint in at least 1 knee . CONCLUSIONS AWDs are frequently used by older adults . Knee pain and balance problems are significant reasons why older adults initiate use of an AWD . In an exploratory analysis , there was no consistent relation between the use or nonuse of an AWD and WOMAC pain scores or knee joint space narrowing progression . Further studies of the relation of use of AWDs to changes in knee osteoarthritis are needed",
"OBJECTIVES To examine the relationship between indicators of inflammation and the incidence of mobility limitation in older persons . DESIGN Prospect i ve cohort study : the Health , Aging and Body Composition Study . SETTING Pittsburgh , Pennsylvania , and Memphis , Tennessee . PARTICIPANTS A total of 2,979 men and women , aged 70 to 79 , without mobility limitation at baseline . MEASUREMENTS Serum levels of interleukin (IL)-6 , tumor necrosis factor alpha ( TNFalpha ) , and C-reactive protein ( CRP ) and soluble cytokine receptors ( IL-2sR , IL-6sR , TNFsR1 , TNFsR2 ) were measured . Mobility limitation was assessed and defined as reporting difficulty or inability to walk one-quarter of a mile or to climb 10 steps during two consecutive semiannual assessment s over 30 months . RESULTS Of the 2,979 participants , 30.1 % developed incident mobility limitation . After adjustment for confounders ( demographics , prevalent conditions at baseline , body composition ) , the relative risk ( RR ) of incident mobility limitation per st and ard deviation ( SD ) increase was 1.19 ( 95 % confidence interval (CI)=1.10 - 1.28 ) for IL-6 , 1.20 ( 95 % CI=1.12 - 1.29 ) for TNFalpha , and 1.40 ( 95 % CI=1.18 - 1.68 ) for CRP . The association between inflammation and incident mobility limitation was especially strong for the onset of more severe mobility limitation and when the levels of multiple inflammatory markers were high . When persons with baseline or incident cardiovascular disease events or persons who were hospitalized during study follow-up were excluded , findings remained similar . In a subset ( n=499 ) , high levels of the soluble receptors IL2sR and TNFsR1 ( per SD increase : RR=1.23 ( 95 % CI=1.04 - 1.46 ) and RR=1.28 ( 95 % CI=1.04 - 1.57 ) , respectively ) were also associated with incident mobility limitation . CONCLUSION Findings suggest that inflammation is prognostic for incident mobility limitation over 30 months , independent of cardiovascular disease events and incident severe illness",
"OBJECTIVES To determine whether benzodiazepine use is associated with incident disability in mobility and activities of daily living ( ADLs ) in older individuals . DESIGN A prospect i ve cohort study . SETTING Four sites of the Established Population s for Epidemiologic Studies of the Elderly . PARTICIPANTS This study included 9,093 subjects ( aged > or = 65 ) who were not disabled in mobility or ADLs at baseline . MEASUREMENTS Mobility disability was defined as inability to walk half a mile or climb one flight of stairs . ADL disability was defined as inability to perform one or more basic ADLs ( bathing , eating , dressing , transferring from a bed to a chair , using the toilet , or walking across a small room ) . Trained interviewers assessed outcomes annually . RESULTS At baseline , 5.5 % of subjects reported benzodiazepine use . In multivariable models , benzodiazepine users were 1.23 times as likely as nonusers ( 95 % confidence interval ( CI ) = 1.09 - 1.39 ) to develop mobility disability and 1.28 times as likely ( 95 % CI = 1.09 - 1.52 ) to develop ADL disability . Risk for incident mobility was increased with short- ( hazard ratio ( HR ) = 1.27 , 95 % CI = 1.08 - 1.50 ) and long-acting benzodiazepines ( HR = 1.20 , 95 % CI = 1.03 - 1.39 ) and no use . Risk for ADL disability was greater with short- ( HR = 1.58 , 95 % CI = 1.25 - 2.01 ) but not long-acting ( HR = 1.11 , 95 % CI = 0.89 - 1.39 ) agents than for no use . CONCLUSION Older adults taking benzodiazepines have a greater risk for incident mobility and ADL disability . Use of short-acting agents does not appear to confer any safety benefits over long-acting agents",
"OBJECTIVES To determine the rates of clinical ly meaningful transitions in mobility disability ; evaluate how these transitions differ according to age , sex , and physical frailty ; and depict the duration of the result ing episodes of mobility disability . DESIGN Prospect i ve cohort study . SETTING General community in greater New Haven , Connecticut , from March 1998 to October 2004 . PARTICIPANTS Seven hundred fifty-four community-living older persons , aged 70 and older , who were nondisabled ( i.e. , required no personal assistance ) in four activities of daily living . MEASUREMENTS Mobility disability , defined as the inability to walk one quarter of a mile and to climb a flight of stairs , respectively without personal assistance , was assessed every month for up to 5 years . RESULTS For both mobility tasks , rates per 1,000 person-months were higher for transitions from no disability to intermittent disability ( 34.7 for walking one quarter of a mile and 17.4 for climbing a flight of stairs ) , intermittent to continuous disability ( 52.0 and 42.5 ) , continuous to intermittent disability ( 35.4 and 31.5 ) , and intermittent to no disability ( 68.6 and 85.4 ) than for other transitions . Older age , female sex , and physical frailty were associated with greater likelihood of transition to states of greater disability and lower likelihood of regaining independent mobility . CONCLUSION Mobility disability in older persons is a highly dynamic process , characterized by frequent transitions between states of independence and disability . Programs design ed to enhance independent mobility should focus not only on the prevention of mobility disability but also on the restoration and maintenance of independent mobility in older persons who become disabled",
"OBJECTIVE To evaluate , in terms of function and mobility , the predictive value of commonly adopted anthropometric ' definitions ' used in the nutritional assessment of older adults , in a cohort of older Australians . DESIGN Prospect i ve cohort study - Australian Longitudinal Study of Ageing ( ALSA ) . SETTING Adelaide , South Australia ( 1992 - 1994 ) . SUBJECTS Data were analysed from 1272 non-institutionalised ( 685 males , 587 females ) older adults > or = 70 years old in South Australia . Seven ' definitions ' commonly used in the anthropometric assessment of both under- and overnutrition ( including four using body mass index ( BMI ) , waist-to-hip ratio , waist circumference and percentage weight change ) were evaluated at baseline , for their ability to predict functional and mobility limitation assessed ( by self-report question naire ) at two years follow-up . All question naires were administered and anthropometry performed by trained investigators . The associations between the definitions and decline in mobility and physical function were evaluated over two years using multiple logistic regression . RESULTS A BMI > 85th percentile or > 30 kg m-2 or a waist circumference of > 102 cm in males and > 88 cm in females increased risk of functional and mobility limitations . Over two years , a loss of 10 % body weight significantly increased the risk of functional and mobility limitations . CONCLUSION Maintaining weight within older adults , irrespective of initial body weight , may be important in preventing functional and mobility limitations . Excessive weight is associated with an increased risk of limitation in function and mobility , both key components of health-related quality of life",
"BACKGROUND Lower muscle mass has been correlated with poor physical function ; however , no studies have examined this relationship prospect ively . This study aims to investigate whether low muscle mass , low muscle strength , and greater fat infiltration into the muscle predict incident mobility limitation . METHODS Our study cohort included 3075 well-functioning black and white men and women aged 70 - 79 years participating in the Health , Aging , and Body Composition study . Participants were followed for 2.5 years . Muscle cross-sectional area and muscle tissue attenuation ( a measure of fat infiltration ) were measured by computed tomography at the mid-thigh , and knee extensor strength by using a KinCom dynamometer . Incident mobility limitation was defined as two consecutive self-reports of any difficulty walking one-quarter mile or climbing 10 steps . RESULTS Mobility limitations were developed by 22.3 % of the men and by 31.8 % of the women . Cox 's proportional hazards models , adjusting for demographic , lifestyle , and health factors , showed a hazard ratio of 1.90 [ 95 % confidence interval ( CI ) , 1.27 - 2.84 ] in men and 1.68 ( 95 % CI , 1.23 - 2.31 ) in women for the lowest compared to the highest quartile of muscle area ( p muscle strength were 2.02 ( 95 % CI , 1.39 - 2.94 ) and 1.91 ( 95 % CI , 1.41 - 2.58 ) , p muscle attenuation were 1.91 ( 95 % CI , 1.31 - 2.83 ) and 1.68 ( 95 % CI , 1.20 - 2.35 ) , p muscle attenuation and muscle strength independently predicted mobility limitation ( p blacks and whites . CONCLUSION Lower muscle mass ( smaller cross-sectional thigh muscle area ) , greater fat infiltration into the muscle , and lower knee extensor muscle strength are associated with increased risk of mobility loss in older men and women . The association between low muscle mass and functional decline seems to be a function of underlying muscle strength",
"OBJECTIVES To evaluate the validity and reliability of a st and ardized approach for assessing life-space mobility ( the University of Alabama at Birmingham Study of Aging Life-Space Assessment ( LSA ) ) and its ability to detect changes in life-space over time in community-dwelling older adults . DESIGN Prospect i ve , observational cohort study . SETTING Five counties ( three rural and two urban ) in central Alabama . PARTICIPANTS Community-dwelling Medicare beneficiaries ( N=306 ; 46 % male , 43 % African American ) who completed in-home baseline interviews and 2-week and 6-month telephone follow-up interviews . MEASUREMENTS The LSA assessed the range , independence , and frequency of movement over the 4 weeks preceding assessment s. Correlations between the baseline LSA and measures of physical and mental health ( physical performance , activities of daily living , instrumental activities of daily living , a global measure of health ( the short form-12 question survey ) , the Geriatric Depression Scale , and comorbidities ) established validity . Follow-up LSA scores established short-term test-retest reliability and the ability of the LSA to detect change . RESULTS For all LSA scoring methods , baseline and 2-week follow-up LSA correlations were greater than 0.86 ( 95 % confidence interval=0.82 - 0.97 ) . Highest correlations with measures of physical performance and function were noted for the LSA scoring method considering all attributes of mobility . The LSA showed both increases and decreases at 6 months . DISCUSSION Life-space correlated with observed physical performance and self-reported function . It was stable over a 2-week period yet showed changes at 6 months",
"BACKGROUND AND PURPOSE The Performance-Oriented Mobility Assessment ( POMA ) is a widely used instrument that provides an evaluation of balance and gait . It is used clinical ly to determine the mobility status of older adults or to evaluate changes over time . To support the use of the POMA for these purpose s , the clinimetric properties ( in particular , responsiveness ) were determined . SUBJECTS Participants ( 78 % female ; mean age=84.9 years ) were living in either self-care or nursing-care residences . Concurrent and discriminant validity were assessed with the total group ( N=245 ) , whereas reliability and responsiveness were determined with a sub sample ( n=30 ) . Fall-related predictive validity was assessed with a sub sample of 72 participants . METHODS In addition to the POMA , several reference performance tests were administered . The POMA was assessed on 2 consecutive days by 2 raters ( observers ) . The analyses included the calculation of Spearman rank correlation coefficients ( R ) , limits of agreement ( LOA ) with Bl and -Altman plots , minimal detectable changes at the 95 % confidence level ( MDC(95 ) ) , and sensitivity and specificity with regard to predicting falls . When possible , findings for the total scale ( POMA-T ) were complemented by findings for its balance subscale ( POMA-B ) and its gait subscale ( POMA-G ) . RESULTS The interrater and test-retest reliability for the POMA-T and the POMA-B were good ( R=.74-.93 ) , whereas for the POMA-G , the reliability values , although high as well , were systematic ally slightly lower ( R=.72-.89 ) . The Spearman correlations with the reference performance tests ( R=|.64|- |.68| ) indicated satisfactory concurrent validity for the POMA-T and the POMA-B , but the corresponding findings for the POMA-G ( R=|.52|- |.56| ) were less convincing . The discriminant validity values of the 3 scales were about the same . The LOA for the POMA-T were on the order of -4.0 to 4.0 for test-retest agreement and -3.0 to 3.0 for interrater agreement . On the basis of the MDC(95 ) values , it was concluded that changes in POMA-T scores at the individual level should be at least 5 points and that those at the group level ( n=30 ) should be at least 0.8 point to be considered reliable . Even when optimal cutoff points were used , sensitivity and specificity values ( varying between 62.5 % and 66.1 % ) for the POMA-T as well as for its 2 subscales indicated poor accuracy in predicting falls . DISCUSSION AND CONCLUSION The POMA-T and its subscale POMA-B have adequate reliability and validity for assessing mobility in older adults . The POMA-T is useful for demonstrating intervention effects at the group level . Changes within subjects , however , should be at least 5 points before being interpreted as reliable changes . The accuracy of the POMA-T in predicting falls is poor",
"BACKGROUND To examine the impact of educational attainment on the incidence of pre clinical mobility disability ( PCD ) . METHODS The Women 's Health and Aging II Study is a prospect i ve observational cohort study of 436 initially high-functioning community-dwelling women aged 70 - 79 years at baseline in Baltimore , Maryl and . We measured the association of highest attained education level with pre clinical mobility disability ( PCD ) over an 11-year period . PCD is defined as self-reported modification in any of four tasks without reporting difficulty in those tasks . The tasks were walking ½ mile , climbing up steps , doing heavy housework , and getting in/out of bed or chair . RESULTS Participants with less than 9 years of education were more likely to acquire incident PCD ( hazard ratio : 3.1 , 95 % confidence interval = 1.2 - 7.7 ) than their counterparts with more education after adjusting for income , marital status , number of diseases , and high self-efficacy . CONCLUSIONS Lower education level is an independent predictor of incident pre clinical mobility disability . This association has important implication s for primary and secondary prevention and can be easily assessed in clinical encounters",
"Background and Purpose : Mobility disability is a serious and frequent adverse health outcome associated with aging . Early identification of individuals at risk for mobility disability is important if interventions to prevent disability are to be instituted . The objectives of this prospect i ve study were to ( 1 ) determine the magnitude of stance time variability ( STV ) that discriminates individuals who currently have mobility disability ( prevalent mobility disability ) and ( 2 ) determine the magnitude of STV that predicts a new onset of mobility disability at 1 year ( incident mobility disability ) . Methods : A total of 552 community-dwelling older adults were evaluated as part of the Cardiovascular Health Study , a longitudinal cohort study . Stance time , in milliseconds , was determined from 2 passes on a 4-m computerized walkway at self-selected walking speed , and STV was defined as the st and ard deviation from approximately 12 individual steps . Mobility disability was defined as self-reported difficulty walking a one-half mile . Receiver operating characteristic ( ROC ) curves were plotted to determine an optimal cutoff value for STV for prevalent and incident mobility disability , and the area under the receiver operating characteristic curve ( AUC ) was computed . Results : The optimal cutoff score for STV ( maximizing sensitivity and specificity ) for prevalent mobility disability was 0.037 seconds ( sensitivity = 65 % , specificity = 65 % , AUC = 0.70 ) and for incident 1-year mobility disability was 0.034 seconds ( sensitivity = 61 % , specificity = 60 % , AUC = 0.65 ) . The use of likelihood ratios demonstrated a gradient of risk across values of STV , with mobility risk increasing as values of STV increased . Discussion and Conclusion : Values of STV may be useful in identifying older adults with mobility disability and at risk for future disability . We recommend the more conservative estimate for identifying risk , STV = 0.034 seconds , which maximizes the sensitivity and minimizes false negatives . The relatively modest values on the validity indices could possibly be improved by increasing the reliability of the measurement of STV . Clinicians should interpret the cutoff values liberally and use STV in conjunction with other measures until further work is completed to vali date STV as an indicator of mobility disability",
"OBJECTIVE To examine the association of distant vision and physical function in the population of older adults . DESIGN Cross-sectional and cohort study . PARTICIPANTS 5143 older residents of three communities ( Established Population s for the Epidemiologic Studies of the Elderly ) who were interviewed in 1988 - 89 , including residents of two communities who were re-interviewed 15 months later ( n = 3133 , 97 % of those eligible ) . MEASURES Visual acuity screening , self-reported activities of daily living and mobility , and objective physical performance measures of balance , walking , and rising from a chair . RESULTS Limitations in mobility , activities of daily living , and physical performance were associated with worse visual function . In prospect i ve analyses controlling for potential confounders , participants with severe visual impairment had 3-fold higher odds of incident mobility and activity of daily living limitations than those with acuity of 20/40 or better ( P vision with improvement in function , those with poor vision were about half as likely to improve as those with better acuity , but this relationship was only statistically significant for improvement in mobility limitations . CONCLUSIONS Distant visual function appears to play an important role in physical function , particularly for mobility . An intervention to improve vision in at-risk elders might preserve function and prevent disability ; this warrants further investigation",
"OBJECTIVES To investigate the association between different types of physical activity behavior and incident mobility limitation in older men and women and to examine whether muscle parameters mediate these associations . DESIGN Cohort study with 4.5-year follow-up . SETTING Metropolitan areas surrounding Pittsburgh , Pennsylvania , and Memphis , Tennessee . A r and om sample of white Medicare beneficiaries and all age-eligible blacks . PARTICIPANTS Three thous and seventy-five black and white men and women aged 70 to 79 with no self-reported difficulty walking one-quarter of a mile or climbing 10 steps , enrolled in the Health , Aging and Body Composition ( Health ABC ) Study . MEASUREMENTS Participants were classified as exercisers ( reporting > or = 1,000 kcal/wk of exercise activity ) , lifestyle active ( reporting activity and > or = 2,719 kcal/wk of total physical activity ) , or inactive ( reporting exercise activity and incident mobility limitation , was defined as two consecutive , semiannual self-reports of any difficulty walking one quarter of a mile or climbing 10 steps . Thigh muscle area , thigh muscle attenuation ( a marker of fat infiltration in muscle ) , appendicular lean soft tissue mass , and isokinetic knee extensor strength were examined as potential mediators . RESULTS Over 4.5 years , 34.3 % of men and 47.4 % of women developed mobility limitation . Inactive persons had twice the risk of incident mobility limitation as exercisers ( hazard ratio (HR)=2.08 , 95 % confidence interval (CI)=1.60 - 2.70 , for men , HR=1.98 , 95 % CI=1.51 - 2.60 , for women ) . Lifestyle-active men and women had an intermediate risk ( HR=1.47 and 1.44 , respectively ) . For the lifestyle active and inactive , absence of walking activity conferred an additional risk of mobility limitation . Muscle parameters did not mediate the relationship between physical activity and mobility limitation , except for knee extensor strength in men . CONCLUSION Exercise and an active lifestyle that includes walking protect against mobility loss in older men and women . Activity effects on muscle parameters do not explain this association",
"OBJECTIVES To examine the association between stopping to rest during a 400-m usual-pace walk test ( 400-MWT ) and incident mobility disability in older persons with functional limitations . DESIGN Prospect i ve cohort study . SETTING Community based . PARTICIPANTS Four hundred twenty-four participants in the Lifestyle Intervention and Independence for Elders Pilot ( LIFE-P ) Study aged 70 to 89 with functional limitations ( summary score Short Physical Performance Battery ( SPPB ) ) but able to complete the 400-MWT within 15 minutes . MEASUREMENTS Rest stops during the 400-MWT were recorded . The onset of mobility disability , defined as being unable to complete the 400-MWT or taking more than 15 minutes to do so , was recorded at Months 6 and 12 . RESULTS Fifty-four ( 12.7 % ) participants rested during the 400-MWT at baseline , of whom 37.7 % experienced mobility disability during follow-up , versus 8.6 % of those not stopping to rest . Performing any rest stop was strongly associated with incident mobility disability at follow-up ( odds ratio (OR)=5.4 , 95 % confidence interval (CI)=2.7 - 10.9 ) after adjustment for age , sex , and clinic site . This association was weaker , but remained statistically significant , after further adjusting for SPPB and time to complete the 400-MWT simultaneously ( OR=2.6 , 95 % CI=1.2 - 5.9 ) . CONCLUSION Stopping to rest during the 400-MWT is strongly associated with incident mobility disability in nondisabled older persons with functional limitations . Given the prognostic value , rest stops should be recorded as part of the st and ard assessment protocol for the 400-MWT",
"BACKGROUND AND PURPOSE The University of Alabama at Birmingham ( UAB ) Study of Aging Life-Space Assessment ( LSA ) is a relatively new instrument to measure mobility . The purpose of this report is to describe the relationships between LSA and traditional measures of physical function , sociodemographic characteristics , depression , and cognitive status . SUBJECTS Subjects were a stratified r and om sample of 998 Medicare beneficiaries aged > or = 65 years . The sample was 50 % African American , 50 % male , and 50 % from rural ( versus urban ) counties . METHODS In-home interviews were conducted . Mobility was measured using the LSA , which documents where and how often subjects travel and any assistance needed during the 4 weeks prior to the assessment . Basic activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) , cognitive status , income level , presence of depressive symptoms , and transportation re sources were determined . The Short Physical Performance Battery ( SPPB ) was used to assess physical performance . RESULTS Simple bivariate correlations indicated a significant relationship between LSA and all variables except residence ( rural versus urban ) . In a regression model , physical function ( ADL , IADL ) and physical performance ( SPPB ) accounted for 45.5 % of the variance in LSA scores . An additional 12.7 % of the variance was explained by sociodemographic variables , and less than 1 % was explained by cognition and depressive symptoms . DISCUSSION AND CONCLUSION The LSA can be used to document patients ' mobility within their home and community . The LSA scores are associated with a person 's physical capacity and other factors that may limit mobility . These scores can be used in combination with other tests and measures to generate clinical hypotheses to explain mobility deficits and to plan appropriate interventions to address these deficits",
"BACKGROUND Muscle weakness and obesity are two significant threats to mobility facing the increasing number of older adults . To date , there are no studies that have examined the association of strength and body mass index ( BMI ) on event rates on a widely used performance measure of major mobility disability . METHODS This study was a secondary analysis of a r and omized controlled trial in which sedentary functionally limited participants ( 70 - 89 years , Short Physical Performance Battery ≤ 9 ) who were able to complete a 400-m walk test at baseline were r and omized to a physical activity or health education intervention and reassessed for major mobility disability every 6 months for up to 18 months . We evaluated whether baseline grip strength and BMI predicted failure to complete the 400-m walk test in 15 minutes or less ( major mobility disability ) . RESULTS Among N = 406 participants with baseline measures , lower grip strength was associated with an increased risk for developing major mobility disability , with and without covariate adjustment ( p of grip strength was 6.11 ( 2.24 - 16.66 ) . We observed a U-shaped relationship between baseline BMI and the risk of developing major mobility disability , such that the risk for participants with a BMI of 25 - 29 kg/m(2 ) was approximately half that of participants with BMI less than 25 or 30 kg/m(2 ) or more ( p = .04 in fully adjusted analyses ) . CONCLUSIONS Our data highlight the importance of muscle weakness , low BMI , and obesity as risk factors for major mobility disability in older adults . Being overweight may be protective for major mobility disability",
"OBJECTIVES To determine the risk of disability in individuals with coexisting visual and cognitive impairment and to compare the magnitude of risk associated with visual impairment , cognitive impairment , or the multimorbidity . DESIGN Prospect i ve cohort . SETTING North Carolina . PARTICIPANTS Three thous and eight hundred seventy-eight participants in the North Carolina Established Population s for the Epidemiologic Studies of the Elderly with nonmissing visual status , cognitive status , and disability status data at baseline MEASUREMENTS Short Portable Mental Status Question naire ( cognitive impairment defined as > or = 4 errors ) , self reported visual acuity ( visual impairment defined as inability to see well enough to recognize a friend across the street or to read newspaper print ) , demographic and health-related variables , disability status ( activities of daily living ( ADLs ) , instrumental activities of daily living ( IADLs ) , mobility ) , death , and time to nursing home placement . RESULTS Participants with coexisting visual and cognitive impairment were at greater risk of IADL disability ( odds ratio (OR)=6.50 , 95 % confidence interval (CI)=4.34 - 9.75 ) , mobility disability ( OR=4.04 , 95 % CI=2.49 - 6.54 ) , ADL disability ( OR=2.84 , 95 % CI=1.87 - 4.32 ) , and incident ADL disability ( OR=3.66 , 95 % , CI=2.36 - 5.65 ) . In each case , the estimated OR associated with the multimorbidity was greater than the estimated OR associated with visual or cognitive impairment alone , a pattern that was not observed for other adverse outcomes assessed . No significant interactions were observed between cognitive impairment and visual impairment as predictors of disability status . CONCLUSION Individuals with coexisting visual impairment and cognitive impairment are at high risk of disability , with each condition contributing additively to disability risk . Further study is needed to improve functional trajectories in patients with this prevalent multimorbidity . When visual or cognitive impairment is present , efforts to maximize the other function may be beneficial",
"OBJECTIVES To examine joint associations of physical activity and adiposity measures ( body mass index ( BMI ) , waist circumference , percentage body fat ) with incident mobility limitation . DESIGN Prospect i ve observational cohort study . SETTING Memphis , Tennessee and Pittsburgh , Pennsylvania . PARTICIPANTS Two thous and nine hundred and eighty-two black and white men and women aged 70 to 79 participating in the Health , Aging and Body Composition ( Health ABC ) study . MEASUREMENTS Mobility limitation was defined as reported difficulty walking one-quarter of a mile or climbing 10 steps during two consecutive semiannual assessment s over 6.5 years . Three measures of adiposity were included in this study : BMI , total percentage body fat , and waist circumference . Physical activity was assessed using a modified leisure-time physical activity question naire . RESULTS Forty-six percent of the cohort developed mobility limitation . White and black men with a high BMI ( > or = 30 kg/m(2 ) ) , high total percentage body fat ( > 31.3 % ) , or high waist circumference ( > or = 102 cm ) had an approximately 60 % , 40 % , and 40 % , respectively , higher risk of incident mobility limitation than those with low adiposity . In women , high adiposity was also associated with a significantly higher mobility limitation risk than in those with low adiposity . Low physical activity ( lowest quartile ) was associated with a 70 % higher risk of mobility limitation in all groups . Persons with high adiposity and low physical activity were at particularly high risk of mobility limitation . People with high adiposity who were physically active had an equally high risk of mobility limitation as inactive people with low adiposity . CONCLUSION High adiposity and low self-reported physical activity predicted the onset of mobility limitation in well-functioning older persons . Preventing weight gain in old age and promoting physical activity in obese and non-obese older persons may therefore be effective strategies to prevent mobility loss and future disability",
"OBJECTIVES To investigate the extent to which self-reported mobility deficit in the absence of impairment in activities of daily living ( ADL ) is associated with elevated mortality risk . DESIGN Prospect i ve cohort study , with annual assessment s of mobility and ADL status and ongoing monitoring of vital status . SETTING Population -based cohort drawn from Medicare enrollees in New York City . PARTICIPANTS One thous and two hundred ninety-eight older adults reporting functional status at baseline ( 1992 - 1994 ) and 2 years later . MEASUREMENTS Subjects reported mobility ( e.g. , walking , climbing stairs , and rising from a chair ) and ADL ( e.g. , bathing , toilet use , dressing , grooming , and feeding ) limitations . Two-year functional status trajectories were noted . We used two additional follow-up periods , at 2 and 4 years , to examine the likelihood that older people with mobility deficit may face an increased risk of death without first passing through a state of enduring ADL disability . RESULTS At 2 years , 12.7 % had incident mobility deficit without ADL disability , and 21.3 % were persistently disabled in mobility without ADL disability . Relative to subjects free of disability at baseline and follow-up , risk of mortality in the incident mobility deficit group was elevated at 2 and 4 years but did not achieve statistical significance . By contrast , for subjects with persistent mobility impairment who did not report ADL impairment , the mortality risk was significantly elevated both at 2 years ( relative risk ( RR ) = 2.5 ; 95 % confidence interval ( CI ) = 1.1 - 5.7 ) ) and 4 years ( RR = 2.9 ; 95 % CI = 1.7 - 4.9 ) ) of follow-up . Mortality was significantly elevated in this group in analyses restricted to respondents with no or only one comorbid condition . CONCLUSION Continuing , self-reported mobility impairment in the absence of ADL deficit is a risk factor for mortality . Older people with self-reported mobility deficit face an increased risk of mortality without first passing through enduring states of ADL disability",
"Background Functional limitations have been operationally defined for studies of rehabilitation science through measures of physical performance and patient-reported function . Although conceived as representing similar concepts , differences between these 2 modes of measuring physical functioning have not been adequately characterized scientifically . Objective The purpose of this study was to compare the Short Physical Performance Battery ( SPPB ) with the function component of the Late-Life Function and Disability Instrument ( LLFDI ) with respect to their association with physiologic factors and other psychosocial and health factors potentially influencing rehabilitative care . Design This study was a cross-sectional analysis of baseline data from a sample of community-dwelling older adults ( N=137 ) with mobility limitations enrolled in a r and omized controlled trial of exercise . Methods A performance-based measure of function ( the SPPB ) and a self-report measure of function ( the LLFDI ) served as functional outcomes . Physiologic factors included measures of leg strength , leg velocity , and exercise tolerance test ( ETT ) duration , which served as a surrogate measure of aerobic capacity . Psychosocial and health factors included age , sex , height , body mass index , number of chronic conditions , depression , and falls efficacy . Results Separate multivariable regression models predicting SPPB and LLFDI scores described 33 % and 42 % of the variance in each outcome ( R2 ) , respectively . Leg velocity and ETT duration were positively associated with both performance-based and patient-reported functional measures . Leg strength and age were positively associated with SPPB scores , whereas number of chronic conditions , sex , and falls efficacy were associated with the LLFDI scores . Limitations This study included older adults with mobility limitations and may not generalize to other population s. Conclusions Performance-based and patient-reported measures of physical function appear to assess different aspects of an older person 's functioning . The SPPB was associated with age and physiologic factors , whereas patient-reported function measured by the LLFDI was associated with these factors as well as with psychosocial and health factors",
"OBJECTIVES To examine dog walking among dog owners and the relationship between walking behavior of dog owners and non-dog owners and maintained gait speed over 3 years . DESIGN Cross-sectional and longitudinal analyses of a prospect i ve cohort study . SETTING Memphis , Tennessee , and Pittsburgh , Pennsylvania . PARTICIPANTS Two thous and five hundred thirty-three community-dwelling adults aged 71 to 82 at 36 months of the Health , Aging and Body Composition Study . MEASUREMENTS Dog ownership , reported walking behavior , change in walking behavior , and usual and rapid gait speed over 3 years . RESULTS Of 394 dog owners , only 36 % walked their dogs at least three times per week . Cross-sectionally , dog walkers were more likely to achieve 150 minutes of walking per week and had faster usual and rapid walking speeds ( 1.20 vs 1.14 m/s and 1.62 vs 1.52 m/s , respectively ; P .50 ) . Three years later , subjects who had been dog walkers at baseline were approximately twice as likely as any other group to achieve recommended walking levels , independent of covariates . Dog walkers experienced similar declines in usual and rapid walking speed as non-dog owners who walked at least three times per week but maintained their initial mobility advantage . CONCLUSION Although dog ownership appears to facilitate walking behavior , only a minority of older dog owners walk their dogs . The mobility advantage of dog ownership was seen only in dog walkers and was similar to that associated with any walking . Given suboptimal walking activity in older adults , examining the degree to which dog ownership promotes walking activity in persons who do little walking on their own appears worth pursuing",
"PURPOSE We examined the association of relative weight with mobility and changes in mobility over time and whether these associations differed by race . METHODS Data come from a prospect i ve , population -based , observational study of adults aged 65 years or older . Mobility outcomes were assessed at baseline and two follow-up interviews at 3-year intervals . The study included 4195 participants with a mean age of 73.8 + /- 6.3 ( SD ) years ; 61.4 % were women , and 60.9 % were black . Assessment of mobility included a brief self-report instrument and a performance-based walk test . Body mass index ( BMI , kilograms per square meter ) was used as a measure of relative weight . We used generalized estimating equation models to examine change in mobility outcomes over time as a function of BMI . RESULTS Average BMI was 26.6 + /- 5.7 kg/m(2 ) , with 34.0 % overweight and 23.4 % obese . BMI showed a significant curvilinear association with mobility outcomes at baseline ( p mobility during follow-up . Maximum mobility levels occurred at a significantly higher level of BMI among blacks than whites . CONCLUSIONS Higher levels of BMI may lead to mobility impairments earlier in life , but there is little evidence that they increase the rate of decline in mobility in older age itself",
"OBJECTIVES To determine the influence of homocysteine on mobility decline in older adults . DESIGN Prospect i ve cohort . SETTING Einstein Aging Study , community-based aging study . PARTICIPANTS Five hundred seventy-four older adults without dementia ( mean age 80.2 + /- 5.4 , 61 % women ) . MEASUREMENTS Mobility decline defined using gait velocity measurements at baseline and annual follow-up visits . Linear mixed effects models were used to adjust for age , sex , education , and other potential confounders . RESULTS Higher homocysteine levels were associated with slower gait velocity at baseline . Adjusted for age , sex , and education , a one-unit increase in baseline log homocysteine levels was associated with a 2.95-cm/s faster mobility decline per year ( P=.01 ) over a median follow-up of 1.4 years . The 140 subjects in the highest quartile of homocysteine had a faster rate of mobility decline ( 1.75 cm/s per year faster , P=.01 ) than the 434 subjects in the lowest three quartiles of homocysteine ( homocysteine and mobility decline remained robust even after adjusting for multiple confounders and accounting for the presence of clinical gait abnormalities . CONCLUSION Higher homocysteine levels are associated with greater risk of mobility decline in community-residing older adults",
"Objective : To assess the effect of a comprehensive geriatric assessment and individually tailored intervention on mobility in older people . In addition , the effectiveness of the geriatric intervention was evaluated among a subgroup of persons with musculoskeletal pain . Design : Three-year geriatric development project with r and omized assignment to intervention and control group . Setting : Research centre , community and assisted living facilities . Participants : Seven hundred and eighty-one Finnish persons aged 75–98 years were assigned to an intervention ( n = 404 ) or control ( n = 377 ) group . Intervention : A comprehensive geriatric assessment with a multifactorial intervention lasting two years . The intervention included individualized referrals , recommendations , physical activity counselling and supervised resistance training . Measurements : Perceived limitation in walking 400 m was gathered annually during the intervention and at the one-year post-intervention follow-up . Results : The proportion of persons with mobility limitation at the beginning , at the two-year intervention and at the one-year post-intervention follow-up was 16 % , 15 % , 12 % and 14 % , respectively , in the intervention group . In the control group , the corresponding proportions were 19 % , 18 % , 23 % and 26 % . The treatment effect was significant at the end of the two-year intervention ( odds ratio 0.82 , 95 % confidence interval 0.70–0.96 , P = 0.013 ) , and at the one-year post-intervention follow-up ( 0.84 , 0.75–0.94 , P = 0.002 ) . The parallel positive effect of the intervention on mobility was even greater among persons with musculoskeletal pain . Conclusion : The comprehensive geriatric assessment and individually tailored multifactorial intervention had a positive effect on mobility , underlining their importance in health promotion and disability prevention in older people",
"Objectives : To assess the validity and reliability of the Short Physical Performance Battery ( SPPB ) in adults 65 to 74 years old , capable in all basic activities of daily living ( ADL ) , in Quebec and Brazil . Methods : Participants were recruited in St. Bruno ( Quebec ) by local advertisements ( n = 60 ) and in Santa Cruz ( Brazil ) by r and om sampling ( n = 64 ) . The SPPB includes tests of gait , balance , and lower-limb strength . Disability status was categorized as intact mobility , limited mobility , and difficulty in any of ADL . Results : There was a grade d decrease in mean SPPB scores with increasing limitation of lower limbs , disability , and poor health . Using the test – retest reliability the authors evaluated the intraclass correlation coefficient , which was high in both sample s : .89 ( 95 % CI : 0.83 , 0.93 ) in St. Bruno and .83 in Santa Cruz ( 95 % CI : 0.73 , 0.89 ) . Discussion : This study provides evidence for the validity and reliability of SPPB in diverse population",
"BACKGROUND Relatively little is known about why older persons develop long-term disability in community mobility . OBJECTIVE To identify the risk factors and precipitants for long-term disability in walking a quarter mile and driving a car . DESIGN Prospect i ve cohort study from March 1998 to December 2009 . SETTING Greater New Haven , Connecticut . PARTICIPANTS 641 persons , aged 70 years or older , who were active drivers or nondisabled in walking a quarter mile . Persons who were physically frail were over sample d. MEASUREMENTS C and i date risk factors were assessed every 18 months . Disability in community mobility and exposure to potential precipitants , including illnesses or injuries leading to hospitalization or restricted activity , were assessed every month . Disability that lasted 6 or more consecutive months was considered long-term . RESULTS 318 ( 56.0 % ) and 269 ( 53.1 % ) participants developed long-term disability in walking and driving , respectively . Seven risk factors were independently associated with walking disability and 8 were associated with driving disability ; the strongest associations for each outcome were found for older age and lower score on the Short Physical Performance Battery . The precipitants had a large effect on long-term disability , with multivariate hazard ratios for each outcome greater than 6.2 for hospitalization and greater than 2.4 for restricted activity . The largest differences in absolute risk were generally observed in participants with a specific risk factor who were subsequently hospitalized . LIMITATIONS The observed associations may not be causal . The severity of precipitants was not assessed . The effect of the precipitants may have been underestimated because their exposure after the initial onset of disability was not evaluated . CONCLUSION Long-term disability in community mobility is common among older persons . Multiple risk factors , together with subsequent precipitants , greatly increase the likelihood of long-term mobility disability . PRIMARY FUNDING SOURCE National Institute on Aging , National Institutes of Health"
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This systematic review and meta- analysis aim ed to evaluate the efficacy of daily oral bovine lactoferrin versus daily oral ferrous iron preparations for treatment of iron deficiency anemia ( IDA ) during pregnancy . Search es were conducted on PubMed , ScienceDirect , Clinical Trials.gov and CENTRAL data bases from inception to February 2017 and the bibliographies of retrieved articles were screened . The PRISMA Statement was followed . Published English language r and omized trials comparing lactoferrin with oral ferrous iron preparations in pregnant women with iron deficiency anemia were included . Quasi-r and omized , non- r and omized or studies including other known cause of anemia , gestational or pre-existent maternal diseases were excluded . Accordingly , 4 eligible trials ( 600 women ) were analyzed . Primary outcome was change in hemoglobin level at 4 weeks of treatment . Secondary outcomes were ; change in serum ferritin and iron , rates of gastrointestinal side effects , preterm birth , low birthweight , neonatal death and mean birthweight . Quality assessment was performed by the Cochrane risk of bias tool . Odds ratio and mean difference were used to integrate dichotomous and continuous outcomes respectively . Pooled estimates for change in hemoglobin levels at four weeks favored daily oral lactoferrin over daily oral ferrous sulphate ( mean difference 0.77 ; 95 % confidence interval [ CI ] 0.04 - 1.55 ; P=0.04 , 4 trials , 600 women ) . However , after subgroup analysis ( degree of anemia ) , no significant difference in hemoglobin levels were found between both groups in mild anemia ( mean difference 0.80 ; 95 % CI -0.21 to 1.82 , 3 trials , 372 women ) , but a significant increase favoring lactoferrin was reported in moderate anemia ( mean difference 0.68 ; 95 % CI 0.53 - 0.83 ; P gastrointestinal side effects were reported with lactoferrin treatment . No significant differences existed with regard to other outcomes . In conclusion , for pregnant women with IDA , daily oral bovine lactoferrin is just as good as ferrous sulfate in improving hematological parameters with fewer gastrointestinal side effects . Thereby , lactoferrin should be the iron replacement agent of choice for treatment of IDA in pregnancy | [
"Objective To assess the use , side effects and discontinuation rates of iron preparations during pregnancy . Design Six hundred and twelve r and omly selected postpartum women completed a question naire on iron supplement use in the second and third trimesters . Results Of the 517 women ( 84.5 % ) reported using iron supplements , 453 were eligible for the study . The most common preparation was ferrous fumarate ( 46.8 % , P ferrous sulfate ( 31.8 % ) , ferric polymaltose ( 12.4 % ) , and ferric bisglycinate ( 7.3 % ) . Almost half the participants ( 45 % ) reported at least one adverse effect , especially constipation ( 27.4 % , P nausea ( 10.8 % ) . Multivitamin preparations and ferric bisglycinate were associated with the fewest side effects ( 23.7 , 21.2 % respectively , P ferrous sulfate with the most ( 56.3 , 53.7 % respectively ) . Eighty-three women discontinued their originally prescribed iron preparation , mainly ( 89 % ) due to side effects . Discontinuation rates were lowest for the multivitamin and ferric bisglycinate ( 10.5 , 9.1 % , respectively ) . In most cases , the specific preparation was recommended by the women ’s physician ( 76 % ) . Conclusion Ferrous fumarate-containing multivitamin preparations and ferric bisglycinate , although infrequently recommended as the first-line of iron supplementation , may be associated with less side effects and better compliance",
"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",
"Objective Evaluate the safety and efficacy of bovine lactoferrin ( bLf ) versus the ferrous sulphate st and ard intervention in curing iron deficiency ( ID ) and ID anaemia ( IDA ) in pregnant women affected by hereditary thrombophilia ( HT ) . Design Interventional study . Setting Secondary -level hospital for complicated pregnancies in Rome , Italy . Population 295 HT pregnant women ( ≥18 years ) suffering from ID/IDA . Methods Women were enrolled in Arm A or B in accordance with their personal choice . In Arm A , 156 women received oral administration of 100 mg of bLf twice a day ; in Arm B , 139 women received 520 mg of ferrous sulphate once a day . Therapies lasted until delivery . Main outcome measures Red blood cells , haemoglobin , total serum iron , serum ferritin ( haematological parameters ) were assayed before and every 30 days during therapy until delivery . Serum IL-6 , key factor in inflammatory and iron homeostasis disorders , was detected at enrolment and after therapy at delivery . Possible maternal , foetal , and neonatal adverse effects were assessed . Results Haematological parameters were significantly higher in Arm A than in Arm B pregnant women ( P ≤ 0.0001 ) . Serum IL-6 significantly decreased in bLf-treated women and increased in ferrous sulphate-treated women . BLf did not exert any adverse effect . Adverse effects in 16.5 % of ferrous sulphate-treated women were recorded . Arm A women experienced no miscarriage compared to five miscarriages in Arm B women . Conclusions Differently from ferrous sulphate , bLf is safe and effective in curing ID/IDA associated with a consistent decrease of serum IL-6 . The absence of miscarriage among bLf-treated women provided an unexpected benefit . Trial registration : Clinical Trials.gov Identifier NCT01221844",
"Iron homeostasis in pregnancy compensates for increased iron requirements and in women of child-bearing age for iron loss in menses . Oral administration of ferrous sulfate , prescribed to cure iron deficiency ( ID ) and ID anemia ( IDA ) , often fails to increase hematological parameters and causes adverse effects . Recently , we demonstrated safety and efficacy of bovine lactoferrin ( bLf ) in pregnant women suffering from ID/IDA . Two clinical trials were conducted on pregnant and non-pregnant women of child-bearing age suffering from ID/IDA . In both trials , women received oral administration of bLf 100 mg/twice/day ( Arm A ) , or ferrous sulfate 520 mg/day ( Arm B ) . Hematological parameters , serum IL-6 and prohepcidin were assayed before and after therapy . Unlike ferrous sulfate , bLf increased hematological parameters ( P pregnant women , bLf decreased serum IL-6 ( P increased prohepcidin ( P=0.0007 ) . In non-pregnant women bLf did not change the low IL-6 levels while it increased prohepcidin ( P increased IL-6 ( P decreased prohepcidin ( P=0.093 ) . bLf established iron homeostasis by modulating serum IL-6 and prohepcidin synthesis , whereas ferrous sulfate increased IL-6 and failed to increase hematological parameters and prohepcidin . bLf is a more effective and safer alternative than ferrous sulfate for treating ID and IDA",
"Abstract Objective : This study was conducted to evaluate the efficacy and safety of lactoferrin in comparison to ferrous sulphate for the treatment of iron deficiency anemia ( IDA ) during pregnancy . Material s and methods : This prospect i ve , r and omized , parallel-group , single-center study was conducted in the Department of Obstetrics and Gynecology at Menoufia University Hospital , Egypt and included a total of 200 pregnant women in the second trimester with IDA who were enrolled and r and omly assigned either to receive 150 mg of dried ferrous sulphate capsules or lactoferrin 250 mg capsules once daily for eight consecutive weeks . The primary efficacy parameter was the amount of increase in hemoglobin concentration by 4 and 8 weeks , the adverse effects related to iron therapy and the patient compliance to the treatment . Results : Total increase in Hb after 2 months with lactoferrin was higher ( 2.26 ± 0.51 g/dL ) compared to ferrous sulfate ( 1.11 ± 0.22 g/dL ) ( p 0.001 ) . Gastrointestinal adverse events occurred more frequently with ferrous sulphate than the lactoferrin group ( p number of women requesting change the drug was higher in the ferrous sulphate group ( p Conclusion : Lactoferrin was more effective than ferrous sulfate over a two-month period in pregnant women with IDA , with fewer gastrointestinal adverse events and better treatment acceptability",
"BACKGROUND Routine intake of iron supplements during pregnancy improves maternal health and pregnancy outcomes . This is observed in a background of increased availability and compliance to routine antenatal iron supplements . Poor compliance arises not only because of patient behavior but also from factors that may be out of patient 's control . The aim of this study was to determine the proportion of patients who comply , the level of compliance with the iron prescription given at the antenatal clinic as well as propose interventions aim ed at increasing compliance amongst the antenatal population . METHODS A total of five hundred antenatal clients were recruited r and omly ( the 3rd of clients presenting to the clinic ) during their antenatal visits between 1st May and 30th June , 2009 at the UPTH . Prescriptions for iron supplements and folic acid were given and they were interviewed using a st and ard structured question naire . Women with low or high compliance were asked to explain what influenced their adherence to iron supplementation . RESULTS Overall compliance in this study was 88.0 % . Women who complied fully were of the perception that good blood level and birth weight were beneficial effects of the routine iron supplement . Gastrointestinal side effects and forgetfulness were the main reasons for low compliance",
"Lactoferrin ( Lf ) is an approximately 80-kDa iron-binding glycoprotein , belonging to the transferrin family , with well-known bacteriostatic and bactericidal properties . It is produced and stored in specific ( secondary ) neutrophil granules and released during neutrophil activation and degranulation . Nowadays , Lf has a well-known therapeutic indication for combating iron deficiency anemia ( IDA ) in pregnant women . Studies suggest that Lf plays an important role against cervicovaginal infections by decreasing cytokines levels , such as interleukin (IL)-6 , in cervicovaginal fluid . The aim of this preliminary trial was to evaluate the effectiveness of Lf in preventing preterm delivery caused by cervical infections and ripening . From November 2009 to August 2010 , 21 pregnant women ( 26 - 32 weeks pregnant ) , aged between 22 and 36 years , suffering from IDA , at risk of preterm delivery , were prospect ively enrolled in the study . One group ( N=14 ) received 100 mg of recombinant human lactoferrin ( bLf ) [ corrected ] ( lattoferrina ; AG-pharma ) twice a day before meals , for one month . The other group ( N=7 ) received 520 mg of ferrous sulfate ( Ferro-Grad ; Abbott Laboratories , USA ) once a day . The patients underwent transvaginal ultrasound to evaluate cervical length and funneling , and vaginal swabs were used to detect infections and cervicovaginal fluid sample collection to determine IL-6 levels . The results showed a correlation between the oral administration of 200 mg of bLf [ corrected ] with both the normalization of vaginal flora ( vaginal infection disappearance ) and the decrease in IL-6 cervicovaginal fluid levels in women at risk of preterm delivery",
"Iron deficiency anemia ( IDA ) during pregnancy continues to be of world-wide concern . IDA is a risk factor for preterm delivery and subsequent low birth weight , and possibly for poor neonatal health . Iron supplementation in pregnancy is a widely recommended practice , yet intervention programs have met with many controversies . In our study , 300 women at different trimesters of pregnancy were enrolled in a trial of oral administration of ferrous sulfate ( 520 mg once a day ) or 30 % iron-saturated bovine lactoferrin ( bLf ) ( 100 mg twice a day ) . Pregnant women refusing treatment represented the control group . In this group hemoglobin and total serum iron values measured after 30 d without treatment decreased significantly , especially in women at 18 - 31 weeks of pregnancy . In contrast , after 30 d of oral administration of bLf , hemoglobin and total serum iron values increased and to a greater extent than those observed in women treated orally for 30 d with ferrous sulfate , independently of the trimester of pregnancy . Unlike ferrous sulfate , bLf did not result in any side effects . These findings lead us to hypothesize that lactoferrin could influence iron homeostasis directly or through other proteins involved in iron transport out of the intestinal cells into the blood",
"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",
"Objective . To compare the effects of bovine lactoferrin with ferrous sulfate on iron nutritional status and to evaluate their tolerability in 100 pregnant women with iron deficiency anemia . Design . Prospect i ve , r and omized , controlled , double blind trial . Setting . Obstetrics clinic of a University Department of Obstetrics and Gynecology . Population . One‐hundred pregnant , healthy women to be treated either with one capsule of 100 mg bovine lactoferrin twice a day ( Group A ; n = 49 ) and 520 mg ferrous sulfate once a day ( Group B ; n = 48 ) . Methods . After 30 days , we evaluated hemoglobin ( Hb ) , serum ferritin , serum iron and total iron‐ binding capacity ( TIBC ) values . All women were asked to keep a diary of five potential gastrointestinal side effects ( abdominal pain , nausea , vomiting , diarrhea and constipation ) . For each symptom , patients had to rate its severity according to a scale ranging from 0 ( absent ) to 3 ( severe ) . Main outcome measures . Hb level before and after treatment . Secondary outcomes were serum ferritin , serum iron and TIBC levels and the difference in symptom scores between groups . Results . In Groups A and B , Hb , serum ferritin and iron were significantly increased while TIBC was significantly reduced in comparison with basal values . No significant differences were observed between Groups A and B. The median scores of abdominal pain and constipation were significantly higher in patients treated with ferrous sulfate in comparison with those treated with bovine lactoferrin . Conclusions . The results show that bovine lactoferrin has the same efficacy as ferrous sulfate in restoring iron deposits with significantly fewer gastrointestinal side effects"
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Background Although hypnosis and hypnotherapy have become more popular in recent years , the evidence for hypnosis to influence perceived stress is unclear . In this systematic review we search ed and evaluated r and omized clinical studies investigating the effect of hypnosis on perceived stress reduction and coping . Methods The Cochrane Central Register of Controlled Trials , the Cochrane Data base of Systematic Review s , the Data base of Abstract s of Review of Effects , EMBASE , Medline , PsycINFO , PSYNDEX and PubMed were systematic ally screened from their inception until December 2015 for r and omized controlled trials ( RCTs ) reporting about hypnosis or hypnotherapy for stress reduction in healthy participants . Risk of Bias was assessed according the Cochrane Collaboration recommendations . Results Nine RCTs with a total of 365 participants met the inclusion criteria and were included in this review . Most included participants were medical students , predominantly female ( n = 211 ) . Mean age of participants ranged in most studies between 20 and 25 years , in three studies the mean ages were between 30 and 42 years . Perceived stress was measured by a wide range of psychological question naires including Face Valid Stress Test , Stress Thermometer , and immunological data was collected . All nine included studies used explorative design s and showed a high risk of bias . Six out of nine studies reported significant positive effects of hypnosis for stress reduction in the main outcome parameter compared to control groups ( 3 active controls , 3 no therapy controls ) . Immunological outcomes were assessed in six studies , the results were inconclusive . Conclusions Due to exploratory design s and high risk of bias , the effectiveness of hypnosis or hypnotherapy in stress reduction remains still unclear . More high quality clinical research is urgently needed | [
"Background Distress and burnout among medical and psychology professionals are commonly reported and have implication s for the quality of patient care delivered . Already in the course of university studies , medicine and psychology students report mental distress and low life satisfaction . There is a need for interventions that promote better coping skills in students in order to prevent distress and future burnout . This study examines the effect of a seven-week Mindfulness-Based Stress Reduction ( MBSR ) programme on mental distress , study stress , burnout , subjective well-being , and mindfulness of medical and psychology students . Methods A total of 288 students ( mean age = 23 years , 76 % female ) from the University of Oslo and the University of Tromsø were r and omly allocated to an intervention or control group . The control group continued with their st and ard university courses and received no intervention . Participants were evaluated using self-reported measures both before and after the intervention . These were : the ‘ General Health Question naire , Maslach Burnout Inventory Student version , Perceived Medical School Stress , Subjective Well-being , and Five Facet Mindfulness Question naire ’ and additional indices of compliance . Results Following the intervention , a moderate effect on mental distress ( Hedges’g 0.65 , CI = .41 , .88 ) , and a small effect on both subjective well-being ( Hedges’g 0.40 , CI = .27 , .63 ) and the mindfulness facet ‘ non-reacting ’ ( Hedges’g 0.33 , CI = .10 , .56 ) were found in the intervention group compared with the control group . A higher level of programme attendance and reported mindfulness exercises predicted these changes . Significant effects were only found for female students who additionally reported reduced study stress and an increase in the mindfulness facet ‘ non-judging ’ . Gender specific effects of participation in the MBSR programme have not previously been reported , and gender differences in the present study are discussed . Conclusion Female medical and psychology students experienced significant positive improvements in mental distress , study stress , subjective well-being and mindfulness after participating in the MBSR programme . Trial registration",
"In a prospect i ve r and omised controlled trial , 48 students were r and omly assigned to stress reduction training before exams with self-hypnosis , Johrei or a mock neurofeedback relaxation control . Peripheral blood lymphocyte sub population s and self-reported stress ( Perceived Stress Scale ) were measured before training and 1 - 2 months later as exams approached . Absolute number and percentages of CD3(+)CD4(+ ) and CD3(+)CD8(+ ) T lymphocytes , CD3(-)CD56(+ ) Natural Killer cells ( NK cells ) and NK cell cytotoxic activity was measured from venous blood . Stressed participants showed small but significant declines in both CD3(-)CD56(+ ) NK cell percentages and NK cell cytotoxic activity levels while CD3(+)CD4(+ ) T cell percentages increased , changes supported by correlations with perceived stress . The effects of stress were moderated in those who learned Johrei at exam time ; 11/12 showed increases in CD3(-)CD56(+ ) NK cell percentages with decreased percentages of CD3(+)CD4(+ ) T cells , effects not seen in the relaxation control group . Stress was also buffered in those who learned and practised self-hypnosis in whom CD3(-)CD56(+ ) NK cell and CD3(+)CD4(+ ) T cell levels were maintained , and whose CD3(+)CD8(+ ) T cell percentages , shown previously to decline with exams , increased . The results compliment beneficial effects on mood of self-hypnosis and Johrei . The results are in keeping with beneficial influences of self-hypnosis and provide the first evidence of the suggestive value of the Japanese Johrei procedure for stress reduction , which clearly warrants further investigation",
"Abstract This study ( N = 35 ) used a r and omized control design , and participants were collected from a variety of groups . After evaluating their degree of stress and burnout , coping styles , general well-being , and hypnotizability , participants were matched by stress level and r and omly assigned to an intervention or wait-list group . The intervention comprised an audio recording of a hypnotic induction accompanied by suggestions for progressive relaxation , imagery , and anchoring to be used for 2 weeks . The results show that , as compared with baseline and wait-list conditions , the hypnotic intervention had a medium-to-large beneficial effect on participants ’ experience of stress , burnout , and well-being . Some participants also decreased their use of the coping strategy escape-avoidance postintervention . Hypnotizability correlated significantly or marginally with some outcomes of the intervention , but only for 1 group",
"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",
"AIM The aim of this investigation was to measure the impact of a self-administered hypnosis intervention on resilience and the inflammatory cytokine IL-6 . METHOD Over a period of 12 weeks , 11 participants listened to a self-administered hypnosis stress reduction program design ed to recondition and improve participants ' emotional and physical reactions to perceived work and life stressors . Subjects were administered subjective measures of coping , resilience , and stress tolerance , as well as , IL-6 , an objective blood measure of inflammatory activity . RESULTS After 12 weeks , participants were observed to have a significantly lower IL-6 serum level from baseline . Further , participants reported a significant decrease in the use of negative appraisal coping ( such as , self-deprecating statements , perfectionism , and catastrophic and pessimistic thinking ) , and an improvement in eating/nutritional habits following the intervention . Baseline eating/nutritional habits and threat minimization coping significantly predicted a change in serum IL-6 over the course of the intervention in stepwise hierarchical regression analyses . CONCLUSION Pilot study provides support that a brief self-administered CD hypnosis stress reduction program can modify a physiological measure of inflammation ( IL-6 ) , and improve coping and resilience in the face of work and life stress",
"Background Chronic stress affects many Americans . Stress management programs may be prohibitively expensive or have limited access . Purpose This study aims to determine feasibility of an 8-week Internet-based stress management program ( ISM ) based on mindfulness principles in reducing stress in a 12-week , parallel , r and omized , controlled trial . Methods Participants were r and omly allocated to ISM , ISM plus online message board ( ISM+ ) , or control groups . Perceived stress , mindfulness , self-transcendence , psychological well-being , vitality , and quality of life were measured at baseline , week 8 , and week 12 using st and ard vali date d question naires . Results ISM and ISM+ groups demonstrated statistically significant improvements compared with control on all measures except vitality and physical health . Conclusions The ISM program effectively and sustainably reduced measures of stress . The magnitude of improvement is comparable to traditional mindfulness programs , although fewer participants were engaged . This feasibility study provides strong support for online stress management programs , which increase access at a fraction of cost of traditional programs",
"The effects of self-hypnosis training on immune function and mood were examined in medical students at exam time . Hypnosis involved relaxation and imagery directed at improved immune function and increased energy , alertness and concentration . Hypotheses were made about activated and withdrawn personality differences . Eight high and eight low hypnotically susceptible participants were given 10 sessions of hypnosis , one live and nine tape-recorded , and were compared with control subjects ( N=12 ) . CD3 , CD4 , CD8 , CD19 and CD56 NK cells and blood cortisol were assayed . Life-style , activated vs. withdrawn temperament , arousal and anxiety question naires were administered . Self-hypnosis buffered the decline found in controls in NK ( P CD8 cells ( P CD8/CD4 % ( P cortisol ( P change in NK cell counts correlated positively with changes in both CD8 cells and cortisol . Results were independent of changes in life-style . Energy ratings were higher after hypnosis ( P increased calmness with hypnosis correlated with an increase in CD4 counts ( P temperament , notably the cognitive subscale ( speaking and thinking quickly ) , was predictive of exam levels of T and B lymphocytes ( P&z . Lt;0.08-P cell-mediated immunity achieved by a relatively brief , low cost psychological intervention in the face of a compelling , but routine , stress in young , healthy adults have implication s for illness prevention and for patients with compromised immunity",
"This study assessed the psychosocial modulation of cellular immunity in 34 medical-student volunteers . The first blood sample was obtained 1 month before examinations , and the second on the day of examinations . There were significant declines in the percentage of helper/inducer T- lymphocytes , in the helper/inducer-suppressor/cytotoxic-cell ratio , and in natural killer-cell activity in the blood sample s obtained on the day of examinations . Half of the subjects were r and omly assigned to a relaxation group which met between sample points ; the frequency of relaxation practice was a significant predictor of the percentages of helper/inducer cells in the examination sample . Three biochemical nutritional assays ( albumin , transferrin , and total iron-binding protein ) were within normal limits on both sample s. Data from the Brief Symptom Inventory showed significantly increased global self-rated distress associated with examinations in the no-intervention group , compared to nonsignificant change in the relaxation group . Clinical and theoretical implication s are discussed",
"It has been suggested that teacher stress might be reduced through cognitive restructuring which is aim ed at improving the rationality of their thinking . To test this hypothesis , 40 high school teachers were paired on their level of reasonable thinking , operationalized in terms of scores on the Teacher Idea Inventory ( Bernard , Joyce , & Rosewarne , 1983 ) , and allocated at r and om to one of 2 groups . They also completed the Face Valid Stress Test . The experimental group participated in 4 weekly treatment sessions involving a hypnotic induction and suggestions derived from key elements of Rational-Emotive Therapy . These focused on the reduction of what Ellis ( Ellis & Grieger , 1977 ) , the originator of this treatment , calls \" irrational thinking . \" The control group spent the same amount of time discussing stress reduction methods . Both the Face Valid Stress Test and the Teacher Idea Inventory were re-administered at the end of this period and again 12 months after conclusion of the experiment . Results indicated that both the experimental and control groups significantly reduced their levels of irrational thinking and stress , although the former 's improvement was more marked , particularly at the 12-month follow-up",
"Post-ischaemic flow mediated dilation of peripheral arteries ( FMD ) is transiently reduced during mental stress . This experiment was aim ed at assessing whether hypnosis , which is a powerful relaxation technique , modulated the FMD response to mental stress in subjects with different hypnotic susceptibility . Results showed that hypnotic relaxation prevented the expected stress-related reduction of FMD only in highly hypnotizable subjects , suggesting a protective role of hypnotisability against vascular damage",
"This study implemented an innovative new model of delivering a Mindfulness-Based Stress Reduction ( MBSR ) program that replaces six of the eight traditional in-person sessions with group telephonic sessions ( tMBSR ) and measured the program 's impact on the health and well-being of nurses employed within a large health care organization . As part of a nonr and omized pre – post intervention study , 36 nurses completed measures of health , stress , burnout , self-compassion , serenity , and empathy at three points in time . Between baseline ( Time 1 ) and the end of the 8-week tMBSR intervention ( Time 2 ) , participants showed improvement in general health , t(37 ) = 2.8 , p .01 , decreased stress , t(37 ) = 6.8 , p .001 , decreased work burnout , t(37 ) = 4.0 , p .001 , and improvement in several other areas . Improvements were sustained 4 months later ( Time 3 ) , and individuals who continued their MBSR practice after the program demonstrated better outcomes than those that did not . Findings suggest that the tMBSR program can be a low cost , feasible , and scalable intervention that shows positive impact on health and well-being , and could allow MBSR to be delivered to employees who are otherwise unable to access traditional , on-site programs",
"To assess the influence of a hypnotic intervention on cellular immune function during a commonplace stressful event , the authors selected 33 medical and dental students on the basis of hypnotic susceptibility . Initial blood sample s were obtained during a lower stress period , and a second sample was drawn 3 days before the first major exam of the term . Half of the participants were r and omly assigned to hypnotic-relaxation training in the interval between sample s. Participants in the hypnotic group were , on average , protected from the stress-related decrements that were observed in control participants ' proliferative responses to 2 mitogens , percentages of CD3 + and CD4 + T-lymphocytes , and interleukin 1 production by peripheral blood leukocytes . More frequent hypnotic-relaxation practice was associated with higher percentages of CD3 + and CD4 + T-lymphocytes . These data provide encouraging evidence that interventions may reduce the immunological dysregulation associated with acute stressors",
"& NA ; Stress reducing strategies are useful in patients undergoing surgery . Hypnosis is also known to alleviate acute and chronic pain . We therefore compared the effectiveness of these two psychological approaches for reducing perioperative discomfort during conscious sedation for plastic surgery . Sixty patients scheduled for elective plastic surgery under local anesthesia and intravenous sedation ( midazolam and alfentanil upon request ) were included in the study after providing informed consent . They were r and omly allocated to either stress reducing strategies ( control : CONT ) or hypnosis ( HYP ) during the entire surgical procedure . Both techniques were performed by the same anesthesiologist ( MEF ) . Patient behavior was noted during surgery by a psychologist , the patient noted anxiety , pain , perceived control before , during and after surgery , and postoperative nausea and vomiting ( PONV ) . Patient satisfaction and surgical conditions were also recorded . Peri‐ and postoperative anxiety and pain were significantly lower in the HYP group . This reduction in anxiety and pain were achieved despite a significant reduction in intraoperative requirements for midazolam and alfentanil in the HYP group ( alfentanil : 8.7±0.9 & mgr;g kg−1/h−1 vs. 19.4±2 & mgr;g kg−1/h−1 , P : 0.04±0.003 mg kg−1/h−1 vs. 0.09±0.01 mg kg−1/h−1 , P intraoperative control than those in the CONT group ( P were significantly reduced in the HYP group ( 6.5 % vs. 30.8 % , P were better in the HYP group . Less signs of patient discomfort and pain were observed by the psychologist in the HYP group ( P ) . Vital signs were significantly more stable in the HYP group . Patient satisfaction score was significantly higher in the HYP group ( P better perioperative pain and anxiety relief , allows for significant reductions in alfentanil and midazolam requirements , and improves patient satisfaction and surgical conditions as compared with conventional stress reducing strategies support in patients receiving conscious sedation for plastic surgery",
"This study was a 19-week prospect i ve conducted to determine the effectiveness of a self-hypnosis/relaxation intervention to relieve symptoms of psychological distress and moderate immune system reactivity to examination stress in 35 first-year medical students . Twenty-one subjects were r and omly selected for training in the use of self-hypnosis as a coping skill and were encouraged to practice regularly and to maintain daily diary records related to mood , sleep , physical symptoms , and frequency of relaxation practice . An additional 14 subjects received no explicit training in stress-reduction strategies , but completed similar daily diaries . Self-report psychosocial and symptom measures , as well as blood draws , were obtained at four time points : orientation , late semester , examination period , and postsemester recovery . It was found that significant increases in stress and fatigue occurred during the examination period , paralleled by increases in counts of B lymphocytes and activated T lymphocytes , PHA-induced and PWM-induced blastogenesis , and natural killer cell ( NK ) cytotoxicity . No immune decreases were observed . Subjects in the self-hypnosis condition reported significantly less distress and anxiety than their nonintervention counterparts , but the two groups did not differ with respect to immune function . Nevertheless , within the self-hypnosis group , the quality of the exercises ( ie , relaxation ratings ) predicted both the number of NK cells and NK activity . It was concluded that stress associated with academic dem and s affects immune function , but immune suppression is not inevitable . Practice of self-hypnosis reduces distress , without differential immune effects . However , individual responses to the self-hypnosis intervention appear to predict immune outcomes",
"Abstract Hemophilia , the bleeder 's disease , is characterized by internal bleeding episodes which have been associated anecdotally with psychological stress . The focus of the present investigation was to study the potential utility of a comprehensive self-hypnosis training program to decrease stress and to assess the amount of clotting factor used for bleeding by those individuals trained in self-hypnosis compared to a control group . 30 severe hemophiliacs on home therapy were r and omly assigned to a treatment or to a waiting list control group . The treatment group received a comprehensive 6-week training program including support , education , deep relaxation , and self-hypnosis . Over the 18-week follow-up , the treatment group significantly reduced the amount of factor concentrate used to control bleeding in comparison to controls . The treatment group also significantly reduced general distress level as measured by a symptom checklist . The training was extremely cost effective , and the results support the eff",
"This study evaluated the effects of a behavioral stress-management program on anxiety , mood , self-esteem , and T-cell count in a group of HIV-positive men who were asymptomatic except for T-cell counts below 400 . The program consisted of 20 biweekly sessions of progressive muscle relaxation and electromyograph biofeedback-assisted relaxation training , meditation , and hypnosis . Ten subjects were r and omly assigned to either a treatment group or a no-treatment control group , and the 2 groups were compared on pre- to posttreatment changes in the dependent measures . Analysis showed that , compared with the no-treatment group , the treatment group showed significant improvement on all the dependent measures , which was maintained at a 1-mo . follow-up . Since stress is known to compromise the immune system , these results suggest that stress management to reduce arousal of the nervous system and anxiety would be an appropriate component of a treatment regimen for HIV infection",
"The present study examined the effectiveness of a hypnotherapeutic treatment program for patients suffering from recurrent orofacial herpes infections . Twenty-one patients were r and omly allocated to either an experimental group ( n=10 ) or a control condition ( n=11 ) . During five weekly individual therapy sessions the participants received symptom-oriented treatment . In addition , they learnt how to improve their stress coping skills and their management of aversive emotions . The final assessment took place 6 months after treatment . Besides documentation of the frequency and intensity of symptoms , question naires were administered to assess stress coping mechanisms ( SVF ) , skin disease-related subjective strain ( MHF ) and perceptions of control ( KKG ) . A significant reduction of disease intensity could be confirmed . Individual scales of the SVF and MHF also revealed significant results . For an effective treatment of severe herpes infections a mere focus on physical changes appears to be insufficient . A common reflection of a person 's sensuality and expectations of closeness and distance seem to influence treatment success remarkably",
"The study investigated whether participants who received Reiki would show greater health and well-being benefits than a group who received no Reiki . A method of blinding participants to Reiki was also tested , where non-contact Reiki or No-Reiki with r and om assignment was given to 35 healthy psychology undergraduates whose attention was absorbed in one of three tasks involving self-hypnosis/relaxation . Participants experienced ten 20-min intervention sessions over a period of two and a half to 12 weeks . Reiki was directed by the experimenter who sat behind the participants as they were absorbed in the tasks . Self-report measures of illness symptoms , mood and sleep were assessed pre-post-intervention as was salivary cortisol . While the Reiki group had a tendency towards a reduction in illness symptoms , a substantive increase was seen in the No-Reiki . The Reiki group also had a near-significant comparative reduction in stress , although they also had significantly higher baseline illness symptoms and stress scores . The Reiki blinding was successful - the groups did not differ statistically in their beliefs regarding group membership . The results are suggestive that the Reiki buffered the substantive decline in health in the course of the academic year seen in the No-Reiki group"
] | 4116635c-06ff-11f0-808a-c43d1ab1c353 |
Study Design : Retrospective literature review of spine surgical site infection ( SSI ) . Objective : To perform a review of SSI risk factors and more specifically , categorize them into patient and surgical factors . Methods : A review of published literature on SSI risk factors in adult spine surgery was performed . We included studies that reported risk factors for SSI in adult spinal surgery . Excluded are pediatric patient population s , systematic review s , and meta-analyses . Overall , we identified 72 cohort studies , 1 controlled-cohort study , 1 matched-cohort study , 1 matched-paired cohort study , 12 case-controlled studies ( CCS ) , 6 case series , and 1 cross-sectional study . Results : Patient-associated risk factors — diabetes mellitus , obesity ( body mass index > 35 kg/m2 ) , subcutaneous fat thickness , multiple medical comorbidities , current smoker , and malnutrition were associated with SSI . Surgical associated factors — preoperative radiation/postoperative blood transfusion , combined anterior/posterior approach , surgical invasiveness , or levels of instrumentation were associated with increased SSI . There is mixed evidence of age , duration of surgery , surgical team , intraoperative blood loss , dural tear , and urinary tract infection/urinary catheter in association with SSI . Conclusion : SSIs are associated with many risk factors that can be patient or surgically related . Our review was able to identify important modifiable and nonmodifiable risk factors that can be essential in surgical planning and discussion with patients | [
"Background : Postoperative infection is one of the most common complications after spine surgeries . In our study , surgical site infection ( SSI ) is described as ; superficial ( i.e. , skin and subcutaneous tissues ) and deep ( i.e. , fascia and muscles ) infections occurring in the short term ( i.e. , 1-month ) after spine surgeries ( Centers for Disease Control and Prevention definition 81.00–81.08 ) . To detect the risk factors for the occurrence of such a complication , studies require a large number of patients , a high quality of data and adequate analysis . In this study , we prospect ively enrolled 987 patients undergoing spinal surgery over a 3 years period . Methods : From November 2010 to November 2013 , 987 patients had a variety of spinal operations that included ; disc herniation , spinal stenosis , spondylolisthesis , fracture-dislocations , spine and spinal cord tumors , and syringomyelia . Patients under the age of 10 , those with a recent history of infection and antibiotherapy , and patients with immunodeficiency disorders were excluded . Results : Of the 987 spine procedures performed , 27 ( 2.73 % ) developed postoperative infections . Multi-variant data analysis indicated that multiple factors correlated with an increased risk of SSI in descending order ; trauma , a past history of diabetes , smoking , being confined to bed , in the perioperative period , mean blood sugar levels above 120 mg/dl , longer lengths of incisions , and longer hospital stay . Conclusion : Considering the preventable nature of most of the factors contributing to SSI , it should be possible to reduce these complications",
"Study Design . Prospect i ve cohort study . Objective . To study risk factors linked to spinal fusion surgical wound infection ( SWI ) incidence and compare the incidence with rates in Madrid Region , Spain and United States as a whole . Summary of Background Data . SWI is one of the complications posed by spinal surgery . Indeed , spinal surgery has a higher infection rate than do other orthopedic surgeries such as total hip or knee arthroplasty . The study of risk factors that are susceptible to be modified will enable both the incidence of SWI and , by extension , related morbidity , mortality , and costs to be reduced . Methods . All patients undergoing spinal fusion at a tertiary hospital from June 2011 to June 2014 were included . Infection rate was calculated , and the association between risk factors and SWI incidence was assessed by reference to odds ratio ( OR ) with univariate and multivariate analysis . Results . The study population ( n = 892 ) had a SWI rate of 3.9 % . The st and ardized infection ratio of our hospital was 0.58 with respect to the Madrid Region , 0.76 with respect to Spain 's national rate and 2.05 with respect to the US NHSN/CDC . The multivariate analysis showed that predictive factors of SWI were diabetes mellitus ( OR 2.81 , 95 % confidence interval , CI : 1.18–6.72 , P chronic obstructive pulmonary disease ( COPD ) ( OR 5.16 , 95 % CI : 2.04–13.08 , P duration of surgery higher than the 75th percentile ( OR 5.39 , 95 % CI : 1.77–110.84 , P dirty surgery ( OR 14.01 , 95 % CI : 1.01–28.88 , P SWI in spinal fusion are existence of diabetes mellitus , COPD , duration of surgery higher than the 75th percentile and dirty surgery . Knowing these risk factors enables action to be taken to reduce the SWI rate . Level of Evidence :",
"Purpose Studies have examined infection rates following spine surgery and their relationship to post-operative complications and increased length of stay . Few studies , however , have investigated predictors of infection , specifically in the setting of operative intervention for cervical spondylotic myelopathy ( CSM ) . This study aims to identify the incidence and factors predictive of infection amongst this cohort . Methods This study performed a retrospective review of the prospect ively collected American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) data base . Patients included those treated surgically for CSM ( ICD-9 code 721.1 ) from 2010 to 2012 . Patient demographics and surgical data were collected with outcome variables including the occurrence of one of the following surgical site infections ( SSIs ) within 30 days of index operation : superficial SSI , deep incisional SSI , and organ/space SSI . Results 3057 patients were included in this analysis . Overall infection rate was 1.15 % ( 35/3057 ) , of which 54.3 % ( 19/35 ) were superficial SSIs , 28.6 % ( 10/35 ) were deep incisional SSI , and 20 % ( 7/35 ) were peri-spinal SSI . Logistic regression revealed factors associated with SSI included : higher BMI [ OR 1.162 ( CI 1.269–1.064 ) , p = 0.001 ] and operative time ≥208 min [ OR 4.769 ( CI 20.220–1.125 ) , p = 0.034 ] . Conclusions The overall SSI rate for the examined CSM cohort was 1.15 % . This study identified increased BMI and operative time ≥208 min as predictors of infection in surgical CSM patients . This information should be carefully considered in delivering patient education and future efforts to optimize risk in CSM patients indicated for surgical intervention",
"Study Design . A retrospective review of prospect ively collected data . Objective . The aim of this study was to determine the impact of current smoking or prior smoking cessation on 30-day morbidity risk following lumbar spine surgery . Summary of Background Data . Prior studies have reported conflicting data regarding the impact of smoking on morbidity risk , and few studies have investigated smoking cessation . Methods . A large , multicenter , prospect ively collected clinical registry was queried for all adult patients undergoing lumbar spine surgery in 2012 and 2013 , and 35,477 cases were identified . Morbidity data are collected by on-site clinical personnel for 30 days postoperatively . Patients were divided into categories of “ never-smoker , ” for patients with no reported cigarette use ( n = 27,246 ) , “ former smoker , ” for patients who quit smoking more than 12 months before surgery ( n = 562 ) , and “ current smoker , ” for patients still using cigarettes ( n = 7669 ) . A univariate analysis was conducted to identify un-adjusted differences in morbidity risk , and a multivariate analysis was conducted in an attempt to control for confounders . Results . In the multivariate analysis , current smokers had a significantly higher risk of both superficial surgical site infection and overall wound complications , than never-smokers ( P total 30-day morbidity ( P = 0.04 ) . There was a trend toward former smokers also having an increased risk , but this did not reach significance in any category . Patients with a pack-year smoking history of 1 to 20 pack-years and more than 40 pack-years both had a significantly higher risk of superficial surgical site infections ( P systemic morbidity and wound complications following elective lumbar spine procedures . Increasing pack year history was also associated with wound complication risk , suggesting a dose-related effect . The data provide preliminary support for future studies on smoking cessation . Level of Evidence :",
"OBJECT Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy ( CSM ) are not clear . Appreciating these risks is important for patient counseling and quality improvement . The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM . METHODS Data from the AOSpine North America Cervical Spondylotic Myelopathy Study , a prospect i ve , multicenter study , were analyzed . Outcomes data , including adverse events , were collected in a st and ardized manner and externally monitored . Rates of perioperative complications ( within 30 days of surgery ) and delayed complications ( 31 days to 2 years following surgery ) were tabulated and stratified based on clinical factors . RESULTS The study enrolled 302 patients ( mean age 57 years , range 29 - 86 ) years . Of 332 reported adverse events , 73 were classified as perioperative complications ( 25 major and 48 minor ) in 47 patients ( overall perioperative complication rate of 15.6 % ) . The most common perioperative complications included minor cardiopulmonary events ( 3.0 % ) , dysphagia ( 3.0 % ) , and superficial wound infection ( 2.3 % ) . Perioperative worsening of myelopathy was reported in 4 patients ( 1.3 % ) . Based on 275 patients who completed 2 years of follow-up , there were 14 delayed complications ( 8 minor , 6 major ) in 12 patients , for an overall delayed complication rate of 4.4 % . Of patients treated with anterior-only ( n = 176 ) , posterior-only ( n = 107 ) , and combined anterior-posterior ( n = 19 ) procedures , 11 % , 19 % , and 37 % , respectively , had 1 or more perioperative complications . Compared with anterior-only approaches , posterior-only approaches had a higher rate of wound infection ( 0.6 % vs 4.7 % , p = 0.030 ) . Dysphagia was more common with combined anterior-posterior procedures ( 21.1 % ) compared with anterior-only procedures ( 2.3 % ) or posterior-only procedures ( 0.9 % ) ( p incidence of C-5 radiculopathy was not associated with the surgical approach ( p = 0.8 ) . The occurrence of perioperative complications was associated with increased age ( p = 0.006 ) , combined anterior-posterior procedures ( p = 0.016 ) , increased operative time ( p = 0.009 ) , and increased operative blood loss ( p = 0.005 ) , but it was not associated with comorbidity score , body mass index , modified Japanese Orthopaedic Association score , smoking status , anterior-only versus posterior-only approach , or specific procedures . Multivariate analysis of factors associated with minor or major complications identified age ( OR 1.029 , 95 % CI 1.002 - 1.057 , p = 0.035 ) and operative time ( OR 1.005 , 95 % CI 1.002 - 1.008 , p = 0.001 ) . Multivariate analysis of factors associated with major complications identified age ( OR 1.054 , 95 % CI 1.015 - 1.094 , p = 0.006 ) and combined anterior-posterior procedures ( OR 5.297 , 95 % CI 1.626 - 17.256 , p = 0.006 ) . CONCLUSIONS For the surgical treatment of CSM , the vast majority of complications were treatable and without long-term impact . Multivariate factors associated with an increased risk of complications include greater age , increased operative time , and use of combined anterior-posterior procedures",
"BACKGROUND CONTEXT There is a lack of information about postoperative outcomes and related risk factors associated with spinal surgery in patients with Parkinson 's disease ( PD ) . PURPOSE This study aim ed to investigate the postoperative morbidity and mortality associated with spinal surgery for patients with PD , and the risk factors for poor outcomes . STUDY DESIGN This is a retrospective matched-pair cohort study . PATIENT SAMPLE Data of patients who underwent elective spinal surgery between July 2010 and March 2013 were extracted from the Diagnosis Procedure Combination data base , a nationwide inpatient data base in Japan . OUTCOME MEASURES In-hospital mortality and occurrence of postoperative complications . METHODS For each patient with PD , we r and omly selected up to four age- and sex-matched controls in the same hospital in the same year . The differences in in-hospital mortality and occurrence of postoperative complications were compared between patients with PD and controls . A multivariable logistic regression model fitted with a generalized estimation equation was used to identify significant predictors of major complications ( surgical site infection , sepsis , pulmonary embolism , respiratory complications , cardiac events , stroke , and renal failure ) . Multiple imputation was used for missing data . RESULTS Among 154,278 patients undergoing spinal surgery , 1,423 patients with PD and 5,498 matched controls were identified . Crude in-hospital mortality was higher in patients with PD than in controls ( 0.8 % vs. 0.3 % , respectively ) . The crude proportion of major complications was also higher in patients with PD ( 9.8 % vs. 5.1 % in controls ) . Postoperative delirium was more common in patients with PD ( 30.3 % ) than in controls ( 4.3 % ) . Parkinson 's disease was a significant predictor of major postoperative complications , even after adjusting for other risk factors ( odds ratio , 1.74 ; 95 % confidence intervals , 1.37 - 2.22 ; p Patients with PD had a significantly increased risk of postoperative complications following spinal surgery . Postoperative delirium was the most frequently observed complication",
"INTRODUCTION Spine surgery is known to have a high risk of surgical site infection ( SSI ) . Multiple studies have looked into the risk factors and incidence of SSI during elective surgery , but only two retrospective studies have specifically evaluated SSI during surgery following spine trauma . MATERIAL S AND METHODS This work was based on a prospect i ve cohort study that included all the patients operated on for spinal trauma at 13 French hospitals over a three-month period . The main endpoint was the occurrence of a SSI during the three-month period . Patients with multiple trauma or open fractures were excluded from the study . RESULTS Of the 169 patients re-examined after a minimum of three months , six had had an acute SSI ( 3.55 % ) . The following factors were significantly related to a SSI : age , ASA score , diabetes , procedure duration , delay elapsed between accident and procedure , number of levels fused , bleeding and prolonged presence of urinary catheter . DISCUSSION Our results were consistent with the published infection rates of 2 to 10 % . The risk factors identified have all been described in previous studies on elective spine surgery . LEVEL OF EVIDENCE Level IV , prospect i ve cohort study",
"Study Design . Retrospective review of three spine surgery data bases . Objectives . The purpose of the present study is to determine whether predictors of hospital readmission and surgical site infection ( SSI ) after lumbar fusion will be the same in United States , Denmark , and Japan . Summary of Background Data . Because clinical decision making becomes more data driven , risk stratification will be crucial to minimize complications . Spine surgeons worldwide face this issue , leading to parallel efforts to address risk stratification . This raises the question as to whether pooled data would be valuable and whether models generated in one country would be applicable to other population s. Methods . Predictors of SSI and 30-day readmission from three prospect i ve data bases ( National Neurosurgery Quality and Outcomes Data base [ N2QOD ] N = 2653 , DaneSpine N = 1993 , Japan Multicenter Spine Data base [ JAMSD ] N = 3798 ) were determined and compared to identify common or divergent predictive risks . Results . Predictive variables differed in the three data bases , for both readmission and SSI . Factors predictive for hospital readmission were American Society of Anesthesiologists ( ASA ) grade in N2QOD ( P = 0.013 , odds ratio [ OR ] 2.08 ) , fusion levels in DaneSpine ( P = 0.005 , OR 1.67 ) , and sex in JAMSD ( P = 0.001 , OR = 2.81 ) . Associated differences in demographics and procedural factors included mean ASA grade ( N2QOD = 2.45 , JAMSD = 1.72 ) and fusion levels ( N2QOD = 1.39 , DaneSpine = 1.52 , JAMSD = 1.34 ) . For SSI , sex ( P = 0.000 , OR = 3.30 ) , diabetes ( P = 0.000 , OR = 2.90 ) , and length of stay ( P = 0.000 , OR = 1.02 ) were predictive in JAMSD . No predictors were identified in N2QOD or DaneSpine . Conclusion . Predictors of SSI and hospital readmission differ in the United States , Denmark , and Japan , suggesting that risk stratification models may need to be population specific or adjusted . Some differences in measured parameters exist in the three data bases analyzed ; however , patient and procedure selection also appear to differ and may limit the ability to directly pool data from different regions . Therefore , risk stratification models developed in one country may not be directly applicable to other countries . Level of Evidence :",
"Background Surgical site infection ( SSI ) ranges from 1.9 % to 5.5 % in most large series . Minimally invasive surgery ( MIS ) has been postulated to reduce SSI rates . Questions / purpose s(1 ) Is MIS associated with a lower incidence of SSI compared with open spinal surgery ? ( 2 ) Are there other independent risk factors associated with SSI ? ( 3 ) What bacteria are most common in spinal SSI ? Methods Medical records of 2299 patients who underwent transforaminal lumbar interbody fusion , laminectomy , or discectomy were analyzed and selected for a nested case-control analysis . Twenty-seven cases with SSI were matched with 162 control subjects without SSI stratified based on procedure performed within 28 days of the case ’s date of surgery . Patients were identified from an institutional data base at a tertiary care hospital . MIS involved spinal procedures performed through a tubular retractor system . Univariate and multivariate analyses were performed . Results Patients undergoing open spinal surgery were 5.77 times more likely to develop SSI compared with MIS approaches ( odds ratio [ OR ] , 5.77 ; 95 % confidence interval [ CI ] , 1.0–32.7 ; p = 0.048 ) . Also , from the multivariate regression model , diabetes ( OR , 4.7 ; 95 % CI , 1.3–17.0 ; p = 0.018 ) , number of levels operated on ( OR , 3.5 ; 95 % CI , 1.6–7.5 ; p = 0.001 ) , and body mass index ( OR , 1.2 ; 95 % CI , 1.0–1.3 ; p = 0.010 ) were predictive of an increased risk in SSI . Staphylococcus aureus was most frequently identified , being present in 12 of 21 ( 52.4 % ) patients in whom positive cultures were obtained . Four of the 12 patients had methicillin-resistant S aureus infection . Conclusions In our series , MIS has a lower incidence of SSI . The risk factors predictive of SSI should be further evaluated in well- design ed prospect i ve trials . Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Study Design . A retrospective review of prospect ively collected data bases of 139 consecutive patients who underwent transoral surgery for lesions of the upper cervical spine . Objective . To analyze the incidence and risk factors of local infection after transoral surgery for the craniocervical junction in a single institution and to compare the findings with the literature . Summary of Background Data . One of the primary risks associated with transoral approach for lesions in the upper cervical spine is postoperative surgical wound infection . Methods . From April 1994 to December 2012 , 139 consecutive transoral surgical procedures were performed at a single referral center . The mean age at presentation was 53.6 years ( range : 5–87 yr ) , and more than half of the patients were males ( 58.3 % ) . The majority of cases were experiencing rheumatic diseases ( 43.9 % ) , whereas tumor destruction was the indication for surgery in 23.7 % of the cases . A total of 23 % had fracture of the upper cervical spine and primary infection was found in 7 patients ( 5 % ) . The mean follow-up period was 4.5 years . Results . Infection of the pharyngeal wound occurred in 5 patients ( 3.6 % ) , solely in the rheumatic and tumor groups . The presentation was mostly in the first 4 months . A single patient with cage reconstruction after giant cell tumor C2 presented with a late infection 5 years postoperatively . Debridement and primary closure was possible in 2 patients , whereas flap coverage of the pharyngeal wall was necessary in 3 patients . The presence of implant did not have a statistically significant effect on the occurrence of infection . However , infection in the presence of titanium cage mostly necessitated flap coverage of the pharyngeal wall after removal of the cage . Conclusion . The transoral route has proved to be an invaluable method of approaching pathological lesions in the upper cervical spine . The infection rate in this work was 3.6 % . Patients with rheumatic diseases and patients presenting with tumors were more susceptible to postoperative surgical wound infection . Level of Evidence :",
"Background : Surgical site infections ( SSI ) after spinal surgery increase morbidity , mortality , length of hospital stay , and costs . Most previously identified risk factors for these infections , such as severity of illness and procedure duration , are not amenable to intervention . This study sought to identify modifiable risk factors associated with SSI after spinal surgery . Methods : This is a case-control study including case identification and review of medical records . A total of 104 patients with SSI after spinal surgery were compared to 104 r and omly selected control patients without SSI after spinal surgery in a 926-bed tertiary care hospital in Baltimore , Maryl and , between April 1 , 2001 and December 31 , 2004 . Results : Multivariate analysis identified independent risk factors for SSI after spinal surgery including prolonged procedure duration ( odds ratio [ OR ] , 4.7 ; 95 % confidence interval [ 95 % CI ] , 1.6–14 ; P American Society of Anesthesiologists score of 3 or greater ( OR , 9.7 ; 95 % CI , 3.7–25 ; P lumbar-sacral operative level ( OR , 2.9 ; 95 % CI , 1.2–7.1 ; P = 0.02 ) , posterior approach ( OR , 3.5 ; 95 % CI , 1.2–9.7 ; P = 0.02 ) , instrumentation ( OR , 2.5 ; 95 % CI , 1.1–6.0 ; P = 0.03 ) , obesity ( OR , 4.0 ; 94 % CI , 1.6–10 ; P razor shaving before surgery ( OR , 3.6 ; 95 % CI , 1.2–11 ; P = 0.02 ) , and intraoperative administered fraction of inspired oxygen of less than 50 % ( OR , 12 ; 94 % CI , 4.5–33 ; P SSI after spinal surgery",
"Background Surgical site infection is a serious and significant complication after spinal surgery and is associated with high morbidity rates , high healthcare costs and poor patient outcomes . Accurate identification of risk factors is essential for developing strategies to prevent devastating infections . The purpose of this study was to identify independent risk factors for surgical site infection among posterior thoracic and /or lumbar spinal surgery in adult patients using a prospect i ve multicenter surveillance research method . Methods From July 2010 to June 2012 , we performed a prospect i ve surveillance study in adult patients who had developed surgical site infection after undergoing thoracic and /or lumbar posterior spinal surgery at 11 participating hospitals . Detailed preoperative and operative patient characteristics were prospect ively recorded using a st and ardized data collection format . Surgical site infection was based on the definition established by the Centers for Disease Control and Prevention . Results A total of 2,736 consecutive adult patients were enrolled , of which 24 ( 0.9 % ) developed postoperative deep surgical site infection . Multivariate regression analysis indicated four independent risk factors . Preoperative steroid therapy ( P = 0.001 ) , spinal trauma ( P = 0.048 ) and gender ( male ) ( P = 0.02 ) were statistically significant independent patient-related risk factors , whereas an operating time ≥3 h ( P Conclusion Preoperative steroid therapy , spinal trauma , male gender and an operating time ≥3 h were independent risk factors for deep surgical site infection after thoracic and /or lumbar spinal surgery in adult patients . Identification of these risk factors can be used to develop protocol s aim ed at decreasing the risk of surgical site infection ",
"Surgical site infections ( SSI ) are undesired and troublesome complications after spinal surgery . The reported infection rates range from 0.7 to 11.9 % , depending on the diagnosis and the complexity of the procedure . Besides operative factors , patient characteristics could also account for increased infection rates . Because the medical , economic and social costs of SSI are enormous , any significant reduction in risks will pay dividends . The purpose of this study is to compare patients who developed deep SSI following lumbar or thoracolumbar spinal fusion with a r and omly selected group of patients who did not develop this complication in order to identify changeable risk factors . With a case – control analysis nested in a historical cohort of patients who had had a spinal fusion between January 1999 and December 2008 , we identified 36 cases with deep SSI ( CDC criteria ) . Information regarding patient-level and surgical-level risk factors was derived from st and ardized but routinely recorded data and compared with those acquired in a r and om selection of 135 uninfected patients . Univariate analyses and a multivariate logistic regression were performed . The overall rate of infection in 1,615 procedures ( 1,568 patients ) was 2.2 % . A positive history of spinal surgery was associated with an almost four times higher infection rate ( OR = 3.7 , 95 % BI = 1.6–8.6 ) . The risk of SSI increased with the number of levels fused , patients with diabetes had an almost six times higher risk and smokers had more than a two times higher risk for deep SSI . The most common organism cultured was Staphylococcus aureus . All infected patients underwent at least one reoperation , including an open débridement and received appropriate antibiotics to treat the organism . Patients who had had a previous spinal surgery are a high-risk group for infection compared with those that never had surgery . Total costs associated with preventive measures are substantial and should be compensated by health care insurance companies by means of separate clinical pathways . High-risk patients should be informed about the increased risk of complications ",
"Background : Nutritional status is a critical factor in patient outcomes in a variety of medical context s. In the surgical fields , there is substantial evidence suggesting that clinical outcomes including infection risk and surgical efficacy may be affected by preoperative nutritional status . The purpose of this study is to evaluate preoperative serum prealbumin levels , the currently preferred serum biomarker of nutritional deficiency , in relation to the risk of developing a surgical site infection . Methods : A retrospective case – control series was conducted comparing prospect ively collected preadmission serum prealbumin levels to the risk for surgical site infection following elective spine surgery . The analysis was conducted under an approved institutional quality assurance protocol . Patients were identified by querying the department billing codes for deep wound washouts over a 3-year period . A cohort of 32 patients with preoperative prealbumin levels who underwent spine surgery complicated by postoperative deep tissue infection was identified . This was compared against a case – control cohort of 74 patients who underwent spine surgery and did not experience postoperative infection . Clinical variables included demographic information , body mass index , smoking , diabetes , steroid use , length of the procedure , and length of hospital stay . The data were analyzed using multivariate Cox regression . Results : Two variables : Preoperative prealbumin were both statistically significant predictors for the risk of developing a postoperative infection with hazard ratios of 2.12 ( 95 % confidence interval [ CI ] : 1.03–4.37 ) and 2.22 ( 95 % CI : 1.04–4.75 ) , respectively . Conclusions : Our results reinforce the relationship between preoperative nutritional status and outcomes in elective spine surgery . The data indicate that preoperative prealbumin levels may be useful in risk stratification . Further study is needed to determine whether nutritional supplementation may reduce the risk of infection",
"Study Design . A retrospective case control analysis of 48 cases of postoperative infection following spinal procedures . Objectives . Spinal procedures that became infected after surgery were analyzed to identify the significance of preoperative and intraoperative risk factors . Characterization of the nature and timing of the infections was also performed . Summary of Background Data . The rate of postoperative infection following spinal surgery varies widely depending on the nature of the procedure and the patient ’s diagnosis . Preoperative comorbidities and risk factors also influence the likelihood of infection . Methods . A review of 1629 procedures performed on 1095 patients revealed that a postoperative infection developed in 48 patients ( 4.4 % ) . Data regarding preoperative and intraoperative risk factors were gathered from patient charts for these and a r and omly selected control group of 95 uninfected patients . For analysis , these patient groups were further divided into adult and pediatric subgroups , with an age cutoff of 18 years . Preoperative risk factors review ed included smoking , diabetes , previous surgery , previous infection , steroid use , body mass index , and alcohol abuse . Intraoperative factors review ed included staging of procedures , estimated blood loss , operating time , and use of allograft or instrumentation . Results . The majority of infections occurred during the early postoperative period ( less than 3 months ) . Age > 60 years , smoking , diabetes , previous surgical infection , increased body mass index , and alcohol abuse were statistically significant preoperative risk factors . The most likely procedure to be complicated by an infection was a combined anterior/posterior spinal fusion performed in a staged manner under separate anesthesia . Infections were primarily monomicrobial , although 5 patients had more than 4 organisms identified . The most common organism cultured from the wounds was Staphylococcus aureus . All patients were treated with surgical irrigation and débridement , and appropriate antibiotics to treat the cultured organism . Conclusions . Aggressive treatment of patients undergoing complex or prolonged spinal procedures is essential to prevent and treat infections . Underst and ing a patient ’s preoperative risk factors may help the physician to optimize a patient ’s preoperative condition . Additionally , awareness of critical intraoperative parameters will helpto optimize surgical treatment . It may be appropriate to increase the duration of prophylactic antibiotics or implement other measures to decrease the incidence of infection for high risk patients",
"Objective : To study the incidence and risk factors of deep-wound and organ-space surgical site infection ( SSI ) following surgery for degenerative spine disease . Methods : Data from the American College of Surgeons National Surgical Quality Improvement Program were obtained for the years 2006–2012 . All adult patients over 40 years of age who underwent elective cervical or lumbar spine surgery for degenerative spine disease were identified . Rates of deep-wound and organ-space SSI were calculated for each procedure . A multivariate logistic regression analysis was conducted to identify independent risk factors for SSI development . Results : A total of 36,440 patients were identified , with 7,627 patients ( 20.93 % ) undergoing cervical spine surgery and 28,813 patients ( 79.07 % ) undergoing lumbar spine surgery . The overall rate of SSI was 0.72 % ( n = 264 ) ; there were 189 deep-wound infections ( 0.52 % ) and 75 organ-space infections ( 0.21 % ) . The highest rates of SSI were for patients undergoing a posterolateral fusion of the lumbar spine ( 1.04 % ) , followed by patients undergoing a posterior cervical decompression ( 1.02 % ) ; the lowest rates were for patients undergoing cervical disc replacement ( 0.00 % ) . The multivariate analysis revealed that chronic steroid use ( OR 3.66 ) and increasing operative time ( OR 1.002 ) were the strongest independent risk factors for SSI development in the cervical spine , and renal morbidity ( OR 3.93 ) , hemato-oncological morbidity ( OR 2.55 ) , and chronic steroid use ( 2.04 ) were the strongest risk factors for lumbar SSI . Additionally , patients with a SSI had longer lengths of stay and higher mortality rates ( 0.76 % ) when compared to patients without a SSI ( 0.09 % ) . Conclusion : Deep-wound and organ-space infections are severe complications in patients undergoing spine surgery . In this study of a multi-centre and prospect ively collected data base , the rate of SSI was 0.72 % . Patients with renal disorders , chronic steroid use , hemato-oncological disease , and diabetes , among others , had significantly higher odds of SSI development",
"Study Design . This is a multivariate analysis of a prospect ively collected data base . Objective . To determine preoperative , intraoperative , and patient characteristics that contribute to an increased risk of postoperative wound infection in patients undergoing spinal surgery . Summary of Background Data . Current literature sites a postoperative infection rate of approximately 4 % ; however , few have completed multivariate analysis to determine factors which contribute to risk of infection . Methods . Our study identified patients who underwent a spinal decompression and fusion between 1997 and 2006 from the Veterans Affairs ’ National Surgical Quality Improvement Program data base . Multivariate logistic regression analysis was used to determine the effect of various preoperative variables on postoperative infection . Results . Data on 24,774 patients were analyzed . Wound infection was present in 752 ( 3.04 % ) patients , 287 ( 1.16 % ) deep , and 468 ( 1.89 % ) superficial . Postoperative infection was associated with longer hospital stay ( 7.12 vs. 4.20 days ) , higher 30-day mortality ( 1.06 % vs. 0.5 % ) , higher complication rates ( 1.24 % vs. 0.05 % ) , and higher return to the operating room rates ( 37 % vs. 2.45 % ) . Multivariate logistic regression identified insulin dependent diabetes ( odds ratios [ OR ] = 1.50 ) , current smoking ( OR = 1.19 ) ASA class of 3 ( OR = 1.45 ) or 4 to 5 ( OR = 1.66 ) , weight loss ( OR = 2.14 ) , dependent functional status ( 1.36 ) preoperative HCT 6 hours ( OR = 1.40 ) as statistically significant predictors of postoperative infection . Conclusion . Using multivariate analysis of a large prospect ively collected data from the National Surgical Quality Improvement Program data base , we identified the most important risk factors for increased postoperative spinal wound infection . We have demonstrated the high mortality , morbidity , and hospitalization costs associated with postoperative spinal wound infections . The information provided should help alert clinicians to presence of these risks factors and the likelihood of higher postoperative infections and morbidity in spinal surgery patients",
"Purpose To investigate the incidence of surgical-site infection ( SSI ) and determinate the risk factors of SSI in the context of spinal injury . Methods From February 1 , 2011 to July 31 , 2011 , for a multicentre cohort of patients with acute spinal injury , we prospect ively censored those with SSI for at least 12 months . We recorded epidemiologic characteristics and details of surgical procedure and postoperative care for each patient . We calculated the incidence of SSI at 1 , 3 and 12 months after surgery . Univariate and multivariate analysis were used to establish the association of risk factors and SSI . We studied clinical outcomes by a visual analog scale for pain and physical and mental component summaries ( PCS and MCS ) of the Medical Outcomes Survey 36-Item Short Form ( SF-36 ) . Results At 1 year , among 518 patients , we recorded 25 SSI events , with median occurrence at 16 days ( 25–75 % quartile : 13–44 days ) . Incidence of SSI was 3.2 % ( 95 % confidence interval [ 1.9–5.3 % ] ) at 1 month , 3.7 % ( 95 % [ 2.2–5.8 % ] ) at 3 months and 4.6 % ( 95 % CI [ 3–6.9 % ] ) at 12 months . On multivariate analysis , age , presence of diabetes and surgical duration were predictors of SSI ( p = 0.009 , p = 0.047 , and p = 0.015 respectively ) . At 12 months , infected and non-infected patients did not differ in pain ( p = 0.58 ) or SF-36 PCS ( p = 0.8 ) or MCS ( p = 0.68 ) . Conclusions In this large prospect i ve multicentre study in the context of spinal injury , we obtained an equivalent incidence rate and risk factors of SSI as found in the literature for elective spinal surgery",
"Study Design . A retrospective review of data collected prospect ively by the American College of Surgeons National Surgical Quality Improvement Program ( ACS-NSQIP ) . Objective . The aim of this study was to investigate the association between preoperative hypoalbuminemia , a marker for malnutrition , and complications during the 30 days following posterior lumbar fusion surgery . Summary of Background Data . Malnutrition is a potentially modifiable risk factor that may contribute to complications following spinal surgery . Although prior studies have identified associations between malnutrition , delayed wound healing , and surgical site infection ( SSI ) , the evidence for such a relationship within spine surgery is mixed . Methods . Patients who underwent posterior lumbar spinal fusion of one to three levels as part of the ACS-NSQIP were identified . Patients without preoperative serum albumin concentration were excluded . Outcomes were compared between patients with and without hypoalbuminemia ( defined as serum albumin concentration Four thous and three hundred ten patients were included . The prevalence of hypoalbuminemia was 4.8 % . In comparison to patients with normal albumin concentration , patients with hypoalbuminemia had a higher risk for occurrence of wound dehiscence [ 1.5 % vs. 0.2 % , adjusted relative risk ( RR ) = 5.8 , P = 0.006 ] , SSI ( 5.4 % vs. 1.7 % , adjusted RR = 2.3 , P = 0.010 ) , and urinary tract infection ( 5.4 % vs. 1.5 % , adjusted RR = 2.5 , P = 0.005 ) . Similarly , patients with hypoalbuminemia had a higher risk for unplanned hospital readmission within 30 days of surgery ( 11.7 % vs. 5.4 % , RR = 1.8 , P mean inpatient stay ( 5.2 vs. 3.7 days , RR = 1.2 , P length of stay and readmission . Future studies should evaluate methods of correcting malnutrition before lumbar spinal surgery . Such efforts have the potential to meaningfully decrease the rates of adverse events following this procedure . Level of Evidence :",
"BACKGROUND CONTEXT The impact of surgical site infection ( SSI ) is substantial . Although previous study has determined relative risk and odds ratio ( OR ) values to quantify risk factors , these values may be difficult to translate to the patient during counseling of surgical options . Ideally , a model that predicts absolute risk of SSI , rather than relative risk or OR values , would greatly enhance the discussion of safety of spine surgery . To date , there is no risk stratification model that specifically predicts the risk of medical complication . PURPOSE The purpose of this study was to create and vali date a predictive model for the risk of SSI after spine surgery . STUDY DESIGN This study performs a multivariate analysis of SSI after spine surgery using a large prospect i ve surgical registry . Using the results of this analysis , this study will then create and vali date a predictive model for SSI after spine surgery . PATIENT SAMPLE The patient sample is from a high- quality surgical registry from our two institutions with prospect ively collected , detailed demographic , comorbidity , and complication data . OUTCOME MEASURES An SSI that required return to the operating room for surgical debridement . MATERIAL S AND METHODS Using a prospect ively collected surgical registry of more than 1,532 patients with extensive demographic , comorbidity , surgical , and complication details recorded for 2 years after the surgery , we identified several risk factors for SSI after multivariate analysis . Using the beta coefficients from those regression analyses , we created a model to predict the occurrence of SSI after spine surgery . We split our data into two subsets for internal and cross-validation of our model . We created a predictive model based on our beta coefficients from our multivariate analysis . RESULTS The final predictive model for SSI had a receiver-operator curve characteristic of 0.72 , considered to be a fair measure . The final model has been uploaded for use on SpineSage.com . CONCLUSIONS We present a vali date d model for predicting SSI after spine surgery . The value in this model is that it gives the user an absolute percent likelihood of SSI after spine surgery based on the patient 's comorbidity profile and invasiveness of surgery . Patients are far more likely to underst and an absolute percentage , rather than relative risk and confidence interval values . A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery . In addition , a tool such as this can be of great use particularly as health care trends toward pay for performance , quality metrics ( such as SSI ) , and risk adjustment . To facilitate the use of this model , we have created a Web site ( SpineSage.com ) where users can enter patient data to determine likelihood for SSI",
"Study Design . Retrospective cohort study using data from the Nationwide Inpatient Sample administrative data from 1988 through 2003 . Objective . To examine perioperative morbidity and mortality for patients with and without diabetes mellitus following lumbar spinal fusion . Summary of Background Data . Diabetes has been associated with worse outcomes in a variety of orthopedic procedures including spinal surgery . There is limited evidence that diabetic patients have more complications following lumbar fusion with little published data to support this conclusion . Methods . Data from 197,461 patients who underwent lumbar fusion were included . Over 11,000 patients ( 5.6 % ) with a postoperative diagnosis of diabetes mellitus were identified . Selected variables were used for comparison of patients with and without diabetes . Bivariate statistical analyses compared postoperative complication rates while multivariate statistics were used to determine likelihood of complications with diabetes . Results . Bivariate analysis demonstrated that diabetes was significantly associated with postoperative infection , need for transfusion , pneumonia , in-hospital mortality , and nonroutine discharge ( P ≤ 0.001 ) . Adjusted multivariate regression analyses , however , suggested no difference in mortality although infection , transfusion , and nonroutine discharge continued to be highly significant ( P ≤ 0.002 ) . Significantly higher inflation adjusted total charges were also present with patients with diabetes as well as increased lengths of stay ( P representative study of in patients in the United States provides evidence that diabetes is associated with increased risk for postoperative complications , nonroutine discharge , increased total hospital charges , and length of stay following lumbar fusion . Prospect i ve studies to determine causality as well as the potential impact of diabetes control on these variables have not yet been done",
"BACKGROUND CONTEXT Surgical site infection ( SSI ) is one of the most serious complications of spine surgery . Its predisposing factors , especially in routine surgeries , are less reported . However , a number of patient- and procedure-related risk factors could be avoided or at least determined preoperatively . Moreover , the patient-specific risk for SSI could be estimated before the elective surgery . PURPOSE The aim of the present study was to analyze the preoperatively determinable risk factors for SSI in patients who require elective routine surgery related to lumbar disc degeneration and to build a multivariable model for the individual risk prediction . STUDY DESIGN Analysis of prospect ively collected st and ardized clinical data and the validation of the results on an independent prospect i ve cohort were performed . PATIENT SAMPLE One thous and thirty ( N=1,030 ) patients were included in the study . All subjects underwent primary lumbar single- or two-level decompression , microdiscectomy , or instrumented fusion . OUTCOME MEASURES Occurrence of an SSI defined according to the current Centers for Disease Control and Prevention guidelines that required surgical or nonsurgical therapy . METHODS The effect of preoperative patient characteristics , comorbidities , disease history , and invasiveness of the elective surgery on the risk of SSI was determined in uni- and multivariate logistic regression models in the test cohort ( N=723 ) . The performance of the final multivariable regression model was assessed by measuring its discriminative ability ( c-index ) in receiver operating characteristic analysis . Performance of the multivariable risk estimation model was tested on the validation ( N=307 ) cohort . RESULTS The prevalence of SSI was 3.5 % and 3.9 % in the test and in the validation cohorts , respectively . The final multivariable regression model predictive ( p=.003 ) for SSI contained the patient 's age , body mass index ( BMI ) , and the presence of 5 comorbidities , such as diabetes , ischemic heart disease , arrhythmia , chronic liver disease , and autoimmune disease as risk factors . The c-index of the model was 0.71 , showing good discriminative ability , and it was confirmed by the data of the independent validation cohort ( c=0.72 ) . CONCLUSIONS Predisposing factors for SSI were older age , higher BMI , and the presence of certain comorbidities in the present study . The cumulative number of risk factors significantly associated with the increasing risk for an SSI ( p<.0001 ) . Our model needs further validation but it may be used for individual risk assessment and reduction in the future",
"BACKGROUND CONTEXT The impact of patient factors and medical comorbidities on the risk of mortality and complications after spinal arthrodesis has not been well described . Prior works have been limited by small sample size , single center data , or the inability to be broadly generalized . PURPOSE To determine if there is an association between the patient demographic factors , comorbidities , nutritional status , and surgical characteristics and the occurrence of mortality and complications after spinal arthrodesis . STUDY DESIGN Retrospective review of prospect ively collected data in the National Surgical Quality Improvement Program ( NSQIP ) . PATIENT SAMPLE Patients who underwent spinal arthrodesis and had data registered with the NSQIP between 2005 and 2010 . OUTCOME MEASURES Primary outcomes were death or any complication after spinal arthrodesis . Secondary measures were the development of a specific complication , including wound infection , thromboembolic disease , or cardiac arrest/myocardial infa rct ion . METHODS The data set of the NSQIP from 2005 to 2010 was queried to identify all patients who underwent spinal arthrodesis . Demographic information , body mass index ( BMI ) , medical comorbidities , arthrodesis procedure , operative time , American Society of Anesthesiologists ( ASA ) classification , and preoperative albumin were recorded for all patients identified . Mortality , the development of postoperative complications , and the presence of specific complications were also abstract ed . Risk factors for mortality and complications were initially evaluated using chi-square and univariate logistic regression analyses . The risk factors that maintained p values less than .2 in univariate analysis were then combined in a multivariate fashion that identified significant , independent , predictors of mortality and complications while controlling for other factors present in the model . Sensitivity analysis was also performed , discriminating between the impact of risk factors on major and minor complications and the relative contribution to overall risk of morbidity . Multivariate analysis result ed in odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) for each risk factor . Only those predictors with ORs and 95 % CI exclusive of 1.0 and p values less than .05 were considered statistically significant . RESULTS In all , 5,887 patients who underwent spinal arthrodesis were identified . The average age of patients was 55.9 ( ±14.5 ) years . Twenty-five ( 0.42 % ) patients died after surgery , whereas 608 ( 10 % ) sustained a complication . Wound infection was the most common specific complication occurring in 2 % of the cohort . Age ( p=.03 ) and pulmonary conditions ( p=.002 ) were found to have a significant association with the risk of mortality . Age exceeding 80 years was found to carry the highest risk of mortality . Age , pulmonary conditions , BMI , history of infection , ASA classification more than 2 , neurologic conditions , resident ( i.e. , trainee ) involvement , and procedural times exceeding 309 minutes increased the risk of complications . Body mass index , ASA classification more than 2 , resident involvement , and procedural times exceeding 309 minutes were associated with the risk of infection . Although limited to univariate analysis , serum albumin 3.5 g/dL or less increased the risk of mortality , complications , wound infection , and thromboembolic disease . The OR for postoperative mortality among patients with albumin 3.5 g/dL or less was 13.8 ( 95 % CI , 4.6 - 41.6 ; p risk of postoperative morbidity to varying degrees . The risk factors identified here may be more generalizable to the American population as a whole because of the design and methodology of the NSQIP in comparison with previously published studies",
"Study Design . We conducted a retrospective , case control study on patients undergoing surgery for spinal tumors . Objective . Our aim was to determine the incidence and to identify risk factors for surgical site infections ( SSIs ) in patients undergoing surgery for spinal tumors . Summary of Background Data . SSIs after spinal tumor surgery may be particularly devastating as they may add to substantial surgical morbidity and may further exacerbate already existing neurologic deficits . Incidence and risk factors predisposing to SSIs in patients undergoing surgery for spinal tumors are not well studied yet . Methods . Between January 1995 and February 2008 , 971 procedures for spinal tumors were performed on 739 patients . Excluding sacral tumors from the current study , 895 procedures on 678 patients were review ed to identify those cases with SSIs . Furthermore , 65 infected cases and a r and omly selected subset of 162 controls were analyzed by logistic regression modeling to identify the risk factors associated with SSIs . Results . There were 678 patients that were included in this study with 364 men ( 54 % ) and 314 women ( 46 % ) , with an average age of 47.2 year . Sixty-five patients who developed SSIs underwent a total of 162 procedures including 78 procedures for wound debridement and washout . The incidence of SSIs was 8.89 % for primary nonbony spinal tumors , 9.5 % for metastatic spinal tumors , and 13.7 % for primary bony spinal tumors . Staphylococcus aureus was the most commonly isolated organism ( n = 22 of 65 , 33 % ) . In the multivariate logistic regression model , previous spinal surgeries , complex plastic closures , increasing number of comorbidities , presence of a hospital acquired infection at the time of a previous surgery , and increasing duration of hospital stay during primary surgery were significantly associated with increased likelihood of developing postoperative SSIs . Conclusion . Surgery for spine tumors appears to be associated with a higher incidence of SSI than nontumor spine surgery . Identification of perioperative risk factors will help delineate this subset of patients with high risk for developing SSIs thus potentially allowing perioperative modification for such factors , which may lead to an overall better clinical outcome and patient satisfaction",
"Study Design . Prospect i ve cohort study . Objective . To create and vali date an index describing the extent of spine surgical intervention to allow fair comparisons of complication rates among patients treated by different surgeons , devices , or hospitals . Summary of Background Data . Safety comparisons in spine surgery are limited by lack of methods that adjust for important variations in the surgical “ case-mix . ” Among other factors , the magnitude of an operation is likely to have a substantial influence on the likelihood of complications . Methods . We created a spine surgery invasiveness index defined as the sum , across all vertebral levels , of 6 possible interventions on each operated vertebra : anterior decompression , anterior fusion , anterior instrumentation , posterior decompression , posterior fusion , and posterior instrumentation . We assessed the validity of this index by examining its association with blood loss and surgery duration in 1723 spine surgeries , adjusting for important factors including age , gender , body mass index , diagnosis , neurologic deficit , revision surgery , and vertebral level of surgery . Results . Blood loss increased by 11.5 % and surgery duration increased by 12.8 minutes for each unit increase in the invasiveness index . The invasiveness index explained 44 % of the variation in blood loss and 52 % of the variation in surgery duration . For specific surgical components , blood loss increased by 9.4 % and surgery duration by 11.4 minutes for each vertebral level of anterior decompression , 19.4 % and 33.8 minutes for each segment of anterior instrumentation , 12.9 % and 22.7 minutes for each level of posterior decompression , and 25.1 % and 18.8 minutes for each segment of posterior instrumentation . Conclusion . An “ invasiveness ” index based on the number of vertebrae decompressed , fused , or instrumented showed the expected associations with both blood loss and surgery duration . This quantitative description of surgery invasiveness may be useful to adjust for surgical variations when making safety comparisons in spine surgery",
"BACKGROUND CONTEXT The incidence of surgical site infection ( SSI ) following posterior cervical surgery has been reported as high as 18 % in the literature . Few large studies have specifically examined posterior cervical procedures . PURPOSE The study aims to examine the incidence , timing , and risk factors for SSI following posterior cervical surgery . DESIGN This is a retrospective cohort study of prospect ively collected data in a national surgical outcomes data base . PATIENT SAMPLE The sample includes patients who underwent posterior cervical spine surgery between 2005 and 2012 identified in the American College of Surgeons National Surgical Quality Improvement Project ( ACS NSQIP ) Participant Use Data File . OUTCOME MEASURES The 30-day rate of postoperative SSI , timing of diagnosis , and associated risk factors were determined . METHODS The ACS NSQIP was used to identify 5,441 patients who underwent posterior cervical spine surgery by Current Procedural Terminology codes from 2005 to 2012 . Thirty-day readmission data were obtained for 2011 - 2012 . The incidence and timing of SSI were determined . Multivariable logistic regression analysis was then performed to identify significant risk factors . RESULTS Of the 5,441 patients identified as having undergone posterior cervical surgery , 3,724 had a posterior cervical decompression , 1,310 had a posterior cervical fusion , and 407 underwent cervical laminoplasty . Surgical site infection within 30 days was identified in 160 patients ( 2.94 % ) , with 80 of those cases being superficial SSI . There was no significant difference in SSI rate among the three procedure groups . The average time for diagnosis of SSI was over 2 weeks . In 2011 - 2012 , 36.9 % of patients with SSI were readmitted within 30 days . Several significant predictors of SSI were identified in univariate analysis , including body mass index ( BMI ) > 35 , chronic steroid use , albumin hematocrit platelets American Society of Anesthesiologists class , longer operative time , and longer hospital admission . Independent risk factors , including BMI > 35 ( odds ratio [OR]=1.78 , p=.003 ) , chronic steroid use ( OR=1.73 , p=.049 ) , and operative time > 197 minutes ( OR=2.08 , p=.005 ) , were identified in multivariable analysis . CONCLUSIONS Optimization of preoperative nutritional status , serum blood cell counts , and operative efficiency may lead to a reduction in SSI rates . Obese patients and patients on chronic steroid therapy should be counseled on elevated SSI risk",
"Study Design . The Spine End Results Registry ( 2003–2004 ) is a registry of prospect ively collected data of all patients undergoing spinal surgery at the University of Washington Medical Center and Harborview Medical Center . Insurance data were prospect ively collected and used in multivariate analysis to determine risk of perioperative complications . Objective . Given the negative financial impact of surgical site infections ( SSIs ) and the higher overall complication rates of patients with a Medicaid payer status , we hypothesized that a Medicaid payer status would have a significantly higher SSI rate . Summary of Background Data . The medical literature demonstrates lesser outcomes and increased complication rates in patients who have public insurance than those who have private insurance . No one has shown that patients with a Medicaid payer status compared with Medicare and privately insured patients have a significantly increased SSI rate for spine surgery . Methods . The prospect ively collected Spine End Results Registry provided data for analysis . SSI was defined as treatment requiring operative debridement . Demographic , social , medical , and the surgical severity index risk factors were assessed against the exposure of payer status for the surgical procedure . Results . The population included Medicare ( N = 354 ) , Medicaid ( N = 334 ) , the Veterans ' Administration ( N = 39 ) , private insurers ( N = 603 ) , and self-pay ( N = 42 ) . Those patients whose insurer was Medicaid had a 2.06 odds ( 95 % confidence interval : 1.19–3.58 , P = 0.01 ) of having a SSI compared with the privately insured . Conclusion . The study highlights the increased cost of spine surgical procedures for patients with a Medicaid payer status with the passage of the Patient Protection and Affordable Care Act of 2010 . The Patient Protection and Affordable Care Act of 2010 provisions could cause a reduction in reimbursement to the hospital for taking care of patients with Medicaid insurance due to their higher complication rates and higher costs . This very issue could inadvertently lead to access limitations . Level of Evidence :",
"Study Design . Prospect i ve analysis of 600 extreme lateral interbody fusion ( XLIF ) approach procedures for intraoperative and perioperative complications . Objective . To delineate and describe complications in a large , prospect i ve series of minimally invasive lateral lumbar fusion procedures ( XLIF ) . Summary of Background Data . While some small series of lateral lumbar fusion have discussed complications , no results from large studies have been reported . Methods . A total of 600 patients were treated with a lateral approach to fusion ( XLIF ) for degenerative spinal conditions . Data were collected prospect ively on all patients and analyzed for demographic , diagnostic , and hospitalization information to identify operative and early postoperative complications . Documented complication types and rates in this large series were compared with smaller prior reports on lateral approach fusions , as well as other minimally invasive ( mini-anterior lumbar interbody fusion and minimally invasive surgical [ MIS ] transforaminal lumbar interbody fusion ) and more traditional fusion approaches ( posterior intertransverse fusion , anterior lumbar interbody fusion , posterior lumbar interbody fusion , transforaminal lumbar interbody fusion ) . Results . Seven hundred forty-one levels were treated , 80.8 % single level , 15.0 % 2 level , 4.0 % 3 level , 0.2 % 4 level ; 59.3 % , including the L4 to L5 levels . A total of 99.2 % included supplemental internal fixation ; 83.2 % included pedicle screw fixation ( predominantly unilateral ) . Hemoglobin change from pre- to postoperation averaged 1.38 . Hospital stay averaged 1.21 days . The overall incidence of perioperative complications ( intraoperation and out to 6 weeks postoperation ) was 6.2 % : 9 ( 1.5 % ) in-hospital surgery-related events , 17 ( 2.8 % ) in-hospital medical events , 6 ( 1.0 % ) out-of-hospital surgery-related events , and 5 ( 0.8 % ) out-of-hospital medical events . There were no wound infections , no vascular injuries , no intraoperative visceral injuries , and 4 ( 0.7 % ) transient postoperative neurologic deficits . Eleven events ( 1.8 % ) result ed in additional procedures /reoperation . Conclusions . Compared with traditional open approaches , the MIS lateral approach to fusion by using the XLIF technique result ed in a lower incidence of infection , visceral and neurologic injury , and transfusion as well as markedly shorter hospitalization . Complications in MIS XLIF compare favorably with those from other MIS fusion procedures ; duration of hospitalization is shorter than with any previously reported technique"
] | 41166398-06ff-11f0-808a-c43d1ab1c353 |
Purpose Currently , radiofrequency ( RF ) and cryoballoon are the most commonly used ablation technologies for atrial fibrillation ( AF ) . We performed a meta- analysis to assess the efficacy and safety of the second-generation cryoballoons ( CB-2 ) compared with RF for paroxysmal atrial fibrillation ( PAF ) ablation . Methods The PubMed , Cochrane Library , and Embase data bases were search ed and qualified studies were identified . The primary clinical outcome was the recurrence rate of atrial tachyarrhythmia ( AT ) , and the secondary clinical outcomes were procedure time , fluoroscopy time , and the complications that followed . Results Nine observational studies ( 2336 patients ) with a mean follow-up period ranging from 8.8 to 16.8 months were included . The CB-2 group was associated with a significantly lower recurrence rate of ATs ( 20.8 versus 29.8 % , p = 0.01 ) . In subgroup analysis , compared with non-contact force sensing ( NCF ) catheter , using CB-2 showed significantly reduced incidence of ATs ( 22.0 versus 38.5 % , p CB-2 group had a tendency to decrease procedure time ( weighted mean difference −39.72 min , p = 0.0003 ) , whereas fluoroscopy time was similar between the two groups . The total complication rate showed no statistical difference ( 8.8 versus 4.4 % , p = 0.08 ) . Almost all the cases of phrenic nerve palsy occurred in the CB-2 group , whereas pericardial tamponade was seldom manifested in the CB-2 group . Conclusions CB-2 tended to be more effective in comparison to NCF catheter and at least non-inferior to CF catheter , with shorter procedure time and similar safety endpoint | [
"OBJECTIVES This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology design ed to achieve single-delivery pulmonary vein ( PV ) isolation . BACKGROUND St and ard radiofrequency ablation is effective in eliminating atrial fibrillation ( AF ) but requires multiple lesion delivery at the risk of significant complications . METHODS Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 r and omization to either cryoballoon ablation ( n = 163 ) or drug therapy ( n = 82 ) . A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary . Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months . RESULTS Patients had highly symptomatic AF ( 78 % paroxysmal , 22 % early persistent ) and experienced failure of at least one antiarrhythmic drug . Cryoablation produced acute isolation of three or more PVs in 98.2 % and all four PVs in 97.6 % of patients . PVs isolation was achieved with the balloon catheter alone in 83 % . At 12 months , treatment success was 69.9 % ( 114 of 163 ) of cryoblation patients compared with 7.3 % of antiarrhythmic drug patients ( absolute difference , 62.6 % [ p recurrent , symptomatic AF , constituting drug treatment failure . There were 7 of the result ing 228 cryoablated patients ( 3.1 % ) with a > 75 % reduction in PV area during 12 months of follow-up . Twenty-nine of 259 procedures ( 11.2 % ) were associated with phrenic nerve palsy as determined by radiographic screening ; 25 of these had resolved by 12 months . Cryoablation patients had significantly improved symptoms at 12 months . CONCLUSIONS The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF , for whom at least one antiarrhythmic drug has failed , with risks within accepted st and ards for ablation therapy . ( A Clinical Study of the A rct ic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [ Stop AF ] ; NCT00523978 )",
"INTRODUCTION There are limited comparative data on catheter ablation of atrial fibrillation ( CAAF ) using the second-generation cryoballoon ( CB-2 ) versus point-by-point radiofrequency ( RF ) . This study examines the acute/long-term CAAF outcomes using these 2 strategies . METHODS AND RESULTS In this multicenter , retrospective , nonr and omized analysis , procedural and clinical outcomes of 1,196 patients ( 76 % with paroxysmal AF ) undergoing CAAF using CB-2 ( n = 773 ) and open-irrigated , non-force sensing RF ( n = 423 ) were evaluated . Pulmonary vein isolation was achieved in 98 % with CB-2 and 99 % with RF ( P = 0.168 ) . CB-2 was associated with shorter ablation time ( 40 ± 14 min vs. 66 ± 26 min ; P and procedure time ( 145 ± 49 minutes vs. 188 ± 42 minutes ; P greater fluoroscopic utilization ( 29 ± 13 minutes vs. 23 ± 14 minutes ; P transient ( 7.6 % vs. 0 % ; P persistent ( 1.2 % vs. 0 % ; P = 0.026 ) phrenic nerve palsy occurred exclusively with CB-2 , other adverse event rates were similar between CB-2 ( 1.6 % ) and RF ( 2.6 % ) ; P = 0.207 . However , freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 ( 76.6 % ) versus RF ( 60.4 % ) ; P patients with paroxysmal AF ( P Additionally , CB-2 was associated with reduced long-term need for antiarrhythmic therapy ( 16.7 % vs. 22.0 % ; P = 0.024 ) and repeat ablations ( 14.6 % vs. 24.1 % ; P CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated , non-force sensing RF , alone",
"OBJECTIVES The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation ( AF ) after pulmonary vein ( PV ) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters . BACKGROUND Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size . METHODS This was a prospect i ve observational study involving 605 consecutively enrolled patients with symptomatic paroxysmal AF ( n = 579 ) or persistent AF . Cryoballoon size was based on magnetic resonance imaging and /or conventional angiograms . Patients were followed up every 3 months during the first year after discharge and every 6 months in the second year . After 24 months , follow-up was on an outpatient basis with documented AF episodes recorded . RESULTS The PV isolation was achieved without touch-up in 91.1 % of patients , using the smaller balloon in 26.7 % , the larger balloon in 25.6 % , and both balloons in 47.7 % of patients . Follow-up data for > 12 months ( median 30 months ; interquartile range 18 to 48 months ) were available for 451 patients , 278 ( 61.6 % ) of whom were free of AF recurrence with no need for repeat procedures after the 3-month blanking period . Rates of freedom from AF after 1 , 2 , and 3 repeat procedures ( using cryoballoon or radiofrequency ablation with similar success rates ) were 74.9 % , 76.2 % , and 76.9 % , respectively . Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF . Phrenic nerve palsy occurred in 12 patients ( 2 % ) , resolving within 3 to 9 months . CONCLUSIONS Rates of long-term freedom from AF after cryoballoon ablation are similar to those reported for radiofrequency ablation . A choice between balloons may improve outcomes",
"BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome ",
"Background — There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency ( RF ) and cryoballoon catheter ( CB ) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation . Methods and Results — In a prospect i ve , noninferiority study , 315 patients were r and omly assigned to RF ( n=159 ) or CB ( n=156 ) ablation . The primary end point was freedom from atrial arrhythmia with absence of persistent complications . Patients were largely comparable between groups with more vascular disease in the RF group ( 8.2 % versus 2.6 % for CB ; P=0.028 ) . The primary end point at 12 months was achieved by 70.7 % with RF and 73.6 % with CB ( multiple procedure success ) , including 31 redo procedures in each group ( 19.5 % of RF versus 19.9 % of CB ; P=0.933 ) . For the intention-to-treat population , noninferiority of CB was revealed for the predefined inferiority margin ( risk difference , 0.029 ; 95 % confidence interval , −0.074 to 0.132 ; P Rates at 6 months were 63.1 % and 64.1 % for the RF and CB groups ( single procedure success ) , and noninferiority was confirmed ( risk difference , 0.010 ; 95 % confidence interval , −0.097 to 0.116 ; P=0.002 ) . Periprocedural complications for the index procedure were more frequent in the CB group ( 5.0 % RF , 12.2 % CB ; P=0.022 ) with a significant difference in phrenic nerve palsies ( 0 % RF , 5.8 % CB ; P=0.002 ) . Conclusion — This large , prospect i ve , r and omized , controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00774566",
"BACKGROUND Catheter ablation is an established treatment for atrial fibrillation ( AF ) . Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to compare procedural times , safety , and efficacy of CBA against RFA . METHODS A single-center prospect i ve cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1 , 2010 and October 31 , 2013 . Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded . The primary end point was freedom from AF , atrial flutter , and atrial tachycardia ( FFAF ) > 30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs . We also compared rates of successful pulmonary vein isolation ( PVI ) , fluoroscopy and procedure times , and major complication rates . RESULTS A total of 201 patients were included ( CBA = 101 , RFA = 100 ) . The rate of successful PVI was 99.3 % in CBA versus 97.4 % in RFA ( P = 0.08 ) . Procedure times were shorter with CBA ( 192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes , P total fluoroscopy times ( 46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes , P 0.001 ) . Overall complication rates were equivalent ; however , fewer cardiac perforations occurred with CBA ( 0 % vs 4 % , P = 0.042 ) . The 1-year FFAF rates were 60.3 % for CBA and 61.1 % for RFA ( log rank P = 0.93 ) . CONCLUSION CBA was associated with equivalent 1-year FFAF rate as RFA for pAF . Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred",
"BACKGROUND Inflammation plays a prominent role in the etiology of the early recurrence of atrial fibrillation ( ERAF ) . We prospect ively compared the proportion of ERAF and time-course patterns of biomarkers between radiofrequency ( RF ) and cryoballoon ( CB ) ablation . METHODS AND RESULTS We enrolled 82 consecutive paroxysmal AF patients undergoing pulmonary vein ( PV ) isolation , performed with either a 28-mm 2nd-generation CB and 3-min freeze technique or point-by-point RF ablation . Each group had 41 patients . In the RF group , all PVs were successfully isolated with 28.9 ± 6.5 min of RF delivery . In the CB group , a mean of 5.3 ± 1.4 applications/patient was delivered . The proportion of ERAF was similar between the groups . The time-course patterns significantly differed between the groups for high-sensitivity C-reactive protein ( hs-CRP ) value ( P=0.006 ) and myocardial injury markers ( P Greater myocardial injury was observed in the CB than in the RF group ( P peak hs-CRP value was comparable between the groups . The 2-day post-procedure hs-CRP value was the sole factor correlating with ERAF as identified by the multivariable analysis ( hazard ratio 1.697 ; 95 % confidence interval , 1.005 - 2.865 ; P=0.048 ) in the RF , but not the CB group . CONCLUSIONS The proportion of ERAF was comparable after RF and 2nd-generation CB ablation . Despite CB ablation exhibiting greater myocardial injury than RF ablation , the inflammatory responses were comparable between the groups . The inflammatory response extent predicted ERAF post-RF ablation but not post-CB ablation",
"INTRODUCTION Catheter ablation of paroxysmal AF using the Cryoballoon ( CRYO ) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation ( RFCA ) , but r and omized data are lacking . Pilot data suggested a high success rate with a combined approach ( COMBINED ) using wide encirclement with RFCA followed by 2 CRYO applications to each vein . We compared these 3 strategies in a r and omized controlled trial . METHODS AND RESULTS Patients undergoing first time paroxysmal AF ablation were r and omized to RFCA , CRYO , or COMBINED . Patients were followed up at 3 , 6 , and 12 months with 7 days of ambulatory ECG monitoring . Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure . A total of 237 patients were r and omized . Success at 1 year was achieved in 47 % in the RFCA group , 67 % in the CRYO group , and 76 % in the COMBINED group ( P RFCA vs. CRYO , P Procedure time was 211 ( IQR 174 - 256 ) minutes for RFCA compared to 167 ( 136 - 202 ) minutes for CRYO and 278 ( 243 - 327 ) minutes for COMBINED ( P CRYO and results in a higher single procedure success rate than conventional point by point RFCA . The COMBINED approach was not superior to CRYO alone",
"Background — Contact force ( CF ) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation . This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation . Methods and Results — A total of 300 patients with symptomatic , drug-refractory , paroxysmal atrial fibrillation were enrolled in a prospect i ve , multicenter , r and omized , controlled trial and r and omized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter ( control ) . The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months . The primary safety end point included device-related serious adverse events . End points were powered to show noninferiority . All pulmonary veins were isolated in both groups . Effectiveness was achieved in 67.8 % and 69.4 % of subjects in the CF and control arms , respectively ( absolute difference , −1.6 % ; lower limit of 1-sided 95 % confidence interval , −10.7 % ; P=0.0073 for noninferiority ) . When the CF arm was stratified into optimal CF ( ≥90 % ablations with ≥10 g ) and nonoptimal CF groups , effectiveness was achieved in 75.9 % versus 58.1 % , respectively ( P=0.018 ) . The primary safety end point occurred in 1.97 % and 1.40 % of CF patients and control subjects , respectively ( absolute difference , 0.57 % ; upper limit of 1-sided 95 % confidence interval , 3.61 % ; P=0.0004 for noninferiority ) . Conclusions — The CF ablation catheter met the primary safety and effectiveness end points . Additionally , optimal CF was associated with improved effectiveness . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01278953",
"AIMS In the setting of paroxysmal atrial fibrillation ( AF ) , there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation ( PVI ) catheter ablation using contact-force (CF)-guided radiofrequency ( RF ) vs. second-generation balloon cryotherapy . METHODS AND RESULTS Prospect i ve single-centre evaluation , carried out from March 2011 to February 2013 , comparing CF radiofrequency ( Thermocool ( ® ) SmartTouch ™ , Biosense Webster , Inc. ) ( CF group ) with cryoballoon ablation ( A rct ic Front Advance ™ 28 mm cryoballoon , Medtronic , Inc. ) ( CB group ) , in regards to procedural safety and efficacy , as well as recurrence at 12 months . Overall , 150 consecutive patients were enrolled ( 75 in each group ) . The characteristics of patients of both the groups were similar ( 61.2 ± 9.9 years , women 25.3 % , mean AF duration 4.1 ± 4.0 years , mean CHA2DS2-VASc score 1.4 ± 1.3 , mean HAS-BLED 1.4 ± 0.6 ) . Duration of the procedure was significantly lower in the CF group ( 110.7 ± 32.5 vs. 134.5 ± 48.3 min , P = 0.001 ) , with a lower duration of fluoroscopy ( 21.5 ± 8.5 vs. 25.3 ± 9.9 min , P = 0.017 ) and X-ray exposure ( 4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm² , P = 0.001 ) . In contrast , no significant difference was found regarding significant procedural complication ( 2.7 vs. 1.3 % in CF and CB groups , respectively ; P = 0.56 ) , and PVI was eventually achieved in all cases . At 12 months , AF recurrence occurred in 11 patients ( 14.7 % ) in the CB group and in 9 patients ( 12.0 % ) in the CF group ( HR = 1.20 95 % CI 0.50 - 2.90 ; log rank P = 0.682 ) . CONCLUSIONS Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation",
"BACKGROUND Results from r and omized trials design ed to compare cryoenergy with radiofrequency for pulmonary vein ( PV ) isolation are lacking . OBJECTIVE To compare the efficacy of a simplified strategy for PV cryoablation ( group C ) vs PV isolation with open-irrigated radiofrequency catheters ( group R ) . METHODS Fifty patients with paroxysmal atrial fibrillation ( AF ) and 4 independent PVs received a Reveal XT implantable cardiac monitor and were r and omized to group C or group R. In group C , PV ablation was done with a single A rct ic Front balloon ( 23 or 28 mm ) per patient and two 300-second applications per PV . No further applications were delivered to close residual conduction gaps . In group R , bidirectional PV conduction block was pursued with Lasso and Navistar ThermoCool catheters and the CARTO system . The primary end point was the proportion of patients remaining free from AF recurrences ≥2 minutes without taking antiarrhythmic drugs 12 months after ablation . RESULTS The primary end point was met by 12 ( 48 % ) patients in group C and 25 ( 68 % ) patients in group R ( odds ratio 0.43 ; P = .05 ) . This difference disappeared after adjustment for acute procedural outcome . In patients for whom all 4 PVs were blocked at the end of the procedure , there was no difference between group C and group R in the primary end point ( 67 % vs 68 % ; P = .94 ) . CONCLUSIONS The efficacy of the simplified strategy for PV cryoablation tested in this study is inferior to PV isolation using open-irrigated radiofrequency catheters with electrophysiological and electroanatomical guidance . Complete PV conduction block is critical to the success of AF ablation",
"INTRODUCTION Hemi-diaphragmatic paralysis is the most common complication associated with cryoballoon ablation for atrial fibrillation , yet the histopathology of phrenic nerve injury has not been well described . METHODS AND RESULTS A pre clinical r and omized study was conducted to characterize the histopathology of phrenic nerve injury induced by cryoballoon ablation and assess the potential for electromyographic ( EMG ) monitoring to limit phrenic nerve damage . Thirty-two dogs underwent cryoballoon ablation of the right superior pulmonary vein with the objective of inducing phrenic nerve injury . Animals were r and omized 1:1 to st and ard monitoring ( i.e. , interruption of ablation upon reduction in diaphragmatic motion ) versus EMG guidance ( i.e. , cessation of ablation upon a 30 % reduction in the diaphragmatic compound motor action potential [ CMAP ] amplitude ) . The acute procedural endpoint was achieved in all dogs . Phrenic nerve injury was characterized by Wallerian degeneration , with subperineural injury to large myelinated axons and evidence of axonal regeneration . The degree of phrenic nerve injury paralleled the reduction in CMAP amplitude ( P = 0.007 ) . Animals r and omized to EMG guidance had a lower incidence of acute hemi-diaphragmatic paralysis ( 50 % vs 100 % ; P = 0.001 ) , persistent paralysis at 30 days ( 21 % vs 75 % ; multivariate odds ratio 0.12 , 95 % confidence interval [ 0.02 , 0.69 ] , P = 0.017 ) , and a lesser severity of histologic injury ( P = 0.001 ) . Mature pulmonary vein ablation lesion characteristics , including circumferentiality and transmurality , were similar in both groups . CONCLUSION Phrenic nerve injury induced by cryoballoon ablation is axonal in nature and characterized by Wallerian degeneration , with potential for recovery . An EMG-guided approach is superior to st and ard monitoring in limiting phrenic nerve damage",
"BACKGROUND Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation . Radiofrequency ablation is the most common method , and cryoballoon ablation is the second most frequently used technology . METHODS We conducted a multicenter , r and omized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation . The primary efficacy end point in a time-to-event analysis was the first documented clinical failure ( recurrence of atrial fibrillation , occurrence of atrial flutter or atrial tachycardia , use of antiarrhythmic drugs , or repeat ablation ) following a 90-day period after the index ablation . The noninferiority margin was prespecified as a hazard ratio of 1.43 . The primary safety end point was a composite of death , cerebrovascular events , or serious treatment-related adverse events . RESULTS A total of 762 patients underwent r and omization ( 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation ) . The mean duration of follow-up was 1.5 years . The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 34.6 % and 35.9 % , respectively ; hazard ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.76 to 1.22 ; P primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 10.2 % and 12.8 % , respectively ; hazard ratio , 0.78 ; 95 % CI , 0.52 to 1.18 ; P=0.24 ) . CONCLUSIONS In this r and omized trial , cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation , and there was no significant difference between the two methods with regard to overall safety . ( Funded by Medtronic ; FIRE AND ICE Clinical Trials.gov number , NCT01490814 . )",
"BACKGROUND Phrenic nerve palsy ( PNP ) is the most frequently observed complication during cryoballoon ablation ( CB ; A rct ic Front , Medtronic , MN ) occurring in roughly 7%-9 % of the cases . The new second-generation cryoballoon ablation A rct ic Front Advance ( CB-A ) ( A rct ic Front ) has recently been launched in the market . OBJECTIVE To evaluate the incidence of right PNP with the new CB-A in comparison with the first-generation balloon in a series of consecutive patients that underwent pulmonary vein isolation with this modality . METHODS The study was design ed as an observational study with a prospect i ve follow-up . In total , 121 consecutive patients were included : 80 patients with the CB ( group 1 ) and 41 with the CB-A ( group 2 ) . RESULTS Mean procedural times , fluoroscopic times , and time to pulmonary vein isolation documented by real-time recordings were significantly lower in group 2 ( P ≤ .05 ) . The occurrence of PNP was significantly higher in group 2 ( 6.25 % [ 5 of 80 ] in group 1 vs 19.5 % [ 8 of 41 ] in group 2 ; P = .033 ) . At 7 months , PNP persisted in 1 ( 2.5 % ) patient in the CB-A group . CONCLUSIONS Right PNP seems to occur in a significantly larger number of patients with the second-generation CB-A. However , this complication is reversible in nearly all cases on short-term follow-up . More refined phrenic nerve monitoring during right-sided pulmonary vein ablation and less vigorous wedging maneuvers in the pulmonary vein ostia might significantly reduce the occurrence of this complication",
"OBJECTIVES The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device ( A rct ic Front , Cryocath , Quebec , Canada ) . BACKGROUND Antral pulmonary vein ( PV ) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation ( PAF ) . A novel double lumen cryoballoon catheter was design ed for circumferential pulmonary vein isolation ( PVI ) with the cryoablation technique . METHODS We consecutively enrolled 346 patients with symptomatic , drug refractory paroxysmal ( n = 293 ) or persistent ( n = 53 ) atrial fibrillation ( AF ) . In all patients , PVI of all targeted PVs was the therapeutic aim . The primary end points of this nonr and omized study were : 1 ) acute isolation rate of targeted PV ; and 2 ) first electrocardiogram-documented recurrence of AF . The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula . RESULTS The 1,360 of 1,403 PVs ( 97 % ) were targeted with balloons or balloons in combination with the use of Freezor Max ( Cryocath ) . We found that ablation with the cryoballoon result ed in maintenance of sinus rhythm in 74 % of patients with PAF and 42 % of patients with persistent AF . No PV narrowing occurred . The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV . CONCLUSIONS Pulmonary vein isolation with a new cryoballoon technique is feasible . Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system . Cryoablation was less effective in patients with persistent AF than in patients with PAF"
] | 411663d4-06ff-11f0-808a-c43d1ab1c353 |
UNLABELLED The purpose of this systematic review was to quantitatively find out whether resin-modified glass-ionomers ( RM-GIC ) , in comparison to fluoride-containing composite resin and composite resin without fluoride , are associated with a more effective reduction of demineralization in hard tooth tissues under caries challenge . Five data bases were systematic ally search ed on clinical trials up to 6 April 2009 . Article inclusion criteria : titles/ abstract s relevant in answering the review question , published in English , two-arm ( prospect i ve ) longitudinal trial ; EXCLUSION CRITERIA not all included subjects accounted for at the end of the trial ; subjects of both groups not followed up the same way ; no r and omized , quasi-r and omized controlled study design for in situ and clinical trials ; contains no computable continuous data . Quality assessment of the accepted in situ and clinical trials was performed . Data were extracted in the form of data sets , containing numbers of evaluated sample s and mean result with st and ard deviation for both groups . Fifteen articles were selected for review . Two lacked computable data and were excluded ; nine laboratory trials , three r and omized in situ trials and one r and omized control trial were accepted . From these , 97 continuous data sets were extracted . The evidence suggests that RM-GIC is associated with a higher reduction of demineralization in adjacent hard tooth tissue than composite resin without fluoride . No difference was found when RM-GIC was compared with fluoride-containing composite resin . RM-GIC showed efficacy in reducing demineralization . However , the internal validity of the current evidence is limited and further high- quality trials 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",
"PURPOSE As clinical diagnosis of secondary caries is the most common reason for restoration replacement , fluoride-releasing restorative material s have been developed to address this problem . The purpose s of this study were to verify demineralization inhibition produced by 5 restorative material s su bmi tted to two methods of in vitro cariogenic challenge and verify whether these methods influence material behavior by means of polarized light microscopy and microhardness . METHODS Class V cavities were prepared on buccal surfaces of 100 extracted primary molars and r and omly restored with 1 of the 4 fluoride-releasing material s , Fuji IX , Vitremer , Dyract , Tetric Ceram , and Filtek Z250 as control material ( N=10 ) . Specimens were su bmi tted to in vitro caries induction by two different methods , acid gel immersion , and pH cycling . Teeth su bmi tted to gel were then sectioned and prepared for polarized light microscopy in water , while teeth cycled were prepared for microhardness evaluation . RESULTS Polarized light microscopy : Means of demineralization areas ( microm(2 ) ) differed significantly , depending on the restorative material . Tukey 's test revealed the smallest demineralization areas adjacent to Fuji IX and Vitremer restorations , with no difference between them ( P>.05 ) . The greatest demineralization area mean values were verified using Dyract and Filtek Z250 , without differences between them ( P>.05 ) . Microhardness : Glass ionomer cements ( GICs ) performed better on the area of great cariogenic challenge , closer to the surface , than other material s indicating minor mineral loss during pH cycling . The compomer Dyract presented similar performance to GICs and composite resin Tetric Ceram , but it was better than Filtek Z250 . CONCLUSION The experimental model of caries lesion induction may influence material performance . GICs , however , are superior in preventing in vitro demineralization independently of the method",
"Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature",
"OBJECTIVE The aim of this in vitro study was to evaluate the interaction between two sources of fluoride ( restorative systems and dentifrices ) in inhibiting artificial root caries development . METHODS One hundred and eighty tooth segments were embedded in polyester resin , and s and ed flat . Cylindrical cavities 1.0mm-deep and 1.5mm-diameter were prepared in root dentin and r and omly restored by fluoride-containing restorative systems : Ketac-fil/Espe ( Ke ) , Fuji II LC/GC Corp ( Fj ) , F2000/3 M ( F2 ) , Surefil/Dentsply ( Su ) or a control : Filtek Z250/3 M ( Z2 ) . Ten experimental groups were made to test the association among the five restorative systems and two dentifrices : with F(- ) ( Sensodyne Baking Soda ) or without F(- ) ( Sensodyne Original ) ( n=18 ) . After surface polishing , a 1mm-wide margin around the restorations was demarcated and initial dentin surface Knoop microhardness values ( KHN(i ) ) were obtained . The specimens were su bmi tted to a pH-cycling model , and to applications of slurries of dentifrice . Afterwards the final dentin surface Knoop microhardness values ( KHN(f ) ) were measured . RESULTS The differences between KHN(i ) and KHN(f ) , and the covariate KHN(i ) were considered by the ANCOVA and Tukey 's test ( alpha=0.05 ) . The interaction between restorative system and dentifrice was statistically significant ( p=0.0026 ) . All restorative systems provided some protection against artificial caries challenge when associated with the fluoride-containing dentifrice treatment . The means ( st and ard deviation ) of reductions in Knoop hardness values for systems associated with the fluoride-containing dentifrice were : Ke : 40.0(1.02)(a ) , Fj : 41.9(1.02)(b ) , F2 : 43.3(1.04)(c ) , Su : 43.5(1.00)(c ) , Z2 : 44.0(1.02)(c ) ; and with the non-fluoride-containing dentifrice were : Ke : 42.9(1.02)(a ) , Fj : 44.7(1.01)(b ) , F2 : 45.2(1.09)(bc ) , Su : 46.0(0.99)(c ) , Z2 : 46.6(0.99)(c ) ( statistical differences were expressed by different letters ) . CONCLUSION The cariostatic effect shown by the fluoride-containing dentifrice could enhance that shown by Ketac-fil and Fuji II LC , and could mask that shown by F2000",
"There is no consensus about an association between microleakage and secondary caries , especially considering the presence of fluoride ( F ) at the tooth/restoration interface . Thus , a r and omized , double-blind , crossover study was carried out to evaluate in situ the effect of microleakage on caries around enamel-dentine restorations in the presence of F from dental material s or dentifrice , either alone or in combination . In 4 phases of 14 days each , 14 volunteers wore palatal devices containing dental slabs restored with composite resin ( CR ) or resin-modified glass ionomer cement ( GI ) . Restorations were made without leakage ( L– ) , following the recommended adhesive procedures , or with leakage ( L+ ) , in the absence of adhesive procedures . Plaque-like biofilm ( PLB ) was left to accumulate on the restored slabs , which were exposed extraorally to a 20 % sucrose solution 10 × /day . The volunteers used a non-F ( NF ) or an F ( FD ) dentifrice 3 × /day , depending on the experimental phase . No differences were found between L+ or L– restorations ( p > 0.05 ) . Higher demineralization in both enamel and dentine around CR restorations was observed under NF ( p ) . F concentration was higher in the fluid of PLB exposed to FD or formed onto GI restoration ( p increased F levels in the PLB , thereby decreasing caries progression",
"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",
"PURPOSE Enamel demineralization adjacent to orthodontic brackets is one of the risks associated with orthodontic treatment . Glass ionomer cements have been shown to decrease enamel demineralization adjacent to brackets and b and s but do not exhibit bond strengths comparable to resin composites . The purpose of this in vitro study was to compare a fluoride-releasing resin composite versus a resin-modified glass ionomer cement for inhibition of enamel demineralization surrounding orthodontic brackets . METHODS Forty-five teeth were r and omly assigned to 3 groups of 15 teeth . Fifteen were bonded with Concise ( 3 M ) , a non-fluoride-releasing resin composite ( control ) ; 15 teeth were bonded with Light Bond ( Reliance ) , a fluoride-releasing resin composite ; and 15 teeth were bonded with Fuji Ortho LC ( GC Corporation ) , a resin-modified glass ionomer cement . The teeth were placed in an artificial caries solution to create lesions . Following sectioning of the teeth in a buccolingual direction , polarized light microscopy was utilized to evaluate enamel demineralization adjacent to the orthodontic bracket . The area of the lesion was measured 100 microns from the orthodontic bracket and bonding agent . RESULTS MANOVA ( P 's test ( P resin-modified glass ionomer cement ( Fuji Ortho LC ) and the fluoride-releasing resin composite ( Light Bond ) had significantly less adjacent enamel demineralization than the non-fluoride-releasing resin composite control . However , there was no significant difference between the resin-modified glass ionomer cement and the fluoride-releasing resin composite . CONCLUSIONS Based on the results of this in vitro study , it can be concluded that Fuji Ortho LC and Light Bond exhibit significant inhibition of adjacent demineralization compared to the non-fluoride-releasing control",
"The aim was to study the effect of three fluoride – releasing restorative material s on sound enamel of approximal teeth under cariogenic conditions intraorally . Bovine enamel slabs were paired with four hemispherical sample s from each of three test material s ( Ketac Molar , ESPE ; Vitremer , F–2000 , both from 3 M ) and one control material ( Pertac II , ESPE ) . Their curved surface touched enamel at a contact point allowing space for plaque accumulation . Pairs were inserted in the buccal flanges of 2 lower dentures for 70 days . Initially and upon dismantling , enamel surface microhardness was measured and the increase in length of indentation in micrometers was recorded at a distance of 0 , 0.4 , 0.8 and 1.2 mm from the contact point . Respective values were : Pertac II : 16.0±7.5 , 27.6±15.4 , 38.6±23.3 , 47.8±25.2 ; F–2000 : 11.89±9.6 , 15.8±14.2 , 21.0±15.0 , 25.1±15.2 ; Ketac Molar : 6.6±6.8 , 9.4±7.0 , 9.5±8.0 ) , 13.4±9.4 ; Vitremer : 2.7±4.1 , 3.5±3.5 , 3.6±4.5 ) , 7.4±5.2 . Caries protection was Vitremer 82 % > Ketac Molar 69 % > F–2000 42 % in relation to Pertac II ( p subsurface lesions only in the Pertac II group , areas of pseudoisotropy in the F–2000 and Ketac Molar groups and no signs of lesion in the Vitremer group",
"This study evaluated the extent of the cariostatic effect on root dentin provided by four fluoride-containing restorative systems : Ketac-Fil/ESPE [ Ke ] , Fuji II LC Improved/GC Corp [ Fj ] , Dyract AP/Dentsply [ Dy ] and SureFil/Dentsply [ Su ] , and one without fluoride : Z250/3 M [ control ] . Ninety-five bovine root dentin fragments ( 5.0 x 6.0 mm ) were obtained , embedded in polyester resin and planed . Cavities ( 1.5 x 3.5 x 1.0 mm ) were made and restored by the five restorative systems ( n=19 ) in a r and omized complete block design according to the manufacturers ' instructions . After 24 hours , the dentin/restoration surface was polished . The restoration surface and an adjacent area of 3.0 x 3.0 mm were demarcated and su bmi tted to a pH-cycling model . Dentin surface Knoop microhardness values were obtained ( 5.0-g , 5.0-s ) for 10 distances : 50 , 100 , 150 , 300 , 600 , 900 , 1200 , 1500 , 1800 and 2100 microm from the margin of the restoration . The dentin microhardness means for each restorative material at each distance was considered by the ANOVA multi-factor split-plot method . The interaction between the restorative system and distance was statistically significant ( p Tukey test and the regression analysis showed that the means of [ Ke ] and [ Fj ] were similar up to 300 microm , the [ Ke ] means being higher than the [ control ] at distances 50 , 100 , 150 and 300 microm . The [ Fj ] means were higher than the [ control ] at distances 50 , 100 and 150 microm . The microhardness means of [ Dy ] and [ Su ] were not statistically different from the [ control ] and remained steady throughout the studied distances . This study concluded that the extent of the cariostatic effect on root dentin was 300 microm for [ Ke ] and 150 microm for [ Fj ] . [ Dy ] and [ Su ] did not show any cariostatic effect"
] | 41166410-06ff-11f0-808a-c43d1ab1c353 |
Over the past decade , a large body of observational evidence has suggested an association between lower vitamin D status ( 25-hydroxyvitamin D ) and multiple acute and chronic disorders , including cancer , multiple sclerosis , depression and respiratory tract infections . This evidence has fostered the hypothesis that increasing vitamin D intake may treat and prevent such disorders . Our objective was to perform a critical analysis of the highest-level evidence for ten common beliefs regarding vitamin D for the prevention of falls , fractures and respiratory tract infections , the reduction of cancer incidence/mortality and overall mortality , and the prevention or treatment of depression/mental well-being , rheumatoid arthritis and multiple sclerosis , as well as maximum dosing and regular testing . We search ed the Cochrane Data base of Systematic Review s and PubMed ( up to August 2014 ) for r and omized controlled trials and systematic review s/meta-analyses based on those studies . All search es were performed , all evidence review ed and each section written by at least two authors . The evidence shows that vitamin D supplementation provides some benefit in fracture prevention ( likely ∼10–15 % relative reduction ) , particularly at a dose ≥800 IU and with calcium ; a likely benefit in the rate of falls , though it is less clear whether the number of fallers changes ; and a possible small ( ∼5 % ) relative reduction in mortality . Evidence does not support the use of vitamin D supplementation for the prevention of cancer , respiratory infections or rheumatoid arthritis . Similarly , evidence does not support vitamin D supplementation for the treatment of multiple sclerosis and rheumatoid arthritis or for improving depression/mental well-being . Regular testing of 25-hydroxyvitamin D is generally not required , and mega-doses ( ≥300,000 IU ) appear to increase harms . Much of the evidence is at high risk of bias , with multiple flaws , including analyses of secondary endpoints , small and underpowered studies , inconsistent results and numerous other issues . Therefore , enthusiasm for a vitamin D panacea should be tempered | [
"Background For adults , vitamin D intake of 100 mcg ( 4000 IU)/day is physiologic and safe . The adequate intake ( AI ) for older adults is 15 mcg ( 600 IU)/day , but there has been no report focusing on use of this dose . Methods We compared effects of these doses on biochemical responses and sense of wellbeing in a blinded , r and omized trial . In Study 1 , 64 out patients ( recruited if summer 2001 25(OH)D 15 or 100 mcg/day vitamin D in December 2001 . Biochemical responses were followed at subsequent visits that were part of clinical care ; 37 patients completed a wellbeing question naire in December 2001 and February 2002 . Subjects for Study 2 were recruited if their 25(OH)D was vitamin D ; 51 completed a wellbeing question naire in both December 2002 and February 2003 . Results In Study 1 , basal summer 25-hydroxyvitamin D [ 25(OH)D ] averaged 48 ± 9 ( SD ) nmol/L. Supplementation for more than 6 months produced mean 25(OH)D levels of 79 ± 30 nmol/L for the 15 mcg/day group , and 112 ± 41 nmol/L for the 100 mcg/day group . Both doses lowered plasma parathyroid hormone with no effect on plasma calcium . Between December and February , wellbeing score improved more for the 100-mcg/day group than for the lower-dosed group ( 1-tail Mann-Whitney p = 0.036 ) . In Study 2 , 25(OH)D averaged 39 ± 9 nmol/L , and winter wellbeing scores improved with both doses of vitamin D ( two-tail p for vitamin D brought summertime 25(OH)D to > 40 nmol/L , lowered PTH , and its use was associated with improved wellbeing . The 100 mcg/day dose produced greater responses . Since it was ethically necessary to provide a meaningful dose of vitamin D to these insufficient patients , we can not rule out a placebo wellbeing response , particularly for those on the lower dose . This work confirms the safety and efficacy of both 15 and 100 mcg/day vitamin D3 in patients who needed additional vitamin",
"Background Controversies are common in medicine . Some arise when the conclusions of research publications directly contradict each other , creating uncertainty for frontline clinicians . Discussion In this paper , we review how research ers can look at very similar data yet have completely different conclusions based purely on an over-reliance of statistical significance and an unclear underst and ing of confidence intervals . The dogmatic adherence to statistical significant thresholds can lead authors to write dichotomized absolute conclusions while ignoring the broader interpretations of very consistent findings . We describe three examples of controversy around the potential benefit of a medication , a comparison between new medications , and a medication with a potential harm . The examples include the highest levels of evidence , both meta-analyses and r and omized controlled trials . We will show how in each case the confidence intervals and point estimates were very similar . The only identifiable differences to account for the contrasting conclusions arise from the serendipitous finding of confidence intervals that either marginally cross or just fail to cross the line of statistical significance . Summary These opposing conclusions are false disagreements that create unnecessary clinical uncertainty . We provide helpful recommendations in approaching conflicting conclusions when they are associated with remarkably similar results",
"OBJECTIVE To compare the effects of dydrogesterone and calcium plus vitamin D in women with severe premenstrual syndrome ( PMS ) . METHOD In this r and omized , double-blind , placebo-controlled study , 180 Shiraz University students with PMS used question naires daily to rate their symptoms for 2 menstrual cycles . Then , the students were r and omly assigned to take a tablet containing either 5 mg of dydrogesterone , 500 mg of calcium plus 200 mg of vitamin D , or a placebo twice daily from the 15th to the 24th day of the cycle for 2 more cycles , and to use the same question naires during the intervention cycles . The collected data were then analyzed by repeated-measurement design and multilevel modeling tests . RESULT Treatment with dydrogesterone or calcium plus vitamin D decreased symptom severity in a similar way ( by 4.64 % and 4.20 % , respectively ) and placebo was associated with a 3.42 % decrease . CONCLUSION Treatment with dydrogesterone or calcium plus vitamin D had a similar effect on symptom severity in women with PMS",
"OBJECTIVE : Observational studies suggest that serum levels of 25-hydroxyvitamin D ( 25[OH]D ) are inversely associated with acute respiratory infections ( ARIs ) . We hypothesized that vitamin D supplementation of children with vitamin D deficiency would lower the risk of ARIs . METHODS : By using cluster r and omization , classrooms of 744 Mongolian schoolchildren were r and omly assigned to different treatments in winter ( January – March ) . This analysis focused on a subset of 247 children who were assigned to daily ingestion of unfortified regular milk ( control ; n = 104 ) or milk fortified with 300 IU of vitamin D3 ( n = 143 ) . This comparison was double-blinded . The primary outcome was the number of parent-reported ARIs over the past 3 months . RESULTS : At baseline , the median serum 25(OH)D level was 7 ng/mL ( interquartile range : 5–10 ng/mL ) . At the end of the trial , follow-up was 99 % ( n = 244 ) , and the median 25(OH)D levels of children in the control versus vitamin D groups was significantly different ( 7 vs 19 ng/mL ; P receiving vitamin D reported significantly fewer ARIs during the study period ( mean : 0.80 vs 0.45 ; P = .047 ) , with a rate ratio of 0.52 ( 95 % confidence interval : 0.31–0.89 ) . Adjusting for age , gender , and history of wheezing , vitamin D continued to halve the risk of ARI ( rate ratio : 0.50 [ 95 % confidence interval : 0.28–0.88 ] ) . Similar results were found among children either below or above the median 25(OH)D level at baseline ( rate ratio : 0.41 vs 0.57 ; Pinteraction = .27 ) . CONCLUSIONS : Vitamin D supplementation significantly reduced the risk of ARIs in winter among Mongolian children with vitamin D deficiency",
"OBJECTIVES To determine the prevalence of vitamin D deficiency in older people in residential care and the influence that the level of vitamin D may have on their incidence of falls . DESIGN Prospect i ve cohort . SETTING Residential care facilities for older people in several states of Australia . PARTICIPANTS Six hundred sixty-seven women in low-level care and 952 women in high-level care , mean age 83.7 years . MEASUREMENTS Serum 25-hydroxyvitamin D ( 25D ) levels and recognized risk factors for falls including current medication use , a history of previous fractures , weight , tibial length ( as a surrogate for height ) , cognitive function , walking ability , and frequency of going outdoors were determined . The women in low-level care and high-level care were followed for an average of 145 and 168 days , respectively . Falls were recorded prospect ively in diaries completed monthly by residential care staff . RESULTS Vitamin D deficiency ( defined as a serum 25D level below 25 nmol/L ) was present in 144 ( 22 % ) women in low-level care and 428 ( 45 % ) in high-level care . After excluding 358 bed-bound residents and adjusting for weight , cognitive status , psychotropic drug use , previous Colles fracture , and the presence of w and ering behavior , log serum 25D level remained independently associated with time to first fall . The adjusted hazards ratio was 0.74 ( 95 % confidence interval=0.59 - 0.94 ; P=.01 ) , implying a 20 % reduction in the risk of falling with a doubling of the vitamin D level . CONCLUSION Vitamin D deficiency is common in residential care in Australia . A low level of serum vitamin D is an independent predictor of incident falls",
"BACKGROUND Numerous observational studies have found supplemental calcium and vitamin D to be associated with reduced risk of common cancers . However , interventional studies to test this effect are lacking . OBJECTIVE The purpose of this analysis was to determine the efficacy of calcium alone and calcium plus vitamin D in reducing incident cancer risk of all types . DESIGN This was a 4-y , population -based , double-blind , r and omized placebo-controlled trial . The primary outcome was fracture incidence , and the principal secondary outcome was cancer incidence . The subjects were 1179 community-dwelling women r and omly selected from the population of healthy postmenopausal women aged > 55 y in a 9-county rural area of Nebraska centered at latitude 41.4 degrees N. Subjects were r and omly assigned to receive 1400 - 1500 mg supplemental calcium/d alone ( Ca-only ) , supplemental calcium plus 1100 IU vitamin D3/d ( Ca + D ) , or placebo . RESULTS When analyzed by intention to treat , cancer incidence was lower in the Ca + D women than in the placebo control subjects ( P unadjusted relative risks ( RR ) of incident cancer in the Ca + D and Ca-only groups were 0.402 ( P = 0.01 ) and 0.532 ( P = 0.06 ) , respectively . When analysis was confined to cancers diagnosed after the first 12 mo , RR for the Ca + D group fell to 0.232 ( CI : 0.09 , 0.60 ; P treatment and serum 25-hydroxyvitamin D concentrations were significant , independent predictors of cancer risk . CONCLUSIONS Improving calcium and vitamin D nutritional status substantially reduces all-cancer risk in postmenopausal women . This trial was registered at clinical trials.gov as NCT00352170",
"BACKGROUND Epidemiological evidence supports a relationship between vitamin D and mental well-being , although evidence from large-scale placebo-controlled intervention trials is lacking . AIMS To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women ; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms ; and if there is an association between serum 25-hydroxyvitamin D levels and mental health . METHOD A double-blind , r and omised , placebo-controlled trial of women aged 70 or older ( the Vital D Study : IS RCT N83409867 and ACTR12605000658617 ) . Participants were r and omly assigned to receive 500 000 IU vitamin D(3 ) ( cholecalciferol ) orally or placebo every autumn/winter for 3 - 5 consecutive years . The tools utilised at various time points were the General Health Question naire , the 12-item Short Form Health Survey , the Patient Global Impression-Improvement scale and the WHO Well-Being Index . Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants . RESULTS In this non- clinical population , no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health . Serum 25-hydroxyvitamin D levels in the vitamin D group were 41 % higher than the placebo group 12 months following their annual dose . Despite this difference , scores from the question naires did not differ . Furthermore , there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups . CONCLUSIONS The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3 ) is a practical intervention to prevent depressive symptoms in older community-dwelling women",
"BACKGROUND To our knowledge , no rigorously design ed clinical trials have evaluated the relation between vitamin D and physician-diagnosed seasonal influenza . OBJECTIVE We investigated the effect of vitamin D supplements on the incidence of seasonal influenza A in schoolchildren . DESIGN From December 2008 through March 2009 , we conducted a r and omized , double-blind , placebo-controlled trial comparing vitamin D(3 ) supplements ( 1200 IU/d ) with placebo in schoolchildren . The primary outcome was the incidence of influenza A , diagnosed with influenza antigen testing with a nasopharyngeal swab specimen . RESULTS Influenza A occurred in 18 of 167 ( 10.8 % ) children in the vitamin D(3 ) group compared with 31 of 167 ( 18.6 % ) children in the placebo group [ relative risk ( RR ) , 0.58 ; 95 % CI : 0.34 , 0.99 ; P = 0.04 ] . The reduction in influenza A was more prominent in children who had not been taking other vitamin D supplements ( RR : 0.36 ; 95 % CI : 0.17 , 0.79 ; P = 0.006 ) and who started nursery school after age 3 y ( RR : 0.36 ; 95 % CI : 0.17 , 0.78 ; P = 0.005 ) . In children with a previous diagnosis of asthma , asthma attacks as a secondary outcome occurred in 2 children receiving vitamin D(3 ) compared with 12 children receiving placebo ( RR : 0.17 ; 95 % CI : 0.04 , 0.73 ; P = 0.006 ) . CONCLUSION This study suggests that vitamin D(3 ) supplementation during the winter may reduce the incidence of influenza A , especially in specific subgroups of schoolchildren . This trial was registered at https://center.umin.ac.jp as UMIN000001373",
"To determine whether calcium plus vitamin D supplementation ( CaD ) affects incidence of rheumatoid arthritis ( RA ) . Participants enrolled in the Women ’s Health Initiative CaD trial ( n = 36,282 ) were r and omized to 1,000 mg calcium carbonate plus 400 IU of vitamin D3 daily or to placebo . Incident RA cases were identified via self-report and vali date d rheumatic medication use . Cox proportional hazards models were used to compare RA incidence in the treatment versus placebo groups . The analysis included 32,435 women without the history of RA , of which 163 incident RA cases were identified over an average of 5.1 years . No significant differences in demographics , total personal vitamin D intake [ P = 0.36 ] , or solar irradiance [ P = 0.68 ] were seen between the groups . In intention-to-treat analyses , no differences were observed in RA incidence [ HR 1.04 , 95 % CI 0.76 , 1.41 ] . No significant modifying effects were seen for stratum of age , solar irradiance , or total vitamin D intake , overall or when adjusted for adherence . Significant effect modifications were seen between CaD and total vitamin D intake and CaD and solar irradiance that suggest increased RA incidence with high vitamin D exposure . CaD supplementation did not demonstrate a significant effect on RA incidence in postmenopausal women . Modifying effects between CaD and both solar irradiance and dietary vitamin D intake are suggestive that multiple high vitamin D exposures may increase RA incidence . Further research is needed to fully explore the benefits and possible adverse effects of vitamin D supplementation on RA",
"Objectives : Vitamin D has immune-modulating effects and may protect against the development of systemic lupus erythematosus ( SLE ) and rheumatoid arthritis ( RA ) . Methods : We identified incident cases of SLE and RA among 186 389 women followed from 1980 to 2002 in the Nurses ’ Health Study and Nurses ’ Health Study II cohorts . We excluded subjects where SLE or RA was not confirmed by medical record review , and those who failed to return question naires . Semi-quantitative food frequency question naires assessed vitamin D intake from food and supplements . We used cumulative-up date d total energy-adjusted dietary exposures for each 2-year cycle . Relationships between vitamin D intake and incident SLE and RA were examined in age-adjusted and Cox proportional hazards models , adjusted for confounders . Results were pooled using meta- analysis r and om effects models . Results : We confirmed 190 incident cases of SLE and 722 of RA with dietary information . Increasing levels of vitamin D intake had no relationship to the relative risk of developing either SLE or RA . Conclusions : Vitamin D intake was not associated with risk of SLE or RA in these large prospect i ve cohorts of women",
"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",
"Summary Background Vitamin D has a role in regulating immune function , and its deficiency is a suggested risk factor for childhood pneumonia . Our aim was to assess whether oral supplementation of vitamin D3 ( cholecalciferol ) will reduce the incidence and severity of pneumonia in a high-risk infant population . Methods We did a r and omised placebo-controlled trial to compare oral 100 000 IU ( 2·5 mg ) vitamin D3 with placebo given to children aged 1–11 months in Kabul , Afghanistan . R and omisation was by use of a computer-generated list . Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months . Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically . Our primary outcome was the first or only episode of radiologically confirmed pneumonia . Our analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00548379 . Findings 1524 children were assigned to receive vitamin D3 and 1522 placebo . There was no significant difference between the incidence of first or only pneumonia between the vitamin D ( 0·145 per child per year , 95 % CI 0·129–0·164 ) and the placebo group ( 0.137 , 0·121–0·155 ) ; the incidence rate ratio was 1·06 ( 95 % CI 0·89–1·27 ) . From 652 children during five separate periods of testing serum calcifediol , only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group — a toxic level . Interpretations Quarterly bolus doses of oral vitamin D3 supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting . Funding Wellcome Trust and British Council",
"Objective : Low vitamin D status has been associated with multiple sclerosis ( MS ) prevalence and risk , but the therapeutic potential of vitamin D in established MS has not been explored . Our aim was to assess the tolerability of high-dose oral vitamin D and its impact on biochemical , immunologic , and clinical outcomes in patients with MS prospect ively . Methods : An open-label r and omized prospect i ve controlled 52-week trial matched patients with MS for demographic and disease characteristics , with r and omization to treatment or control groups . Treatment patients received escalating vitamin D doses up to 40,000 IU/day over 28 weeks to raise serum 25-hydroxyvitamin D [ 25(OH)D ] rapidly and assess tolerability , followed by 10,000 IU/day ( 12 weeks ) , and further downtitrated to 0 IU/day . Calcium ( 1,200 mg/day ) was given throughout the trial . Primary endpoints were mean change in serum calcium at each vitamin D dose and a comparison of serum calcium between groups . Secondary endpoints included 25(OH)D and other biochemical measures , immunologic biomarkers , relapse events , and Exp and ed Disability Status Scale ( EDSS ) score . Results : Forty-nine patients ( 25 treatment , 24 control ) were enrolled [ mean age 40.5 years , EDSS 1.34 , and 25(OH)D 78 nmol/L ] . All calcium-related measures within and between groups were normal . Despite a mean peak 25(OH)D of 413nmol/L , no significant adverse events occurred . Although there may have been confounding variables in clinical outcomes , treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls . Conclusions : High-dose vitamin D ( ∼10,000 IU/day ) in multiple sclerosis is safe , with evidence of immunomodulatory effects . Classification of evidence : This trial provides Class II evidence that high-dose vitamin D use for 52 weeks in patients with multiple sclerosis does not significantly increase serum calcium levels when compared to patients not on high-dose supplementation . The trial , however , lacked statistical precision and the design requirements to adequately assess changes in clinical disease measures ( relapses and Exp and ed Disability Status Scale scores ) , providing only Class level IV evidence for these outcomes",
"OBJECTIVE Vitamin D is a potent regulator of calcium homeostasis and may have immunomodulatory effects . The influence of vitamin D on human autoimmune disease has not been well defined . The purpose of this study was to evaluate the association of dietary and supplemental vitamin D intake with rheumatoid arthritis ( RA ) incidence . METHODS We analyzed data from a prospect i ve cohort study of 29,368 women of ages 55 - 69 years without a history of RA at study baseline in 1986 . Diet was ascertained using a self-administered , 127-item vali date d food frequency question naire that included supplemental vitamin D use . Risk ratios ( RRs ) and 95 % confidence intervals ( 95 % CIs ) were estimated using Cox proportional hazards regression , adjusting for potential confounders . RESULTS Through 11 years of followup , 152 cases of RA were vali date d against medical records . Greater intake ( highest versus lowest tertile ) of vitamin D was inversely associated with risk of RA ( RR 0.67 , 95 % CI 0.44 - 1.00 , P for trend = 0.05 ) . Inverse associations were apparent for both dietary ( RR 0.72 , 95 % CI 0.46 - 1.14 , P for trend = 0.16 ) and supplemental ( RR 0.66 , 95 % CI 0.43 - 1.00 , P for trend = 0.03 ) vitamin D. No individual food item high in vitamin D content and /or calcium was strongly associated with RA risk , but a composite measure of milk products was suggestive of an inverse association with risk of RA ( RR 0.66 , 95 % CI 0.42 - 1.01 , P for trend = 0.06 ) . CONCLUSION Greater intake of vitamin D may be associated with a lower risk of RA in older women , although this finding is hypothesis generating",
"Background Epidemiological research links vitamin D status to various brain-related outcomes . However , few trials examine whether supplementation can improve such outcomes and none have examined effects on cognition . This study examined whether Vitamin D supplementation led to improvements in diverse measures of cognitive and emotional functioning , and hypothesised that supplementation would lead to improvements in these outcomes compared to placebo . Methods /Principal Findings Healthy young adults were recruited to a parallel-arm , double-blind trial conducted at The University of Queensl and . Participants were r and omly allocated to receive Vitamin D ( one capsule daily , containing 5000 IU cholecalciferol ) or identical placebo capsule for six weeks . All participants and outcome assessors were blinded to group assignment . Primary outcome measures assessed at baseline and 6 weeks were working memory , response inhibition and cognitive flexibility . Secondary outcomes were : hallucination-proneness , psychotic-like experiences , and ratings of depression , anxiety and anger . 128 participants were recruited , r and omised and included in primary analyses ( vitamin D n = 63 ; placebo n = 65 ) . Despite significant increases in vitamin D status in the active group , no significant changes were observed in working memory ( F = 1.09 ; p = 0.30 ) , response inhibition ( F = 0.82 ; p = 0.37 ) , cognitive flexibility ( F = 1.37 ; p = 0.24 ) or secondary outcomes . No serious adverse effects were reported . Conclusions Our findings indicate that vitamin D supplementation does not influence cognitive or emotional functioning in healthy young adults . Future controlled trials in targeted population s of interest are required to determine whether supplementation can improve functioning in these domains . Australian and New Zeal and Clinical Trials Registry ; ACTRN12610000318088",
"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",
"OBJECTIVES The objective of the present study was to examine the cross-sectional relation between serum 25-hydroxyvitamin D [ 25-(OH ) D ] levels and depression in overweight and obese subjects and to assess the effect of vitamin D supplementation on depressive symptoms . DESIGN Cross-sectional study and r and omized double blind controlled trial of 20,000 or 40,000 IU vitamin D per week versus placebo for 1 year . SETTING A total of 441 subjects ( body mass index 28 - 47 kg m(-2 ) , 159 men and 282 women , aged 21 - 70 years ) recruited by advertisements or from the out-patient clinic at the University Hospital of North Norway . MAIN OUTCOME MEASURES Beck Depression Inventory ( BDI ) score with subscales 1 - 13 and 14 - 21 . RESULTS Subjects with serum 25(OH)D levels depressive traits ) than those with serum 25(OH)D levels > or = 40 nmol L(-1 ) on the BDI total [ 6.0 ( 0 - 23 ) versus 4.5 ( 0 - 28 ) ( median and range ) ] and the BDI subscale 1 - 13 [ 2.0 ( 0 - 15 ) versus 1.0 ( 0 - 29.5 ) ] ( P vitamin D , but not in the placebo group , there was a significant improvement in BDI scores after 1 year . There was a significant decrease in serum parathyroid hormone in the two vitamin D groups without a concomitant increase in serum calcium . CONCLUSIONS It appears to be a relation between serum levels of 25(OH)D and symptoms of depression . Supplementation with high doses of vitamin D seems to ameliorate these symptoms indicating a possible causal relationship",
"Abstract Mood changes synchronised to the seasons exist on a continuum between individuals , with anxiety and depression increasing during the winter months . An extreme form of seasonality is manifested as the clinical syndrome of seasonal affective disorder ( SAD ) with carbohydrate craving , hypersomnia , lethargy , and changes in circadian rhythms also evident . It has been suggested that seasonality and the symptoms of SAD may be due to changing levels of vitamin D3 , the hormone of sunlight , leading to changes in brain serotonin . Forty-four healthy subjects were given 400 IU , 800 IU , or no vitamin D3 for 5 days during late winter in a r and om double-blind study . Results on a self-report measure showed that vitamin D3 significantly enhanced positive affect and there was some evidence of a reduction in negative affect . Results are discussed in terms of their implication s for seasonality , SAD , serotonin , food preference , sleep , and circadian rhythms",
"BACKGROUND Recent studies suggest a role for vitamin D in innate immunity , including the prevention of respiratory tract infections ( RTIs ) . We hypothesize that serum 25-hydroxyvitamin D ( 25[OH]D ) levels are inversely associated with self-reported recent upper RTI ( URTI ) . METHODS We performed a secondary analysis of the Third National Health and Nutrition Examination Survey , a probability survey of the US population conducted between 1988 and 1994 . We examined the association between 25(OH)D level and recent URTI in 18 883 participants 12 years and older . The analysis adjusted for demographics and clinical factors ( season , body mass index , smoking history , asthma , and chronic obstructive pulmonary disease ) . RESULTS The median serum 25(OH)D level was 29 ng/mL ( to convert to nanomoles per liter , multiply by 2.496 ) ( interquartile range , 21 - 37 ng/mL ) , and 19 % ( 95 % confidence interval [ CI ] , 18%-20 % ) of participants reported a recent URTI . Recent URTI was reported by 24 % of participants with 25(OH)D levels less than 10 ng/mL , by 20 % with levels of 10 to less than 30 ng/mL , and by 17 % with levels of 30 ng/mL or more ( P 25(OH)D levels were independently associated with recent URTI ( compared with 25[OH]D levels of > or = 30 ng/mL : odds ratio [ OR ] , 1.36 ; 95 % CI , 1.01 - 1.84 for 25(OH)D level and URTI seemed to be stronger in individuals with asthma and chronic obstructive pulmonary disease ( OR , 5.67 and 2.26 , respectively ) . CONCLUSIONS Serum 25(OH)D levels are inversely associated with recent URTI . This association may be stronger in those with respiratory tract diseases . R and omized controlled trials are warranted to explore the effects of vitamin D supplementation on RTI",
"To determine the efficacy of oral vitamin D [ 25(OH)D ] in patients with active rheumatoid arthritis ( RA ) who are in methotrexate ( MTX ) therapy , patients receiving stable doses of MTX were r and omized to one of two dose groups and received 12 weeks of double-blind vitamin D[25(OH)D ] ( 50,000 IU per week ) or matching placebo . The moderate and major efficacy measure was the proportion of patients with > 0.6 and > 1.2 improvement in RA based on the Disease Activity Score 28(DAS 28 ) at 12 weeks . Safety measures included adverse events and laboratory assessment s. On a background of MTX , the percentage of patients with a moderate/major DAS 28 response at week 12 in the vitamin D groups ( 76/44 % ) was not significantly different from placebo ( 64.6/33.4 % ) . Adverse events were typically mild and included small hepatic enzyme elevation ; we did not have any undesirable events result ing in discontinuation of study drug . In patients with active RA receiving stable doses of MTX , vitamin D showed non-significant improvement in efficacy outcomes compared to placebo",
"Abstract The correlation between vitamin D deficiency and depression has recently been put forward and result ed in controversial findings . The present study was conducted to find out the effect of 2 single injections of 150,000 and 300,000 IU of vitamin D on improving the depression in depressed patients with vitamin D deficiency . This clinical trial study was carried out during 2011–2012 in Yazd , Islamic Republic of Iran . A total of 120 patients who had a Beck Depression Inventory II score of 17 + and were affected with vitamin D deficiency were r and omly assigned to 3 groups of 40 . They included G300 , G150 , and NTG . G300 and G150 received an intramuscular single dose of 300,000 and 150,000 IU of vitamin D , respectively , and the NTG group received nothing . After 3 months of intervention , the depression state , serum vitamin D , calcium , phosphorus , and parathormone were measured . The median of serum vitamin D after intervention were 60.2 , 54.6 , and 28.2 nmol/L ( P Percentages of vitamin D deficiency after intervention were 18 , 20 , and 91.2 for the groups , respectively . The serum calcium mean showed a statistically significant increase in just the 2 test groups receiving vitamin D. There was only significant difference in mean of Beck Depression Inventory II test score between G300 and NTG ( P = 0.003).The results of the study revealed that first , the correction of vitamin D deficiency improved the depression state , and second , a single injection dose of 300,000 IU of vitamin D was safe and more effective than a 150,000-IU dose",
"Very frail older people constitute an increasing proportion of ageing population s and often have vitamin D deficiency . Falls are frequent in this population and have usually been associated with vitamin D deficiency . In this prospect i ve study we measured serum 25-hydroxyvitamin D ( 25OHD ) , serum PTH , and falls in 637 ambulatory subjects living in institutional aged care facilities ( intermediate-care hostels or nursing homes ) . The study sample comprised 121 men ( mean age , 82.1 yr ) and 516 women ( mean age , 86.7 yr ) . Two hundred and seventy-four subjects fell one or more times over a mean duration of follow-up of 10.2 months . Vitamin D deficiency , defined as a serum 25OHD level below 39 nmol/liter was present in 73.6 % . Baseline serum 25OHD and PTH were significantly associated with falls in univariate analyses . In multivariate analyses that also corrected for balance and health status , PTH remained a significant predictor of falls independent of 25OHD . Serum PTH is a predictor of time to first fall in the frail elderly independent of vitamin D status and measures of general health",
"CONTEXT Observational studies have reported an inverse association between serum 25-hydroxyvitamin D ( 25-OHD ) levels and incidence of upper respiratory tract infections ( URTIs ) . However , results of clinical trials of vitamin D supplementation have been inconclusive . OBJECTIVE To determine the effect of vitamin D supplementation on incidence and severity of URTIs in healthy adults . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted among 322 healthy adults between February 2010 and November 2011 in Christchurch , New Zeal and . INTERVENTION Participants were r and omly assigned to receive an initial dose of 200,000 IU oral vitamin D3 , then 200,000 IU 1 month later , then 100,000 IU monthly ( n = 161 ) , or placebo administered in an identical dosing regimen ( n = 161 ) , for a total of 18 months . MAIN OUTCOME MEASURES The primary end point was number of URTI episodes . Secondary end points were duration of URTI episodes , severity of URTI episodes , and number of days of missed work due to URTI episodes . RESULTS The mean baseline 25-OHD level of participants was 29 ( SD , 9 ) ng/mL. Vitamin D supplementation result ed in an increase in serum 25-OHD levels that was maintained at greater than 48 ng/mL throughout the study . There were 593 URTI episodes in the vitamin D group and 611 in the placebo group , with no statistically significant differences in the number of URTIs per participant ( mean , 3.7 per person in the vitamin D group and 3.8 per person in the placebo group ; risk ratio , 0.97 ; 95 % CI , 0.85 - 1.11 ) , number of days of missed work as a result of URTIs ( mean , 0.76 days in each group ; risk ratio , 1.03 ; 95 % CI , 0.81 - 1.30 ) , duration of symptoms per episode ( mean , 12 days in each group ; risk ratio , 0.96 ; 95 % CI , 0.73 - 1.25 ) , or severity of URTI episodes . These findings remained unchanged when the analysis was repeated by season and by baseline 25-OHD levels . CONCLUSION In this trial , monthly administration of 100,000 IU of vitamin D did not reduce the incidence or severity of URTIs in healthy adults . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12609000486224",
"Seasonal Affective Disorder ( SAD ) is prevalent when vitamin D stores are typically low . Broad-spectrum light therapy includes wavelengths between 280 - 320 nm which allow the skin to produce vitamin D. This study was design ed to test the hypothesis that vitamin D deficiency might play a role in SAD . A prospect i ve , r and omized controlled trial was conducted in a group of 15 subjects with SAD . Eight subjects received 100,000 I.U. of vitamin D and seven subjects received phototherapy . At the onset of treatment and after 1 month of therapy subjects were administered the Hamilton Depression scale , the SIGH-SAD , and the SAD-8 depression scale . All subjects also had serum levels of 25-hydroxyvitamin D ( 25-OH D ) measured before and 1 week after intervention therapy . All subjects receiving vitamin D improved in all outcome measures . The phototherapy group showed no significant change in depression scale measures . Vitamin D status improved in both groups ( 74 % vitamin D group , p Improvement in 25-OH D was significantly associated with improvement in depression scale scores ( r2=0.26 ; p=0.05 ) . Vitamin D may be an important treatment for SAD . Further studies will be necessary to confirm these findings",
"Objective : To compare the therapeutic effects of vitamin D3 plus fluoxetine and fluoxetine alone in patients with major depressive disorder . Methods : In the present double-blind , r and omized , placebo-controlled trial , 42 patients with a diagnosis of major depressive disorder based on DSM-IV criteria were r and omly assigned into two groups to receive daily either 1500 IU vitamin D3 plus 20 mg fluoxetine or fluoxetine alone for 8 weeks . Depression severity was assessed at 2-week intervals using the 24-item Hamilton Depression Rating Scale ( HDRS ) as a primary outcome measure and the 21-item Beck Depression Inventory ( BDI ) as a secondary outcome measure . Serum 25(OH ) vitamin D was measured at baseline and after intervention . Results : Forty patients completed the trial . A two-way repeated- measures analysis of variance showed that depression severity based on HDRS and BDI decreased significantly after intervention , with a significant difference between the two groups . The vitamin D + fluoxetine combination was significantly better than fluoxetine alone from the fourth week of treatment . Conclusions : In the present 8-week trial , the vitamin D + fluoxetine combination was superior to fluoxetine alone in controlling depressive symptoms",
"OBJECTIVES Low trauma fractures in older people incur enormous physical , social and economic costs . Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group . This strategy requires validation in a population setting . METHODS R and omized , double-blind , placebo-controlled trial of 300,000 IU intramuscular ( i.m . ) vitamin D2 ( ergocalciferol ) injection or matching placebo every autumn over 3 years . 9440 people ( 4354 men and 5086 women ) aged 75 yrs and over were recruited from general practice registers in Wessex , Engl and . Primary outcome measure was all non-vertebral fracture . Secondary outcomes were hip and wrist fractures , and all falls . RESULTS 585 subjects had incident non-spine fractures ( hip 110 , wrist 116 , ankle 37 ) . Hazard ratios ( HRs ) for fracture in the vitamin D group were : 1.09 [ 95 % confidence interval ( CI ) 0.93 - 1.28 , P = 0.29 ] for any first fracture , 1.49 ( 95 % CI 1.02 - 2.18 , P = 0.04 ) for hip and 1.22 ( 95 % CI 0.85 - 1.76 , P = 0.28 ) for wrist . There was no effect on falls : HR 0.98 ( 0.93 - 1.04 ) . No protective effect was observed in any subgroup when the cohort was stratified by sex , age , previous fracture or mobility . CONCLUSIONS An annual i.m . injection of 300,000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population",
"While observational studies have suggested that vitamin D deficiency increases risk of depression , few clinical trials have tested whether vitamin D supplementation affects the occurrence of depression symptoms . The authors evaluated the impact of daily supplementation with 400 IU of vitamin D(3 ) combined with 1,000 mg of elemental calcium on measures of depression in a r and omized , double-blinded US trial comprising 36,282 postmenopausal women . The Burnam scale and current use of antidepressant medication were used to assess depressive symptoms at r and omization ( 1995 - 2000 ) . Two years later , women again reported on their antidepressant use , and 2,263 completed a second Burnam scale . After 2 years , women r and omized to receive vitamin D and calcium had an odds ratio for experiencing depressive symptoms ( Burnam score ≥0.06 ) of 1.16 ( 95 % confidence interval : 0.86 , 1.56 ) compared with women in the placebo group . Supplementation was not associated with antidepressant use ( odds ratio = 1.01 , 95 % confidence interval : 0.92 , 1.12 ) or continuous depressive symptom score . Results stratified by baseline vitamin D and calcium intake , solar irradiance , and other factors were similar . The findings do not support a relation between supplementation with 400 IU/day of vitamin D(3 ) along with calcium and depression in older women . Additional trials testing higher doses of vitamin D are needed to determine whether this nutrient may help prevent or treat depression ",
"OBJECTIVES To evaluate the association between serum 25-hydroxyvitamin D ( 25(OH)D ) levels and mortality in a representative U.S. sample of older adults . DESIGN Prospect i ve cohort from the Third National Health and Nutrition Examination Survey ( NHANES III ) and linked mortality files . SETTING Noninstitutionalized U.S. civilian population . PARTICIPANTS Three thous and four hundred eight NHANES III participants aged 65 and older enrolled from 1988 to 1994 and followed for mortality through 2000 . MEASUREMENTS Primary exposure was serum 25(OH)D level at enrollment . Primary and secondary outcomes were all-cause and cardiovascular disease ( CVD ) mortality , respectively . RESULTS During the median 7.3 years of follow-up , there were 1,493 ( 44 % ) deaths , including 767 CVD-related deaths . Median 25(OH)D level was 66 nmol/L. Adjusting for demographics , season , and cardiovascular risk factors , baseline 25(OH)D levels were inversely associated with all-cause mortality risk ( adjusted hazard ratio (HR)=0.95 , 95 % confidence interval (CI)=0.92 - 0.98 , per 10 nmol/L 25[OH]D ) . Compared with subjects with 25(OH)D levels of 100 nmol/L or higher , the adjusted HR for subjects with levels less than 25.0 nmol/L was 1.83 ( 95 % CI=1.14 - 2.94 ) and for levels of 25.0 to 49.9 nmol/L was 1.47 ( 95 % CI=1.09 - 1.97 ) . The association appeared stronger for CVD mortality ( adjusted HR=2.36 , 95 % CI=1.17 - 4.75 , for subjects with 25[OH]D levels or = 100.0 nmol/L ) than for non-CVD mortality ( adjusted HR=1.42 , 95 % CI=0.73 - 2.79 , for subjects with 25[OH]D levels or = 100.0 nmol/L ) . CONCLUSION In noninstitutionalized older adults , a group at high risk for all-cause mortality , serum 25(OH)D levels had an independent , inverse association with CVD and all-cause mortality . R and omized controlled trials of vitamin D supplementation in older adults are warranted to determine whether this association is causal and reversible",
"In a double-blind clinical trial on 49 patients with rheumatoid arthritis , calciferol was given in a dose of 100 000 IU per day for 1 year to 24 patients , while the remaining 25 received placebo . Objective and subjective improvement was noted in 67 % of the calciferol group and in 36 % of the control group , while objective and subjective deterioration was noted in 4 % of the calciferol group and in 32 % of the control group . The mean values for sedimentation rate and a2-globulin decreased and the mean hemoglobin level increased in the calciferol group . The consumption of analgesics and antiinflammatory medicines decreased significantly in the calciferol group and after 1 year morning stiffness had eased and h and strength had increased in this group",
"A 1-year prospect i ve study of seasonal mood changes was conducted in 250 female Boston area residents , aged 43 to 72 , who were participants in a study of vitamin D supplementation . Each woman completed the Profile of Mood States question naire at four study visits . There were significant changes over the year in scores for Tension-Anxiety , Depression-Dejection , Anger-Hostility , Fatigue-Inertia , and Confusion-Bewilderment . These scores were all highest or \" worst \" in the fall and lowest in the spring or summer . Worse mood scores were associated with fewer hours of sleep . Serum thyroxine was positively associated with higher Depression-Dejection scores in August through November and with higher ( better ) Vigor-Activity scores in February through May. Supplementation with 400 IU of vitamin D did not appear to affect levels or changes in mood scores",
"OBJECTIVE To examine the association of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment in a r and omized , double-blind , placebo-controlled trial . METHODS Adult primary care patients in Duluth , Minnesota , were screened for vitamin D deficiency in February 2007 . Participants completed question naires pertaining to a variety of symptoms , vitamin D intake , and selected medical conditions . Patients with mild to moderate vitamin D deficiency ( 25-hydroxyvitamin D [ 25(OH)D ] , 10 - 25 ng/mL ) participated in a r and omized controlled trial ( RCT ) of vitamin D replacement and its effect on symptoms . Participants were r and omly assigned to receive 50 000 units of cholecalciferol ( vitamin D3 ) weekly or placebo for 8 weeks . Patients with severe vitamin D deficiency ( 25[OH]D A total of 610 patients underwent initial screening , and 100 patients with mild to moderate vitamin D deficiency participated in the RCT . Thirty-eight severely deficient patients were treated in an unblinded fashion . On initial screening , 46.2 % of participants were deficient in vitamin D. Self-reported vitamin D supplementation , milk intake , celiac disease , gastric bypass , and chronic pancreatitis were predictive of vitamin D status . Severely deficient participants reported increased musculoskeletal symptoms , depression ( including seasonal ) , and higher ( worse ) scores on a fibromyalgia assessment question naire . In the RCT , the treated group showed significant improvement in fibromyalgia assessment scores ( P = 0.03 ) , whereas the placebo-treated participants did not . Severely deficient patients did not show symptom improvement over the 8-week trial period or when followed up 1 year later . CONCLUSIONS Compared with participants in the placebo group , patients in the treatment group showed mild short-term improvement in the overall fibromyalgia impact score , but did not show significant improvement in most musculoskeletal symptoms or in activities of daily living",
"Objective The aim of this study was to examine the effect of hormone therapy and calcitriol on depression in older postmenopausal women and to determine whether the response was associated with polymorphisms of estrogen receptor & agr ; and vitamin D receptor . Methods In a double-blind placebo-controlled prospect i ve trial involving 489 postmenopausal older women , a secondary analysis of depression was done . The Geriatric Depression Scale was used to screen for depression . We used binary logistic regression to examine the effect of treatment on depression and one-way analysis of variance to find a relationship between gene polymorphisms and depression . Results There was no effect of hormone therapy ( odds ratio [ OR ] , 1.65 ; 95 % CI , 0.66 - 4.12 ; P = 0.277 ) , calcitriol ( OR , 1.15 ; 95 % CI , 0.43 - 3.11 ; P = 0.772 ) , or hormone therapy with calcitriol ( OR , 1.01 ; 95 % CI , 0.36 - 2.80 ; P = 0.979 ) on depression . Neither the polymorphisms of estrogen receptor & agr ; ( XbaI-&bgr ; = 0.093 ; CI , −0.337 to 1.350 ; P = 0.239 and PvuII-&bgr ; = −0.064 ; CI , −1.171 to 0.491 , P = 0.421 ) nor those of vitamin D receptor ( BsmI-&bgr ; = 0.044 , CI −2.546 to 3.030 , P = 0.865 and TaqI-&bgr ; = −0.015 , CI −2.900 to 2.738 , P = 0.955 ) were associated with depression . Conclusion In older postmenopausal women , there was no effect of hormone therapy and calcitriol either individually or in combination with depression . Estrogen receptor & agr ; and vitamin D receptor polymorphisms are not associated with depression or the response to intervention in older postmenopausal women . Additional trials are required to confirm these findings",
"OBJECTIVE Ecologic and observational studies have suggested an association between serum 25-hydroxyvitamin D ( 25(OH)D ) levels and cardiovascular disease ( CVD ) risk factors , CVD mortality , and cancer mortality . Based on this , low serum 25(OH)D levels should be associated with higher all-cause mortality in a general population . This hypothesis was tested in the present study . DESIGN The Tromsø study is a longitudinal population -based multi purpose study initiated in 1974 with focus on lifestyle-related diseases . Our data are based on the fourth Tromsø study carried out in 1994 - 1995 . METHODS Information about death and cause of death was registered by obtaining information from the National Directory of Residents and the Death Cause Registry . Serum 25(OH)D was measured in 7161 participants in the fourth Tromsø study . Results are presented for smokers ( n=2410 ) and non-smokers ( n=4751 ) separately as our immunoassay seems to overestimate 25(OH)D levels for smokers . RESULTS During a mean 11.7 years of follow-up , 1359 ( 19.0 % ) participants died . In multivariate regression models , there was a significantly increased risk of all-cause mortality ( hazard ratio ( HR ) 1.32 , confidence interval ( CI ) 1.07 - 1.62 ) among non-smoking participants in the lowest 25(OH)D quartile when compared with participants in the highest quartile . Equivalent results for smokers were not significant ( HR 1.06 , CI 0.83 - 1.35 ) . CONCLUSIONS Low serum 25(OH)D levels were associated with increased all-cause mortality for non-smokers , but the results did not reach statistical significance for smokers . However , low 25(OH)D levels are known to be associated with impaired general health , and r and omized controlled studies are needed to address the question of causality"
] | 4116644c-06ff-11f0-808a-c43d1ab1c353 |
Chronic cancer pain is a serious complication of malignancy or its treatment . Currently , no comprehensive , universally accepted cancer pain classification system exists . Clarity in classification of common cancer pain syndromes would improve clinical assessment and management . Moreover , an evidence -based taxonomy would enhance cancer pain research efforts by providing consistent diagnostic criteria , ensuring comparability across clinical trials . As part of a collaborative effort between the Analgesic , Anesthetic , and Addiction Clinical Trial Translations , Innovations , Opportunities , and Networks ( ACTTION ) and the American Pain Society ( APS ) , the ACTTION-APS Pain Taxonomy initiative worked to develop the characteristics of an optimal diagnostic system . After the establishment of these characteristics , a working group consisting of clinicians and clinical and basic scientists with expertise in cancer and cancer-related pain was convened to generate core diagnostic criteria for an illustrative sample of 3 chronic pain syndromes associated with cancer ( ie , bone pain and pancreatic cancer pain as models of pain related to a tumor ) or its treatment ( ie , chemotherapy-induced peripheral neuropathy ) . A systematic review and synthesis was conducted to provide evidence for the dimensions that comprise this cancer pain taxonomy . Future efforts will subject these diagnostic categories and criteria to systematic empirical evaluation of their feasibility , reliability , and validity and extension to other cancer-related pain syndromes | [
"Abstract Background and objective : Neuropathic pain ( NP ) is a common type of chronic pain in which 60 % of patients present with localized symptoms . Early diagnosis of NP is often a challenge in primary care . Moreover , so far no st and ard diagnostic procedure for localized NP ( LNP ) is available . To help general practitioners , a screening tool was developed and evaluated . Research design and methods : The development of the screening tool was based on the grading system principles for NP proposed by the IASP , focusing on medical history and distribution of painful symptoms and sensory signs . It was tested by 31 general practitioners and evaluated against the NP diagnosis of three pain specialists as reference in a single center prospect i ve study in Spain using a cohort study design including an adult population of chronic pain patients . This design avoids spectrum bias where the spectrum of disease is not correctly reflected in the study population . Main outcome measures : General practitioners rated usefulness , simplicity , and time requirements of the tool . Diagnostic accuracy was expressed by sensitivity , specificity , and positive and negative predictive values . Results : General practitioners consecutively screened 2079 chronic pain patients ( mean age 60.7 ± 11.1 years , 69.9 % female ) . Using the tool , 394 patients were diagnosed with LNP . Screening including sensory examination took 7 min ( median ) . General practitioners rated the tool as useful ( 24/31 ; 77.4 % ) or very useful ( 7/31 ; 22.6 % ) for diagnosing LNP and facilitating clinical practice ( 30/31 ; 96.8 % ) . Under daily practice conditions , sensitivity and specificity of the tool for detecting LNP was 46.7 % and 86.6 % , respectively . Conclusions : The proposed screening tool was shown to be easy and useful for detecting NP and LNP in chronic pain patients as a fast first assessment tool in primary care , thus facilitating the choice of a topical treatment . Limitations and strengths : The drop-out rate was high but was accounted for by using correction factors in the diagnostic accuracy calculations . A strength is the unselected chronic patient population : spectrum of disease correctly reflects day-to-day clinical practice and is not biased . Diagnostic accuracy of the tool therefore appears to be realistic",
"Neurolytic celiac plexus block ( NCPB ) is cl aim ed to be an effective method of pain control for pancreatic cancer pain . However , the factors that may influence long-term analgesia , adverse effects , and quality of life after performing NCPB have never been determined . In a prospect i ve multicenter study , 22 patients who underwent NCPB were followed until death . Numerous parameters other than pain and symptom intensity were evaluated , including age , gender , initial site of cancer , sites of pain , possible peritoneal involvement , technique , and oncologic interventions . Indices were calculated to determine the opioid consumption ratio ( EAS ) and the trend of opioid escalation ( OEI ) . NCPB was effective in reducing opioid consumption and gastrointestinal adverse effects for at least 4 weeks . In the last four weeks prior to death , there was the typical trend of increasing symptom intensity common to the terminal cancer population . None of the factors studied influenced the analgesic effectiveness of NPCB . NPCB , performed by skilled clinicians , regardless of the technique chosen , is a safe and useful means that should be considered as an adjuvant to common analgesic regimens at any stage , as it may allow the reduction of the visceral component of pancreatic pain that may prevail in certain phases of the illness . The analgesic and symptomatic effect of NCPB is presumably advantageous for about four weeks . A possible factor interfering with long-term outcome includes the capacity of cancer to involve the celiac axis , which can distort the anatomy and prevent neurolytic spread , or modify the pain mechanisms . Outcomes are strongly based on individual variation",
"The optimal assessment of cancer pain includes a detailed description of pain characteristics and classification by both syndrome and likely mechanisms . In the clinical setting , the interpretation of this information is aided by knowledge of the available clinical experiences on these aspects of the pain . Unfortunately , existing data are limited . There have been few large surveys of cancer pain characteristics and syndromes , and comparative data from patients in different parts of the world are entirely lacking . To better define the characteristics of cancer pain syndromes the Task Force on Cancer Pain of the International Association for the Study of Pain ( IASP ) conducted a prospect i ve , cross-sectional , international , multicenter survey of pain specialists and their patients . From a total of 100 clinicians who described themselves as cancer pain practitioners in the IASP membership directory , 51 agreed to participate in the survey and a total of 58 provided data . These clinicians resided in 24 countries and evaluated a total of 1095 patients with severe cancer pain mostly requiring opioid medication , using a combination of patient-rated and observer-rated measures . The patient-rated scales comprised a pain intensity measure chosen from the brief pain inventory . The observer-rated information included demographic and tumor-related data , and responses on checklists of pain syndromes and pathophysiologies . Patients were heterogeneous in terms of demographics and tumor-related information . More than 76 % had a Kamofsky performance status score or = 70 . Almost one-quarter of the patients experienced two or more pains . A large majority of the patients ( 92.5 % ) had one or more pains caused directly by the cancer ; 20.8 % of patients had one or more pains caused by cancer therapies . The average ( SD ) duration of pain was 5.9 ( 10.5 ) months . Approximately two-thirds of patients ( 66.7 % ) reported that the worst pain intensity during the day prior to the survey was > or = 7 on a 10-point numeric scale . The factors that were univariately associated with higher pain intensity included the presence of breakthrough pain , somatic pain or neuropathic pain , age younger than 60 years , and lower performance status score . A multivariate model suggested that the presence of breakthrough pain , somatic pain , and lower performance status were the most important predictors of intense pain . Pains that were inferred by the treating clinician to be nociceptive and due to somatic injury occurred in 71.6 % of the patients . Pains labeled nociceptive visceral were noted in 34.7 % and pains inferred to have neuropathic mechanisms occurred in 39.7 % . In a broad classification , the major pain syndromes comprised bone or joint lesions ( 41.7 % of patients ) , visceral lesions ( 28.1 % ) , soft tissue infiltration ( 28.3 % ) , and peripheral nerve injuries ( 27.8 % ) . Twenty-two types of pain syndromes were most prevalent . Large differences in the diagnosis of breakthrough pain by clinicians of different countries suggest that this phenomenon is either defined or recognized differently across countries . These data confirm , in segment of the cancer population experiencing severe pain , in different parts of the world , that cancer pain characteristics , syndromes and pathophysiologies are very heterogeneous . Predictors of worsening pain can be identified . The data provide a useful context for the interpretation of pain-related information acquired in both clinical and research setting s. They suggest the need for future studies and the potential usefulness of a written checklist for cancer pain syndromes and pathophysiologies",
"Individuals with a family history of pancreatic cancer have an increased risk of developing pancreatic cancer . Quantification of this risk provides a rational basis for cancer risk counseling and for screening for early pancreatic cancer . In a prospect i ve registry-based study , we estimated the risk of pancreatic cancer in individuals with a family history of pancreatic cancer . St and ardized incidence ratios were calculated by comparing the number of incident pancreatic cancers observed with those expected using Surveillance , Epidemiology and End Results ( SEER ) rates . Familial pancreatic cancer ( FPC ) kindreds were defined as kindreds having at least one pair of first-degree relatives with pancreatic cancer , and sporadic pancreatic cancer ( SPC ) kindreds as families without such an affected pair . Nineteen incident pancreatic cancers developed among 5,179 individuals from 838 kindreds ( at baseline , 370 FPC kindreds and 468 SPC kindreds ) . Of these 5,179 individuals , 3,957 had at least one first-degree relative with pancreatic cancer and contributed 10,538 person-years of follow-up . In this group , the observed-to-expected rate of pancreatic cancer was significantly elevated in members of FPC kindreds [ 9.0 ; 95 % confidence interval ( CI ) , 4.5–16.1 ] , but not in the SPC kindreds ( 1.8 ; 95 % CI . , 0.22–6.4 ) . This risk in FPC kindreds was elevated in individuals with three ( 32.0 ; 95 % CI , 10.2–74.7 ) , two ( 6.4 ; CI , 1.8–16.4 ) , or one ( 4.6 ; CI , 0.5–16.4 ) first-degree relative(s ) with pancreatic cancer . Risk was not increased among 369 spouses and other genetically unrelated relatives . Risk was higher in smokers than in nonsmokers . Individuals with a strong family history of pancreatic cancer have a significantly increased risk of developing pancreatic cancer",
"BACKGROUND Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence , but at the expense of increased musculoskeletal side-effects , such as carpal tunnel syndrome . The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2 - 3 years of tamoxifen . METHODS In the Intergroup Exemestane Study , postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2 - 3 years of tamoxifen were r and omised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment . The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events , analysed in the safety population , which consisted of all patients who had received any trial treatment . As well as case-report forms , question naires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome . The relation between musculoskeletal symptoms reported by 6 months from r and omisation and survival from 9 months onwards was assessed by Cox proportional hazards models . The trial is registered , number IS RCT N11883920 . It has completed accrual and follow-up is continuing for enrolled participants . FINDINGS After a median follow-up of 91·0 months ( IQR 83·0 - 99·2 ) , carpal tunnel syndrome had been reported for 66 ( 2·8 % ) of 2319 patients in the exemestane group compared with 13 ( 0·6 % ) of 2338 in the tamoxifen group ( odds ratio [ OR ] 5·23 , 99 % CI 2·39 - 11·49 ; p . More events occurred during treatment in the exemestane group than in the tamoxifen group ( 66 [ 2·8 % ] vs seven [ 0·3 % ] , adjusted OR 9·90 , 99 % CI 3·52 - 27·82 ; p had musculoskeletal symptoms than in the tamoxifen group ( 901 of 2338 , 38·5 % ; OR 1·48 , 99 % CI 1·32 - 1·67 , p ) . More events occurred during treatment in the exemestane group than in the tamoxifen group ( 984 [ 42·4 % ] vs 776 [ 33·2 % ] , adjusted OR 1·59 , 99 % CI 1·32 - 1·91 ; p 73 on-treatment cases of carpal tunnel syndrome , 58 ( 79·5 % ) completed question naires were available . 27 patients ( 46·6 % ) had bilateral carpal tunnel syndrome and 31 ( 53·4 % ) had unilateral disease ; 40 ( 69·0 % ) underwent surgical release . The disorder greatly affected daily-life activities in 21 ( 36·2 % ) cases . Occurrence of musculoskeletal symptoms , including carpal tunnel syndrome , was associated with improved disease-free survival in unadjusted analysis ( p=0·023 ) , but not with overall survival ( p=0·36 ) . However , after adjustment for possible confounding factors , musculoskeletal symptoms were not associated with disease-free survival ( hazard ratio [ HR ] 0·96 , 95 % CI 0·82 - 1·14 , p=0·67 ) or overall survival ( HR 1·02 , 95 % CI 0·84 - 1·25 , p=0·82 ) . INTERPRETATION Occurrence of carpal tunnel syndrome is higher in patients with breast cancer given exemestane than in those treated with tamoxifen , and surgical release might be necessary in most cases . Development of musculoskeletal symptoms in the first 6 months of treatment is not an independent biomarker of improved disease outcome . Further investigation is warranted into the relation between treatment-emergent musculoskeletal symptoms and clinical outcome in patients with breast cancer receiving hormonal therapy . FUNDING Pfizer",
"Purpose Chemotherapy-induced peripheral neuropathy is a major complication in the treatment for cancer , including multiple myeloma ( MM ) . Patients may develop painful and non-painful ( e.g. , numbness ) neuropathy symptoms that impair function and often persist after therapy is terminated . This study tested the hypothesis that baseline sub clinical neuropathy , as assessed by sensory thresholds , is related to the development of neuropathy symptoms ( e.g. , pain and numbness ) in patients with MM undergoing treatment with chemotherapy . Methods Patients ( n = 56 ) who had undergone two or fewer cycles of induction therapy and who had no evident neuropathy were assessed using quantitative sensory tests to determine multiple-modality sensory thresholds . Patient-reported pain and numbness were assessed through induction therapy ( 16 weeks ) via the MD And erson Symptom Inventory . A subset of participants ( n = 15 ) continued reporting on their symptoms for an additional 16 weeks ( “ maintenance phase ” ) . Results Patients with sharpness detection deficits at baseline ( n = 11 , 20 % of sample ) reported less severe pain and numbness during induction therapy and less numbness during maintenance therapy ( P severe pain and numbness , and those with skin temperature deficits ( n = 7 , 47 % of maintenance sample ) reported more severe pain ( P walking , a common symptom of peripheral neuropathy . Conclusion Our results suggest that baseline sub clinical sensory deficits may be related to a patient ’s risk for developing chemotherapy-induced peripheral neuropathy",
"It has been estimated that familial aggregation and genetic susceptibility play a role in as many as 10 % of patients with pancreatic cancer ( PC ) . The quantified prospect i ve risk of PC among first-degree relatives of PC patients has not been investigated . Families enrolled in the National Familial Pancreas Tumor Registry ( NFPTR ) prior to September 1 , 1998 were followed to estimate the risk and incidence of PC among first-degree relatives of patients with PC . Analyses were performed separately on kindreds with at least two first-degree relatives with PC ( familial pancreatic carcinoma ( PC ) ; n = 150 ) at the time the kindred was enrolled in the NFPTR and on kindreds without a pair of affected first-degree relatives ( sporadic PC ; n = 191 ) . A sub analysis was performed on familial PC kindreds containing three or more affected members at the time of enrollment in the NFPTR ( n = 52 ) . Risk was estimated by comparing observed new cases of PC during the observation period with expected numbers based on the United States population -based Surveillance , Epidemiology and End Results program data . Incidence was estimated using person-years risk analyses . During the observational period , six incident PCs developed in the first-degree relatives : two in the sporadic PC kindreds , and four in the familial PC kindreds . The PC risk in the sporadic PC kindreds was not significantly greater than expected [ observed/expected = 6.5 ( 95 % CI = 0.78 - 23.3 ) ] with an incidence rate of 24.5/10(5)/ year . There was a significantly increased 18-fold risk ( 95 % CI = 4.74 - 44.5 ) of PC among first-degree relatives in familial PC kindreds , with an incidence of 76.0/10(5)/year . In the subset of familial PC kindreds with three or more affected family members at the time of enrollment , there was a 57-fold ( 95 % CI = 12.4 - 175 ) increased risk of PC and an incidence of 301.4/10(5)/year compared with the Surveillance , Epidemiology and End Result age-adjusted incidence of PC in the U.S. ( 8.8/10(5)/year ) . When stratified by age , the risk was largely confined to relatives over the age of 60 . This study is the first analysis of incident PC occurring in familial PC kindreds . The risk and incidence of PC is exceptionally high among at-risk first-degree relatives in familial PC kindreds in which at least three first-degree relatives have already been diagnosed with PC . Familial PC kindreds are a reasonable high-risk group for PC screening and chemoprevention research",
"BACKGROUND The European Pain in Cancer survey sought to increase underst and ing of cancer-related pain and treatment across Europe . PATIENTS AND METHODS Patients with all stages of cancer participated in a two-phase telephone survey conducted in 11 European countries and Israel in 2006 - 2007 . The survey screened for patients experiencing pain at least weekly , then r and omly selected adult patients with pain of at least moderate intensity occurring several times per week for the last month completed a detailed attitudinal question naire . RESULTS Of 5084 adult patients contacted , 56 % suffered moderate-to-severe pain at least monthly . Of 573 patients r and omly selected for the second survey phase , 77 % were receiving prescription-only analgesics , with 41 % taking strong opioids either alone or with other drugs for cancer-related pain . Of those prescribed analgesics , 63 % experienced breakthrough pain . In all , 69 % reported pain-related difficulties with everyday activities ; however , 50 % believed that their quality of life was not considered a priority in their overall care by their health care professional . CONCLUSIONS Across Europe and Israel , treatment of cancer pain is suboptimal . Pain and pain relief should be considered integral to the diagnosis and treatment of cancer ; management guidelines should be revised to improve pain control in patients with cancer",
"Objectives The purpose of this prospect i ve study was to analyze time course of pain relief by radiotherapy for cancer pain . Methods A total of 91 patients with painful bone metastases were treated by radiotherapy with a median total dose of 46 Gy . Pain of the irradiated site was assessed using a numerical rating scale ( pain score : 0 to 10 ) once a week from the beginning of radiotherapy ( day 1 ) for about 5 weeks . Results In time course analysis of the 91 cases , the mean ( ±SD ) pain scores at day 5 , day 12 , day 19 , day 26 , day 33 , and day 40 were 7.8 ( ±1.6 ) , 5.3 ( ±2.5 ) , 3.5 ( ±2.5 ) , 2.4 ( ±2.5 ) , 1.6 ( ±2.1 ) , and 1.1 ( ±1.9 ) , respectively , and mean pain score was significantly reduced with time from the start of radiotherapy ( P ) . Mean pain score was significantly reduced every week by d33 ( P . Complete pain relief was obtained in 45/91 ( 49 % ) cases , and partial ( ≥50 % ) pain relief was obtained in 83/91 ( 91 % ) cases . The mean time to obtain 50 % pain relief was 13 days . The mean time to obtain complete pain relief ( n=45 ) was 24 days . Doses of analgesics were reduced in 28/64 ( 44 % ) cases at the end of radiotherapy . Discussion Telling approximate time course of pain relief seems to reduce patients ' anxiety , and knowing time course of pain relief seems to be useful to determine optimal dose of anlagesics that changes according to the course",
"Abstract Chemotherapy-induced peripheral neuropathy ( CIPN ) is a common side effect of cancer therapy . This study evaluates symptoms of CIPN and CIPN-related pain and its influence on psychological functioning and potential predictors of chronic CIPN and pain . In this large prospect i ve question naire study , 174 patients receiving adjuvant oxaliplatin or docetaxel were consecutively included . Patients were asked to complete a question naire with vali date d questions on peripheral neuropathy , pain , anxiety and depression , and quality of life at baseline , after the first cycle , halfway through therapy , and 1 year after baseline . Chronic CIPN symptoms ( tingling and /or numbness ) in the feet at 1-year follow-up were present in 63.6 % of patients without preexisting neuropathy in the oxaliplatin group and in 44.8 % in the docetaxel group , whereas pain in h and s and feet was found in 31.3 % and 35.1 % , respectively . Both groups had significantly different pain profiles , and persistent pain in the docetaxel group was found to have effect on psychological function . Cumulative dose predicted oxaliplatin-induced neuropathy ( P = 0.004 ) , whereas endocrine therapy predicted peripheral pain in the docetaxel group ( P = 0.04 ) . There are important differences in acute neuropathic symptoms and chronic pain profiles in patients after oxaliplatin and docetaxel treatment . It is , however , important to recognize that chronic peripheral pain may be unrelated to neuropathy and can be caused by concomitant treatments . Future studies should focus on characterizing and distinguishing CIPN-related pain from other types of pain to determine the best outcome measures for trials on prevention or relief",
"We describe the symptoms , physical findings , treatment interventions , risk factors , and length of survival in persons with pancreatic cancer referred to a palliative care service ( PCS ) in a tertiary care facility . Data were collected prospect ively over a 2-yr period using a st and ard clinical assessment tool in 39 patients with unresectable pancreatic cancer . Common symptoms include pain ( 82 % ) , anorexia ( 64 % ) , early satiety ( 62 % ) , xerostomia and sleep problems ( both 54 % ) , and weight loss ( 51 % ) . Analyzed retrospectively , 82 % had at least one known risk factor for the development of pancreatic cancer . Twenty-five people presented to the PCS within 1 mo of diagnosis ; in this group , length of survival was analyzed according to the presence of specific symptoms , and a significant inverse relationship between the presence of dyspnea and length of survival was found . As there is no effective treatment for surgically unresectable pancreatic cancer , palliation of common symptoms should be the primary emphasis of therapy",
"Background Neurolytic celiac plexus block ( NCPB ) is an effective way of treating severe pain in some patients with pancreatic malignancy . However , there are no studies to date that evaluate the effectiveness of NCPB related to the site of primary pancreas cancer . The aim of the study was to assess the effectiveness of NCPB in pancreatic cancer pain , depending on the location of the pancreatic tumor . Methods The prospect i ve study was conducted in 50 consecutive patients diagnosed with pancreatic cancer . The patients were categorized into two different groups depending on tumor localization : group 1 : patients with the cancer of the head of the pancreas and group 2 : patients with the cancer of the body and tail of the pancreas . The qualitative and quantitative pain analyses were performed before and after NCPB . The patients underwent prognostic celiac plexus block with bupivacaine , followed by neurolysis during fluoroscopic control within the next 24 h. Results After NCPB , 37 patients ( 74 % ) had effective pain relief during the first 3 months or until death . Of the 37 patients who had effective pain relief , 33 ( 92 % ) were from group 1 and 4 ( 29 % ) were from group 2 . In the remaining 13 patients ( 3 patients from group 1 and 10 patients from group 2 ) , pain relief after NCPB was not satisfactory . Those patients were scheduled for repeated retrocrural neurolysis during computed tomography control . Computed tomography showed massive growth of the tumor around the celiac axis with metastases . After repeated neurolysis , pain relief clinical ly still was not satisfactory , necessitating additional opioid treatment . Conclusion In this study , unilateral transcrural celiac plexus neurolysis has been shown to provide effective pain relief in 74 % of patients with pancreatic cancer pain . Neurolysis was more effective in cases with tumor involving the head of the pancreas . In the cases with advanced tumor proliferation , regardless of the technique used , the analgesic effects of NCPB were not satisfactory",
"& NA ; In the cancer population , the term breakthrough pain typically refers to a transitory flare of pain in the setting of chronic pain managed with opioid drugs . The prevalence and characteristics of this phenomenon have not been defined , and its impact on patient care is unknown . We developed operational definitions for breakthrough pain and its major characteristics , and applied these in a prospect i ve survey of patients with cancer pain . Data were collected during a 3 month period from consecutive patients who reported moderate pain or less for more than 12 h daily and stable opioid dosing for a minimum of 2 consecutive days . Of 63 patients surveyed , 41 ( 64 % ) reported breakthrough pain , transient flares of severe or excruciating pain . Fifty‐one different pains were described ( median 4 pains/day ; range 1–3600 ) . Pain characteristics were extremely varied . Twenty‐two ( 43 % ) pains were paroxysmal in onset ; the remainder were more gradual . The duration varied from seconds to hours ( median/range : 30 min/1–240 min ) , and 21 ( 41 % ) were both paroxysmal and brief ( lancinating pain ) . Fifteen ( 29 % ) of the pains were related to the fixed opioid dose , occurring solely at the end of the dosing interval . Twenty‐eight ( 55 % ) of the pains were precipitated ; of these , 22 were caused by an action of the patient ( incident pain ) , and 6 were associated with a non‐volitional precipitant , such as flatulence . The pathophysiology of the pain was believed to be somatic in 17 ( 33 % ) , visceral in 10 ( 20 % ) , neuropathic in 14 ( 27 % ) , and mixed in 10 ( 20 % ) . Pain was related to the tumor in 42 ( 82 % ) , the effects of therapy in 7 ( 14 % ) , and neither in 2 ( 4 % ) . Diverse interventions were employed to manage these pains , with variable efficacy . These data clarify the spectrum of breakthrough pains and indicate their importance in cancer pain management",
"BACKGROUND Intravenous injection is the st and ard administration route of bortezomib ; however , subcutaneous administration is an important alternative . We compared the efficacy and safety of subcutaneous versus intravenous bortezomib at the approved 1·3 mg/m(2 ) dose and twice per week schedule in patients with relapsed multiple myeloma . METHODS This r and omised , phase 3 study was undertaken at 53 centres in ten countries in Europe , Asia , and South America . Patients aged 18 years and older with relapsed multiple myeloma after one to three previous lines of therapy were r and omly assigned to receive up to eight 21-day cycles of bortezomib 1·3 mg/m(2 ) , on days 1 , 4 , 8 , and 11 , by subcutaneous injection or intravenous infusion . R and omisation was by an interactive voice response system based on a computer-generated r and omisation schedule , stratified by number of previous lines and disease stage . Patients and treating physicians were not masked to treatment allocation . The primary objective was to show non-inferiority of subcutaneous versus intravenous bortezomib in terms of overall response rate ( ORR ) after four cycles in all patients with a diagnosis of measurable , secretory multiple myeloma who received one or more dose of drug ( response-evaluable population ) . Non-inferiority was defined as retaining 60 % of the intravenous treatment effect . This study is registered with Clinical Trials.gov , number NCT00722566 , and is ongoing for long-term follow-up . FINDINGS 222 patients were r and omly assigned to receive subcutaneous ( n=148 ) or intravenous ( n=74 ) bortezomib . The response-evaluable population consisted of 145 patients in the subcutaneous group and 73 in the intravenous group . Patients received a median of eight cycles ( range one to ten ) in both groups . ORR after four cycles was 42 % in both groups ( 61 patients in subcutaneous group and 31 in intravenous group ; ORR difference -0·4 % , 95 % CI -14·3 to 13·5 ) , showing non-inferiority ( p=0·002 ) . After a median follow-up of 11·8 months ( IQR 7·9 - 16·8 ) in the subcutaneous group and 12·0 months ( 8·1 - 15·6 ) in the intravenous group , there were no significant differences in time to progression ( median 10·4 months , 95 % CI 8·5 - 11·7 , vs 9·4 months , 7·6 - 10·6 ; p=0·387 ) and 1-year overall survival ( 72·6 % , 95 % CI 63·1 - 80·0 , vs 76·7 % , 64·1 - 85·4 ; p=0·504 ) with subcutaneous versus intravenous bortezomib . Grade 3 or worse adverse events were reported in 84 ( 57 % ) patients in the subcutaneous group versus 52 ( 70 % ) in the intravenous group ; the most common were thrombocytopenia ( 19 [ 13 % ] vs 14 [ 19 % ] ) , neutropenia ( 26 [ 18 % ] vs 13 [ 18 % ] ) , and anaemia ( 18 [ 12 % ] vs six [ 8 % ] ) . Peripheral neuropathy of any grade ( 56 [ 38 % ] vs 39 [ 53 % ] ; p=0·044 ) , grade 2 or worse ( 35 [ 24 % ] vs 30 [ 41 % ] ; p=0·012 ) , and grade 3 or worse ( nine [ 6 % ] vs 12 [ 16 % ] ; p=0·026 ) was significantly less common with subcutaneous than with intravenous administration . Subcutaneous administration was locally well tolerated . INTERPRETATION Subcutaneous bortezomib offers non-inferior efficacy to st and ard intravenous administration , with an improved safety profile . FUNDING Johnson & Johnson Pharmaceutical Research and Development , and Millennium Pharmaceuticals",
"Objectives : To characterize the natural history of oxaliplatin-associated neuropathy ( ON ) and determine whether intraepidermal nerve fiber density ( IENFD ) is a sensitive measure of neuropathy progression . In addition , we sought to assess the potential of ON as a neuroprotection model and gain insight into the relationship between axon loss and neuropathic symptoms . Methods : Eight subjects receiving oxaliplatin for advanced colorectal cancer were prospect ively followed prior to starting chemotherapy and at 30 , 90 , 180 , and 360 days ( 180 days after completing treatment ) . Electrophysiology , punch biopsies , symptom assessment , and examinations with calculation of a reduced total neuropathy score ( rTNS ) were performed at each time point . Changes over time were assessed through Poisson regression for IENFD and a mixed effects model for rTNS and electrophysiology measures . Results : The distal leg IENFD , rTNS , peroneal , and sural amplitudes were all significantly reduced over time , while conduction velocity ( peroneal and sural ) and distal thigh IENFD were not . Measures of axon loss continued to worsen following discontinuation of oxaliplatin . Five of 8 subjects reported prominent symptoms associated with oxaliplatin administration . Conclusions : This study demonstrates that oxaliplatin is associated with mild , sensory , and motor axon loss that may not be reversible . Axonal loss was detected by electrophysiology , rTNS , and distal leg IENFD . Several subjects reported prominent sensory symptoms that were not associated with axon loss , and that may or may not represent neuropathy . ON is an attractive paradigm for neuroprotection studies and the distal leg IENFD is an objective measure that requires minimal subject participation or study site expertise",
"Summary It is suggested that there are several distinct pain sensory profiles across various neuropathic pain disorders that may reflect distinct pathophysiological mechanisms . ABSTRACT This manuscript aim ed to characterize the clinical profile of various neuropathic pain ( NeP ) disorders and to identify whether patterns of sensory symptoms/signs exist , based on baseline responses on the Neuropathic Pain Symptom Inventory ( NPSI ) question naire and the quantitative sensory testing ( QST ) . These post hoc analyses were based on data from 4 r and omized , double‐blind , placebo‐controlled clinical studies of pregabalin ( 150–600 mg/day ) in patients with NeP syndromes : central poststroke pain , posttraumatic peripheral pain , painful HIV neuropathy , and painful diabetic peripheral neuropathy . The NPSI question naire includes 10 different pain symptom descriptors . QST was used to detect sensory thresholds of accurately calibrated sensory stimuli and to quantify the intensity of evoked sensation . To identify symptoms/signs clusters and select the number of clusters , a principal component analysis ( PCA ) and hierarchical clustering methods with clinical input were used . Analysis of the NPSI pain qualities and individual QST measures at baseline indicated no clear association between particular symptoms/signs profiles and etiologies . Based on NPSI symptoms , PCA identified 3 pain dimensions : provoked , deep , and pinpoint . A hierarchical cluster analysis identified 3 clusters with distinct pain characteristics profiles independent of NeP syndrome . Based on QST signs , PCA identified 2 pain dimensions : evoked by cold and evoked by touch . A hierarchical cluster analysis identified 4 clusters with distinct pain characteristics profiles . These “ trans‐etiological ” profiles may reflect distinct pathophysiological mechanisms and therefore , potential differential responses to treatment"
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BACKGROUND Work-related upper limb and neck musculoskeletal disorders ( MSDs ) are one of the most common occupational disorders around the world . Although ergonomic design and training are likely to reduce the risk of workers developing work-related upper limb and neck MSDs , the evidence is unclear . OBJECTIVES To assess the effects of workplace ergonomic design or training interventions , or both , for the prevention of work-related upper limb and neck MSDs in adults . SEARCH METHODS We search ed MEDLINE , EMBASE , the Cochrane Central Register of Controlled Trials ( CENTRAL ) , CINAHL , AMED , Web of Science ( Science Citation Index ) , SPORTD iscus , Cochrane Occupational Safety and Health Review Group Data base and Cochrane Bone , Joint and Muscle Trauma Group Specialised Register to July 2010 , and Physiotherapy Evidence Data base , US Centers for Disease Control and Prevention , the National Institute for Occupational Safety and Health data base , and International Occupational Safety and Health Information Centre data base to November 2010 . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) of ergonomic workplace interventions for preventing work-related upper limb and neck MSDs . We included only studies with a baseline prevalence of MSDs of the upper limb or neck , or both , of less than 25 % . DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed risk of bias . We included studies with relevant data that we judged to be sufficiently homogeneous regarding the intervention and outcome in the meta- analysis . We assessed the overall quality of the evidence for each comparison using the GRADE approach . MAIN RESULTS We included 13 RCTs ( 2397 workers ) . Eleven studies were conducted in an office environment and two in a healthcare setting . We judged one study to have a low risk of bias . The 13 studies evaluated effectiveness of ergonomic equipment , supplementary breaks or reduced work hours , ergonomic training , a combination of ergonomic training and equipment , and patient lifting interventions for preventing work-related MSDs of the upper limb and neck in adults . Overall , there was moderate- quality evidence that arm support with alternative mouse reduced the incidence of neck/shoulder disorders ( risk ratio ( RR ) 0.52 ; 95 % confidence interval ( CI ) 0.27 to 0.99 ) but not the incidence of right upper limb MSDs ( RR 0.73 ; 95 % CI 0.32 to 1.66 ) ; and low- quality evidence that this intervention reduced neck/shoulder discomfort ( st and ardised mean difference ( SMD ) -0.41 ; 95 % CI -0.69 to -0.12 ) and right upper limb discomfort ( SMD -0.34 ; 95 % CI -0.63 to -0.06).There was also moderate- quality evidence that the incidence of neck/shoulder and right upper limb disorders were not reduced when comparing alternative mouse and conventional mouse ( neck/shoulder RR 0.62 ; 95 % CI 0.19 to 2.00 ; right upper limb RR 0.91 ; 95 % CI 0.48 to 1.72 ) , arm support and no arm support with conventional mouse ( neck/shoulder RR 0.67 ; 95 % CI 0.36 to 1.24 ; right upper limb RR 1.09 ; 95 % CI 0.51 to 2.29 ) , and alternative mouse with arm support and conventional mouse with arm support ( neck/shoulder RR 0.58 ; 95 % CI 0.30 to 1.12 ; right upper limb RR 0.92 ; 95 % CI 0.36 to 2.36).There was low- quality evidence that using an alternative mouse with arm support compared to conventional mouse with arm support reduced neck/shoulder discomfort ( SMD -0.39 ; 95 % CI -0.67 to -0.10 ) . There was low- to very low- quality evidence that other interventions were not effective in reducing work-related upper limb and neck MSDs in adults . AUTHORS ' CONCLUSIONS We found moderate- quality evidence to suggest that the use of arm support with alternative mouse may reduce the incidence of neck/shoulder MSDs , but not right upper limb MSDs . Moreover , we found moderate- quality evidence to suggest that the incidence of neck/shoulder and right upper limb MSDs is not reduced when comparing alternative and conventional mouse with and without arm support . However , given there were multiple comparisons made involving a number of interventions and outcomes , high- quality evidence is needed to determine the effectiveness of these interventions clearly . While we found very-low- to low- quality evidence to suggest that other ergonomic interventions do not prevent work-related MSDs of the upper limb and neck , this was limited by the paucity and heterogeneity of available studies . This review highlights the need for high- quality RCTs examining the prevention of MSDs of the upper limb and neck | [
"BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the \" no stretching \" ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted",
"Background Low back pain ( LBP ) and neck pain ( NP ) are a major public health problem with considerable costs for individuals , companies and society . Therefore , prevention is imperative . The Stay@Work study investigates the (cost-)effectiveness of Participatory Ergonomics ( PE ) to prevent LBP and NP among workers . Methods In a r and omised controlled trial ( RCT ) , a total of 5,759 workers working at 36 departments of four companies is expected to participate in the study at baseline . The departments consisting of about 150 workers are pre-stratified and r and omised . The control departments receive usual practice and the intervention departments receive PE . Within each intervention department a working group is formed including eight workers , a representative of the management , and an occupational health and safety coordinator . During a one day meeting , the working group follows the steps of PE in which the most important risk factors for LBP and NP , and the most adequate ergonomic measures are identified on the basis of group consensus . The implementation of ergonomic measures at the department is performed by the working group . To improve the implementation process , so-called ' ergocoaches ' are trained . The primary outcome measure is an episode of LBP and NP . Secondary outcome measures are actual use of ergonomic measures , physical workload , psychosocial workload , intensity of pain , general health status , sick leave , and work productivity . The cost-effectiveness analysis is performed from the societal and company perspective . Outcome measures are assessed using question naires at baseline and after 6 and 12 months . Data on the primary outcome as well as on intensity of pain , sick leave , work productivity , and health care costs are collected every 3 months . Discussion Prevention of LBP and NP is beneficial for workers , employers , and society . If the intervention is proven (cost-)effective , the intervention can have a major impact on LBP and NP prevention and , thereby , on work disability prevention . Results are expected in 2010.Trial registration IS RCT",
"Abstract Background : While preliminary laboratory tests indicate that a hip belt reduces the load on the back , neck and shoulders associated with musculoskeletal strain , an orchard trial is needed to more realistically assess both effectiveness and acceptability . Objective : to evaluate the hip belt 's effectiveness in three areas : worker acceptance , worker productivity , and one-day muscle fatigue of the back and shoulder . Methods : Ninety-six New York apple harvest workers were r and omly assigned to use the intervention hip belt or placebo belt for one week . In a second week all workers switched conditions . Subjects were interviewed at the end of each week to ascertain intervention acceptance . Employer records were review ed to determine bushels picked per day . Subjects also underwent muscle fatigue testing at the beginning and again at the end of one workday during each week . Results : Ninety-one percent of the subjects favored the intervention hip belt . Use of the intervention did not appreciably slow picking speed ( bushels per hour ) as compared to placebo ( 8.8 bu/ hr vs. 8.89 bu/hr ) . Both were significantly faster than the regular equipment condition ( 8.13 bu/hr ) . No significant differences in one-day muscle fatigue were found with intervention use . Conclusions : The belt was acceptable to the workers and did not hinder productivity . However , the anticipated ergonomic benefits were not demonstrable using one-day strength testing",
"This study examined the effects of supplementary rest breaks on musculoskeletal discomfort , eyestrain , mood , and performance in data -entry workers . Two rest break schedules were compared in a within-subjects design . Workers alternated between a ‘ conventional ’ and a ‘ supplementary ’ schedule in 4-week intervals . The conventional schedule contained a 15-min break during the first half of the work shift and a 15-min break during the second half of the shift . The supplementary schedule contained the same two 15-min breaks , and a 5-min break during each hour which otherwise did not contain a break , for a total of 20 extra minutes of break time . Results are based on data from 42 workers . They indicated that discomfort in several areas of the body , and eyestrain , were significantly lower under the supplementary than under the conventional schedule . While symptoms increased from pre- to post-work periods under both schedules , the magnitude of the increases was significantly less under the supplementary schedule . In addition , increases in discomfort of the right forearm , wrist and h and over the course of the work week under the conventional schedule were eliminated under the supplementary schedule . These beneficial effects were obtained without reductions in data -entry performance",
"Introduction : Lateral and medial epicondylitis associated with work activity is a common upper extremity musculoskeletal disorder with a prevalence of 4–30 % depending upon the work setting and diagnostic criteria . The influence of treatment , ergonomic factors , medical history , psychosocial variables , and aging on the improvement of symptoms has not been well defined . Methods : This was a prospect i ve cohort study of a cohort of 45 workers with active elbow tendonitis for an average of 13 months . Complete resolution of symptoms was the defined outcome measure . Results : The predictive factors for persistent elbow tendonitis included older age ( OR = 1.1 , 95 % CI : 0.99 , 1.33 ) , higher h and repetition level for their job(s ) ( OR = 2.5 , 95 % CI : 1.00 , 6.25 ) , more deviation from a neutral wrist position during the work activity ( OR = 2.0 , 95 % CI : 0.80 , 5.56 ) , and lower perceived decision authority on the job ( OR = 0.9 , 95 % CI : 0.79 , 0.98 ) . Other ergonomic , psychosocial , and electrophysiologic measures were not predictive . The models had relatively high sensitivity and specificity . Treatment effects could not be evaluated due to incomplete data available . Conclusions : Older workers with jobs requiring more repetition and awkward wrist postures , and less decision authority were less likely to have resolution of their elbow tendonitis . Implication s : Workers at highest risk for persistent elbow tendonitis should be placed at jobs with lower repetition levels and that use more neutral wrist postures . Effective interventions must address both the ergonomic and psychosocial risk factors in a multifaceted approach to this problem",
"Objectives : To study the effectiveness of using a computer mouse with a feedback signal for upper extremity musculoskeletal symptoms in office workers . Methods : A r and omised controlled trial with 8 months of follow-up was carried out . The intervention consisted of a computer mouse with a feedback signal . In total , 354 subjects were allocated to the intervention group or the control group . Measurements were performed with electronic question naires at baseline , after 4 months and after 8 months . Outcome variables were the prevalence and incidence of upper extremity musculoskeletal symptoms and disability in the upper extremities . The intervention process was evaluated by software registration . Results : The use of the mouse with a feedback signal result ed in a significant decrease in duration of mouse usage over time . No differences were found in the number of mouse usage rest breaks . No differences were found in the prevalence ( p = 0.29 ) or incidence ( p = 0.832 ) of upper extremity musculoskeletal symptoms between the groups 8 months after baseline . The prevalence decreased from 49 % at baseline to 44 % after 8 months in the control group , while it remained at 36 % in the intervention group . The incidence was 21 % in the control group and 22 % in the intervention group . Among the population with upper extremity musculoskeletal symptoms at baseline , the risk of experiencing symptoms after 8 months did not differ between the groups ( p = 0.49 ) . Minor disability was found in both groups . In the intervention group , a lower level of physical disability over time was reported than in the control group ( p = 0.02 ) . Conclusions : A feedback signal computer mouse does not affect the prevalence and incidence of upper extremity musculoskeletal symptoms , but it does lower disability scores . Given the high prevalence , study ing preventive interventions for upper extremity musculoskeletal symptoms is of high importance . Trial registration number : IS RCT N13222474",
"Background : Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders . Methods : This one year , r and omised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company . Participants were r and omised to receive ( 1 ) ergonomics training only , ( 2 ) training plus a trackball , ( 3 ) training plus a forearm support , or ( 4 ) training plus a trackball and forearm support . Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention . Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors , baseline pain levels , and psychosocial job factors . Results : Post-intervention , 63 participants were diagnosed with one or more incident musculoskeletal disorders . Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders ( HR = 0.49 , 95 % CI 0.24 to 0.97 ) after adjusting for baseline pain levels and demographic and psychosocial factors . The armboard also significantly reduced neck/shoulder pain ( p = 0.01 ) and right upper extremity pain ( p = 0.002 ) in comparison to the control group . A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months . Conclusion : Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees",
"Sixteen full-time clerical and office workers participated in this prospect i ve parallel-r and omized trial . Intervention consisted of four hours of individualized training through a multi-faceted injury prevention program . In Phase I , musculoskeletal symptoms , stress , and energy levels were measured before and after intervention . Differences between Group A ( intervention ) and Group B ( control ) were described ; pre to post differences between members within each group were also described . In Phase II , there were a greater number of statistically and clinical ly relevant differences within Group A at week 16 ( eleven weeks following intervention ) than at week five ( immediately post-intervention ) . The eyes , neck , shoulder , elbow-forearm , and wrist-h and were impacted most positively by intervention , however , the frequency and intensity of headaches increased . Stress and energy level differences were minimal . Group B workers received intervention during weeks 18 - 21 . Differences in average measures from pre to immediately post-intervention were greater within Group B than Group A. Both groups reported fewer sick days during the month of intervention than during pre and post-intervention months",
"Background and Purpose The purpose of this study was to evaluate the efficacy of a preventive ergonomic intervention , which was provided by physical therapists , on spinal and upper-extremity work-related posture and symptom complaints of workers who use video display terminals ( VDT ) . Subjects Two hundred employees who spent at least 20 hours per week at a VDT were r and omly divided into 2 groups . Group E received the ergonomic intervention and an informative brochure , and group I received only the brochure . Methods Both groups were evaluated at the beginning of the study and at a follow-up 5 months later . The following tools were used : a pain drawing and the Rapid Entire Body Assessment ( REBA ) method to assess spinal and upper-extremity work-related posture . Results Group E had a lower REBA score and reduced lower back , neck , and shoulder symptoms compared with group I. Discussion and Conclusion The results suggest that a personalized preventive ergonomic intervention can improve spinal and upper-extremity work-related posture and musculoskeletal symptoms for workers who use VDTs",
"Aims : To examine the effect of two workstation and postural interventions on the incidence of musculoskeletal symptoms among computer users . Methods : R and omised controlled trial of two distinct workstation and postural interventions ( an alternate intervention and a conventional intervention ) among 376 persons using computer keyboards for more than 15 hours per week . The incidence of neck/shoulder symptoms and h and /arm symptoms during six months of follow up among individuals in the intervention groups was compared to the incidence in computer users who did not receive an intervention ( comparison group ) . For individuals in the intervention groups , study staff adjusted workstations , where possible , and trained individuals to assume the intervention postures . Individuals reported musculoskeletal symptoms in a weekly diary . Participants who reported discomfort intensity of 6 or greater on a 0–10 visual analogue scale or who reported musculoskeletal symptoms requiring use of analgesic medication were considered symptomatic . Results : There were no significant differences in the incidence of musculoskeletal symptoms among the three intervention groups . Twenty two ( 18.5 % ) participants in the alternate intervention group , 25 ( 20.2 % ) in the conventional intervention group , and 25 ( 21.7 % ) in the comparison group developed incident arm or h and symptoms . Thirty eight ( 33.3 % ) participants in the alternate intervention group , 36 ( 31.0 % ) in the conventional intervention group , and 33 ( 30.3 % ) in the comparison group developed incident neck or shoulder symptoms . Compliance with all components of the intervention was attained for only 25–38 % of individuals , due mainly to the inflexibility of workstation configurations . Conclusions : This study provides evidence that two specific workplace postural interventions are unlikely to reduce the risk of upper extremity musculoskeletal symptoms among computer users",
"We investigated , on behalf of a large electronics manufacturer , two types of worker training interventions for their efficacy in preventing unnecessary muscle tension and the symptoms of work-related musculoskeletal disorders . The first intervention , Muscle Learning Therapy ( MLT ) , used electromyographic ( sEMG ) feedback and operant conditioning to decrease muscle tension during complex work tasks . The second intervention used adult learning and cognitive behavioral techniques in small group discussion to advance the worker 's capabilities for symptom and stress management and problem-solving . Workers were r and omly assigned to a control group or one of the two treatment conditions . Prior to training , baseline data were collected using symptom diaries and sEMG recordings of the trapezius and forearm muscles of the left and right arms . The training interventions were conducted for 6 weeks with reinforcement training provided at 18 and 32 weeks post-baseline . Follow-up data were collected after the initial 6-week training period and at 32 weeks , prior to the reinforcement training . Symptom outcomes demonstrated significant differences at 6 weeks , increasing in severity for the control group and declining modestly for the educational group , with little change for the MLT group . These differences were not maintained at further follow-up . The MLT group was consistently effective in reducing muscle tension in the trapezius areas after 6 and 32 weeks , and was partially effective for the forearms . Further testing is recommended of these training interventions , especially with the inclusion of strategic , periodic reinforcement of the worker 's learning",
"Using a computer keyboard with the forearms unsupported has been proposed as a causal factor for neck/shoulder and arm/h and diagnoses . Recent laboratory and field studies have demonstrated that forearm support might be preferable to working in the traditional \" floating \" posture . The aim of this study was to determine whether providing forearm support when using a normal computer workstation would decrease musculoskeletal discomfort in intensive computer users in a call centre . A r and omised controlled study ( n = 59 ) , of 6 weeks duration was conducted . Thirty participants ( Group 1 ) were allocated to forearm support using the desk surface with the remainder ( Group 2 ) acting as a control group . At 6 weeks , the control group was also set up with forearm support . Both groups were then monitored for another 6 weeks . Question naires were used at 1 , 6 and 12 weeks to obtain information about discomfort , workstation setup , working posture and comfort . Nine participants ( Group 1 n = 6 , Group 2 n = 3 ) withdrew within a week of commencing forearm support either due to discomfort or difficulty in maintaining the posture . At 6 weeks , the group using forearm support generated significantly fewer reports of discomfort in the neck and back , although the difference between the groups was not statistically significant . At 12 weeks , there were fewer reports of neck , back and wrist discomfort when preintervention discomfort was compared with post intervention discomfort . These findings indicate that for the majority of users , forearm support may be preferable to the \" floating \" posture implicit in current guidelines for computer workstation setup",
"The purpose of this study was to describe , and analyse the effect of an intervention on , the biomechanical workload in the neck and shoulder region of female hairdressers . Arm elevation was measured by inclinometers and muscular load of m. trapezius by electromyography . The intervention comprised working technique recommendations , e.g. to work with less elevated arms and more relaxed muscles . The subjects were r and omised between two different intensity levels of the intervention , one with written information only and the other with additional personal follow-up . The effect of the intervention was evaluated after 1 - 2 months . The hairdressers worked with their arms elevated 60 degrees or more for approximately 13 % of the total working time and 16 % during the specific hairdressing tasks . The intervention group including personal follow-up instructions had a reduction in workload from 4.0 % to 2.5 % of hairdressing time with highly elevated right upper arm , i.e. above 90 degrees . No effect was detected on muscular load or neck and shoulder symptoms after the intervention",
"Study Design . A prospect i ve r and omized control trial . Objective . To determine the degree to which a new behavior-based lift training program ( LiftTrainer ™ ; Ascension Technology , Burlington , VT ) could reduce the incidence of low back disorder in distribution center jobs that require repetitive lifting . Summary of Background Data . Most studies show programs aim ed at training lifting techniques to be ineffective in preventing low back disorders , which may be due to their conceptual rather than behavioral learning approach . Methods . A total of 2144 employees in 19 distribution centers were r and omized into either the LiftTrainer ™ program or a video control group . In the LiftTrainer ™ program , participants were individually trained in up to 5 , 30-minute sessions while instrumented with motion capture sensors to quantify the L5/S1 moments . Twelve months following the initial training , injury data were obtained from company records . Results . Survival analyses ( Kaplan-Meier ) indicated that there was no difference in injury rates between the 2 training groups . Likewise , there was no difference in the turnover rates . However , those with a low ( average twisting moment at the end of the first session experienced a significantly ( P lower rate of low back disorder than controls . Conclusions . While overall the LiftTrainer ™ program was not effective , those with twisting moments below 30 Nm reported fewer injuries , suggesting a shift in focus for “ safe ” lifting programs",
"Microbreaks are scheduled rest breaks taken to prevent the onset or progression of cumulative trauma disorders in the computerized workstation environment . The authors examined the benefit of microbreaks by investigating myoelectric signal ( MES ) behavior , perceived discomfort , and worker productivity while individuals performed their usual keying work . Participants were r and omly assigned to one of three experimental groups . Each participant provided data from working sessions where they took no breaks , and from working sessions where they took breaks according to their group assignment : microbreaks at their own discretion ( control ) , microbreaks at 20 min intervals , and microbreaks at 40 min intervals . Four main muscle areas were studied : the cervical extensors , the lumbar erector spinae , the upper trapezius/supraspinatus , and the wrist and finger extensors . The authors have previously shown that when computer workers remained seated at their workstation , the muscles performing sustained postural contractions displayed a cyclic trend in the mean frequency ( MNF ) of the MES ( McLean et al. , J. Electrophysiol . Kinesiol . 10 ( 1 ) ( 2000 ) 33 ) . The data provided evidence ( p microbreak protocol s were associated with a higher frequency of MNF cycling at the wrist extensors , at the neck when microbreaks were taken by the control and 40 min protocol groups , and at the back when breaks were taken by the 20 and 40 min protocol groups . No significant change in the frequency of MNF cycling was noted at the shoulder . It was determined ( p microbreaks had a positive effect on reducing discomfort in all areas studied during computer terminal work , particularly when breaks were taken at 20 min intervals . Finally , microbreaks showed no evidence of a detrimental effect on worker productivity . The underlying cause of MNF cycling , and its relationship to the development of discomfort or cumulative trauma disorders remains to be determined",
"Objectives : To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers . Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders , but evidence for its effectiveness is sparse . Methods : A cluster r and omised controlled trial among the 504 workers of 119 kitchens in Finl and was conducted during 2002–2005 . Kitchens were r and omised to an intervention ( n = 59 ) and control ( n = 60 ) group . The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload , was 11 to 14 months . In total , 402 ergonomic changes were implemented . The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites , local fatigue after work , and sick leave due to musculoskeletal disorders . Individual level data were collected by a question naire at baseline and every 3 months during the intervention and 1-year follow-up period . All response rates exceeded 92 % . Results : No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up . Conclusions : The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers . It may be that a more comprehensive re design of work organisation and processes is needed , taking more account of workers ’ physical and mental re sources",
"BACKGROUND Low back injuries are common and costly , accounting for 15 to 25 percent of injuries covered by workers ' compensation and 30 to 40 percent of the payments made under that program . The high costs of injury , the lack of effective treatment . and the evidence that there are behavioral risk factors have led to widespread use of employee education programs that teach safe lifting and h and ling . The effectiveness of those programs , however , has received little rigorous evaluation . METHODS We evaluated an educational program design ed to prevent low back injury in a r and omized , controlled trial involving about 4000 postal workers . The program , similar to that in wide use in so-called back schools , was taught by experienced physical therapists . Work units of workers and supervisors were trained in a two-session back school ( three hours of training ) , followed by three to four reinforcement sessions over the succeeding few years . Injured subjects ( from both the intervention and the control groups ) were r and omized a second time to receive either training or no training after their return to work . RESULTS Physical therapists trained 2534 postal workers and 134 supervisors . Over 5.5 years of follow-up , 360 workers reported low back injuries , for a rate of 21.2 injuries per 1000 worker-years of risk . The median time off from work per injury was 14 days ( range , 0 to 1717 ) ; the median cost was $ 204 ( range , zero to $ 190,380 ) . After their return to work , 75 workers were injured again . Our comparison of the intervention and control groups found that the education program did not reduce the rate of low back injury , the median cost per injury , the time off from work per injury , the rate of related musculoskeletal injuries , or the rate of repeated injury after return to work ; only the subjects ' knowledge of safe behavior was increased by the training . CONCLUSIONS A large-scale , r and omized , controlled trial of an educational program to prevent work-associated low back injury found no long-term benefits associated with training",
"OBJECTIVES This study evaluated the effect of an ergonomic training program on workstation changes and on the prevalence of musculoskeletal disorders among video display unit ( VDU ) users at a large university . METHODS A pretest-posttest design with a reference group was used with r and om allocation of administrative and geographic units . In each group , the measurements involved direct observation of the workstations , a self-administered question naire , and a physical examination . The measurements were performed 2 weeks before and 6 months after the training in parallel in both groups . The study population was composed of 627 workers ( 81 % of those eligible ) . RESULTS The prevalence of all 3 of the postural stressors evaluated decreased in the experimental group after the training . In the reference group , 2 of the 3 stressors decreased in frequency but to a less extent . Some of these beneficial changes were more frequent in workers under 40 years of age . The prevalence of musculoskeletal disorders decreased among the workers under 40 years of age in the experimental group , from 29 % to 13 % determined by question naire and from 19 % to 3 % determined by physical examination . In other groups , there was no significant change in the prevalence of musculoskeletal disorders . CONCLUSIONS Improvements in postural stressors occurred more frequently in the experimental group , and these beneficial changes tended to be more frequent in workers under 40 years of age . Improvements in musculoskeletal disorders occurred in the experimental group among the workers under 40 years of age",
"Objectives : The aim of this intervention study was to determine the effects of an alternative mouse and /or a forearm support board on the change in upper body discomfort scores and the development of incident musculoskeletal disorders . Methods : This r and omised controlled intervention trial followed 206 engineers for one year . Participants were r and omised to receive ( 1 ) a conventional mouse only , ( 2 ) an alternative mouse only , ( 3 ) a forearm support board , or ( 4 ) an alternative mouse plus forearm support board . Outcome measures included weekly upper body discomfort scores and incident musculoskeletal disorders . Results : During the study , 42 participants were diagnosed with an incident musculoskeletal disorder . The group that received the forearm support board experienced a reduction in their right upper extremity discomfort ( beta-coefficient −0.35 , 95 % CI −0.67 to −0.03 ) in comparison to those who did not receive a forearm board . The group that received the alternative mouse had a protective , but non-significant ( p = 0.20 ) , effect on incident cases of right upper extremity musculoskeletal disorders ( HR 0.57 , 95 % CI 0.24 to 1.34 ) and a non-significant reduction in neck/shoulder discomfort ( beta-coefficient −0.23 , 95 % CI −0.056 to 0.10 ) in comparison to those who received a conventional mouse . Conclusions : In engineers who use a computer for more than 20 h per week , a forearm support board may reduce right upper extremity discomfort attributed to computer use",
"Eighty computer users with musculoskeletal disorders participated in a six-month , r and omized , placebo-controlled trial evaluating the effects of four computer keyboards on clinical findings , pain severity , functional h and status , and comfort . The alternative geometry keyboards tested were : the Apple Adjustable Keyboard ™ [ kb1 ] , Comfort Keyboard System ™ [ kb2 ] , Microsoft Natural Keyboard ™ [ kb3 ] and placebo . Compared to placebo , kb3 and to a lesser extent kb1 groups demonstrated an improving trend in pain severity and h and function following six months of keyboard use . However , there was no corresponding consistent improvement in clinical findings in the alternative geometry keyboard groups compared to the placebo group . Overall , there was a significant correlation between improvement of pain severity and greater satisfaction with the keyboards . These results provide evidence that keyboard users may experience a reduction in h and pain after several months of use of some alternative geometry keyboards",
"OBJECTIVES A cross-sectional study was conducted to assess the association of upper extremity musculoskeletal disorders and work-related factors among employees using video display terminals at a large metropolitan newspaper . METHODS The study included 1050 r and omly selected workers from four departments . The workers were asked to complete question naires on symptoms , job tasks , and psychosocial and work organization conditions . Musculoskeletal disorders of the upper extremities were defined by frequency , duration , and intensity of symptoms not attributable to acute injury . Data were analyzed with the use of logistic regression . RESULTS A total of 973 workers completed the survey . The one-year period prevalence rate for any musculoskeletal disorder of the upper extremities was 41 % . Neck symptoms ( 26 % ) were the most frequently reported , followed by h and or wrist ( 22 % ) , shoulder ( 17 % ) , and elbow ( 10 % ) symptoms . Greater time working at the video display station was associated with increased h and or wrist symptoms in a dose-response relationship . In addition , variables corresponding to increased work-load dem and s ( eg , increased time working under deadline and increased job pressure ) were associated with increased neck , shoulder , and h and or wrist disorders . Women were more likely to report symptoms in several areas , but this finding may reflect the concentration of women in jobs involving more risk factors . CONCLUSIONS The results suggest a high prevalence of musculoskeletal disorders of the upper extremities among newspaper employees , and they provide additional evidence that increased work load , time pressure , and greater hours of computer use are related to the occurrence of work-related musculoskeletal disorders among these workers , particularly for disorders in the h and or wrist area",
"Study Design . R and omized controlled trial ( RCT ) . Objectives . To compare the effectiveness of training and equipment to reduce musculoskeletal injuries , increase comfort , and reduce physical dem and s on staff performing patient lifts and transfers at a large acute care hospital . Summary of Background Data . Back injury to nursing staff during patient h and ling tasks is a major issue in health care . The value of mechanical assistive devices in reducing injuries to these workers is unclear . Methods . This three-armed RCT consisted of a “ control arm , ” a “ safe lifting ” arm , and a “ no strenuous lifting ” arm . A medical , surgical , and rehabilitation ward were each r and omly assigned to each arm . Both intervention arms received intensive training in back care , patient assessment , and h and ling techniques . Hence , the “ safe lifting ” arm used improved patient h and ling techniques using manual equipment , whereas the “ no strenuous lifting ” arm aim ed to eliminate manual patient h and ling through use of additional mechanical and other assistive equipment . Results . Frequency of manual patient h and ling tasks was significantly decreased on the “ no strenuous lifting ” arm . Self-perceived work fatigue , back and shoulder pain , safety , and frequency and intensity of physical discomfort associated with patient h and ling tasks were improved on both intervention arms , but staff on the mechanical equipment arm showed greater improvements . Musculoskeletal injury rates were not significantly altered . Conclusions . The “ no strenuous lifting ” program , which combined training with assured availability of mechanical and other assistive patient h and ling equipment , most effectively improved comfort with patient h and ling , decreased staff fatigue , and decreased physical dem and s. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators",
"OBJECTIVE The purpose of this study was to evaluate the effectiveness of an active ergonomics training ( AET ) program in computer users . Two constructs from the social-cognitive theory were adopted to provide a more comprehensive assessment of the proximal markers of behavior change . METHOD Eighty-seven symptomatic and asymptomatic employees who worked at a computer for a minimum of 10 hours per week took part in a prospect i ve r and omized controlled study . Subjects participated in a six-hour training intervention at their workplace . Key elements of the AET intervention were skill development in workstation analysis , active participation , and implementation of multiple prevention strategies . RESULTS After receiving AET , risk factor exposure was significantly reduced for participants at higher risk [ F(1,82 ) = 6.42 , p knowledge [ F(1,74 ) = 8.39 , p self-efficacy [ F(1,73 ) = 6.95 , p outcome expectations [ F(1,75 ) = 8.75 , p AET intervention had significantly less upper back pain intensity ( z = -2.03 , p pain frequency ( z = -2.70 , p pain duration ( z = -3.25 , p work postures , work practice s , risk factor exposure , and pain",
"OBJECTIVES This study evaluated the effect of an intensive ergonomic approach and education on workstation changes and musculoskeletal disorders among workers who used a video display unit ( VDU ) . METHODS A r and omized controlled design was used . The subjects ( N=124 ) were allocated into three groups ( intensive ergonomics , ergonomic education , reference ) using stratified r and om sampling . The evaluation involved question naires , a diary of discomfort , measurements of workload , and an ergonomic rating of the workstations . The assessment s were made 2 weeks before the intervention and after 2 and 10 months of follow-up . RESULTS The intensive and training groups showed less musculoskeletal discomfort than the reference group after 2 months of follow-up . Positive effects on discomfort were seen primarily for the shoulder , neck , and upper back areas . No significant differences were found for the strain levels or prevalence of pain . After the intervention the ergonomic level was distinctly higher in the intensive ergonomic group than in the education or reference group . CONCLUSIONS Both the intensive ergonomics approach and education in ergonomics help reduce discomfort in VDU work . In attempts to improve the physical ergonomics of VDU workstations , the best result will be achieved with cooperative planning in which both workers and practitioners are actively involved",
"Study Design . This is a 4-month r and omized controlled trial to evaluate the effect of chair design on neck/shoulder pain among sewing machine operators . Objective . Determine whether a chair with a curved seat pan leads to improved changes in monthly neck/shoulder pain scores compared with a control intervention . Summary of Background Data . Sewing machine operators experience a high prevalence and severity of neck and shoulder pain in comparison to other working population s probably due to the sustained shoulder abduction and neck and upper back flexion required of the task . An adjustable height task chair that supports a forward sitting posture may reduce these posture-related risk factors and reduce neck/shoulder pain . Material s and Methods . A total of 277 sewing machine operators with neck/shoulder pain were assigned to receive 1 ) miscellaneous items ( control group ) , 2 ) a chair with a flat seat pan plus miscellaneous items , or 3 ) a chair with a curved seat pan plus miscellaneous items . Participants completed a monthly question naire assessing neck/shoulder pain severity . Results . Based on estimates of pain score changes from a repeat- measures linear regression , participants who received the flat seat chair experienced a decline in pain of 0.14 ( 95 % confidence interval , 0.07–0.22 ) points per month compared with those in the control group , while those who received the curved seat experienced a decline of 0.34 ( 95 % confidence interval , 0.28–0.41 ) points per month compared with those in the control group . These estimates did not change after adjustment for potential covariates . Conclusions . These findings demonstrate that an adjustable height task chair with a curved seat pan can reduce neck and shoulder pain severity among sewing machine operators",
"The study has a parallel group design with two intervention groups ( T and S ) and one control group ( C ) of VDU operators . Three serial interventions were carried out in the T and S groups , first a new lighting system , then new workplaces and last an optometric examination and corrections if needed . The new lighting gave significantly increased illuminance levels , increased luminances of the room surfaces and better luminance distribution . The two intervention groups reported significant improvement of the lighting conditions , as well as of the visual conditions and significantly reduced visual discomfort and glare . Significant reduction of headache was found in one of the intervention groups . Optometric corrections reduced the visual discomfort in both the intervention groups . When looking at those given new corrections , a significant reduction was found in the T group and a clear tendency was also found in the S group . The C group reported no improvements for any of these health outcomes . The workplace intervention gave the operator the possibility to support the whole forearm and h and on the table top . Before the intervention there were no significant differences between the three groups regarding shoulder pain and static trapezius electromyographic ( EMG ) load . Two years after the intervention , a significant reduction of shoulder pain was reported in the T and S groups in parallel with a significant reduction in static trapezius load , while no such reduction was found in the C group . At the same time , both static trapezius load and shoulder pain were significantly lower in the T and S groups compared with the C group . Pain in the forearm and h and showed no significant changes in any of the groups during the study period . However , there seem to be a relationship between pain in the forearm and h and and the time the operator used the mouse . The C group reported significantly higher intensity of pain and used the mouse significantly more than the S group",
"The effects of Ergorest ® arm supports on wrist angles and musculoskeletal strain in the neck-shoulder-arm region and electrical activity in the shoulder and arm muscles were studied during typing or the use of the mouse in work with a visual display unit ( VDU ) . Twenty-one women were r and omized into 3 groups ( 1 arm support , 2 arm supports , and control ) . Measurements were carried out before and after the 6-week intervention . The wrist extension of the mouse h and , the muscle activity of the trapezius muscle , and the subjective discomfort ratings indicated that 2 arm supports were better than 1 in work with a mouse . The Ergorest ® arm support alleviates muscle and joint strain in VDU work when used for both arms",
"H and cultivation and harvest of agricultural products constitute strenuous physical tasks . Working with labor-management ergonomics committees in agricultural setting s , the UC Agricultural Ergonomics Research Center ( AERC ) tested an experimental rest and recovery protocol for its impact on symptoms and productivity during two types of work tasks . The experimental condition consisted of adding a 5 min rest break to every working hour in which there was no other scheduled break ( e.g. , lunchtime ) . This result ed in an additional 20 min of rest per workday . We tested the intervention in two trials : Trial one compared workers ( n=66 ) r and omly assigned to an experimental or a control group during the harvest of commercial strawberries . Trial two utilized a cross-over design ( n=16 pairs of workers ) to compare experimental and control conditions while workers inserted bud grafts into young 18 ' ' high citrus trees . For both trials , workers under the experimental condition reported significantly less severe symptoms than workers under control conditions . The order in which the intervention was given , however , appeared to result in variations in productivity . We conclude that the introduction of frequent , brief rest breaks may improve symptoms for workers engaged in strenuous work tasks ",
"OBJECTIVES This study examined the health-related effects of two worksite interventions , physical exercise and reduced workhours , on women employed in dentistry . METHODS Six workplaces were r and omized to one of the following three conditions : ( i ) 2.5 hours of weekly , m and atory physical exercise of middle-to-high intensity to be performed during workhours ( N=62 ) , ( ii ) a reduction of full-time weekly workhours from 40 to 37.5 hours ( N=50 ) , and ( iii ) reference . In all , 177 women participated . Biomarkers and self-ratings in question naires were obtained before the intervention ( T ( 1 ) ) , and six ( T ( 2 ) ) and 12 months ( T ( 3 ) ) after the intervention . RESULTS The results showed increased levels of physical activity and exercise in all of the groups , the level of physical exercise being significantly greater in the physical exercise group . Repeated- measures analyses of variance using data from T ( 1 ) and T (3)for biological measures and all three time points for self-ratings produced significant interaction effects for glucose , waist-to-hip ratio , and work ability and clear trends for general symptoms and upper-extremity disorders . Posthoc analyses showed that the results of the health-related measures differed between the interventions , decreased glucose and upper-extremity disorders in the exercise group , and increased high-density lipoprotein and waist-to-hip ratio among those working reduced hours . CONCLUSIONS These results show that the two interventions had small and varied effects on biomarkers and self-reports of different aspects of health among women . It is suggested that interventions involving a modest reduction in workhours seem to be more effective if these hours are used for physical exercise",
"BACKGROUND The purpose of this study was to determine the effects of an alternative mouse and /or a forearm support board on nerve function at the wrist among engineers . METHODS This r and omized controlled intervention trial followed 206 engineers for 1 year . Distal motor latency ( DML ) at baseline and follow-up was conducted for the median and ulnar nerves at the right wrist . RESULTS One hundred fifty-four subjects agreed to a nerve conduction study at the beginning and end of the study period . Those who received the alternative mouse had a protective effect ( OR = 0.47 , 95 % CI 0.22 - 0.98 ) on change in the right ulnar DML . There was no significant effect on the median nerve DML . The forearm support board had no significant effect on the median or ulnar nerve DML . CONCLUSIONS In engineers who use a computer for more than 20 hr per week , an alternative mouse may have a protective effect for ulnar nerve function at the wrist . No protective effect of a forearm support board was found for the median nerve"
] | 411664c4-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To combine evidence from r and omized controlled trials to assess the effect of Fe-fortified foods on mean Hb concentration in children ( DESIGN We conducted a meta- analysis of r and omized , controlled , Fe-fortified feeding trials that evaluated Hb concentration . The weighted mean difference was calculated for net changes in Hb by using r and om-effects models . Meta-regression and covariate analyses were performed to explore the influence of confounders on the net pooled effect . SETTING Trials were identified through a systematic search of PubMed , the Cochrane Library and secondary references . SUBJECTS Eighteen studies covering 5142 participants were identified . The duration of feeding of fortified foods ranged from 6 to 12 months in these studies . RESULTS Eighteen studies were included and evaluated in the meta- analysis . The overall pooled estimate of Hb concentration showed a significant increase in the fortification group compared with the control group ( weighted mean difference = 5·09 g/l ; 95 % CI 3·23 , 6·95 g/l ; I 2 = 90 % , τ 2 = 18·37 , P the effect size ( regression coefficient = 0·368 ; 95 % CI 0·005 , 0·731 ; P of Fe-fortified foods and Hb concentration in children aged . Fe-fortified foods could be an effective strategy for reducing Fe-deficiency anaemia in children | [
"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",
"OBJECTIVES This study hypothesized that besides iron deficiency , intestinal parasites infection is also a determinant of anemia in schoolchildren in rural Vietnam . METHODS 400 primary schoolchildren from 20 primary schools in Tam Nong district , a poor rural area in Vietnam , were r and omly selected from enrollment lists . Venous blood ( 5ml ) was collected in a cross sectional study and analyzed for hemoglobin ( Hb ) , serum ferritin ( SF ) , serum transferrin receptor ( TfR ) , serum C-reactive protein ( CRP ) and total immunoglobulin E ( IgE ) . Stools sample s were examined for hookworm , Trichuris , and Ascaris infection . Logistic regression was used to assess the effect of intestinal parasites on anemia . RESULTS The prevalence of anemia ( Hb Iron deficiency ( TfR > 8.5mg/L ) occurred in 2 % of the children . The prevalence of intestinal parasites was 92 % with the highest prevalence for Trichuris ( 76 % ) and Ascaris ( 71 % ) . More than 30 % and 80 % of the children showed an elevated CRP ( > or = 8 mg/L ) and IgE ( > 90 IU/ml ) concentration . Anemia status was borderline significantly associated with SF and not associated with TfR and CRP . The prevalence odds ratio for Trichuris infection was 1.96 ( 95 % CI 1.07 - 3.59 ) and 2.00 ( 95 % CI 1.08 - 3.65 ) with iron deficiency reflected by TfR and SF , respectively . CONCLUSION Anemia is highly prevalent among schoolchildren in Vietnam but may not be associated with iron deficiency . Trichuris infection is associated with a doubled risk of anemia , not mediated through iron deficiency . Chronic infection may play a role in anemia , but needs further investigation",
"BACKGROUND Children participating in the Integrated Child Development Service ( ICDS ) in India have high rates of iron and vitamin A deficiency . OBJECTIVE The objective was to assess the efficacy of a premix fortified with iron and vitamin A and added at the community level to prepared khichdi , a rice and dal mixture , in increasing iron and vitamin A stores and decreasing the prevalence of iron deficiency , anemia , and vitamin A deficiency . DESIGN This cluster , r and omized , double-blind , controlled trial was initiated in 30 Anganwadi centers ( daycare centers ) in West Bengal state , India . Children aged 36 - 66 mo ( n = 516 ) attending village-based ICDS centers were r and omly assigned to receive either a fortified or a nonfortified premix for 24 wk . Blood was drawn at 0 and 24 wk by venipuncture for the measurement of hemoglobin , serum ferritin , and serum retinol . RESULTS The change in the hemoglobin concentration of anemic children was significantly different between fortified and nonfortified khichdi groups ( P Prevalence rates of anemia , iron deficiency , and iron deficiency anemia were significantly lower after 24 wk in the fortified-khichdi group than in the nonfortified-khichdi group ( P serum retinol concentrations or in the prevalence of vitamin A deficiency between the fortified- and nonfortified-khichdi groups . CONCLUSION A premix fortified with iron , vitamin A , and folic acid and added to supplementary food at the community level can be effective at increasing iron stores and reducing the prevalence of iron deficiency and anemia",
"BACKGROUND Iron fortification of rice could be an effective strategy for reducing iron deficiency anemia in South Asia . OBJECTIVE We aim ed to determine whether extruded rice grains fortified with micronized ground ferric pyrophosphate ( MGFP ) would increase body iron stores in children . DESIGN In a double-blind , 7-mo , school-based feeding trial in Bangalore , India , iron-depleted , 6 - 13-y-old children ( n = 184 ) were r and omly assigned to receive either a rice-based lunch meal fortified with 20 mg Fe as MGFP or an identical but unfortified control meal . The meals were consumed under direct supervision , and daily leftovers were weighed . All children were dewormed at baseline and at 3.5 mo . Iron status and hemoglobin were measured at baseline , 3.5 mo , and 7 mo . RESULTS At baseline , the prevalences of iron deficiency and iron deficiency anemia in the total sample were 78 % and 29 % , respectively . After 7 mo of feeding , there was a significant increase in body iron stores in both study groups ( P interaction for iron deficiency , which fell from 78 % to 25 % in the dewormed iron group and from 79 % to 49 % in the dewormed control group . Iron deficiency anemia decreased from 30 % to 15 % ( NS ) in the iron group but remained virtually unchanged in the control group ( 28 % and 27 % ) . In sensory tests , the MGFP-fortified rice ( fortified at 3 and 5 mg Fe/100 g ) was indistinguishable from natural rice , in both cooked and uncooked form . CONCLUSIONS Extruded rice fortified with MGFP has excellent sensory characteristics . Fed in a school lunch meal , it increases iron stores and reduces the prevalence of iron deficiency in Indian children",
"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",
"BACKGROUND Iron deficiency anemia is the most prevalent nutrition problem in young children . One possible strategy to prevent iron deficiency anemia in this population group is the fortification of affordable food . OBJECTIVE This study was design ed to assess whether iron-fortified c and ies can improve iron status and are acceptable to children aged 4 - 6 y. DESIGN A double-blind , placebo-controlled intervention study was conducted in Jakarta , INDONESIA : The children were r and omly assigned to 1 of 2 treatment groups : a fortified group ( n = 57 ) and a placebo group ( n = 60 ) . Every week for 12 wk , 30 g ( 10 pieces ) c and y was given to the children . The c and y given to the fortified group contained 1 mg elemental Fe/g and very small amounts of other vitamins and minerals . RESULTS The hemoglobin concentration of the fortified group increased by 10.2 g/L ( 95 % CI : 8.3 , 12 g/L ) whereas that of the placebo group increased by 4.0 g/L ( 2.0 , 6.0 g/L ; P Anemia prevalence decreased from 50.9 % at the start of the intervention to 8.8 % after 12 wk of intervention in the fortified group ( P serum ferritin concentration was 71 % higher than at baseline in the fortified group and 28 % higher in the placebo group ( P Acceptability of the iron-fortified c and ies was good . The per capita cost of the supplement was approximately US$ 0.96 - 1.20 for the 12 wk of intervention . CONCLUSION Iron-fortified c and ies were effective for improving the iron status of young children and might be an affordable way to combat iron deficiency in children of low-to-middle income groups",
"OBJECTIVE We assessed the effect of a daily intake of a micronutrient-fortified beverage for 14 mo on indicators of biochemical status of important micronutrients in schoolchildren . METHODS A double-blind , placebo-controlled , matched-pair , cluster , r and omization study design was used . Biochemical indicators of micronutrient status were evaluated at baseline and at the end of 14 mo on a sub sample in nine matched pairs . Prevalence ( percentage ) of sub clinical deficiency , mean , and mean increments of each indicator were compared between supplemented and placebo groups . RESULTS Extent of inadequacy at baseline was more or less 100 % for folic acid , 65 % for vitamins B2 and B6 , and 55 % for vitamins C and A. Prevalence of anemia among subjects was 55 % , with inadequacy of vitamin B12 being 40 % and that of vitamin D being 30 % . No subject had inadequacy of iodine based on urinary iodine . Supplementation of a micronutrient-enriched beverage for 14 mo significantly improved the status of many of the nutrients . The effect was significant with respect to vitamins A , B2 , and B12 , folic acid , vitamin D , parathyroid hormone , and thyroid-stimulating hormone in children who received the supplement compared with those who received only placebo . Hemoglobin status improved only in children who had anemia in the supplemented group . CONCLUSIONS Prevalence of multiple sub clinical micronutrient deficiencies are high in middle-income Indian school children . Daily consumption of a micronutrient-enriched beverage had positive effects that were confined to those nutrients that were inadequate at baseline",
"OBJECTIVE To evaluate the long-term effect on micronutrient status of a beta-carotene- , iron- and iodine-fortified biscuit given to primary school children as school feeding . DESIGN Children receiving the fortified biscuit were followed in a longitudinal study for 2.5 years ( n = 108 ) ; in addition , cross-sectional data from three subsequent surveys conducted in the same school are reported . SETTING A rural community in KwaZulu-Natal , South Africa . SUBJECTS Children aged 6 - 11 years attending the primary school where the biscuit was distributed . RESULTS There was a significant improvement in serum retinol , serum ferritin , haemoglobin , transferrin saturation and urinary iodine during the first 12 months of the biscuit intervention . However , when the school reopened after the summer holidays , all variables , except urinary iodine , returned to pre-intervention levels . Serum retinol increased again during the next 9 months , but was significantly lower in a subsequent cross-sectional survey carried out directly after the summer holidays ; this pattern was repeated in two further cross-sectional surveys . Haemoglobin gradually deteriorated at each subsequent assessment , as did serum ferritin ( apart from a slight increase at the 42-month assessment at the end of the school year ) . CONCLUSIONS This study has shown that fortification of a biscuit with beta-carotene at a level of 50 % of the Recommended Dietary Allowance ( RDA ) was enough to maintain serum retinol concentrations from day to day , but not enough to sustain levels during the long school holiday break . Other long-term solutions , such as local food production programmes combined with nutrition education , should also be examined . The choice of the iron compound used as fortificant in the biscuit needs further investigation",
"AIMS To assess the quality of r and omized controlled trials ( RCTs ) published in Neurourology and Urodynamics ( NAU ) by using three types of analytical tools . METHODS MEDLINE was used to extract RCTs from original articles published in the NAU from 1993 to 2012 . The relationship between the number of articles and RCTs with time and that between various factors and the quality of RCTs were analyzed . To analyze the quality of the RCTs , the time period was divided into four sections and three tools were applied ( e.g. , the Jadad scale , van Tulder scale , and Cochrane Collaboration Risk of Bias Tool [ CCRBT ] ) . RESULTS Among the 1,957 original articles , 93 ( 4.75 % ) were RCTs . The ratio between the number of NAU and RCTs over time increased . The Jadad score for years 1993 - 1997 was 3.25 ± 1.71 , 1998 - 2002 was 2.10 ± 0.74 , 2003 - 2007 was 2.09 ± 1.12 , and 2008 - 2012 was 2.80 ± 1.09 ( P = 0.014 ) . The van Tulder scales were 6.25 ± 3.10 , 4.40 ± 1.65 , 4.97 ± 1.99 , and 5.93 ± 1.98 , respectively ( P = 0.055 ) . The CCRBT identified a low risk of bias in 1 ( 25 % ) , 0 ( 0 % ) , 1 ( 2.86 % ) , and 5 ( 11.36 % ) articles , respectively . Trials with allocation concealment , Institutional review board ( IRB ) approval , and blinded studies had significantly higher quality than others . CONCLUSIONS The quantitative increase of RCT presented in NAU over time was observed but there was no definite qualitative improvement . Effort is required to improve the quality of RCTs published in NAU from the design step",
"OBJECTIVE . Chronic lead poisoning and iron deficiency are concentrated in urban children from lower socioeconomic strata , and both impair neurocognitive development . Our study objective was to determine if iron fortification reduces blood lead levels in urban , lead-exposed , iron-deficient children in Bangalore , India . DESIGN , SETTING , AND PARTICIPANTS . A r and omized , double-blind , controlled school-based feeding trial was done in 5- to 13-year-old iron-deficient children ( n = 186 ) . At baseline , a high prevalence of lead poisoning was found in the younger children . Subsequently , all 5- to 9-year-old children participating in the trial ( n = 134 ) were followed to determine if iron fortification would affect their blood lead levels . INTERVENTION . Children were dewormed and fed 6 days/week for 16 weeks either an iron-fortified rice meal ( ∼15 mg of iron per day as ferric pyrophosphate ) or an identical control meal without added iron . Feeding was directly supervised and compliance monitored . OUTCOME MEASURES . Hemoglobin , serum ferritin , C-reactive protein , transferrin receptor , zinc protoporphyrin , and blood lead concentrations were measured . RESULTS . The prevalence of iron deficiency was significantly reduced in the iron group ( from 70 % to 28 % ) compared with the control group ( 76 % to 55 % ) . There was a significant decrease in median blood lead concentration in the iron group compared with the control group . The prevalence of blood lead levels ≥10 μg/dL was significantly reduced in the iron group ( from 65 % to 29 % ) compared with the control group ( 68 % to 55 % ) . CONCLUSIONS . Our findings suggest providing iron in a fortified food to lead-exposed children may reduce chronic lead intoxication . Iron fortification may be an effective and sustainable strategy to accompany environmental lead abatement",
"BACKGROUND Sodium iron edetic acid ( NaFeEDTA ) might be a more bioavailable source of iron than electrolytic iron , when added to maize flour . We aim ed to assess the effect , on children 's iron status , of consumption of whole maize flour fortified with iron as NaFeEDTA or electrolytic iron . METHODS 516 children , aged 3 - 8 years , from four schools in Marafa , Kenya , were r and omly assigned to four groups . All were given the same amount of porridge five times a week . The porridge for one group was made from unfortified whole maize flour ; for the other three groups it was fortified with either high-dose NaFeEDTA ( 56 mg/kg ) , low-dose NaFeEDTA ( 28 mg/kg ) , or electrolytic iron ( 56 mg/kg ) . Concentrations of haemoglobin , plasma ferritin , and transferrin receptor were analysed in sample s taken at baseline and at the end of the 5-month intervention . The primary outcome was iron-deficiency anaemia . We analysed data on an intention-to-treat basis . This trial is registered with Clinical Trials.gov , number NCT00386074 . FINDINGS The prevalence of iron-deficiency anaemia in children given unfortified flour was 10 % . Compared with placebo , the prevalence of iron-deficiency anaemia in children given flour fortified with high-dose NaFeEDTA , low-dose NaFeEDTA , and electrolytic iron changed by -89 % ( 95 % CI -97 % to -49 % ) , -48 % ( -77 % to 20 % ) , and 59 % ( -18 % to 209 % ) , respectively . Consumption of high-dose NaFeEDTA improved all measured iron-status indicators . Low-dose NaFeEDTA decreased the prevalence of iron deficiency but did not noticeably change the prevalence of anaemia . Electrolytic iron did not improve any of these iron-status indicators . Children who were iron-deficient at baseline benefited more from high-dose and low-dose NaFeEDTA than those with sufficient iron at baseline . INTERPRETATION Consumption of whole maize flour fortified with NaFeEDTA caused modest , dose-dependent improvements in children 's iron status . Fortification with electrolytic iron did not improve their iron status . Therefore , in high-phytate flours , NaFeEDTA is more suitable than electrolytic iron for supplementation of iron in the diet",
"Food fortification is an important long-term strategy for addressing micronutrient deficiencies . Finding the ideal Fe fortification compound , however , remains a challenge . In the present study the effect of ferrous bisglycinate as fortificant in brown bread was compared with that of electrolytic Fe among Fe-deficient school children in a r and omised controlled trial . Children ( n 160 ) , aged 6 - 11 years , with serum ferritin , were r and omly assigned to one of three treatment categories : ( i ) st and ard unfortified bread ; ( ii ) bread with electrolytic Fe as fortificant ; and ( iii ) bread with ferrous bisglycinate as fortificant . Each child received four slices of bread ( 120 g ) on school days , which supplied an average of 3.66 mg elemental Fe per intervention day for 137 d ( 2.52 mg/d for 75 d and 5.04 mg/d for 62 d ) over a period of 7.5 months . Hb , serum ferritin , serum Fe and transferrin saturation were measured at baseline and at the end of the intervention . Significant treatment effects were observed for Hb ( P = 0.013 ) , serum Fe ( P = 0.041 ) and transferrin saturation ( P = 0.042 ) in the ferrous bisglycinate group , but not in the electrolytic Fe group . There were no significant intervention effects for serum ferritin in either treatment group . Overall , ferrous bisglycinate as Fe fortificant in brown bread performed better than electrolytic Fe in a group of Fe-deficient school children over a period of 7.5 months",
"The aim of this study was to determine the iron status of infants who consumed porridge cooked in water with added ferrous sulphate . A total of 234 infants , aged 6 - 12 months , were recruited from 36 nurseries in the Democratic Peoples Republic of Korea ( DPRK North Korea ) and r and omly divided into iron ( Fe ) and placebo groups . At baseline , almost half the children had Hb no significant differences between the two groups were found with regard to hemoglobin concentration and anemia prevalence . The Fe group received rice porridge fortified with 10 mg of iron ( as ferrous sulfate ) per day , added to the water in which the rice was cooked and the placebo group non-fortified cereal for 6 months . After which , the hemoglobin ( Hb ) , serum ferritin ( SF ) and packed cell volume ( PCV ) were measured and it was found that the proportion of children with anemia ( Hb Hb levels ( 117.6 g/L v 109.8 g/L p serum ferritin were higher ( 40.7 v 26.8 mcg/L p iron deficiency anemia ( Hb Ferrous sulphate , added to the water in which rice was cooked , lowered the prevalence of iron deficiency anemia of infants in the DPRK with no adverse reactions . This simple fortification would be suitable as a nationwide program in the DPRK and other countries with large infant nurseries",
"Background Multiple micronutrient deficiencies are highly prevalent among preschool children and often lead to anemia and growth faltering . Given the limited success of supplementation and health education programs , fortification of foods could be a viable and sustainable option . We report results from a community based double-masked , r and omized trial among children 1–4 years evaluating the effects of micronutrients ( especially of zinc and iron ) delivered through fortified milk on growth , anemia and iron status markers as part of a four group study design , running two studies simultaneously . Methods and Findings Enrolled children ( n = 633 ) were r and omly allocated to receive either micronutrients fortified milk ( MN = 316 ) or control milk ( Co = 317 ) . Intervention of MN milk provided additional 7.8 mg zinc , 9.6 mg iron , 4.2 µg selenium , 0.27 mg copper , 156 µg vitamin A , 40.2 mg vitamin C , and 7.5 mg vitamin E per day ( three serves ) for one year . Anthropometry was recorded at baseline , mid- and end- study . Hematological parameters were estimated at baseline and end- study . Both groups were comparable at baseline . Compliance was over 85 % and did not vary between groups . Compared to children consuming Co milk , children consuming MN milk showed significant improvement in weight gain ( difference of mean : 0.21 kg/year ; 95 % confidence interval [ CI ] 0.12 to 0.31 , p and height gain ( difference of mean : 0.51 cm/year ; 95 % CI 0.27 to 0.75 , p ) . Mean hemoglobin ( Hb ) ( difference of 13.6 g/L ; 95 % CI 11.1 to 16.0 , p ) and serum ferritin levels ( difference of 7.9 µg/L ; 95 % CI 5.4 to 10.5 , p risk of iron deficiency anemia . Conclusions / Significance Milk provides an acceptable and effective vehicle for delivery of specific micronutrients , especially zinc and iron . Micronutrient bundle improved growth and iron status and reduced anemia in children 1–4 years old . Trial Registration Clinical Trials.gov",
"OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries",
"A previous longitudinal three-country study in Egypt , Kenya and Mexico found significant positive associations between intake of animal source foods ( ASF ) and growth , cognitive development and physical activity . To test for a causal relationship , a controlled school feeding intervention study was design ed to test the hypotheses that ASF would improve micronutrient status , growth and cognitive function in Kenyan primary school children . Twelve rural Kenyan schools with 554 children were r and omized to four feeding interventions using a local vegetable stew as the vehicle . The groups were design ated as Meat , Milk , Energy and Control , who received no feedings . Feeding was carried out on school days for seven terms during 21 mo . Preintervention baseline measures included nutritional status , home food intake , anthropometry , biochemical measures of micronutrient status , malaria , intestinal parasites , health status and cognitive and behavioral measures . The measurements of each child were repeated at intervals over 2 y. Baseline data revealed stunting and underweight in approximately 30 % of children and widespread inadequate intakes and /or biochemical evidence of micronutrient deficiencies , particularly of iron , zinc , vitamins A and B-12 , riboflavin and calcium . Little or no ASF were eaten and fat intake was low . Malaria was present in 31 % of children , and hookworm , amebiasis and giardia were widely prevalent . The outcomes measured were rates of change or increase during the intervention in cognitive function , growth , physical activity and behavior and micronutrient status . Hierarchical linear r and om effects modeling was used for analysis of outcomes",
"INTRODUCTION Iron deficiency is widespread in the developing world and is especially common in young children who live on the Indian subcontinent . Supplementation with iron and folic acid alleviates severe anaemia and enhances neurodevelopment in deficient population s , but little is known about the risks of mortality and morbidity associated with supplementation . METHODS We did a community-based , cluster-r and omised , double-masked , placebo-controlled , 2x2 factorial trial in children aged 1 - 36 months and residing in southern Nepal . We r and omly assigned children daily oral supplementation to age 36 months with : iron ( 12.5 mg ) and folic acid ( 50 microg ; n=8337 ) , zinc alone ( 10 mg ) , iron , folic acid , and zinc ( n=9230 ) , or placebo ( n=8683 ) ; children aged 1 - 11 months received half the dose . Our primary outcome measure was all-cause mortality , and our secondary outcome measures included cause-specific mortality and incidence and severity of diarrhoea , dysentery , and acute respiratory illness . Analyses were by intention to treat . This study is registered at , number NCT00109551 . FINDINGS The iron and folic acid-containing groups of the study were stopped early in November , 2003 , on the recommendation of the data and safety monitoring board ; mortality in these groups did not differ from placebo and there was low power to detect positive or negative effects by the time enrollment was completed . We continued to enroll children to the placebo and zinc alone groups . 25,490 children participated and analyses are based on 29,097.3 person-years of follow-up . There was no difference in mortality between the groups who took iron and folic acid without or with zinc when compared with placebo ( HR 1.03 , 95 % CI 0.78 - 1.37 , and 1.00 , 0.74 - 1.34 , respectively ) . There were no significant differences in the attack rates for diarrhoea , dysentery , or respiratory infections between groups , although all the relative risks except one indicated modest , non-significant protective effects . INTERPRETATION Daily supplementation of young children in southern Nepal with iron and folic acid with or without zinc has no effect on their risk of death , but might protect against diarrhoea , dysentery , and acute respiratory illness",
"Previous data from Vietnam show that anaemia is highly prevalent among schoolchildren , who are considered not to be iron deficient . Trichuris infection doubled the risk of anaemia . The present study aim ed to evaluate the hypothesis that de-worming is more effective than iron fortification in an anaemic , infection-prone population . In a trial with a 2 x 2 factorial design , 425 anaemic children aged 6 - 8 years were r and omly assigned to receive either iron-fortified noodles or placebo , and mebendazole or placebo . Outcomes considered were change in haematological indicators of iron status ( Hb , serum ferritin ( SF ) , serum transferrin receptor ( TfR ) and haemoglobinopathies analysis ) ; inflammations ( C-reactive protein ( CRP ) ) ; parasite infection status ( hookworm , Trichuris and Ascaris infection ) ; and IgE. ANOVA and logistic regression were used to assess the effects of iron fortification and de-worming on Hb , SF , TfR , body iron and anaemia . Hb improved in all groups after 6 months of intervention . Iron fortification significantly improved Hb , SF and body iron ( 2.6 g/l , 16.3 microg/l and 1 mg/kg , respectively ) . Prevalence of elevated IgE was very high at baseline ( 99 % ) and significantly reduced to about 75 % in all groups after intervention . De-worming unexpectedly showed no effect on Hb , iron status and IgE level . It is concluded that iron fortification slightly improved anaemia and iron status in anaemic schoolchildren in rural Vietnam that were not considered iron deficient . Chronic infection or other unidentified factors may play an important role in the seasonal reduction of anaemia seen in all treatment groups",
"The effectiveness of bread fortified with iron bis-glycinate chelate for the control of iron deficiency and iron deficiency anemia was evaluated in 89 preschool children from families of low socioeconomic level attending 2 day nurseries of the Sao Paulo City Council . During the intervention 's time of 6 months the children received besides their usual center 's diet , a daily supplement of two sweet rolls fortified with 2 mg each of iron from the chelate for a total daily iron intake of 4 mg . After six months of intervention there was a significant decrease in the prevalence of iron deficiency anemia from 62 to 22 % . There was a mean hemoglobin improvement of 1.1 g/dL , and in children with initial hemoglobin levels hemoglobin was 1.42 g/dL. The total mean plasma ferritin values increased from 11.34 to 20.2 micrograms/L , and in those children originally iron depleted the ferritin values normalized . A significant increase in the \" z \" score for weight/height was also observed . We concluded that the use of sweet rolls fortified with 2 mg of iron from the bis-glycinate chelate is highly effective for the control of iron deficiency and iron deficiency anemia in young children",
"BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application",
"Concurrent micronutrient deficiencies are prevalent among Vietnamese school children . A school-based program providing food fortified with multiple micronutrients could be a cost-effective and sustainable strategy to improve health and cognitive function of school children . However , the efficacy of such an intervention may be compromised by the high prevalence of parasitic infestation . To evaluate the efficacy of school-based intervention using multi-micronutrient-fortified biscuits with or without deworming on anemia and micronutrient status in Vietnamese schoolchildren , a r and omized , double-blind , placebo-controlled trial was conducted among 510 primary schoolchildren , aged 6 - 8 y , in rural Vietnam . Albendazole ( Alb ) ( 400 mg ) or placebo was given at baseline . Nonfortified or multi-micronutrient-fortified biscuits including iron ( 6 mg ) , zinc ( 5.6 mg ) , iodine ( 35 microg ) , and vitamin A ( 300 microg retinol equivalents ) were given 5 d/wk for 4 mo . Multi-micronutrient fortification significantly improved the concentrations of hemoglobin ( + 1.87 g/L ; 95 % CI : 0.78 , 2.96 ) , plasma ferritin ( + 7.5 microg/L ; 95 % CI : 2.8 , 12.6 ) , body iron ( + 0.56 mg/kg body weight ; 95 % CI : 0.29 , 0.84 ) , plasma zinc ( + 0.61 micromol/L ; 95 % CI : 0.26 , 0.95 ) , plasma retinol ( + 0.041 micromol/L ; 95 % CI : 0.001 , 0.08 ) , and urinary iodine ( + 22.49 micromol/L ; 95 % CI : 7.68 , 37.31 ) . Fortification reduced the risk of anemia and deficiencies of zinc and iodine by > 40 % . Parasitic infestation did not affect fortification efficacy , whereas fortification significantly enhanced deworming efficacy , with the lowest reinfection rates in children receiving both micronutrients and Alb . Multi-micronutrient fortification of biscuits is an effective strategy to improve the micronutrient status of Vietnamese schoolchildren and enhances effectiveness of deworming",
"BACKGROUND Some r and omised controlled trials ( RCTs ) done in German-speaking Europe are published in international English- language journals and others in national German- language journals . We assessed whether authors are more likely to report trials with statistically significant results in English than in German . METHODS We studied pairs of RCT reports , matched for first author and time of publication , with one report published in German and the other in English . Pairs were identified from reports round in a manual search of five leading German- language journals and from reports published by the same authors in English found on Medline . Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors ' identities , affiliations , and other characteristics of trial reports . Main study endpoints were selected by two investigators who were unaware of trial results . Our main outcome was the number of pairs of studies in which the levels of significance ( shown by p values ) were discordant . FINDINGS 62 eligible pairs of reports were identified but 19 ( 31 % ) were excluded because they were duplicate publications . A further three pairs ( 5 % ) were excluded because no p values were given . The remaining 40 pairs were analysed . Design characteristics and quality features were similar for reports in both language s. Only 35 % of German- language articles , compared with 62 % of English- language articles , reported significant ( p 0.05 ) differences in the main endpoint between study and control groups ( p = 0.002 by McNemar 's test ) . Logistic regression showed that the only characteristic that predicted publication in an English- language journal was a significant result . The odds ratio for publication of trials with significant results in English was 3.75 ( 95 % CI 1.25 - 11.3 ) . INTERPRETATION Authors were more likely to publish RCTs in an English- language journal if the results were statistically significant . English language bias may , therefore , be introduced in review s and meta-analyses if they include only trials reported in English . The effort of the Cochrane Collaboration to identify as many controlled trials as possible , through the manual search of many medical journals published in different language s will help to reduce such bias",
"OBJECTIVE Compare milk-based , iron-fortified formulas containing 7.4 and 12.7 mg/L iron and breast-feeding during the first year of life . DESIGN Partially r and omized , double-blind trial : non-breast-fed infants r and omly assigned to receive one of two coded formulas , identical except for iron content ; infants discontinuing breast-feeding between 1 and 8 weeks of age r and omly assigned to a formula late-start group . SETTING Five general community pediatric practice s in Missouri , Indiana , Illinois , and Pennsylvania . PARTICIPANTS Sample of 347 healthy , term infants , enrolled within 1 week after birth ; 172 included in statistical analyses . OUTCOME MEASURES Length , weight , and indicators of formula intolerance recorded at clinic visits ; formula consumption , bowel movements , stool consistency , and other tolerance indicators recorded by parents on daily and weekly report forms ; hemoglobin , hematocrit , and serum ferritin , iron zinc , and copper measured at 6 and 12 months . RESULTS No significant differences between formula-fed groups in growth , attrition , formula consumption , bowel movements , hematocrit , hemoglobin level , and serum iron , zinc , and copper levels ( P > .05 ) ; first 6-month weight and length changes of the breast-fed group significantly less than in both formula-fed groups ( P serum ferritin level of the formula-fed , high-iron group significantly higher than that of the low-iron and breast-fed groups ( P formula tolerance and stool characteristics but data were not analyzed statistically . CONCLUSIONS Milk-based formulas containing either 7.4 or 12.7 mg/L iron support normal growth and iron status of healthy , term , normally fed infants during the first year and both are well tolerated and accepted",
"Anemia and micronutrient deficiencies are common among Indian schoolchildren . We assessed the effectiveness of micronutrient fortification of meals cooked and fortified at school on anemia and micronutrient status of schoolchildren in Himalayan villages of India . In this placebo-controlled , cluster-r and omized study , 499 schoolchildren ( 6 - 10 y ) received either multiple micronutrients ( treatment group ) or placebo ( control group ) as part of school meals ( 6 d/wk ) for 8 mo . Both groups were dewormed at the beginning of the study . The micronutrient premix provided 10 mg iron , 375 microg vitamin A , 4.2 mg zinc , 225 microg folic acid , and 1.35 microg vitamin B-12 for each child per day ( approximately 75 % recommended dietary allowance ) . Blood sample s drawn before and after the intervention were analyzed for hemoglobin , ferritin , retinol , zinc , folate , and vitamin B-12 . Baseline prevalence of anemia ( 37 % ) , iron deficiency anemia ( 10 % ) , low serum ferritin ( 24 % ) , retinol ( 56 % ) , zinc ( 74 % ) , folate ( 68 % ) , and vitamin B-12 ( 17 % ) did not differ between groups . Postintervention , fewer in the treatment group had lower serum retinol [ odds ratio ( OR ) ( 95 % CI ) : 0.57 ( 0.33 - 0.97 ) ] and folate [ OR ( 95 % CI ) : 0.47 ( 0.26 - 0.84 ) ] than the control group . The serum vitamin B-12 concentration decreased in both groups , but the magnitude of change was less in the treatment than in the control group ( P Total body iron ( TBI ) increased in both groups ; however , the change was greater in the treatment than in the control group ( P Micronutrient fortification of school meals by trained school personnel was effective in improving vitamin A , folate , and TBI status while also reducing the magnitude of a decrease in vitamin B-12 status"
] | 41166500-06ff-11f0-808a-c43d1ab1c353 |
This article presents a systematic review of the scientific evidence linking sugar consumption and health in the adult population performed by a group of experts , m and ated by the French Agence nationale de sécurité sanitaire de l'alimentation , de l'environnement , et du travail ( ANSES ) . A literature search was performed by crossing search terms for overweight/obesity , diabetes/insulin resistance , dyslipidemia/cardiovascular diseases , non-alcoholic fatty liver diseases ( NAFLD ) , and uric acid concentrations on one h and and for intake of sugars on the other . Controlled mechanistic studies , prospect i ve cohort studies , and r and omized clinical trials were extracted and assessed . A literature analysis supported links between sugar intake and both total energy intake and body weight gain , and between sugar intake and blood triglycerides independently of total energy intake . The effects of sugar on blood triglycerides were shown to be mediated by the fructose component of sucrose and were observed with an intake of fructose > 50 g/day . In addition , prospect i ve cohort studies showed associations between sugar intake and the risk of diabetes/insulin resistance , cardiovascular diseases , NAFLD , and hyperuricemia . Based on these observations , ANSES proposed to set a maximum limit to the intake of total sugars containing fructose ( sucrose , glucose⁻fructose syrups , honey or other syrups , and natural concentrates , etc . ) of 100 g/day | [
"BACKGROUND It has been extensively shown , mainly in US population s , that sugar-sweetened beverages ( SSBs ) are associated with increased risk of type 2 diabetes ( T2D ) , but less is known about the effects of artificially sweetened beverages ( ASBs ) . OBJECTIVE We evaluated the association between self-reported SSB , ASB , and 100 % fruit juice consumption and T2D risk over 14 y of follow-up in the French prospect i ve Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l'Education Nationale-European Prospect i ve Investigation into Cancer and Nutrition cohort . DESIGN A total of 66,118 women were followed from 1993 , and 1369 incident cases of T2D were diagnosed during the follow-up . Cox regression models were used to estimate HRs and 95 % CIs for T2D risk . RESULTS The average consumption of sweetened beverages in consumers was 328 and 568 mL/wk for SSBs and ASBs , respectively . Compared with nonconsumers , women in the highest quartiles of SSB and ASB consumers were at increased risk of T2D with HRs ( 95 % CIs ) of 1.34 ( 1.05 , 1.71 ) and 2.21 ( 1.56 , 3.14 ) for women who consumed > 359 and > 603 mL/wk of SSBs and ASBs , respectively . Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage ( P = 0.0088 and P BMI , although there was still a strong significant independent effect . No association was observed for 100 % fruit juice consumption . CONCLUSIONS Both SSB consumption and ASB consumption were associated with increased T2D risk . We can not rule out that factors other than ASB consumption that we did not control for are responsible for the association with diabetes , and r and omized trials are required to prove a causal link between ASB consumption and T2D",
"BACKGROUND & AIMS Diets high in fructose have been proposed to contribute to nonalcoholic fatty liver disease . We compared the effects of high-fructose and matched glucose intake on hepatic triacylglycerol ( TAG ) concentration and other liver parameters . DESIGN In a double-blind study , we r and omly assigned 32 healthy but central ly overweight men to groups that received either a high-fructose or high-glucose diet ( 25 % energy ) . These diets were provided during an initial isocaloric period of 2 weeks , followed by a 6-week washout period , and then again during a hypercaloric 2-week period . The primary outcome measure was hepatic level of TAG , with additional assessment s of TAG levels in serum and soleus muscle , hepatic levels of adenosine triphosphate , and systemic and hepatic insulin resistance . RESULTS During the isocaloric period of the study , both groups had stable body weights and concentrations of TAG in liver , serum , and soleus muscle . The high-fructose diet produced an increase of 22 ± 52 μmol/L in the serum level of uric acid , whereas the high-glucose diet led to a reduction of 23 ± 25 μmol/L ( P high-fructose diet also produced an increase of 0.8 ± 0.9 in the homeostasis model assessment of insulin resistance , whereas the high-glucose diet produced an increase of only 0.1 ± 0.7 ( P = .03 ) . During the hypercaloric period , participants in the high-fructose and high-glucose groups had similar increases in weight ( 1.0 ± 1.4 vs 0.6 ± 1.0 kg ; P = .29 ) and absolute concentration of TAG in liver ( 1.70 % ± 2.6 % vs 2.05 % ± 2.9 % ; P = .73 ) and serum ( 0.36 ± 0.75 vs 0.33 ± 0.38 mmol/L ; P = .91 ) , and similar results in biochemical assays of liver function . Body weight changes were associated with changes in liver biochemistry and concentration of TAGs . CONCLUSIONS In the isocaloric period , overweight men who were on a high-fructose or a high-glucose diet did not develop any significant changes in hepatic concentration of TAGs or serum levels of liver enzymes . However , in the hypercaloric period , both high-fructose and high-glucose diets produced significant increases in these parameters without any significant difference between the 2 groups . This indicates an energy-mediated , rather than a specific macronutrient-mediated , effect . Clinical trials.gov no : NCT01050140",
"OBJECTIVE Adverse effects of hypercaloric , high-fructose diets on insulin sensitivity and lipids in human subjects have been shown repeatedly . The implication s of fructose in amounts close to usual daily consumption , however , have not been well studied . This study assessed the effect of moderate amounts of fructose and sucrose compared with glucose on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS Nine healthy , normal-weight male volunteers ( aged 21–25 years ) were studied in this double-blind , r and omized , cross-over trial . All subjects consumed four different sweetened beverages ( 600 mL/day ) for 3 weeks each : medium fructose ( MF ) at 40 g/day , and high fructose ( HF ) , high glucose ( HG ) , and high sucrose ( HS ) each at 80 g/day . Euglycemic-hyperinsulinemic clamps with [6,6]-2H2 glucose labeling were used to measure endogenous glucose production . Lipid profile , glucose , and insulin were measured in fasting sample s. RESULTS Hepatic suppression of glucose production during the clamp was significantly lower after HF ( 59.4 ± 11.0 % ) than HG ( 70.3 ± 10.5 % , P whereas fasting glucose , insulin , and C-peptide did not differ between the interventions . Compared with HG , LDL cholesterol and total cholesterol were significantly higher after MF , HF , and HS , and free fatty acids were significantly increased after MF , but not after the two other interventions ( P 0.05 ) . Subjects ’ energy intake during the interventions did not differ significantly from baseline intake . CONCLUSIONS This study clearly shows that moderate amounts of fructose and sucrose significantly alter hepatic insulin sensitivity and lipid metabolism compared with similar amounts of glucose",
"Background Prospect i ve studies in humans examining the effects of fructose consumption on biological markers associated with the development of metabolic syndrome are lacking . Therefore we investigated the relative effects of 10 wks of fructose or glucose consumption on plasma uric acid and RBP-4 concentrations , as well as liver enzyme ( AST , ALT , and GGT ) activities in men and women . Methods As part of a parallel arm study , older ( age 40–72 ) , overweight and obese male and female subjects ( BMI 25–35 kg/m2 ) consumed glucose- or fructose-sweetened beverages providing 25 % of energy requirements for 10 wks . Fasting and 24-h blood collection s were performed at baseline and following 10 wks of intervention and plasma concentrations of uric acid , RBP-4 and liver enzyme activities were measured . Results Consumption of fructose , but not glucose , led to significant increases of 24-h uric acid profiles ( P and RBP-4 concentrations ( P = 0.012 ) , as well as plasma GGT activity ( P = 0.04 ) . Fasting plasma uric acid concentrations increased in both groups ; however , the response was significantly greater in subjects consuming fructose ( P = 0.002 for effect of sugar ) . Within the fructose group male subjects exhibited larger increases of RBP-4 levels than women ( P = 0.024 ) . Conclusions These findings suggest that consumption of fructose at 25 % of energy requirements for 10 wks , compared with isocaloric consumption of glucose , may contribute to the development of components of the metabolic syndrome by increasing circulating uric acid , GGT activity , suggesting alteration of hepatic function , and the production of RBP-4",
"Background — Sugar-sweetened beverage consumption is associated with weight gain and risk of type 2 diabetes mellitus . Few studies have tested for a relationship with coronary heart disease ( CHD ) or intermediate biomarkers . The role of artificially sweetened beverages is also unclear . Methods and Results — We performed an analysis of the Health Professionals Follow-Up Study , a prospect i ve cohort study including 42 883 men . Associations of cumulatively averaged sugar-sweetened ( eg , sodas ) and artificially sweetened ( eg , diet sodas ) beverage intake with incident fatal and nonfatal CHD ( myocardial infa rct ion ) were examined with proportional hazard models . There were 3683 CHD cases over 22 years of follow-up . Participants in the top quartile of sugar-sweetened beverage intake had a 20 % higher relative risk of CHD than those in the bottom quartile ( relative risk=1.20 ; 95 % confidence interval , 1.09–1.33 ; P for trend Artificially sweetened beverage consumption was not significantly associated with CHD ( multivariate relative risk=1.02 ; 95 % confidence interval , 0.93–1.12 ; P for trend=0.28 ) . Adjustment for self-reported high cholesterol , high triglycerides , high blood pressure , and diagnosed type 2 diabetes mellitus slightly attenuated these associations . Intake of sugar-sweetened but not artificially sweetened beverages was significantly associated with increased plasma triglycerides , C-reactive protein , interleukin-6 , and tumor necrosis factor receptors 1 and 2 and decreased high-density lipoprotein , lipoprotein(a ) , and leptin ( P sugar-sweetened beverages was associated with increased risk of CHD and some adverse changes in lipids , inflammatory factors , and leptin . Artificially sweetened beverage intake was not associated with CHD risk or biomarkers",
"The purpose of this investigation was to learn whether the thermogenic effect in man of sucrose and glucose was similar and whether normal weight and overweight subjects responded in a similar manner . Dietary-induced thermogenesis was calculated for the period 15 to 180 min after ingestion of sucrose or glucose in six normal weight and five obese subjects . The metabolic rate was calculated from the oxygen consumption and carbon dioxide output utilizing the ventilated hood technique . In normal weight subjects , the total dietary-induced thermogenesis was significantly greater after sucrose than after glucose ( p less than 0.005 ) but the difference was much less marked in the obese subjects",
"BACKGROUND Previous short-term studies ( energy expenditure ( EE ) and macronutrient oxidation in response to overfeeding with different types of dietary carbohydrate . This finding could have implication s for obesity . OBJECTIVE We used 96-h continuous whole-body calorimetry in 8 lean and 5 obese women to assess metabolic disposal ( energy dissipation and glycogen or fat storage ) of a controlled excess of dietary energy supplied as different carbohydrate sources or as fat . DESIGN Five dietary treatments were applied in r and om order : energy balance ( control ) and overfeeding by 50 % of energy requirements with fat ( O(fat ) ) or predominantly with glucose , fructose , or sucrose ( O(cho ) ) . Macronutrient oxidation rates were assessed from nonprotein gaseous exchanges . Net macronutrient balances were calculated as cumulative differences between intake and oxidation . RESULTS Increased EE in response to overfeeding dissipated 7.9 % of the energy excess with a variation in EE of EE during the O(fat ) treatment significantly exceeded that during the control treatment in the lean but not in the obese women . There were no significant differences between lean and obese women in macronutrient oxidation or balances , so data were pooled . O(cho ) induced glycogen storage on day 1 ( approximately 100 g ) but thereafter progressively stimulated carbohydrate oxidation so that balance was reached on days 3 and 4 . Fat oxidation was proportionately suppressed . Of the excess carbohydrate , 74 % was oxidized ; there were no significant differences between the various O(cho ) treatments . O(fat ) stimulated fat oxidation by 18 % and suppressed carbohydrate oxidation . On average , 12 % of the excess energy was stored as glycogen and 88 % as fat ; there was no significant difference between overfeeding treatments . CONCLUSION There was no significant difference in fat balance during controlled overfeeding with fat , fructose , glucose , or sucrose",
"BACKGROUND A high fructose intake can lead to postpr and ial hypertriacylglycerolemia . The underlying mechanism is unclear . OBJECTIVE The objective of the study was to investigate the mechanisms involved in fructose-induced hypertriacylglycerolemia and the contribution of de novo lipogenesis in an acute setting . DESIGN In a r and omized , crossover study , 14 subjects were given a fructose or glucose test meal after an overnight fast . [(2)H2]Palmitate and [U(13)C]d-fructose or [U(13)C]d-glucose were added to trace the h and ling of dietary fats and the fate of dietary sugars in the body . Blood sample s were taken before and after the meal . Respiratory exchange ratio was measured by using indirect calorimetry , and breath sample s were collected . RESULTS Plasma triacylglycerol and VLDL-triacylglycerol concentrations were significantly higher ( P = 0.001 for both ) , whereas the concentrations of insulin and [(2)H2]palmitate in nonesterified fatty acids were significantly lower after fructose than after glucose ( P = 0.002 and 0.03 , respectively ) . The respiratory exchange ratio was higher after fructose ( P = 0.04 ) ; significantly ( P = 0.003 ) more carbon from sugars was recovered in breath carbon dioxide over 6 h after fructose ( 30.5 % ) than after glucose ( 24.5 % ) . At 240 min , newly synthesized fatty acids from fructose made up approximately 0.4 % of circulating VLDL-triacylglycerol , whereas newly synthesized triacylglycerol-glycerol made up 38 % . Newly synthesized fatty acids and triacylglycerol-glycerol from glucose contributed almost none of VLDL-triacylglycerol ( P = 0.002 and 0.007 for glucose and fructose , respectively ) . CONCLUSIONS The lower insulin excursion after fructose may result in less activation of adipose tissue lipoprotein lipase , which led to impaired triacylglycerol clearance . The contribution of de novo lipogenesis to fructose-induced hypertriacylglycerolemia is small , but its effect on altering the partitioning of fatty acids toward esterification may be considerable",
"Using a within-subjects design , we gave over-weight and normal-weight subjects a 500-mL drink of fructose , glucose , or aspartame diluted in lemon-flavored water or plain water in a r and omized fashion at about weekly intervals . Food intake was assessed at a buffet lunch that began 38 min after the preload was completed . Blood was drawn throughout and assayed for concentrations of glucose , insulin , glucagon , and free fatty acid . When subjects drank the fructose preload , they subsequently ate fewer overall calories and fewer grams of fat than when they drank any of the other preloads . The aspartame load did not stimulate intake beyond the plain-water control . The effects of the oxidation of fructose as a possible mechanism for the reduction in food intake is discussed . The effects of insulin in stimulating intake are also discussed",
"BACKGROUND High consumption of sugar-sweetened drinks has been associated with weight gain and obesity in the United States . This trend may also be affecting population s with different eating patterns who increasingly are adopting typical US dietary patterns . OBJECTIVE We assessed whether the consumption of sweetened drinks and other food items increased the likelihood of weight gain in a Mediterranean population . DESIGN This was a prospect i ve cohort analysis of 7194 men and women with a mean age of 41 y who were followed-up for a median of 28.5 mo with mailed question naires . Dietary exposure was assessed with a previously vali date d semiquantitative food-frequency question naire . RESULTS During follow-up , we observed that 49.5 % of the participants increased their weight ( x weight gain : 0.64 kg ; 95 % CI : 0.55 , 0.73 kg ) . In the participants who had gained > or =3 kg in the 5 y before baseline , the adjusted odds ratio of subsequent weight gain for the fifth quintile compared with the first quintile of sugar-sweetened soft drink consumption was 1.6 ( 95 % CI : 1.2 , 2.1 ; P for trend = 0.02 ) . This association was absent in the participants who had not gained weight in the 5-y period before baseline . The consumption of hamburgers , pizza , and sausages ( as a proxy for fast-food consumption ) was also independently associated with weight gain ( adjusted odds ratio for the fifth compared with the first quintile = 1.2 ; 95 % CI : 1.0 , 1.4 ; P for trend = 0.05 ) . We also found a significant , but weaker , association between weight gain and both red meat and sweetened fruit juice consumption . CONCLUSION In a Mediterranean cohort , particularly in the participants who had already gained weight , an increased consumption of sugar-sweetened soft drinks and of hamburgers , pizza , and sausages was associated with a higher risk of additional subsequent weight gain",
"BACKGROUND A high dietary protein intake has been shown to blunt the deposition of intrahepatic lipids in high-fat- and high-carbohydrate-fed rodents and humans . OBJECTIVE The aim of this study was to evaluate the effect of essential amino acid supplementation on the increase in hepatic fat content induced by a high-fructose diet in healthy subjects . DESIGN Nine healthy male volunteers were studied on 3 occasions in a r and omized , crossover design after 6 d of dietary intervention . Dietary conditions consisted of a weight-maintenance balanced diet ( control ) or the same balanced diet supplemented with 3 g fructose · kg(-1 ) · d(-1 ) and 6.77 g of a mixture of 5 essential amino acids 3 times/d ( leucine , isoleucine , valine , lysine , and threonine ) ( HFrAA ) or with 3 g fructose · kg(-1 ) · d(-1 ) and a maltodextrin placebo 3 times/d ( HFr ) ; there was a washout period of 4 to 10 wk between each condition . For each condition , the intrahepatocellular lipid ( IHCL ) concentration , VLDL-triglyceride concentration , and VLDL-[(13)C]palmitate production were measured after oral loading with [(13)C]fructose . RESULTS HFr increased the IHCL content ( 1.27 ± 0.31 compared with 2.74 ± 0.55 vol % ; P and VLDL-triglyceride ( 0.55 ± 0.06 compared with 1.40 ± 0.15 mmol/L ; P also enhanced VLDL-[(13)C]palmitate production . HFrAA significantly decreased IHCL compared with HFr ( to 2.30 ± 0.43 vol% ; P change VLDL-triglyceride concentrations or VLDL-[(13)C]palmitate production . CONCLUSIONS Supplementation with essential amino acids blunts the fructose-induced increase in IHCL but not hypertriglyceridemia . This is not because of inhibition of VLDL-[(13)C]palmitate production . This trial was registered at www . clinical trials.gov as NCT01119989",
"BACKGROUND Consumption of liquid calories from beverages has increased in parallel with the obesity epidemic in the US population , but their causal relation remains unclear . OBJECTIVE The objective of this study was to examine how changes in beverage consumption affect weight change among adults . DESIGN This was a prospect i ve study of 810 adults participating in the PREMIER trial , an 18-mo r and omized , controlled , behavioral intervention trial . Measurements ( weight , height , and 24-h dietary recall ) were made at baseline , 6 mo , and 18 mo . RESULTS Baseline mean intake of liquid calories was 356 kcal/d ( 19 % of total energy intake ) . After potential confounders and intervention assignment were controlled for , a reduction in liquid calorie intake of 100 kcal/d was associated with a weight loss of 0.25 kg ( 95 % CI : 0.11 , 0.39 ; P liquid calorie intake had a stronger effect than did a reduction in solid calorie intake on weight loss . Of the individual beverages , only intake of sugar-sweetened beverages ( SSBs ) was significantly associated with weight change . A reduction in SSB intake of 1 serving/d was associated with a weight loss of 0.49 kg ( 95 % CI : 0.11 , 0.82 ; P = 0.006 ) at 6 mo and of 0.65 kg ( 95 % CI : 0.22 , 1.09 ; P = 0.003 ) at 18 mo . CONCLUSIONS These data support recommendations to limit liquid calorie intake among adults and to reduce SSB consumption as a means to accomplish weight loss or avoid excess weight gain . This trial was registered at clinical trials.gov as NCT00000616",
"BACKGROUND Type 2 diabetes mellitus is an increasingly serious health problem among African American women . Consumption of sugar-sweetened drinks was associated with an increased risk of diabetes in 2 studies but not in a third ; however , to our knowledge , no data are available on African Americans regarding this issue . Our objective was to examine the association between consumption of sugar-sweetened beverages , weight gain , and incidence of type 2 diabetes mellitus in African American women . METHODS A prospect i ve follow-up study of 59,000 African American women has been in progress since 1995 . Participants reported on food and beverage consumption in 1995 and 2001 . Biennial follow-up question naires ascertained new diagnoses of type 2 diabetes . The present analyses included 43,960 women who gave complete dietary and weight information and were free from diabetes at baseline . We identified 2713 incident cases of type 2 diabetes mellitus during 338,884 person-years of follow-up . The main outcome measure was the incidence of type 2 diabetes mellitus . RESULTS The incidence of type 2 diabetes mellitus was higher with higher intake of both sugar-sweetened soft drinks and fruit drinks . After adjustment for confounding variables including other dietary factors , the incidence rate ratio for 2 or more soft drinks per day was 1.24 ( 95 % confidence interval , 1.06 - 1.45 ) . For fruit drinks , the comparable incidence rate ratio was 1.31 ( 95 % confidence interval , 1.13 - 1.52 ) . The association of diabetes with soft drink consumption was almost entirely mediated by body mass index , whereas the association with fruit drink consumption was independent of body mass index . CONCLUSIONS Regular consumption of sugar-sweetened soft drinks and fruit drinks is associated with an increased risk of type 2 diabetes mellitus in African American women . While there has been increasing public awareness of the adverse health effects of soft drinks , little attention has been given to fruit drinks , which are often marketed as a healthier alternative to soft drinks",
"OBJECTIVE : To examine the long-term relationship between changes in water and beverage intake and weight change . SUBJECTS : Prospect i ve cohort studies of 50 013 women aged 40–64 years in the Nurses ’ Health Study ( NHS , 1986–2006 ) , 52 987 women aged 27–44 years in the NHS II ( 1991–2007 ) and 21 988 men aged 40–64 years in the Health Professionals Follow-up Study ( 1986–2006 ) without obesity and chronic diseases at baseline . MEASURES : We assessed the association of weight change within each 4-year interval , with changes in beverage intakes and other lifestyle behaviors during the same period . Multivariate linear regression with robust variance and accounting for within-person repeated measures were used to evaluate the association . Results across the three cohorts were pooled by an inverse-variance-weighted meta- analysis . RESULTS : Participants gained an average of 1.45 kg ( 5th to 95th percentile : −1.87 to 5.46 ) within each 4-year period . After controlling for age , baseline body mass index and changes in other lifestyle behaviors ( diet , smoking habits , exercise , alcohol , sleep duration , TV watching ) , each 1 cup per day increment of water intake was inversely associated with weight gain within each 4-year period ( −0.13 kg ; 95 % confidence interval ( CI ) : −0.17 to −0.08 ) . The associations for other beverages were : sugar-sweetened beverages ( SSBs ) ( 0.36 kg ; 95 % CI : 0.24–0.48 ) , fruit juice ( 0.22 kg ; 95 % CI : 0.15–0.28 ) , coffee ( −0.14 kg ; 95 % CI : −0.19 to −0.09 ) , tea ( −0.03 kg ; 95 % CI : −0.05 to −0.01 ) , diet beverages ( −0.10 kg ; 95 % CI : −0.14 to −0.06 ) , low-fat milk ( 0.02 kg ; 95 % CI : −0.04 to 0.09 ) and whole milk ( 0.02 kg ; 95 % CI : −0.06 to 0.10 ) . We estimated that replacement of 1 serving per day of SSBs by 1 cup per day of water was associated with 0.49 kg ( 95 % CI : 0.32–0.65 ) less weight gain over each 4-year period , and the replacement estimate of fruit juices by water was 0.35 kg ( 95 % CI : 0.23–0.46 ) . Substitution of SSBs or fruit juices by other beverages ( coffee , tea , diet beverages , low-fat and whole milk ) were all significantly and inversely associated with weight gain . CONCLUSION : Our results suggest that increasing water intake in place of SSBs or fruit juices is associated with lower long-term weight gain",
"BACKGROUND St and ard behavioral obesity treatment produces poor long-term results . Focusing on healthy eating behaviors rather than energy intake may be an alternative strategy . In addition , important behaviors might differ for short- vs long-term weight control . OBJECTIVE Our aim was to describe and compare associations between changes in eating behaviors and weight after 6 and 48 months . DESIGN We performed secondary analysis of data collected during a r and omized weight-loss intervention trial with 48-month follow-up . PARTICIPANTS We studied 481 overweight and obese postmenopausal women enrolled in the Women on the Move through Activity and Nutrition ( WOMAN ) Study . MAIN OUTCOME MEASURES We measured changes in weight from baseline to 6 and 48 months . STATISTICAL ANALYSES PERFORMED Linear regression models were used to examine the associations between 6- and 48-month changes in eating habits assessed by the Conner Diet Habit Survey and changes in weight . Analyses were conducted in the combined study population and stratified by r and omization group . RESULTS At 6 months in the combined population , weight loss was independently associated with decreased desserts ( P weight loss in controls . At 48 months in the combined population , weight loss was again associated with decreased desserts ( P=0.003 ) and sugar-sweetened beverages ( P=0.011 ) , but also decreased meats/cheeses ( P=0.024 ) and increased fruits/vegetables ( P meats/cheeses predicted weight loss in intervention participants ; desserts , sugar-sweetened beverages , and fruits/vegetables were independently associated in controls . CONCLUSIONS Changes in eating behaviors were associated with weight change , although important behaviors differed for short- and long-term weight change and by r and omization group . Future studies should determine whether interventions targeting these behaviors could improve long-term obesity treatment outcomes",
"BACKGROUND The consumption of sucrose-sweetened soft drinks ( SSSDs ) has been associated with obesity , the metabolic syndrome , and cardiovascular disorders in observational and short-term intervention studies . Too few long-term intervention studies in humans have examined the effects of soft drinks . OBJECTIVE We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition ( in liver and muscle tissue ) . DESIGN Overweight subjects ( n = 47 ) were r and omly assigned to 4 different test drinks ( 1 L/d for 6 mo ) : SSSD ( regular cola ) , isocaloric semiskim milk , aspartame-sweetened diet cola , and water . The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy . Other endpoints were fat mass , fat distribution ( dual-energy X-ray absorptiometry and magnetic resonance imaging ) , and metabolic risk factors . RESULTS The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat ( 132 - 143 % , sex-adjusted mean ; P skeletal muscle fat ( 117 - 221 % ; P visceral fat ( 24 - 31 % ; P blood triglycerides ( 32 % ; P total cholesterol ( 11 % ; P Total fat mass was not significantly different between the 4 beverage groups . Milk and diet cola reduced systolic blood pressure by 10 - 15 % compared with regular cola ( P diet cola had effects similar to those of water . CONCLUSION Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk , diet cola , and water . Thus , daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases . This trial is registered at clinical trials.gov as NCT00777647",
"IMPORTANCE Increases in fructose consumption have paralleled the increasing prevalence of obesity , and high-fructose diets are thought to promote weight gain and insulin resistance . Fructose ingestion produces smaller increases in circulating satiety hormones compared with glucose ingestion , and central administration of fructose provokes feeding in rodents , whereas central ly administered glucose promotes satiety . OBJECTIVE To study neurophysiological factors that might underlie associations between fructose consumption and weight gain . DESIGN , SETTING , AND PARTICIPANTS Twenty healthy adult volunteers underwent 2 magnetic resonance imaging sessions at Yale University in conjunction with fructose or glucose drink ingestion in a blinded , r and om-order , crossover design . MAIN OUTCOME MEASURES Relative changes in hypothalamic regional cerebral blood flow ( CBF ) after glucose or fructose ingestion . Secondary outcomes included whole-brain analyses to explore regional CBF changes , functional connectivity analysis to investigate correlations between the hypothalamus and other brain region responses , and hormone responses to fructose and glucose ingestion . RESULTS There was a significantly greater reduction in hypothalamic CBF after glucose vs fructose ingestion ( -5.45 vs 2.84 mL/g per minute , respectively ; mean difference , 8.3 mL/g per minute [ 95 % CI of mean difference , 1.87 - 14.70 ] ; P = .01 ) . Glucose ingestion ( compared with baseline ) increased functional connectivity between the hypothalamus and the thalamus and striatum . Fructose increased connectivity between the hypothalamus and thalamus but not the striatum . Regional CBF within the hypothalamus , thalamus , insula , anterior cingulate , and striatum ( appetite and reward regions ) was reduced after glucose ingestion compared with baseline ( P contrast , fructose reduced regional CBF in the thalamus , hippocampus , posterior cingulate cortex , fusiform , and visual cortex ( P of fructose vs glucose sessions following correction for multiple comparisons . Fructose vs glucose ingestion result ed in lower peak levels of serum glucose ( mean difference , 41.0 mg/dL [ 95 % CI , 27.7 - 54.5 ] ; P .001 ) , insulin ( mean difference , 49.6 μU/mL [ 95 % CI , 38.2 - 61.1 ] ; P and glucagon-like polypeptide 1 ( mean difference , 2.1 pmol/L [ 95 % CI , 0.9 - 3.2 ] ; P = .01 ) . CONCLUSION AND RELEVANCE In a series of exploratory analyses , consumption of fructose compared with glucose result ed in a distinct pattern of regional CBF and a smaller increase in systemic glucose , insulin , and glucagon-like polypeptide 1 levels",
"Background / Objectives : The results of short-term studies in humans suggest that , compared with glucose , acute consumption of fructose leads to increased postpr and ial energy expenditure and carbohydrate oxidation and decreased postpr and ial fat oxidation . The objective of this study was to determine the potential effects of increased fructose consumption compared with isocaloric glucose consumption on substrate utilization and energy expenditure following sustained consumption and under energy-balanced conditions . Subjects/ Methods : As part of a parallel arm study , overweight/obese male and female subjects , 40–72 years , consumed glucose- or fructose-sweetened beverages providing 25 % of energy requirements for 10 weeks . Energy expenditure and substrate utilization were assessed using indirect calorimetry at baseline and during the 10th week of intervention . Results : Consumption of fructose , but not glucose , led to significant decreases of net postpr and ial fat oxidation and significant increases of net postpr and ial carbohydrate oxidation ( P . Resting energy expenditure ( REE ) decreased significantly from baseline values in subjects consuming fructose ( P=0.031 ) but not in those consuming glucose . Conclusions : Increased consumption of fructose for 10 weeks leads to marked changes of postpr and ial substrate utilization including a significant reduction of net fat oxidation . In addition , we report that REE is reduced compared with baseline values in subjects consuming fructose-sweetened beverages for 10 weeks",
"Reduced thermic response after a glucose load has been reported in liver cirrhosis . To determine the mechanism and the site of this phenomenon , the effects of glucose and fructose on energy expenditure ( EE ) were measured in seven well-nourished cirrhotic patients and in six healthy control subjects . EE and fuel utilization were measured via indirect calorimetry for 3 h after oral glucose or fructose administration ( 1 g/kg body wt ) . After a glucose load , plasma glucose and insulin concentrations were higher in cirrhotic patients than in control subjects ( p glucose trial , the cumulative incremental changes in EE over the 3-h measurement period were lower ( p fructose ingestion , the cumulative changes in the EE of control subjects ( 1.76 + /- 0.24 kJ.kg-1.3 h-1 ) and cirrhotic patients ( 1.59 + /- 0.15 kJ.kg-1.3 h-1 ) were similar . In cirrhotic patients , the EE increase after fructose was higher than after glucose ( p glucose and fructose ingestion , no difference was observed between the carbohydrate oxidation in cirrhotic patients and that in control subjects , and lipid oxidation was suppressed to the same extent in both groups . We conclude that glucose-induced thermogenesis is impaired in liver cirrhosis , whereas fructose can normalize the thermic response . Because fructose is chiefly metabolized in the liver , these findings suggest that extrahepatic tissues are the site of defective thermogenesis in liver cirrhosis",
"Previous studies indicate that leptin secretion is regulated by insulin-mediated glucose metabolism . Because fructose , unlike glucose , does not stimulate insulin secretion , we hypothesized that meals high in fructose would result in lower leptin concentrations than meals containing the same amount of glucose . Blood sample s were collected every 30 - 60 min for 24 h from 12 normal-weight women on 2 r and omized days during which the subjects consumed three meals containing 55 , 30 , and 15 % of total kilocalories as carbohydrate , fat , and protein , respectively , with 30 % of kilocalories as either a fructose-sweetened [ high fructose ( HFr ) ] or glucose-sweetened [ high glucose ( HGl ) ] beverage . Meals were isocaloric in the two treatments . Postpr and ial glycemic excursions were reduced by 66 + /- 12 % , and insulin responses were 65 + /- 5 % lower ( both P area under the curve for leptin during the first 12 h ( -33 + /- 7 % ; P diurnal amplitude ( peak - nadir ) ( 24 + /- 6 % ; P levels of the orexigenic gastroenteric hormone , ghrelin , were suppressed by approximately 30 % 1 - 2 h after ingestion of each HGl meal ( P suppression of ghrelin was significantly less pronounced after HFr meals ( P elevation of plasma triglycerides compared with the HGl day ( P circulating insulin and leptin and increased ghrelin concentrations , as demonstrated in this study , could lead to increased caloric intake and ultimately contribute to weight gain and obesity during chronic consumption of diets high in fructose",
"OBJECTIVE To assess the clinical efficacy of nutritional amounts of grape polyphenols ( PPs ) in counteracting the metabolic alterations of high-fructose diet , including oxidative stress and insulin resistance ( IR ) , in healthy volunteers with high metabolic risk . RESEARCH DESIGN AND METHODS Thirty-eight healthy overweight/obese first-degree relatives of type 2 diabetic patients ( 18 men and 20 women ) were r and omized in a double-blind controlled trial between a grape PP ( 2 g/day ) and a placebo ( PCB ) group . Subjects were investigated at baseline and after 8 and 9 weeks of supplementation , the last 6 days of which they all received 3 g/kg fat-free mass/day of fructose . The primary end point was the protective effect of grape PPs on fructose-induced IR . RESULTS In the PCB group , fructose induced 1 ) a 20 % decrease in hepatic insulin sensitivity index ( P glucose infusion rate ( P systemic ( urinary F2-isoprostanes ) and muscle ( thiobarbituric acid – reactive substances and protein carbonylation ) oxidative stress ( P downregulation of mitochondrial genes and decreased mitochondrial respiration ( P grape PP supplementation . Antioxidative defenses , inflammatory markers , and main adipokines were affected neither by fructose nor by grape PPs . CONCLUSIONS A natural mixture of grape PPs at nutritional doses efficiently prevents fructose-induced oxidative stress and IR . The current interest in grape PP ingredients and products by the global food and nutrition industries could well make them a stepping-stone of preventive nutrition",
"Background The importance of exchanging sucrose for artificial sweeteners on risk factors for developing diabetes and cardiovascular diseases is not yet clear . Objective To investigate the effects of a diet high in sucrose versus a diet high in artificial sweeteners on fasting and postpr and ial metabolic profiles after 10 weeks . Design Healthy overweight subjects were r and omised to consume drinks and foods sweetened with either sucrose ( ∼2 g/kg body weight ) ( n = 12 ) or artificial sweeteners ( n = 11 ) as supplements to their usual diet . Supplements were similar on the two diets and consisted of beverages ( ∼80 weight% ) and solid foods ( yoghurts , marmalade , ice cream , stewed fruits ) . The rest of the diet was free of choice and ad libitum . Before ( week 0 ) and after the intervention ( week 10 ) fasting blood sample s were drawn and in week 10 , postpr and ial blood was sample d during an 8-hour meal test ( breakfast and lunch ) . Results After 10 weeks postpr and ial glucose , insulin , lactate , triglyceride , leptin , glucagon , and GLP-1 were all significantly higher in the sucrose compared with the sweetener group . After adjusting for differences in body weight changes and fasting values ( week 10 ) , postpr and ial glucose , lactate , insulin , GIP , and GLP-1 were significantly higher and after further adjusting for differences in energy and sucrose intake , postpr and ial lactate , insulin , GIP , and GLP-1 levels were still significantly higher on the sucrose-rich diet . Conclusion A sucrose-rich diet consumed for 10 weeks result ed in significant elevations of postpr and ial glycaemia , insulinemia , and lipidemia compared to a diet rich in artificial sweeteners in slightly overweight healthy subjects",
"The long-term impact of dietary carbohydrate type , in particular sucrose , on insulin resistance and the development of diabetes and atherosclerosis is not established . Current guidelines for the healthy population advise restriction of sucrose intake . We investigated the effect of high- versus low-sucrose diet ( 25 vs. 10 % , respectively , of total energy intake ) in 13 healthy subjects aged 33 ± 3 years ( mean ± SE ) , BMI 26.6 ± 0.9 kg/m2 , in a r and omized crossover design with sequential 6-week dietary interventions separated by a 4-week washout . Weight maintenance , eucaloric diets with identical macronutrient profiles and fiber content were design ed . All food was weighed and distributed . Insulin action was assessed using a two-step euglycemic clamp ; glycemic profiles were assessed by the continuous glucose monitoring system and vascular compliance by pulse-wave analysis . There was no change in weight across the study . Peripheral glucose uptake and suppression of endogenous glucose production were similar after each diet . Glycemic profiles and measures of vascular compliance did not change . A rise in total and LDL cholesterol was observed . In this study , a high-sucrose intake as part of an eucaloric , weight-maintaining diet had no detrimental effect on insulin sensitivity , glycemic profiles , or measures of vascular compliance in healthy nondiabetic subjects",
"Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P IHCL ( HFrD : + 52 % , P HGO increased after both diets ( HFrD : + 5 % , P fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose",
"Objective To examine the relation between intake of sugar sweetened soft drinks and fructose and the risk of incident gout in men . Design Prospect i ve cohort over 12 years . Setting Health professionals follow-up study . Participants 46 393 men with no history of gout at baseline who provided information on intake of soft drinks and fructose through vali date d food frequency question naires . Main outcome measure Incident cases of gout meeting the American College of Rheumatology survey criteria for gout . Results During the 12 years of follow-up 755 confirmed incident cases of gout were reported . Increasing intake of sugar sweetened soft drinks was associated with an increasing risk of gout . Compared with consumption of less than one serving of sugar sweetened soft drinks a month the multivariate relative risk of gout for 5 - 6 servings a week was 1.29 ( 95 % confidence interval 1.00 to 1.68 ) , for one serving a day was 1.45 ( 1.02 to 2.08 ) , and for two or more servings a day was 1.85 ( 1.08 to 3.16 ; P for trend=0.002 ) . Diet soft drinks were not associated with risk of gout ( P for trend=0.99 ) . The multivariate relative risk of gout according to increasing fifths of fructose intake were 1.00 , 1.29 , 1.41 , 1.84 , and 2.02 ( 1.49 to 2.75 ; P for trend risk of gout ( P values for trend sugar sweetened soft drinks and fructose is strongly associated with an increased risk of gout in men . Furthermore , fructose rich fruits and fruit juices may also increase the risk . Diet soft drinks were not associated with the risk of gout",
"Aging is associated with a decline in energy expenditure ( EE ) , glucose intolerance , and a reduction in body nitrogen content . In addition , a reduction in the thermic response to glucose but not to fructose or protein has been reported in the elderly . The present study was conducted to further examine nutrient-induced thermogenesis and the effects of specific sugars on amino acid metabolism in relation to age . After 3 days on a weight-maintaining , 250-g carbohydrate diet , 16 healthy non-obese men and women in two age groups ( 18 to 29 and 66 to 80 years ) consumed on 4 different days 500 mL of either a 75-g fructose or 75-g glucose solution , with or without 300 mg caffeine or vitamin C as a placebo . Blood substrate and hormone levels and EE , using indirect calorimetry , were measured at timed intervals for 3 hours after consumption of the drinks . There was no difference in the carbohydrate-induced increase in EE in either young or old even after adjustments for body weight and fat-free mass ( FFM ) . An approximately 20-fold increase in serum caffeine levels increased EE in both groups ( P plasma alanine from combined basal levels of 301 + /- 24 to approximately 500 + /- 18 mumol/L ( mean + /- SEM ) in both groups ( P < .001 ) . However , both fructose and glucose ingestion result ed in a similar decline in branched-chain and aromatic amino acids . ( ABSTRACT TRUNCATED AT 250 WORDS",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
"Results of studies on diet-induced thermogenesis in obese persons are contradictory . A number of factors have been postulated to mediate the obligatory and facultative component of thermogenesis . This study was design ed to investigate some further factors mediating the carbohydrate- induced thermogenesis in obese women . In 13 obese women , thermogenic responses to glucose and fructose were compared and related to subsequent hormonal changes . The thermogenic effect after fructose ingestion was significantly ( p glucose and insulin concentrations . Carbohydrate oxidation was significantly higher after fructose ( 81±7 E% vs 62±10 E% p oxidation of fat was lower ( 10±9 E% vs 21±12 E% p changes in cellular metabolism . No clear relationship could be found between thermogenesis and the activity of the sympathetic nervous system , as expressed by urinary catecholamine levels . These results indicate that not insulin but the cellular rate of carbohydrate metabolism is responsible for the thermogenic response to different carbo-nutrients",
"BACKGROUND Both nutritional and genetic factors are involved in the pathogenesis of nonalcoholic fatty liver disease and insulin resistance . OBJECTIVE The aim was to assess the effects of fructose , a potent stimulator of hepatic de novo lipogenesis , on intrahepatocellular lipids ( IHCLs ) and insulin sensitivity in healthy offspring of patients with type 2 diabetes (OffT2D)--a subgroup of individuals prone to metabolic disorders . DESIGN Sixteen male OffT2D and 8 control subjects were studied in a crossover design after either a 7-d isocaloric diet or a hypercaloric high-fructose diet ( 3.5 g x kg FFM(-1 ) x d(-1 ) , + 35 % energy intake ) . Hepatic and whole-body insulin sensitivity were assessed with a 2-step hyperinsulinemic euglycemic clamp ( 0.3 and 1.0 mU x kg(-1 ) x min(-1 ) ) , together with 6,6-[2H2]glucose . IHCLs and intramyocellular lipids ( IMCLs ) were measured by 1H-magnetic resonance spectroscopy . RESULTS The OffT2D group had significantly ( P IHCLs ( + 94 % ) , total triacylglycerols ( + 35 % ) , and lower whole-body insulin sensitivity ( -27 % ) than did the control group . The high-fructose diet significantly increased IHCLs ( control : + 76 % ; OffT2D : + 79 % ) , IMCLs ( control : + 47 % ; OffT2D : + 24 % ) , VLDL-triacylglycerols ( control : + 51 % ; OffT2D : + 110 % ) , and fasting hepatic glucose output ( control : + 4 % ; OffT2D : + 5 % ) . Furthermore , the effects of fructose on VLDL-triacylglycerols were higher in the OffT2D group ( group x diet interaction : P 7-d high-fructose diet increased ectopic lipid deposition in liver and muscle and fasting VLDL-triacylglycerols and decreased hepatic insulin sensitivity . Fructose-induced alterations in VLDL-triacylglycerols appeared to be of greater magnitude in the OffT2D group , which suggests that these individuals may be more prone to developing dyslipidemia when challenged by high fructose intakes . This trial was registered at clinical trials.gov as NCT00523562",
"CONTEXT Fructose-rich beverages such as sugar-sweetened soda and orange juice can increase serum uric acid levels and , thus , the risk of gout , but prospect i ve data on the relationship are limited . OBJECTIVE To examine the relationship between intake of fructose-rich beverages and fructose and the risk of incident gout among women . DESIGN , SETTING , AND PARTICIPANTS In the Nurses ' Health Study , a US prospect i ve cohort study spanning 22 years ( 1984 - 2006 ) , we analyzed data from 78,906 women with no history of gout at baseline who provided information on intake of beverages and fructose through vali date d food frequency question naires . MAIN OUTCOME MEASURE Incident cases that met the American College of Rheumatology survey criteria for gout . RESULTS During 22 years of follow-up , we documented 778 confirmed incident cases of gout . Increasing intake of sugar-sweetened soda was independently associated with increasing risk of gout . Compared with consumption of less than 1 serving per month of sugar-sweetened soda , the multivariate relative risk of gout for 1 serving per day was 1.74 ( 95 % confidence interval [ CI ] , 1.19 - 2.55 ) and for 2 or more servings per day was 2.39 ( 95 % CI , 1.34 - 4.26 ) ( P absolute risk differences corresponding to these relative risks were 36 and 68 cases per 100,000 person-years for sugar-sweetened soda and 14 and 47 cases per 100,000 person-years for orange juice , respectively . Diet soft drinks were not associated with the risk of gout ( P = .27 for trend ) . Compared with the lowest quintile of fructose intake , the multivariate relative risk of gout in the top quintile was 1.62 ( 95 % CI , 1.20 - 2.19 ; P = .004 for trend ) ( risk difference of 28 cases per 100,000 person-years ) . CONCLUSION Among this cohort of women , consumption of fructose-rich beverages is associated with an increased risk of incident gout , although the contribution of these beverages to the risk of gout in the population is likely modest given the low incidence rate among women"
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Ankylosing spondylitis ( AS ) is a chronic and inflammatory rheumatic disease , characterized by pain and structural and functional impairments , such as reduced mobility and axial deformity , which lead to diminished quality of life . Its treatment includes not only drugs , but also nonpharmacological therapy . Exercise appears to be a promising modality . The aim of this study is to review the current evidence and evaluate the role of exercise either on l and or in water for the management of patients with AS in the biological era . Systematic review of the literature published until November 2016 in Medline , Embase , Cochrane Library , Web of Science and Scopus data bases . Thirty-five studies were included for further analysis ( 30 concerning l and exercise and 5 concerning water exercise ; combined or not with biological drugs ) , comprising a total of 2515 patients . Most studies showed a positive effect of exercise on Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , pain , mobility , function and quality of life . The benefit was statistically significant in r and omized controlled trials . Results support a multimodal approach , including educational sessions and maintaining home-based program . This study highlights the important role of exercise in management of AS , therefore it should be encouraged and individually prescribed . More studies with good method ological quality are needed to strengthen the results and to define the specific characteristics of exercise programs that determine better results | [
"OBJECTIVES This study aims to assess the impact of a structured education and home exercise programme in daily practice patients with ankylosing spondylitis . METHODS A total of 756 patients with ankylosing spondylitis ( 72 % males , mean age 45 years ) participated in a 6-month prospect i ve multicentre controlled study , 381 of whom were r and omised to an education intervention ( a 2-hour informative session about the disease and the implementation of a non-supervised physical activity programme at home ) and 375 to st and ard care ( controls ) . Main outcome measures included Bath Ankylosing Spondylitis Disease Activity and Functional Index ( BASDAI , BASFI ) . Secondary outcome measures were 0 - 10 cm visual analog scale ( VAS ) for total pain , nocturnal pain and global disease activity and quality of life ( ASQoL ) , knowledge of disease ( self-evaluation ordinal scale ) and daily exercise ( diary card ) . RESULTS At 6 months , the adjusted mean difference between control and educational groups for BASDAI was 0.32 , 95 % confidence interval ( CI ) 0.10 - 0.54 , p=0.005 , and for BASFI 0.31 , 95%CI 0.12 - 0.51 , p=0.002 . Significant differences were found also in VAS for total pain , patient´s global assessment and in ASQoL. Patients in the education group increased their knowledge about the disease and its treatments significantly ( p CONCLUSIONS A structured education and home exercise programme for patients with ankylosing spondylitis in daily practice was feasible and helped to increase knowledge and exercise . Although statistically significant , the magnitudes of the clinical benefits in terms of disease activity and physical function were poor",
"Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required",
"Abstract Ankylosing spondylitis ( AS ) is a chronic systemic inflammatory disease that affects mainly the axial skeleton and causes significant pain and disability . Aquatic ( water-based ) exercise may have a beneficial effect in various musculoskeletal conditions . The aim of this study was to compare the effectiveness of aquatic exercise interventions with l and -based exercises ( home-based exercise ) in the treatment of AS . Patients with AS were r and omly assigned to receive either home-based exercise or aquatic exercise treatment protocol . Home-based exercise program was demonstrated by a physiotherapist on one occasion and then , exercise manual booklet was given to all patients in this group . Aquatic exercise program consisted of 20 sessions , 5 × per week for 4 weeks in a swimming pool at 32–33 ° C . All the patients in both groups were assessed for pain , spinal mobility , disease activity , disability , and quality of life . Evaluations were performed before treatment ( week 0 ) and after treatment ( week 4 and week 12 ) . The baseline and mean values of the percentage changes calculated for both groups were compared using independent sample t test . Paired t test was used for comparison of pre- and posttreatment values within groups . A total of 69 patients with AS were included in this study . We observed significant improvements for all parameters [ pain score ( VAS ) visual analog scale , lumbar flexion/extension , modified Schober test , chest expansion , bath AS functional index , bath AS metrology index , bath AS disease activity index , and short form-36 ( SF-36 ) ] in both groups after treatment at week 4 and week 12 ( p improvement in VAS ( p and bodily pain ( p , general health ( p , vitality ( p , social functioning ( p , role limitations due to emotional problems ( p , and general mental health ( p concluded that a water-based exercises produced better improvement in pain score and quality of life of the patients with AS compared with home-based exercise",
"We investigated the effects of home-based daily exercise on joint mobility , functional capacity , pain , and depression in patients with ankylosing spondylitis ( AS ) . The patients were r and omly assigned to a wait-list control group or to an exercise-therapy group . The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks . After 8 weeks , compared with the control group , the exercise group showed improvements in joint mobility ( cervical flexion , extension , shoulder flexion , abduction , hip abduction , and knee flexion ) , finger – floor distance , and functional capacity . Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group . These findings indicate that exercise therapy increases joint mobility and functional capacity , and decreases pain and depression in patients with AS . Home-based exercise , which is easily accessible to patients , might be an effective intervention for AS",
"Despite advances in pharmacological therapy , physical treatment continues to be important in the management of ankylosing spondylitis ( AS ) . The objective of the present study was to evaluate the effects and tolerability of combined spa therapy and rehabilitation in a group of AS patients being treated with TNF inhibitors . Thirty AS patients attending the Rheumatology Unit of the University of Padova being treated with TNF inhibitors for at least 3 months were r and omized and assessed by an investigator independent from the spa staff : 15 were prescribed 10 sessions of spa therapy ( mud packs and thermal baths ) and rehabilitation ( exercises in a thermal pool ) and the other 15 were considered controls . The patients in both groups had been receiving anti-TNF agents for at least three months . The outcome measures utilized were BASFI , BASDAI , BASMI , VAS for back pain and HAQ . The evaluations were performed in all patients at the entry to the study , at the end of the spa treatment , and after 3 and 6 months . Most of the evaluation indices were significantly improved at the end of the spa treatment , as well as at the 3 and 6 months follow-up assessment s. No significant alterations in the evaluation indices were found in the control group . Combined spa therapy and rehabilitation caused a clear , long-term clinical improvement in AS patients being treated with TNF inhibitors . Thermal treatment was found to be well tolerated and none of the patients had disease relapse",
"Abstract Balance impairment is a frequent and undertreated manifestation in ankylosing spondylitis , leading to increased risk of falls and lower quality of life . Our aim was to assess supervised training and home-based rehabilitation efficacy on balance improvement in ankylosing spondylitis subjects on biologic agents . This was a single-blinded , quasi-r and omized parallel study in a single outpatient Rehabilitation Clinic of a tertiary referral center . Subjects with ankylosing spondylitis on biologic agents were assigned either to supervised training and home-based rehabilitation program ( rehabilitation group ) plus educational – behavioral therapy , or to educational – behavioral therapy alone ( educational groups ) . The same therapist provided therapy . Outcome measures were assessed at baseline ( T0 ) , end of treatment ( T1 ) and at 7-month follow-up ( T2 ) . Rheumatologic outcomes were Bath Ankylosing Spondylitis Metrology Index , Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index . Balance parameters ( anterior – posterior oscillation , latero-lateral oscillation , sway area , sway density and sway path ) were evaluated by stabilometry in a condition of open and closed eyes . Forty-six subjects ( 36 M , 10 F ) were enrolled . Demographic data and clinical status at baseline were comparable between the two groups ( 22 rehabilitation group , 20 educational group ) . Primary outcome was sway density that improved both at T1 ( SDy : open eyes p = 0.003 , closed eyes p = 0.004 ) and at T2 ( SDx : open eyes p = 0.0015 , closed eyes p = 0.032 ) . A trend toward improvement in the rehabilitation group rather than in the educational group emerged for balance parameters , especially those measured with closed eyes ( 0.004 Supervised training and home exercise lead to balance improvement in people with ankylosing spondylitis . Eyes-closed trials show a more marked trend toward improvement , and this may suggest a positive effect of rehabilitation on proprioception",
"Aims : To evaluate effects of physiotherapeutic intervention in terms of self- and manual mobilization on chest expansion , vital capacity , posture , spine mobility and experienced consequences of the disease in patients with ankylosing spondylitis . Design : A prospect i ve , r and omized controlled study . Methods : Thirty-two men , aged between 23 and 60 years , with ankylosing spondylitis were r and omized to active or no treatment for eight weeks . Physiotherapeutic intervention included individualized self- and manual mobilization for 1 hour twice a week and individually adjusted home exercises . Two blinded investigators made the assessment s of chest expansion , posture and spinal mobility before and after the treatment period . The patient filled in three and the physiotherapist one of the four Bath Ankylosing Spondylitis scales ( BAS scales ) . Results : In the treatment group chest expansion increased at the level of processus xiphoideus ( P posture improved in the cervical ( C7—wall distance ) ( P Thoracic and lumbar spine flexion improved ( P sagittal range of motion P Bath Ankylosing Spondylitis Metrology Index total scoring improved ( P scales showed no differences between groups . At four months follow-up of the treatment group , cervical spine posture , lumbar flexion and range of motion as well as BAS Metrology Index were still improved . Conclusion : This study shows that eight weeks of self- and manual mobilization treatment improved chest expansion , posture and spine mobility in patients with ankylosing spondylitis",
"AIM The aim of the study was to compare the effects of conventional exercise ( CE ) , swimming and walking on the pulmonary functions , aerobic capacity , quality of life , Bath indexes and psychological symptoms in patients with ankylosing spondylitis ( AS ) . METHODS Forty-five patients were r and omised into either swimming ( group 1 ) , walking ( group 2 ) , CE group ( group 3 ) . Patients in Group 1 performed CE and swimming , patients in Group 2 performed CE and walking and patients in Group 3 performed CE only . Exercise sessions were performed three times a week for a period of six weeks . Patients were assessed before and after the rehabilitation program , with respect to , pulmonary function test ( forced vital capacity [ FVC , mL ] , forced expiration volume in one second [ FEV1 , mL ] , FEV1/FVC ( % ) and vital capacity [ VC , mL ] ) , maximal oxygen uptake ( pV.O2 ) , 6-minute walking test ( 6MWT ) , Bath Ankylosing Spondylitis Functional Index , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Metrology Index , Nottingham Health Profile and Beck Depression Inventory . RESULTS There were significant increases in pVO2 and 6MWT after treatment in Groups 1 and 2 ( P FeV1 , FVC and VC improved significantly with treatment in all three groups ( P energy , emotional reaction and physical mobility sub-scores of NHP in three exercise groups after completion of the exercise program ( P , walking and CE had beneficial effects on the quality of life and pulmonary functions . Aerobic exercises such as swimming and walking in addition to CE increased functional capacities of patients",
"Background Physical therapy is recommended for the management of axial spondyloarthritis ( axSpA ) and flexibility exercises have traditionally been the main focus . Cardiovascular ( CV ) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases . Therefore , the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA. Methods In a single blinded r and omized controlled pilot study the exercise group ( EG ) performed 12 weeks of endurance and strength exercise while the control group ( CG ) received treatment as usual . The primary outcome was the Ankylosing Spondylitis ( AS ) Disease Activity Score ( ASDAS ) . Secondary outcomes included patient reported disease activity ( Bath AS Disease Activity Index [ BASDAI ] ) , physical function ( Bath AS Functional Index [ BASFI ] ) , and CV risk factors measured by arterial stiffness ( Augmentation Index [ Alx ] ) and Pulse Wave Velocity [ PWV ] ) , cardiorespiratory fitness ( VO2 peak ) and body composition . ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences , and Mann Whitney U-test was used for outcomes with skewed residuals . Results Twenty-eight patients were included and 24 ( EG , n = 10 , CG , n = 14 ) completed the study . A mean treatment effect of −0.7 ( 95%CI : −1.4 , 0.1 ) was seen in ASDAS score . Treatment effects were also observed in secondary outcomes ( mean group difference [ 95%CI ] ) : BASDAI : −2.0 ( −3.6 , −0.4 ) , BASFI : −1.4 ( −2.6 , −0.3 ) , arterial stiffness ( estimated median group differences [ 95 % CI ] ) : AIx ( % ) : −5.3 ( −11.0 , −0.5 ) , and for PVW ( m/s ) : −0.3 ( −0.7 , 0.0 ) , VO2 peak ( ml/kg/min ) ( mean group difference [ 95%CI ] : 3.7 ( 2.1 , 5.2 ) and trunk fat ( % ) : −1.8 ( −3.0 , −0.6 ) . No adverse events occurred . Conclusion High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA. These effects will be further explored in a larger trial . Trial Registration Clinical Trials.gov",
"The optimal management of ankylosis spondylitis ( AS ) involves a combination of nonpharmacologic and pharmacologic treatment aim ing to maximize health-related quality of life . The primary objective of our study was to demonstrate the benefits of an original multimodal exercise program combining Pilates , McKenzie and Heckscher techniques on pulmonary function in patients with AS , while secondary objectives were to demonstrate the benefits of the same program on function and disease activity . This is a r and omized controlled study on ninety-six consecutive patients with AS ( axial disease subset ) , assigned on a 1:1 rationale into two groups based on their participation in the Pilates , McKenzie and Heckscher ( group I ) or in the classical kinetic program ( group II ) . The exercise program consisted of 50-min sessions performed 3 times weekly for 48 weeks . St and ard assessment s were done at week 0 and 48 and included pain , modified Schober test ( mST ) and finger – floor distance ( FFD ) , chest expansion ( CE ) and vital capacity ( VC ) , as well as disease activity Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , functional Bath Ankylosing Spondylitis Functional Index ( BASFI ) and metrology index Bath Ankylosing Spondylitis Metrology Index ( BASMI ) . Groups were comparable at baseline ; we demonstrated significant improvement between baseline and after 48 weeks of regular kinetic training for all AS-related parameters in both groups . However , significant improvement was found in pain , lumbar spine motility ( mST , FFD ) , BASFI , BASDAI and BASMI in AS performing the specific multimodal exercise program at the end of study ( p = 0.001 ) . Although there were significant improvements in CE in both groups as compared to baseline ( group I , p = 0.001 ; group II , p = 0.002 ) , this parameter increased significantly only in group I ( p = 0.001 ) . VC measurements were not significantly changed at the end of the study ( group I , p = 0.127 ; group II , p = 0.997 ) , but we found significant differences within groups ( p = 0.011 ) . A multimodal training combining Pilates , McKenzie and Heckscher exercises performed regularly should be included in the routine management of patients with AS for better control of function , disease activity and pulmonary function ",
"The home-based exercise therapy recommended to the patients with ankylosing spondylitis ( AS ) is a simply applicable and cheap method . The aim of this study was to investigate the effects of home-based exercise therapy on pain , mobility , function , disease activity , quality of life , and respiratory functions in patients with AS . Eighty patients diagnosed with AS according to the modified New York criteria were included in the study . Home-based exercise program including range of motion , stretching , strengthening , posture , and respiratory exercises was practically demonstrated by a physiotherapist . A training and exercise manual booklet was given to all patients . Patients following home-based exercise program five times a week at least 30 min per session ( exercise group ) for 3 months were compared with those exercising less than five times a week ( control group ) . Visual analog scale pain ( VASp ) values at baseline were significantly higher in the exercise group . The exercise group showed improvements in VASp , tragus – wall distance , morning stiffness , finger – floor distance , modified Schober 's test , chest expansion , the Bath Ankylosing Spondylitis Disease Activity Index , the Bath Ankylosing Spondylitis Functional Index , Ankylosing Spondylitis Quality of Life Question naire ( ASQoL ) , forced expiratory volume in first second , and forced vital capacity at third month . There was significant difference in ASQoL scores between the two groups in favor of the exercise group at third month . Regular home-based exercise therapy should be a part of main therapy in patients with AS . Physicians should recommend that patients with AS do exercise at least five times a week at least 30 min per session",
"BACKGROUND It is widely accepted that patient education and regular exercises could improve pain , function and maintain posture in ankylosing spondylitis ( AS ) . AIM The main aim of our study was to demonstrate the benefits of a specific , McKenzie training focusing on pain , spine flexibility , disease activity and function , as well as chest expansion in AS . DESIGN Controlled study . SETTING Rheumatology and Rehabilitation Department . POPULATION Patients with early AS . METHODS Prospect i ve 24-week controlled study in 52 patients with early AS ( modified 1984 New York criteria ) r and omly assigned to perform either McKenzie training ( 28 AS ) or classic kinetic exercises ( 24 AS ) . Efficacy parameters comprising pain , lumbar spine mobility ( modified Schober test , mST ; finger-to-floor distance , FFD ; BASMI ) , chest expansion ( CE ) , disease activity ( BASDAI ) and function ( BASFI ) were evaluated during three visits ( week 0 , 12 and 24 after the initiation of the kinetic program ) . The exercise protocol consisted of 50-minute sessions performed 3 times weekly for 24 weeks , with a 12-week learning module assisted by a trained physical therapist in the outpatient rheumatology and rehabilitation department , and a 12-week module performed individually at home . Only subjects attending the kinetic program on a regular basis ( at least 2 times weekly , at least 60 attended sessions during the study ) were and accepted for the final evaluation . RESULTS After 12 and 24 weeks of exercises we reported significant improvement in pain ( P=0.015 and P=0.003 ) , metrology ( mST : P=0.001 and P=0.001 ; FFD : P=0.002 and P=0.001 ; BASMI : P=0.001 and P=0.001 ) , disease activity ( BASDAI : P=0.004 and P=0.001 ) and function ( BASFI : P=0.001 at both visits ) in the McKenzie group . mST , BASDAI , BASFI and BASMI also improved at both visits in controls ( P changed only in long-term assessment ( P specific McKenzie training should be included in the st and ard-care of AS aim ing to improve pain , posture and function , especially in early axial disease . CLINICAL REHABILITATION IMPACT A specific McKenzie training should be included in the st and ard-care of AS",
"Objective . To evaluate the effect of combining incentive spirometer exercise ( ISE ) with a conventional exercise ( CE ) on patients with ankylosing spondylitis ( AS ) stabilized by tumor necrosis factor ( TNF ) inhibitor therapy by comparing a combination group with a CE-alone group . Methods . Forty-six patients ( 44 men , 2 women ) were r and omized to the combination group ( ISE plus CE ; n = 23 ) or the CE group ( n = 23 ) . The CE regimen of both groups consisted of 20 exercises performed for 30 min once a day . The ISE was performed once a day for 30 min . The trial duration was 16 weeks . Patients were assessed before and at the end of treatment by measuring the Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , chest expansion , finger to floor distance , pulmonary function measures , and 6-min walk distance . Results . Both groups improved significantly in terms of chest expansion ( p finger to floor distance ( p BASFI ( p forced vital capacity ( p total lung capacity ( p vital capacity ( p functional disability and pulmonary function measures . Conclusion . Combining ISE with a CE can provide positive results in patients whose AS has been clinical ly stabilized by TNF inhibitor therapy",
"The objective of this study is to assess the effects of Global Postural Reeducation ( GPR ) in patients with ankylosing spondylitis and compare GPR with group conventional segmental self-stretching and breathing exercises . This is a controlled interventional study of 38 patients divided into 2 groups : a GPR group ( n = 22 ) and a control group ( n = 16 ) . Both groups were treated for more than 4 months . With the GPR group patients , positions that stretched the shortened muscle chains were used . With the control group patients , conventional segmental self-stretching and breathing exercises were performed . The variables analyzed were pain intensity , morning stiffness , spine mobility , chest expansion , functional capacity ( Health Assessment Question naire – Spondyloarthropathies – HAQ-S ) , quality of life ( Medical Outcome Study Short Form 36 Healthy Survey – SF-36 ) , and disease activity ( Bath Ankylosing Spondylitis Disease Activity Index – BASDAI ) . Statistical analysis was used with a significance level of P in morning stiffness ( P = 0.013 ) , spine mobility parameters , except finger-floor distance ( P = 0.118 ) , in chest expansion ( P = 0.028 ) , and in the physical aspect component of the SF-36 ( P = 0.001 ) . The results of this study showed that individual treatment with GPR ( overall stretching ) seems to have better clinical outcomes than group treatment with conventional segmental self-stretching and breathing exercises for patients with ankylosing spondylitis",
"The objective of this study was to investigate the effects of Pilates on pain , functional status , and quality of life in patients with ankylosing spondylitis . The study was performed as a r and omized , prospect i ve , controlled , and single-blind trial . Fifty-five participants ( 30 men , 25 women ) who were under a regular follow-up protocol in our Rheumatology Clinic with the diagnosis of AS according to the modified New York criteria were included in the study . The participants were r and omly assigned into two groups : in group I , Pilates exercise program of 1 h was given by a certified trainer to 30 participants 3 times a week for 12 weeks , and in group II , design ed as the control group , 25 participants continued previous st and ard treatment programs . In groups , pre-(week 0 ) and post treatment ( week 12 and week 24 ) evaluation was performed by one of the authors who was blind to the group allocation . Primary outcome measure was functional capacity . Evaluation was done using the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Exploratory outcome measures were Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Metrology Index ( BASMI ) , Chest expansion , and ankylosing spondylitis quality of life ( ASQOL ) question naire . In group I , BASFI showed significant improvement at week 12 ( P = 0.031 ) and week 24 ( P = 0.007 ) . In group II , this parameter was not found to have significantly changed at week 12 and week 24 . Comparison of the groups showed significantly superior results for group I at week 24 ( P = 0.023 ) . We suggest Pilates exercises as an effective and safe method to improve physical capacity in AS patients . Our study is the first clinical study design ed to investigate the role of Pilates method in AS treatment . We believe that further research with more participants and longer follow-up periods could help assess the therapeutic value of this popular physical exercise method in AS",
"Objective : To evaluate the impact of inspiratory muscle training on aerobic capacity and pulmonary function in patients with ankylosing spondylitis . Design : R and omized controlled study . Setting : Rheumatic Rehabilitation Centre . Subjects : A total of 54 ankylosing spondylitis patients , all males , were r and omized to a conventional exercise training associated with an inspiratory muscle training group , or to a conventional exercise training group . Interventions : Group 1 ( 27 patients ) performed eight weeks of conventional exercise training ( supervised weekly group sessions followed by a home-based exercise programme ) associated with inspiratory muscle training sessions . Group 2 ( 27 patients ) received eight weeks of conventional exercise training only . Main measures : Resting pulmonary function ( forced vital capacity − FVC , forced expiratory volume in one second − FEV1 ) ; effort ventilatory efficiency ( lowest ventilatory equivalent ratio for oxygen and carbon dioxide – VE/VO2 and VE/VCO2 ) and aerobic capacity ( peak oxygen uptake – VO2peak ) were assessed at baseline and after eight weeks of exercise-based intervention . Results : After eight weeks follow-up , patients in Group 1 had a significant increased chest expansion and VO2peak compared with Group 2 ( 3.6 ±0.8 cm vs. 3.2 ±0.5 cm , P = 0.032 ; 2.0 ±0.5 l/min vs. 1.8 ±0.3 l/min , P = 0.033 ) . There were no significant differences of spirometric measurements , except FVC which significantly improved in patients who performed inspiratory muscle training ( 82.7 ±5.1 % vs. 79.5 ±3.5 % , P = 0.014 ) . VE/VCO2 also improved significantly in Group 1 ( 26.6 ±3.6 vs. 29.2 ±4.7 , P = 0.040 ) . Conclusions : Ankylosing spondylitis patients who performed eight weeks of inspiratory muscle training associated to conventional exercise training had an increased chest expansion , a better aerobic capacity , resting pulmonary function and ventilatory efficiency than those who performed conventional exercise training only",
"The objective of this non-r and omised controlled trial was to evaluate the impact of group-based exercise programme and a home-based exercise programme on Bath Ankylosing Spondylitis Indices , depression and quality of life in patients with ankylosing spondylitis ( AS ) . Approximately 41 patients in a rehabilitation unit were divided into two groups , either group- or home-based exercise programme . Exercise sessions were performed three times a week for a period of 6 weeks . The patients were compared before and after the rehabilitation programme , with respect to Bath Ankylosing Spondylitis Functional Index ( BASFI ) , Bath Ankylosing Spondylitis Disease Assessment Index ( BASDAI ) , Bath Ankylosing Spondylitis Metrology Index ( BASMI ) , Beck Depression Inventory ( BDI ) and The Nottingham Health Profile ( NHP ) . A statistically significant improvement was observed on BASDAI , BASMI and energy , pain , reaction of emotional and sleep subscores of NHP in both exercise groups after the exercise programme ( p BASFI , BDI and social and mobility subscores of NHP in both exercise groups ( p > 0.05 ) . No statistically significant differences were found between the two exercise programmes ( p > 0.05 ) . Group and home-based exercise programmes are efficient in improving symptoms and mobility and had an important effect on quality of life in patients with AS . Home-based exercise programme , as it is cheaper , more easily performed and efficient , may be preferable for the management programme in AS",
"BACKGROUND AND PURPOSE Few r and omized controlled studies have examined the effects of exercise in patients with ankylosing spondylitis ( AS ) . This study investigated the effects of a 12-week , multimodal exercise program in patients with AS . SUBJECTS A convenience sample of 30 patients with AS ( 18 male , 12 female ) , with a mean age of 34.9 years ( SD=6.28 ) , participated in the study . Twenty-six subjects were classified as having stage I AS and 4 subjects were classified as having stage II AS according to the modified New York Criteria . METHODS This study was a r and omized controlled trial . Subjects were assigned to either a group that received an exercise program or to a control group . The exercise program consisted of 50 minutes of multimodal exercise , including aerobic , stretching , and pulmonary exercises , 3 times a week for 3 months . Subjects in both groups received medical treatment for AS , but the exercise group received the exercise program in addition to the medical treatment . All subjects received a physical examination at baseline and at 12 weeks . The examinations were conducted under the supervision of a physician who specialized in physical medicine and rehabilitation and included the assessment of spinal mobility using 2 methods : clinical measurements ( chin-to-chest distance , Modified Schober Flexion Test , occiput-to-wall distance , finger-to-floor distance , and chest expansion ) and inclinometer measurements ( gross hip flexion , gross lumbar flexion , and gross thoracic flexion ) . In addition , vital capacity was measured by a physiologist , and physical work capacity was evaluated by a doctorally prepared exercise instructor . RESULTS The measurements of the exercise group for chest expansion , chin-to-chest distance , Modified Schober Flexion Test , and occiput-to-wall distance were significantly better than those of the control group after the 3-month exercise period . The spinal movements of the exercise group improved significantly at the end of exercise program , but those of the control group showed no significant change . In addition , the results showed that the posttraining value of gross thoracic flexion of the exercise group was significantly higher than that of the control group . Physical work capacity and vital capacity values improved in the exercise group but decreased in the control group . DISCUSSION AND CONCLUSION In this study , a multimodal exercise program including aerobic , stretching , and pulmonary exercises provided in conjunction with routine medical management yielded greater improvements in spinal mobility , work capacity , and chest expansion",
"OBJECTIVE To evaluate the mean overall effects over a 1-year period of a multidisciplinary in-patient rehabilitation programme for patients with ankylosing spondylitis . DESIGN Observer-blinded , r and omized controlled trial , with assessment s made after 4 and 12 months . PATIENTS Forty-six patients received a 3-week in-patient rehabilitation programme and 49 patients received treatment as usual . METHODS Primary outcomes were disease activity measured with the Bath Ankylosing Spondylitis Disease Activity Scale ( BASDAI ) , and function measured with the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Secondary outcomes included well-being , spinal and hip mobility , and health-related quality of life measured with the Medical Outcome Study Short Form-36 . Overall treatment effects were estimated with Mixed models repeated measures analyses . RESULTS Significant overall treatment effects in favour of the rehabilitation group were found in the BASDAI score ( mean difference over the 1-year period -10.0 , 95 % confidence interval : -3.7 to -16.3 ) , in well-being ( -7.3 , 95 % confidence interval : -1.0 to -14.7 ) , and in the Medical Outcome Study Short Form-36 variables social functioning , role physical , role mental and bodily pain ( mean differences ranging from 5.8 ( pain ) to 10.7 ( role physical ) ) . CONCLUSION A 3-week in-patient rehabilitation programme had positive overall effects on disease activity , pain , function and well-being , and should be considered an important complement to medical disease management in persons with ankylosing spondylitis",
"OBJECTIVE The aim of this study was to evaluate the impact of two different home-based daily exercise programs on pulmonary functions in the patients with ankylosing spondylitis ( AS ) . METHODS Fifty-one patients with AS were distributed into three groups . Group 1 ( n=19 ) was given a conventional exercise regimen . Group 2 ( n=19 ) received exercises based on the Global Posture Reeducation ( GPR ) method . Group 3 ( n=13 ) was accepted as the control group . Patients were assessed according to pain , functional capacity ( The Bath Ankylosing Spondylitis Functional Index - BASFI ) , disease activity ( The Bath Ankylosing Spondylitis Disease Activity Index - BASDAI ) , chest expansion , pulmonary function parameters , and 6-min walk distance ( 6MWD ) test . RESULTS Although there were significant improvements for BASDAI and BASFI scores in all groups , significant improvements in the VAS pain , chest expansion , pulmonary function parameters and 6MWD test were observed in the exercise groups . The improvements in pain , functional capacity , disease activity , chest expansion , pulmonary function parameters and 6MWD test were better in the exercise groups than in the control group . The GPR method result ed in greater improvements than the conventional exercise program in specific pulmonary function parameters like forced vital capacity , forced expiratory volume in 1s , and peak expiratory flow parameters . CONCLUSION Both exercises are efficient in improving pulmonary functions . Since the improvements in pulmonary function tests were greater in the patients who performed the exercise according to GPR method , motivated patients should be encouraged to perform this exercise program",
"OBJECTIVE Home based self-care is essential for successful management of ankylosing spondylitis ( AS ) . We design ed an intervention package aim ed at promoting self-care and regular longterm exercise and evaluated its effect on outcome . METHOD Members of our data base ( n = 4569 ) were r and omly selected and r and omized to an intervention group ( IG ) or a followup control group ( CG ) . The intervention consisted of an exercise/information video , exercise progress chart , patient education booklet , and AS exercise reminder stickers . The outcome measures were function ( BASFI ) , disease activity ( BASDAI ) , global well being ( BAS-G ) , exercise self-efficacy ( ESE ) , arthritis self-efficacy ( SES ) , and quantity of AS mobility/aerobic exercise assessed at baseline and 6 months . RESULTS Of the 200 subjects , 155 completed the study ( 75 IG and 80 CG ) . Baseline analysis showed no differences between the CG and the IG . At 6 months , analysis revealed no statistically significant between-group differences for the BASFI , BASDAI , and BAS-G. although the p value of 0.08 for function approached significance . Self-efficacy for exercise showed a significant improvement in the IG ( p = 0.045 ) . There were no between-group differences for the SES pain and other symptoms subscales . Finally , there was a significant increase in self-reported AS mobility ( p aerobic exercise ( p An exercise intervention package design ed to promote self-management in AS ( 1 ) significantly improves self-efficacy for exercise ; ( 2 ) significantly improves self-reported levels of exercise ; ( 3 ) reveals a trend for improvement in function ( BASFI )",
"Objective . To evaluate the effects of aerobic exercise in patients with ankylosing spondylitis ( AS ) . Methods . Seventy patients classified with AS by the modified New York criteria were included . The patients were r and omly assigned into 2 groups . The intervention group ( IG ) performed 50 min of walking followed by stretching exercises 3 times a week for 12 weeks . The control group ( CG ) performed only stretching exercises . The outcome measurements were the Bath indexes [ Bath AS Functional Index ( BASFI ) , Bath AS Disease Activity Index ( BASDAI ) , and Bath AS Metrology Index ( BASMI ) ] , Health Assessment Question naire for the Spondyloarthropathies ( HAQ-S ) , AS Disease Activity Score ( ASDAS ) , the 6-min walk test ( 6MWT ) , chest expansion , and the Medical Outcomes Study Short Form-36 . Aerobic capacity was assessed by ergospirometry on a treadmill . Routine laboratory techniques were used in determining lipid levels . Assessment s were performed immediately before r and omization and after 6 , 12 , and 24 weeks . Results . Thirty-five patients were r and omized to the IG and 35 to the CG . There was significant improvement in the BASFI , HAQ-S , BASMI , BASDAI , and ASDAS in both groups ( p walking distance in the 6MWT in the IG compared with CG ( p cardiopulmonary capacity compared with CG . Cholesterol and triglyceride levels did not change in either group . Conclusion . In patients with AS , aerobic training improved walking distance and aerobic capacity . Aerobic training did not provide additional benefits in functional capacity , mobility , disease activity , quality of life , and lipid levels when compared with stretching exercises alone",
"Objective : To compare , in patients with ankylosing spondylitis ( AS ) , the effectiveness on pain , functional and psychological status of an intensive group exercise programme under the supervision of a physiotherapist and a home physiotherapy programme . Design : Fifty-one patients with AS were r and omly allocated into study and control groups . The study was design ed as a prospect i ve , double-blind study . Setting : Outpatient department , Istanbul Medical Faculty . Subjects : Patients who consulted with complaints of pain , morning stiffness and restricted range of movement with a confirmed diagnosis of ankylosing spondylitis . Interventions : Before exercise , both groups were given an education programme about AS . For group I patients an intensive exercise programme was organized under the supervision of a physiotherapist for six weeks . Group II patients had to practise exercises individually at home . Main outcome measures : Both groups were evaluated and compared for pain , functional and psychological status before treatment , at the end of treatment and three months after treatment using a visual analogue scale ( VAS ) for pain , Beck Depression Scale and Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Results : Six patients withdrew , four from group I. Results from the remaining 45 showed more positive changes in the patients undertaking group exercise at six weeks and three months after treatment . Values showed a statistical significant difference in favour of group I. Conclusion : Group exercise in hospital may be more effective than home-based exercises at reducing impairment associated with ankylosing spondylitis",
"OBJECTIVE This study aim ed to determine the effects of balneotherapy on disease activity , functional status , metrology index , pulmonary function and quality of life in patients with ankylosing spondylitis ( AS ) . MATERIAL S AND METHODS The study included 28 patients ( 27 male and 1 female ) diagnosed with AS according to modified New York criteria . The patients were treated with balneotherapy for 3 weeks ( 30 min/day , 5 days/week ) . The patients were evaluated using the global index , Bath ankylosing spondylitis disease activity index ( BASDAI ) , disease functional index ( BASFI ) , metrology index ( BASMI ) , chest expansion measures , pulmonary function testing , and the medical outcomes study -short form-36 Health Survey ( SF-36 ) ( measure of quality of life ) before balneotherapy and 1 month after treatment . RESULTS Post balneotherapy BASDAI and global index decreased , BASMI parameters improved , chest expansion increased , and some SF-36 parameters improved ; however , none of these changes were statistically significant ( P > 0.05 ) , except for the decrease in BASMI total score ( P balneotherapy 6 patients had restrictive pulmonary disorder , according to pulmonary function test results . Pulmonary function test results in 3 ( 50 % ) patients were normalized following balneotherapy ; however , as for the other index , balneotherapy did not significantly affect pulmonary function test results . CONCLUSION The AS patients ' symptoms , clinical findings , pulmonary function test results , and quality of life showed a trend to improve following balneotherapy , although without reaching significant differences . Comprehensive r and omized controlled spa intervention studies with longer follow-up periods may be helpful in further delineating the therapeutic efficacy of balneotherapy in AS patients",
"Objective : To assess the 12-month ’s follow-up effects on pain , mobility , and physical function outcomes of a supervised training and home-based rehabilitation for ankylosing spondylitis patients stabilized with TNF-inhibitor therapy . Design : Controlled clinical trial ( sequentially determined allocation ) with 12-months ’ follow-up . Setting : Patients ’ homes . Subjects : A total of 69 subjects were allocated to either a rehabilitation programme ( rehabilitation group , n = 22 ) , an educational-behavioural programme ( educational group , n = 24 ) , and to neither programme ( control group , n = 23 ) . Interventions : Rehabilitation programme included supervised training and home exercises ( stretching , strengthening , aerobic , chest , and spine/hip joint flexibility exercises ) ; educational-behavioural programme included information on ankylosing spondylitis , pain and stress mechanisms , and control . Main measures : Spinal pain intensity , Bath Ankylosing Spondylitis Metrology Index , Bath Ankylosing Spondylitis Functional Index , Bath Ankylosing Spondylitis Disease Activity Index , chest expansion , and cervical and lumbar spine active range of motion measured by a pocket goniometer . Results : At baseline , the three groups exhibited comparable demographic characteristics and basal evaluations . Intra-group changes in the rehabilitation group from baseline to 12 months yielded statistically significant gains ( p control and educational-behavioural , the rehabilitation group exhibited significant differences in chest expansion ( p = 0.001 and p Bath Ankylosing Spondylitis Disease Activity Index ( p = 0.012 and p = 0.050 ) , and in some goniometric measurements as cervical rotation ( p = 0.007 and p = 0.014 ) , toraco-lumbar rotation ( p = 0.009 and p = 0.050 ) , and total cervical movements ( p = 0.009 and p = 0.001 ) . Conclusion : In comparison with the educational-behavioural programme or no intervention , supervised training and home exercises improved long-term outcome in patients with ankylosing spondylitis"
] | 4116656e-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVES To describe a consensus review of optimal perioperative care in colorectal surgery and to provide consensus recommendations for each item of an evidence -based protocol for optimal perioperative care . DATA SOURCES For every item of the perioperative treatment pathway , available English- language literature has been examined . STUDY SELECTION Particular attention was paid to meta-analyses , r and omized controlled trials , and systematic review s. DATA EXTRACTION A consensus recommendation for each protocol item was reached after critical appraisal of the literature by the group . DATA SYNTHESIS For most protocol items , recommendations are based on good- quality trials or meta-analyses of such trials . CONCLUSIONS The Enhanced Recovery After Surgery ( ERAS ) Group presents a comprehensive evidence -based consensus review of perioperative care for colorectal surgery . It is based on the evidence available for each element of the multimodal perioperative care pathway | [
"BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations",
"Postoperative oral nutritional supplementation has been shown to be of clinical benefit . This study examined the clinical effects and cost of administration of oral supplements both before and after surgery",
"BACKGROUND In-vitro studies indicate that platelet function and the coagulation cascade are impaired by hypothermia . However , the extent to which perioperative hypothermia influences bleeding during surgery remains unknown . Accordingly , we tested the hypothesis that mild hypothermia increases blood loss and allogeneic transfusion requirements during hip arthroplasty . METHODS Blood loss and transfusion requirements were evaluated in 60 patients undergoing primary , unilateral total hip arthroplasties who were r and omly assigned to normothermia ( final intraoperative core temperature 36.6 [ 0.4 ] degrees C ) or mild hypothermia ( 35.0 [ 0.5 ] degrees C ) . Crystalloid , colloid , scavenged red cells , and allogeneic blood were administered by strict protocol . FINDINGS Intra- and postoperative blood loss was significantly greater in the hypothermic patients : 2.2 ( 0.5 ) L vs 1.7 ( 0.3 ) L , p allogeneic packed red cells were required in seven of the 30 hypothermic patients , whereas only one normothermic patient required a unit of allogeneic blood ( p core temperature in patients undergoing hip arthroplasty will thus augment blood loss by approximately 500 mL. INTERPRETATION The maintenance of intraoperative normothermia reduces blood loss and allogeneic blood requirements in patients undergoing total hip arthroplasty",
"BACKGROUND Patients who undergo surgery are at risk of malnutrition due to periods of starvation , the stress of surgery , and subsequent increase in metabolic rate . There are limited data on nutritional outcome of surgical patients . AIMS To investigate changes in nutritional status and the influence of oral supplements on nutritional status , morbidity , and quality of life in postoperative surgical patients . METHODS Entry was determined by the presence of malnutrition , as defined by a body mass index ( BMI ) ⩽20 kg/m2 , anthropometric measurements ⩽15th percentile on admission , or initiation of oral diet postoperatively and /or a weight loss of 5 % or more during the operative period . We studied 101 patients : 52 were r and omised to the treatment group ( TG ) and prescribed a 1.5 kcal/ml nutritional supplement ; 49 patients were r and omised to the control group ( CG ) and continued with routine nutritional management . Nutritional status was assessed by weight , anthropometry , and grip strength , with measurements taken at two weekly intervals for 10 weeks . Complications , namely wound infection , chest infection , and antibiotic use were documented . Quality of life ( QOL ) was assessed using the UK SF-36 question naire . RESULTS Patients in the control group lost a maximum mean ( SD ) of 5.96 ( 4.21 ) kg in weight over a period of eight weeks while patients in group TG lost less weight overall ( maximum mean ( SD ) 3.40 ( 0.89 ) kg ( p 4 ) . Anthropometry , grip strength , and QOL were similarly significantly different between groups ( p required antibiotic prescriptions compared with the control group ( 15/49 ) . CONCLUSIONS Nutritional status declined for two months after discharge . Postoperative nutritional supplementation improved nutritional status , QOL , and morbidity in these patients",
"The effect of incision length on patient recovery following cholecystectomy has not been investigated previously . In this study , 30 patients with symptomatic gallstones were r and omized to cholecystectomy through a 6 cm or 15 cm transverse subcostal incision . Postoperative hospital stay was significantly shorter in the 6 cm incision group ( median 3 days vs 5 days ; P = 0.0069 Mann-Whitney U-test ) . In the 6 cm group analgesic requirements were reduced ( median 2.5 vs 4.5 intramuscular opiate injections per patient ) and recovery of depressed postoperative pulmonary function ( FVC and FEV1 ) was faster ( 3 % difference between groups on day 1 and 7 % on day 3 ) , although these differences did not achieve statistical significance . These results suggest that the length of incision may influence patient recovery following elective cholecystectomy . This has important implication s as surgery carried out through shorter and less traumatic incisions may offer a cost-effective alternative to laparoscopic cholecystectomy . Moreover , some surgeons may find mini-laparotomy cholecystectomy easier to adopt than laparoscopic techniques ",
"Background Preoperative mechanical bowel preparation can be question ed as st and ard procedure in colon surgery , based on the result from several r and omised trials . Methods As part of a large multicenter trial , 105 patients planned for elective colon surgery for cancer , adenoma , or diverticulitis in three hospitals were asked to complete a question naire regarding perceived health including experience with bowel preparation . There were 39 questions , each having 3 – 10 answer alternatives , dealing with food intake , pain , discomfort , nausea/vomiting , gas distension , anxiety , tiredness , need of assistance with bowel preparation , and willingness to undergo the procedure again if necessary . Results 60 patients received mechanical bowel preparation ( MBP ) and 45 patients did not ( No-MBP ) . In the MBP group 52 % needed assistance with bowel preparation and 30 % would consider undergoing the same preoperative procedure again . In the No-MBP group 65 % of the patients were positive to no bowel preparation . There was no significant difference between the two groups with respect to postoperative pain and nausea . On Day 4 ( but not on Days 1 and 7 postoperatively ) patients in the No-MBP group perceived more discomfort than patients in the MBP group , p = 0.02 . Time to intake of fluid and solid food did not differ between the two groups . Bowel emptying occurred significantly earlier in the No-MBP group than in the MBP group , p = 0.03 . Conclusion Mechanical bowel preparation is distressing for the patient and associated with a prolonged time to first bowel emptying ",
"Introduction Microcirculatory blood flow , and notably gut perfusion , is important in the development of multiple organ failure in septic shock . We compared the effects of dopexamine and norepinephrine ( noradrenaline ) with those of epinephrine ( adrenaline ) on gastric mucosal blood flow ( GMBF ) in patients with septic shock . The effects of these drugs on oxidative stress were also assessed . Methods This was a prospect i ve r and omized study performed in a surgical intensive care unit among adults fulfilling usual criteria for septic shock . Systemic and pulmonary hemodynamics , GMBF ( laser-Doppler ) and malondialdehyde were assessed just before catecholamine infusion ( T0 ) , as soon as mean arterial pressure ( MAP ) reached 70 to 80 mmHg ( T1 ) , and 2 hours ( T2 ) and 6 hours ( T3 ) after T1 . Drugs were titrated from 0.2 μg kg-1 min-1 with 0.2 μg kg-1 min-1 increments every 3 minutes for epinephrine and norepinephrine , and from 0.5 μg kg-1 min-1 with 0.5 μg kg-1 min-1 increments every 3 minutes for dopexamine . Results Twenty-two patients were included ( 10 receiving epinephrine , 12 receiving dopexamine – norepinephrine ) . There was no significant difference between groups on MAP at T0 , T1 , T2 , and T3 . Heart rate and cardiac output increased significantly more with epinephrine than with dopexamine – norepinephrine , whereas . GMBF increased significantly more with dopexamine – norepinephrine than with epinephrine between T1 and T3 ( median values 106 , 137 , 133 , and 165 versus 76 , 91 , 90 , and 125 units of relative flux at T0 , T1 , T2 and T3 , respectively ) . Malondialdehyde similarly increased in both groups between T1 and T3 . Conclusion In septic shock , at doses that induced the same effect on MAP , dopexamine – norepinephrine enhanced GMBF more than epinephrine did . No difference was observed on oxidative stress",
"In a series of 579 patients undergoing major laparotomy , the direction of incision ( midline or transverse/oblique muscle‐cutting ) was decided r and omly . The severity of postoperative pulmonary complications was expressed by a scoring system which allowed categorization into mild ( score 0–3 ) , moderate ( score 4–6 ) and serious ( score 7 or more ) complications",
"Background The most common side effect of epidural or spinal anesthesia is hypotension with functional hypovolemia prompting fluid infusions or administration of vasopressors . Short-term studies ( 20 min ) in patients undergoing lumbar epidural anesthesia suggest that plasma volume may increase when hypotension is present , which may have implication s for the choice of treatment of hypotension . However , no long-term information or measurements of plasma volumes with or without hypotension after epidural anesthesia are available . Methods In 12 healthy volunteers , the authors assessed plasma ( 125I-albumin ) and erythrocyte ( 51Cr-EDTA ) volumes before and 90 min after administration of 10 ml bupivacaine , 0.5 % , via a thoracic epidural catheter ( T7–T10 ) . After 90 min ( t = 90 ) , subjects were r and omized to administration of fluid ( 7 ml/kg hydroxyethyl starch ) or a vasopressor ( 0.2 mg/kg ephedrine ) , and 40 min later ( t = 130 ) , plasma and erythrocyte volumes were measured . At the same time points , mean corpuscular volume and hematocrit were measured . Systolic and diastolic blood pressure , heart rate , and hemoglobin were measured every 5 min throughout the study . Volume kinetic analysis was performed for the volunteers receiving hydroxyethyl starch . Results Plasma volume did not change per se after thoracic epidural anesthesia despite a decrease in blood pressure . Plasma volume increased with fluid administration but remained unchanged with vasopressors despite that both treatments had similar hemodynamic effects . Hemoglobin concentrations were not significantly altered by the epidural blockade or ephedrine administration but decreased significantly after hydroxyethyl starch administration . Volume kinetic analysis showed that the infused fluid exp and ed a rather small volume , approximately 1.5 l. The elimination constant was 56 ml/min . Conclusions Thoracic epidural anesthesia per se does not lead to changes in blood volumes despite a reduction in blood pressure . When fluid is infused , there is a dilution , and the fluid initially seems to be located central ly . Because administration of hydroxyethyl starch and ephedrine has similar hemodynamic effects , the latter may be preferred in patients with cardiopulmonary diseases in which perioperative fluid overload is undesirable",
"Anastomotic leakage is a major complication of rectal cancer surgery . The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision ( TME )",
"Background Intraoperative hypovolemia is common and is a potential cause of organ dysfunction , increased postoperative morbidity , length of hospital stay , and death . The objective of this prospect i ve , r and omized study was to assess the effect of goal -directed intraoperative fluid administration on length of postoperative hospital stay . Methods One hundred patients who were to undergo major elective surgery with an anticipated blood loss greater than 500 ml were r and omly assigned to a control group ( n = 50 ) that received st and ard intraoperative care or to a protocol group ( n = 50 ) that , in addition , received intraoperative plasma volume expansion guided by the esophageal Doppler monitor to maintain maximal stroke volume . Length of postoperative hospital stay and postoperative surgical morbidity were assessed . Results Groups were similar with respect to demographics , surgical procedures , and baseline hemodynamic variables . The protocol group had a significantly higher stroke volume and cardiac output at the end of surgery compared with the control group . Patients in the protocol group had a shorter duration of hospital stay compared with the control group : 5 ± 3 versus 7 ± 3 days ( mean ± SD ) , with a median of 6 versus 7 days , respectively ( P = 0.03 ) . These patients also tolerated oral intake of solid food earlier than the control group : 3 ± 0.5 versus 4.7 ± 0.5 days ( mean ± SD ) , with a median of 3 versus 5 days , respectively ( P = 0.01 ) . Conclusions Goal -directed intraoperative fluid administration results in earlier return to bowel function , lower incidence of postoperative nausea and vomiting , and decrease in length of postoperative hospital stay ",
"PURPOSE Several r and omized trials have found that discharge planning improves outcomes for hospitalized patients . We do not know if adding a clinical nurse specialist ( CNS ) to physician teams in hospitals that already have discharge planning services makes a difference . METHODS In 2 teaching hospitals , patients were r and omly assigned to regular hospital care or care with a clinical nurse specialist . The clinical nurse specialist facilitated hospital care by retrieving preadmission information , arranging in-hospital consultations and investigations , organizing postdischarge follow-up visits , and checking up on patients postdischarge with a telephone call . In-hospital outcomes included mortality and length of stay . Postdischarge outcomes included time to readmission or death , patient satisfaction , and the risk of adverse event . Adverse events were poor outcomes due to medical care rather than the natural history of disease . RESULTS A total of 620 sequential patients were r and omized ( CNS n = 307 , control n = 313 ) , of which 361 were followed after discharge from hospital ( CNS n = 175 , control n = 186 ) . The groups were similar for the probability of in-hospital death ( CNS 9.3 % vs control 9.7 % ) or being discharged to the community ( 58.0 % vs 60.0 % ) . The groups did not differ for postdischarge outcomes including readmission or death ( 21.6 % vs 15.6 % ; P = 0.16 ) or risk of adverse event ( 23.6 % vs 22.8 % ) . Mean [ SD ] patient ratings of overall quality of care on a scale of 10 was higher in the clinical nurse specialist group ( 8.2 [ 2.2 ] vs 7.6 [ 2.4 ] ; P = 0.052 ) . CONCLUSION The addition of a clinical nurse specialist to a medical team improved patient satisfaction but did not impact hospital efficiency or patient safety",
"Purpose To compare the risk-adapted approach with ondansetron against ondansetron plus dexamethasone to prevent postoperative nausea and vomiting ( PONV ) in a r and omized clinical trial . Methods 460 patients scheduled for elective surgery were enrolled in this prospect i ve study and stratified according to a simplified risk score for PONV . Patients having no or one risk factor were considered at low risk ( group L ) and did not receive study medication . Those with two to four risk factors were considered high risk and were r and omized to receive 4 mg ondansetron plus placebo ( group H-O ) or 4 mg ondansetron plus 8 mg dexamethasone ( group H-OD ) . Incidence and intensity of PONV were observed for 24 hr after surgery . Data were analyzed with Fisher ’s exact or Student ’s t tests;P incidence of PONV was 9 % in group L ( n = 87 ) , 31 % in those receiving ondansetron ( group H-O , n = 185 ) , and 22 % in those receiving both drugs ( group H-OD , n = 181 ) . The incidence of PONV was significantly smaller in both high-risk groups than predicted without treatment ( P incidence of PONV failed statistical significance between the two intervention groups ( P = 0.08 ) , the mean number of episodes of PONV and the mean maximal intensity of each episode of PONV were lower in group H-OD ( P = 0.03 and P = 0.01 , respectively ) . Patients of group H-OD required less antiemetic rescue therapy ( P = 0.004 ) . Conclusions : Ondansetron plus dexamethasone prevents PONV more effectively than ondansetron alone in patients at high risk for PONV.RésuméObjectifComparer l’approche adaptée au risque avec ondansétron ou avec ondansétron et dexaméthasone pour prévenir les nausées et vomissements postopératoires ( NVPO ) dans une étude clinique r and omisée . MéthodeL’étude prospect i ve a porté sur 460 patients , devant subir une intervention chirurgicale réglée , qui ont été stratifiés selon un score de risque simplifié de NVPO . Les patients ont été considérés à faible risque ( groupe F ) s’ils n’avaient aucun ou un facteur de risque et n’ont pas reçu la médication à l’étude . S’ils avaient de deux à quatre facteurs de risque , on les considérait à haut risque et ils recevaient au hasard 4 mg d’ondansétron plus un placebo ( groupe H-O ) ou 4 mg d’ondansétron plus 8 mg de dexaméthasone ( groupe H-OD ) . L’incidence et l’intensité des NVPO ont été observées pendant 24 h après l’opération . Les données ont été analysées par les tests exact de Fisher ou t de Student ; P de NVPO a été de 9 % dans le groupe F ( n = 87 ) , 31 % avec l’ondansétron ( groupe H-O , n = 185 ) et 22 % avec les deux médicaments ( groupe H-OD , n = 181 ) . L’incidence de NVPO a été significativement plus basse dans les deux groupes à haut risque que ce qui avait été prédit sans traitement ( P de NVPO n’était pas statistiquement significative entre les deux groupes expérimentaux ( P = 0,08 ) , le nombre moyen d’épisodes de NVPO et l’intensité maximale moyenne de chacun ont été plus faibles dans le groupe H-OD ( P = 0,03 et P = 0,01 , respectivement ) . Les patients du groupe H-OD ont dem and é moins d’antiémétiques de secours P = 0,004 ) . Conclusion L’ondansétron plus la dexaméthasone préviennent les NVPO plus efficacement que l’ondansétron seul chez des patients à haut risque de NVPO",
"Objective To compare the effectiveness and safety of low-dose unfractionated heparin and a low-molecular-weight heparin as prophylaxis against venous thromboembolism after colorectal surgery . Methods In a multicenter , double-blind trial , patients undergoing resection of part or all of the colon or rectum were r and omized to receive , by subcutaneous injection , either calcium heparin 5,000 units every 8 hours or enoxaparin 40 mg once daily ( plus two additional saline injections ) . Deep vein thrombosis was assessed by routine bilateral contrast venography performed between postoperative day 5 and 9 , or earlier if clinical ly suspected . Results Nine hundred thirty-six r and omized patients completed the protocol and had an adequate outcome assessment . The venous thromboembolism rates were the same in both groups . There were no deaths from pulmonary embolism or bleeding complications . Although the proportion of all bleeding events in the enoxaparin group was significantly greater than in the low-dose heparin group , the rates of major bleeding and reoperation for bleeding were not significantly different . Conclusions Both heparin 5,000 units subcutaneously every 8 hours and enoxaparin 40 mg subcutaneously once daily provide highly effective and safe prophylaxis for patients undergoing colorectal surgery . However , given the current differences in cost , prophylaxis with low-dose heparin remains the preferred method at present",
"Background and objective : Epidural analgesia is widely used for abdominal surgery due to the properties of ' stress-free ' anaesthesia and superior pain control . Nevertheless , sympathomimetics are known to antagonize inflammation . The present study was performed to investigate if epidural local anaesthetics caused increased local oedema formation . Methods : Thirty Dansk L and race pigs were r and omized into three groups : epidural bupivacaine , epidural morphine or intravenous ( i.v . ) fentanyl . All animals were anaesthetized with isoflurane and i.v . midazolam and received an identical fluid regimen . Six small bowel resections were performed over a 3-h period and during the following 3 h the anastomoses were resected . Primary end-points were water content in small bowel and mesentery sample s before and after gut anastomosis , lymph flow and urine production . Results : The water content in the small bowel sample s was not changed by surgery or by the different anaesthetic protocol s. In the mesenteric tissue , there was a highly significant increase in water content of the post-anastomotic sample s compared to pre-anastomotic sample s ( P oedema formation in the epidural local anaesthetic group . Lymph flow did not change during the experiments and there were no significant differences between the groups ( P = 0.80 ) . The mean total urine output was 44 % higher in the epidural morphine group compared to the local anaesthetic group ( P = 0.17 ) . Conclusions : Surgery did not increase gut wall water content , but acute oedema formation result ed in the peri-resectional mesenterial tissue , more prominently so in the bupivacaine group",
" Mechanical bowel preparation ( MBP ) is performed routinely before colorectal surgery to reduce the risk of postoperative infectious complications . The aim of this r and omized clinical trial was to compare the outcome of patients who underwent elective left‐sided colorectal surgery with or without MBP",
"BACKGROUND Epidural block is widely used to manage major abdominal surgery and postoperative analgesia , but its risks and benefits are uncertain . We compared adverse outcomes in high-risk patients managed for major surgery with epidural block or alternative analgesic regimens with general anaesthesia in a multicentre r and omised trial . METHODS 915 patients undergoing major abdominal surgery with one of nine defined comorbid states to identify high-risk status were r and omly assigned intraoperative epidural anaesthesia and postoperative epidural analgesia for 72 h with general anaesthesia ( site of epidural selected to provide optimum block ) or control . The primary endpoint was death at 30 days or major postsurgical morbidity . Analysis by intention to treat involved 447 patients assigned epidural and 441 control . FINDINGS 255 patients ( 57.1 % ) in the epidural group and 268 ( 60.7 % ) in the control group had at least one morbidity endpoint or died ( p=0.29 ) . Mortality at 30 days was low in both groups ( epidural 23 [ 5.1 % ] , control 19 [ 4.3 % ] , p=0.67 ) . Only one of eight categories of morbid endpoints in individual systems ( respiratory failure ) occurred less frequently in patients managed with epidural techniques ( 23 % vs 30 % , p=0.02 ) . Postoperative epidural analgesia was associated with lower pain scores during the first 3 postoperative days . There were no major adverse consequences of epidural-catheter insertion . INTERPRETATION Most adverse morbid outcomes in high-risk patients undergoing major abdominal surgery are not reduced by use of combined epidural and general anaesthesia and postoperative epidural analgesia . However , the improvement in analgesia , reduction in respiratory failure , and the low risk of serious adverse consequences suggest that many high-risk patients undergoing major intra-abdominal surgery will receive substantial benefit from combined general and epidural anaesthesia intraoperatively with continuing postoperative epidural analgesia",
"Abstract Objectives To determine whether 10 mg , 25 mg , or 50 mg metoclopramide combined with 8 mg dexamethasone , given intraoperatively , is more effective in preventing postoperative nausea and vomiting than 8 mg dexamethasone alone , and to assess benefit in relation to adverse drug reactions . Design Four-armed , parallel group , double blind , r and omised controlled clinical trial . Setting Four clinics of a university hospital and four district hospitals in Germany . Participants 3140 patients who received balanced or regional anaesthesia during surgery . Main outcome measures Postoperative nausea and vomiting within 24 hours of surgery ( primary end point ) ; occurrence of adverse reactions . Results Cumulative incidences ( 95 % confidence intervals ) of postoperative nausea and vomiting were 23.1 % ( 20.2 % to 26.0 % ) , 20.6 % ( 17.8 % to 23.4 % ) , 17.2 % ( 14.6 % to 19.8 % ) , and 14.5 % ( 12.0 % to 17.0 % ) for 0 mg , 10 mg , 25 mg , and 50 mg metoclopramide . In the secondary analysis , 25 mg and 50 mg metoclopramide were equally effective at preventing early nausea ( 0 - 12 hours ) , but only 50 mg reduced late nausea and vomiting ( > 12 hours ) . The most frequent adverse drug reactions were hypotension and tachycardia , with cumulative incidences of 8.8 % ( 6.8 % to 10.8 % ) , 11.2 % ( 9.0 % to 13.4 % ) , 12.9 % ( 10.5 % to 15.3 % ) , and 17.9 % ( 15.2 % to 20.6 % ) for 0 mg , 10 mg , 25 mg , and 50 mg metoclopramide . Conclusion The addition of 50 mg metoclopramide to 8 mg dexamethasone ( given intraoperatively ) is an effective , safe , and cheap way to prevent postoperative nausea and vomiting . A reduced dose of 25 mg metoclopramide intraoperatively , with additional postoperative prophylaxis in high risk patients , may be equally effective and cause fewer adverse drug reactions . Trial registration Current Controlled Trials IS RCT",
"BACKGROUND Occult hypovolaemia is a key factor in the aetiology of postoperative morbidity and may not be detected by routine heart rate and arterial pressure measurements . Intraoperative gut hypoperfusion during major surgery is associated with increased morbidity and postoperative hospital stay . We assessed whether using intraoperative oesophageal Doppler guided fluid management to minimize hypovolaemia would reduce postoperative hospital stay and the time before return of gut function after colorectal surgery . METHODS This single centre , blinded , prospect i ve controlled trial r and omized 128 consecutive consenting patients undergoing colorectal resection to oesophageal Doppler guided or central venous pressure (CVP)-based ( conventional ) intraoperative fluid management . The intervention group patients followed a dynamic oesophageal Doppler guided fluid protocol whereas control patients were managed using routine cardiovascular monitoring aim ing for a CVP between 12 and 15 mm Hg . RESULTS The median postoperative stay in the Doppler guided fluid group was 10 vs 11.5 days in the control group P median time to resuming full diet in the Doppler guided fluid group was 6 vs 7 for controls P cardiac output , stroke volume , and oxygen delivery . Twenty-nine ( 45.3 % ) control patients suffered gastrointestinal morbidity compared with nine ( 14.1 % ) in the Doppler guided fluid group P overall morbidity was also significantly higher in the control group P=0.05 . CONCLUSIONS Intraoperative oesophageal Doppler guided fluid management was associated with a 1.5-day median reduction in postoperative hospital stay . Patients recovered gut function significantly faster and suffered significantly less gastrointestinal and overall morbidity",
"OBJECTIVES The objectives of this r and omised controlled study were to determine if pre-admission patient education affects post-operative pain levels , domiciliary self-care capacity and patient recall following a laparoscopic cholecystectomy ( LC ) . Participants were r and omised to receive the st and ard preadmission program ( SP ) or an individualised , education intervention ( El ) . DESIGN A pre-operative question naire was administered in the pre-admission clinic to determine participants ' knowledge of LC and post-operative management . Telephone follow-up and post-operative question naire were conducted approximately 14 days post discharge . SETTING Preadmission clinic of a Sydney , Australia , tertiary referral hospital . SAMPLE Ninety-three elective LC patients . RESULTS EI participants experienced lower pain levels and had significantly greater recall of provided information . However , no significant differences were found between the control and intervention groups for domiciliary self-care . CONCLUSION Pre-admission education intervention helps reduce post-operative pain levels following LC and significantly increases patients ' knowledge of self-care and complication management",
"Abstract . Background : A transverse skin crease incision for right hemicolectomy may result in more rapid recovery than traditional vertical midline incision . This hypothesis was tested with a prospect i ve r and omised trial . Methods : Patients from 2 centres undergoing right hemicolectomy were r and omised to received a midline or transverse incision . Incision lengths were sufficient to enable unrestricted resection of the right colon . Patients and carers were blinded to the incisions using strategically placed dressings . Analgesia and oral intake were controlled by the patient . Operative details and recovery parameters were compared . Results : A total of 28 patients were r and omised . Demographic data and tumour characteristics of the two treatment groups were similar . The transverse incision group had a slightly shorter median wound ( 10 cm vs. 11 cm , p Operative time , analgesia requirements , recovery parameters ( time to discharge , 6.5 vs. 6.5 days ) and frequency of complications were otherwise comparable . Conclusions : A transverse skin crease incision for right hemicolectomy results in a slightly smaller wound but no other advantages were demonstrated compared with a traditional vertical midline incision",
"OBJECTIVE To investigate the effect of a restricted intravenous fluid regimen versus a st and ard regimen on complications after colorectal resection . SUMMARY BACKGROUND DATA Current fluid administration in major surgery causes a weight increase of 3 - 6 kg . Complications after colorectal surgery are reported in up to 68 % of patients . Associations between postoperative weight gain and poor survival as well as fluid overload and complications have been shown . METHODS We did a r and omized observer-blinded multicenter trial . After informed consent was obtained , 172 patients were allocated to either a restricted or a st and ard intraoperative and postoperative intravenous fluid regimen . The restricted regimen aim ed at maintaining preoperative body weight ; the st and ard regimen resembled everyday practice . The primary outcome measures were complications ; the secondary measures were death and adverse effects . RESULTS The restricted intravenous fluid regimen significantly reduced postoperative complications both by intention-to-treat ( 33 % versus 51 % , P = 0.013 ) and per- protocol ( 30 % versus 56 % , P = 0.003 ) analyses . The numbers of both cardiopulmonary ( 7 % versus 24 % , P = 0.007 ) and tissue-healing complications ( 16 % versus 31 % , P = 0.04 ) were significantly reduced . No patients died in the restricted group compared with 4 deaths in the st and ard group ( 0 % versus 4.7 % , P = 0.12 ) . No harmful adverse effects were observed . CONCLUSION The restricted perioperative intravenous fluid regimen aim ing at unchanged body weight reduces complications after elective colorectal resection",
"Background and Objectives Postoperative urinary retention may occur in between 10 % and 60 % of patients after major surgery . Continuous lumbar epidural analgesia , in contrast to thoracic epidural analgesia , may inhibit urinary bladder function . Postoperative urinary drainage has been common in patients with continuous epidural analgesia , despite the lack of scientific evidence for its indication after thoracic epidural analgesia . This study describes 100 patients who underwent elective colonic resection with 48 hours of continuous thoracic epidural analgesia and only 24 hours of urinary drainage . Methods This is a prospect i ve , uncontrolled study with well-defined general anesthesia , postoperative analgesia , and nursing care programs in patients with a planned 2-day hospital stay , urinary catheter removal on the first postoperative morning , and epidural catheter removal on the second postoperative morning . Follow-up in the outpatient clinic was on days 8 and 30 . Results Nine patients needed bladder recatheterization , 8 as a single procedure and 1 patient a second recatheterization with removal on day 7 . This patient had urinary infection on day 10 and was readmitted for 5 days because of urosepsis and , subsequently , for cystitis and left-sided epididymitis . Three patients had uncomplicated urinary infection . No patients had urological complaints at 30 days follow-up ( 95 % confidence limit , 0 % to 3.6 % ) . Conclusion The low incidence of urinary retention ( 9 % ) and urinary infection ( 4 % ) suggests that routine bladder catheterization beyond postoperative day 1 may not be necessary in patients with ongoing continuous low-dose thoracic epidural analgesia",
"The effect of epidural infusions containing fentanyl on maternal gastric emptying in labour was examined using the rate of paracetamol absorption . Women were r and omly allocated to receive one of two epidural infusions , bupivacaine 0.125 % alone or bupivacaine 0.0625 % with fentanyl 2.5 μgml−1 at a rate of 10–12 mlh−1 . Paracetamol 1.5 g was given orally to women after either 30 ml of the infusion solution had been given ( mean time 2.5 h , study A ) or 40–50 ml ( mean time 4.5 h , study B ) . Six venous blood sample s were taken over the next 90 min for measurement of plasma paracetamol concentration . There were no significant differences in maximum plasma paracetamol concentration , time to maximum paracetamol concentration and area under the concentration – time curve between the two groups for study A. In study B the time to maximum plasma paracetamol concentration was significantly delayed in women receiving > 100 μg fentanyl compared with controls ( p delay gastric emptying when given by epidural infusion is greater than 100 μg",
"Objective To evaluate the potential differential effects of dopamine , dopexamine , and dobutamine on jejunal mucosal perfusion , assessed by endoluminal laser Doppler flowmetry in uncomplicated postcardiac surgical patients . Design A prospect i ve , blinded , r and omized , crossover study . Setting A cardiothoracic intensive care unit in a tertiary care center . Patients A total of ten postoperative cardiac surgical patients were studied . Interventions Each patient received sequentially , r and omly , and in a blinded fashion 2.7 ± 0.2 & mgr;g·kg−1·min−1 dopamine , 0.7 ± 0.1 & mgr;g·kg−1·min−1 dopexamine , and 2.7 ± 0.1 & mgr;g·kg−1·min−1 dobutamine . Each inotropic agent was titrated to increase cardiac output by 25 % from baseline . Data on jejunal mucosal perfusion , splanchnic lactate , and oxygen extraction were obtained during a 5-min control period and a 5-min drug infusion period after the target cardiac output was reached . The procedure was sequentially repeated for each agent , and there was a 20- to 30-min washout period between each agent . Measurements and Main Results Dopamine , dopexamine , and dobutamine increased jejunal mucosal perfusion by 27 % ( p increase in jejunal mucosal perfusion by dopamine and dopexamine were significantly more pronounced compared with dobutamine ( p . Splanchnic oxygen extraction decreased to the same extent with all three drugs . Splanchnic lactate extraction did not change for any of the drugs . The effects on central hemodynamics were similar for the three inotropic agents . Conclusions Endoluminal laser Doppler flowmetry is a new tool for the detection of perfusion changes at the local intestinal mucosal level . Dopamine , dopexamine , and dobutamine have differential effects on jejunal mucosal perfusion probably because of their different receptor stimulating properties . These findings may be of clinical importance when the therapeutic goal is to improve gut mucosal perfusion ",
"AIM Recent evidence suggests that the provision of energy-containing fluids is safe and may impact positively on markers of recovery . The aims of this study were to assess the tolerance of preoperative carbohydrate fluid administration and to determine its effect on postoperative metabolic and clinical responses . METHODS Patients admitted to the Royal Infirmary of Edinburgh for major , elective abdominal surgery were recruited to this double-blind , r and omised study and received either a placebo drink or carbohydrate ( 12.6g/100ml ) drink ( CHOD ) . Patients consumed 800 ml of their drink on the evening before surgery and 400 ml on the day of surgery 2 - 3 h before the induction of anaesthesia . Nutritional status was determined using body mass index ( BMI ) and upper arm anthropometry ; all measurements were taken preoperatively , postoperatively and at discharge . Blood glucose and insulin concentrations were also measured preoperatively and on the first post operative day . Length of hospital stay ( LOS ) and postoperative complications were recorded . RESULTS Seventy-two patients were recruited and 65 ( 34 male:31 female ) completed this study . Thirty-four patients were r and omised to receive the placebo drink ( control group ) and 31 patients to receive the carbohydrate drink ( CHOD group ) . Groups were well-matched in terms of gender and age . There were no differences between the two groups at baseline for BMI ( control : -25.1+/-1.7 kg/m2 ; CHOD -25.2+/-1.2 kg/m2 ) , upper arm anthropometry or surgical procedure . At discharge loss of muscle mass ( arm muscle circumference ) was significantly greater in the control group when compared with the CHOD group ( control : -1.1+/-0.15 cm ; CHOD : -0.5+/-0.16 cm ; P Baseline insulin ( control : 20.7+/-4.9 mU/l ; CHOD : 24.6+/-6.2 mU/l ) and glucose ( control : 6.0+/-1.4 mmol/l ; CHOD 5.7+/-1.4 mmol/l ) were comparable in the two groups and did not differ postoperatively . No complications were recorded as a result of preoperative fluid consumption . Postoperative morbidity occurred in six patients from each group . Median LOS in the control group was 10 days ( IQR=6 ) , and 8 days ( IQR=4 ) in the CHOD group . CONCLUSION Preoperative consumption of carbohydrate-containing fluids is safe . Provision of a carbohydrate energy source prior to surgery may attenuate depletion of muscle mass after surgery . Further studies are required to determine if this preservation of muscle mass is reflected in improved function and reduced rehabilitation time",
"We studied the effects of different preoperative oral fluid protocol s on preoperative discomfort , residual gastric fluid volumes , and gastric acidity . Two-hundred-fifty-two elective abdominal surgery patients ( ASA physical status I – II ) were r and omized to preparation with a 12.5 % carbohydrate drink ( CHO ) , placebo ( flavored water ) , or overnight fasting . The CHO and Placebo groups were double-blinded and were given 800 mL to drink on the evening before and 400 mL on the morning of surgery . Visual analog scales were used to score 11 different discomfort variables . CHO did not increase gastric fluid volumes or affect acidity , and there were no adverse events . The visual analog scale scores in a control situation were not different between groups . During the waiting period before surgery , the CHO-treated group was less hungry and less anxious than both the other groups ( P ≤ 0.05 ) . CHO reduced thirst as effectively as placebo ( P decreasing thirst , hunger , anxiety , malaise , and unfitness in the CHO group ( P The Placebo group experienced decreasing unfitness and malaise , whereas nausea , tiredness , and inability to concentrate increased ( P group , hunger , thirst , tiredness , weakness , and inability to concentrate increased ( P conclusion , CHO significantly reduces preoperative discomfort without adversely affecting gastric contents",
"Purpose To determine whether , in obese [ body mass index ( BMI ) > 30 kg·m2 ] patients , oral intake of 300 mL clear liquid two hours before elective surgery affects the volume and pH of gastric contents at induction of anesthesia . Methods A single-blind , r and omized study of 126 adult patients , age ≥18 yr , ASA physical status I or II , BMI > 30 kg·m2 who were scheduled for elective surgery under general anesthesia . Patients were excluded if they had diabetes mellitus , symptoms of gastroesophageal reflux , or had taken medication within 24 hr that affects gastric secretion , gastric fluid pH or gastric emptying . All patients fasted from midnight and were r and omly assigned to fasting or fluid group . Two hours before their scheduled time of surgery , all patients drank 10 mL of water containing phenol red 50 mg . Those in the fluid group followed with 300 mL clear liquid of their choice . Immediately following induction of general anesthesia and tracheal intubation , gastric contents were aspirated through a multiorifice Salem sump tube . The fluid volume , pH and phenol red concentration were recorded . Results Median ( range ) values in fasting vs fluid groups were : gastric fluid volume 26 ( 3–107 ) mL vs 30 ( 3–187 ) mL , pH 1.78 ( 1.31–7.08 ) vs 1.77 ( 1.27–7.34 ) and phenol red retrieval 0.1 (0–30)% vs 0.2 (0–15)% . Differences between groups were not statistically significant . Conclusion Obese patients without comorbid conditions should follow the same fasting guidelines as non-obese patients and be allowed to drink clear liquid until two hours before elective surgery , inasmuch as obesity per se is not considered a risk factor for pulmonary aspiration . RésuméObjectifDéterminer si , chez des patients obèses [ indice de masse corporelle ( IMC ) > 30 kg·m2 ] , la prise orale de 300 mL de liquide clair deux heures avant de subir une opération réglée a un effet sur le volume et le pH du contenu gastrique lors de l’induction anesthésique . MéthodeUne étude r and omisée , à simple insu , a été menée auprès de 126 patients adultes , ≥18 ans , d’état physique ASA I ou II , d’IMC > 30 kg·m2 , devant subir une intervention chirurgicale réglée sous anesthésie générale . La présence de diabète , ou de symptômes de reflux gastro-œsophagien ou la prise de médicaments , dans les 24 h avant l’opération , pouvant affecter la sécrétion gastrique , le pH du liquide gastrique ou l’évacuation gastrique entraînaient l’exclusion du patient . Tous les patients , à jeun depuis minuit , ont été répartis en deux groupes : jeûne ou liquide . Deux heures avant l’heure prévue de l’opération , tous les patients ont bu 10 mL d’eau contenant 50 mg de rouge de phénol . Les patients du groupe « liquide » ont pris ensuite 300 mL d’un liquide clair de leur choix . Immédiatement après l’induction de l’anesthésie et l’intubation endotrachéale , le contenu gastrique a été aspiré au moyen d’une sonde multiorifice Salem . Le volume de liquide , le pH et les concentrations de rouge de phénol ont été notés . RésultatsLes valeurs moyennes ( étendue ) du groupe de jeûne vs le groupe « liquide » ont été : volume de liquide gastrique 26 ( 3–107 ) mL vs 30 ( 3–187 ) mL , pH 1,78 ( 1,31–7,08 ) vs 1,77 ( 1,27–7,34 ) et repérage du rouge de phénol 0,1 ( 0–30 ) % vs 0,2 ( 0–15 ) % . Il n’y avait pas de différence intergroupe significative . Conclusion Les patients obèses , sans symptômes comorbides , devraient suivre les mêmes directives de jeûne que les patients non obèses . Ils peuvent boire un liquide clair jusqu’à deux heures avant une opération réglée , étant donné que l’obésité en elle-même n’est pas considérée comme un facteur de risque d’aspiration pulmonaire",
"Background : The authors assessed the willingness to pay ( WTP ) for “ perfect ” prophylactic antiemetics and analgesics in patients who were scheduled to undergo surgery during general anesthesia . Furthermore , they determined whether postoperative experiences of pain and nausea and vomiting ( PONV ) changed patients ' WTP . Methods : Data were collected alongside a r and omized clinical trial that investigated the incidence of PONV in patients anesthetized with either inhalation anesthesia or total intravenous anesthesia . A subset of 808 consecutive patients participating in the trial completed WTP question naires 1 day before and 2 weeks after surgery . The outcome measure was the maximum amount of money that patients were willing to pay for “ perfect ” antiemetics and analgesics . Preoperative WTP and individual WTP changes after surgery were analyzed in relation to baseline characteristics and postoperative pain and PONV experiences . Results : Prevention of postoperative pain was valued higher than prevention of PONV . The median preoperative WTP for analgesics was US $ 35 ( interquartile range , $ 7–69 ) vs. US $ 17 ( interquartile range , $ 7–69 ) for antiemetics . Individual WTP changes for antiemetics were not related to PONV experience , whereas severe postoperative pain ( numerical rating score ≥ 8) was associated with an increase in the WTP for analgesics . Conclusions : Severe postoperative pain experiences increased patients ' WTP for analgesics , but PONV did not increase WTP for antiemetics . The elicited WTP values were lower than those reported in previous studies , which is possibly related to differences in market culture or patients ' attitudes toward postoperative pain , nausea , and vomiting",
"OBJECTIVE To investigate the feasibility of a 48-hour postoperative stay program after colonic resection . SUMMARY BACKGROUND DATA Postoperative hospital stay after colonic resection is usually 6 to 12 days , with a complication rate of 10 % to 20 % . Limiting factors for early recovery include stress-induced organ dysfunction , paralytic ileus , pain , and fatigue . It has been hypothesized that an accelerated multimodal rehabilitation program with optimal pain relief , stress reduction with regional anesthesia , early enteral nutrition , and early mobilization may enhance recovery and reduce the complication rate . METHODS Sixty consecutive patients undergoing elective colonic resection were prospect ively studied using a well-defined postoperative care program including continuous thoracic epidural analgesia and enforced early mobilization and enteral nutrition , and a planned 48-hour postoperative hospital stay . Postoperative follow-up was scheduled at 8 and 30 days . RESULTS Median age was 74 years , with 20 patients in ASA group III-IV . Normal gastrointestinal function ( defecation ) occurred within 48 hours in 57 patients , and the median hospital stay was 2 days , with 32 patients staying 2 days after surgery . There were no cardiopulmonary complications . The readmission rate was 15 % , including two patients with anastomotic dehiscence ( one treated conservatively , one with colostomy ) ; other readmissions required only short-term observation . CONCLUSION A multimodal rehabilitation program may significantly reduce the postoperative hospital stay in high-risk patients undergoing colonic resection . Such a program may also reduce postoperative ileus and cardiopulmonary complications . These results may have important implication s for the care of patients after colonic surgery and in the future assessment of open versus laparoscopic colonic resection",
"BACKGROUND The routine use of nasogastric tubes in patients undergoing elective abdominal operation is associated with an increased incidence of postoperative fever , atelectasis , and pneumonia . Previous studies have shown that nasogastric tubes have no significant effect on the incidence of gastroesophageal reflux or on lower esophageal sphincter pressure in healthy volunteers . We hypothesized that nasogastric intubation in patients undergoing laparotomy reduces lower esophageal sphincter pressure and promotes gastroesophageal reflux in the perioperative period . METHODS A prospect i ve r and omized case-control study was undertaken in which 15 consenting patients , admitted electively for bowel surgery , were r and omized into 2 groups . Group 1 underwent nasogastric intubation after induction of anesthesia , and Group 2 did not . All patients had manometry and pH probes placed with the aid of endoscopic vision at the lower esophageal sphincter and distal esophagus , respectively . Nasogastric tubes , where present , were left on free drainage , and sphincter pressures and pH were recorded continuously during a 24-hour period . Data were analyzed with 1-way analysis of variance . RESULTS The mean number of reflux episodes ( defined as pH nasogastric tube group was 137 compared with a median of 8 episodes in the group managed without nasogastric tubes ( P = .006 ) . The median duration of the longest episode of reflux was 132 minutes in Group 1 and 1 minute in Group 2 ( P = .001 ) . A mean of 13.3 episodes of reflux lasted longer than 5 minutes in Group 1 , with pH less than 4 for 37.4 % of the 24 hours . This was in contrast to Group 2 where a mean of 0.13 episodes lasted longer than 5 minutes ( P = .001 ) and pH less than 4 for 0.2 % of total time ( P = .001 ) . The mean lower esophageal sphincter pressures were lower in Group 1 . CONCLUSIONS . These findings demonstrate that patients undergoing elective laparotomy with routine nasogastric tube placement have significant gastroesophageal reflux in the perioperative period and a reduced ability to clear refluxed acid from the distal esophagus . Due to the associated risk of postoperative pulmonary complications , we recommend that nasogastric intubation be performed on a selective rather than routine basis",
" The influence of the type of abdominal incision on post‐operative pain and pulmonary function was investigated in patients operated upon for a right‐sided cancer of the large bowel",
"Background : Meta-analyses report similar numbers needed to treat for nonsteroidal antiinflammatory drugs ( NSAIDs ) and opioids . Differences in baseline pain intensity among the studies from which these numbers needed to treat were derived may have confounded the results . NSAIDs have an opioid-sparing effect , but the importance of this effect is unclear . Therefore , the authors sought to compare the proportions of subjects who obtain pain relief with ketorolac versus morphine after surgery and to determine whether the opioid-sparing effect of an NSAID reduces the magnitude of opioid side effects . Methods : The study was a double-blind , r and omized controlled trial . The authors r and omly assigned 1,003 adult patients to receive 30 mg ketorolac or 0.1 mg/kg morphine intravenously . They calculated the proportion of subjects who achieved at least 50 % reduction in pain intensity 30 min after analgesic administration . Further , so long as pain intensity 30 min after analgesic administration was 5 or more out of 10 , patients received 2.5 mg morphine every 10 min until pain intensity was 4 or less out of 10 . The authors assessed the presence of opioid-related side effects . Results : Five hundred patients received morphine and 503 received ketorolac . Fifty percent of patients in the morphine group achieved pain relief , compared with 31 % in the ketorolac group ( difference , 19 % ; 95 % confidence interval , 13–25 % ) . The ketorolac – morphine group required less morphine ( difference , 6.5 mg ; 95 % confidence interval , −5.8 to −7.2 ) and had a lower incidence of side effects ( difference , 11 % ; 95 % confidence interval , 5–16 % ) than the morphine group . Conclusions : Opioids are more efficacious analgesics than NSAIDs , although historic data for these two drugs yield similar numbers needed to treat . Adding NSAIDs to the opioid treatment reduces morphine requirements and opioid-related side effects in the early postoperative period",
"In this study we investigated the effects of preoperative oral carbohydrate administration on postoperative insulin resistance ( PIR ) , gastric fluid volume , preoperative discomfort , and variables of organ dysfunction in ASA physical status III-IV patients undergoing elective cardiac surgery , including those with noninsulin-dependent Type-2 diabetes mellitus . Before surgery , 188 patients were r and omized to receive a clear 12.5 % carbohydrate drink ( CHO ) , flavored water ( placebo ) , or to fast overnight ( control ) . CHO and placebo were treated in double-blind format and received 800 mL of the corresponding beverage in the evening and 400 mL 2 h before surgery . Patients were monitored from induction of general anesthesia until 24 h postoperatively . Exogenous insulin requirements to control blood glucose levels ≤10.0 mmol/L were used as a marker for PIR . Gastric fluid volume was measured by passive gastric reflux and preoperative discomfort using visual analog scales . Postoperative clinical and surgical data were recorded . Blood glucose levels and insulin requirements did not differ between groups . Patients receiving CHO and placebo were less thirsty compared with controls ( P cause increased gastric fluid volume or other adverse events . The CHO group required less intraoperative inotropic support after initiation of cardiopulmonary bypass weaning ( P not affect PIR . Clear fluids reduce thirst and may be recommended as a safe procedure in ASA III-IV patients . Further research is indicated to investigate possible cardioprotective effects of preoperative CHO intake",
"BACKGROUND & AIMS This study review ed the case mix , clinical management , and clinical outcomes of patients undergoing colorectal resection in five European centres performing different forms of conventional or ' fast-track ' perioperative care . METHODS The perioperative care programme and surgical practice in each centre was defined . Patient data were collected by case-note review on an internet-based audit system . Case mix was determined using ASA classification and the P-POSSUM scoring system . RESULTS A total of 451 consecutive patients from units practicing either conventional ( Sweden , n=109 ; UK , n=87 ; Netherl and s , n=76 , Norway , n=61 ) or fast-track surgery ( Denmark , n=118 ) , were studied between 1998 and 2001 . Elements of perioperative practice varied widely both between units practicing ' traditional ' care and the reference ' fast-track ' unit ( Denmark ) . Based on the P-POSSUM scores , the case mix was similar between centres . There were no differences in morbidity or 30-day mortality between the different centres . The median length of stay was 2 days in Denmark and 7 - 9 days in the other centres ( P readmission rate was 22 % in Denmark and 2 - 16 % in the other centres ( P length of hospital stay but may be associated with a higher readmission rate . Morbidity and mortality appears to be similar with either approach . Prospect i ve evaluation of the potential benefits of the fast-track approach in different European centres is merited",
"OBJECTIVE The authors set out to determine whether immediate enteral feeding minimizes early postoperative decreases in h and grip and respiratory muscle strength . SUMMARY BACKGROUND DATA Muscle strength decreases considerably after major surgical procedures . Enteral feeding has been shown to restore strength rapidly in other clinical setting s. METHODS A r and omized , controlled , nonblinded clinical trial was conducted in patients undergoing esophagectomy or pancreatoduodenectomy who received immediate postoperative enteral feeding via jejunostomy ( fed , n = 13 ) , or no enteral feeding during the first 6 postoperative days ( unfed , n = 15 ) . H and grip strength , vital capacity , forced expiratory volume in one second ( FEV1 ) , and maximal inspiratory pressure ( MIP ) were measured before surgery and on postoperative days 2 , 4 , and 6 . Fatigue and vigor were evaluated before surgery and on postoperative day 6 . Mobility was assessed daily after surgery using a st and ardized descriptive scale . Postoperative urine biochemistry was evaluated in daily 24-hour collection s. RESULTS Postoperative vital capacity ( p FEV1 ( p = 0.07 ) were consistently lower ( 18%-29 % ) in the fed group than in the unfed group , whereas grip strength and maximal inspiratory pressure were not significantly different . Postoperative mobility also was lower in the fed patients ( p Fatigue increased and vigor decreased after surgery ( both p Intensive care unit and postoperative hospital stay did not differ between groups . CONCLUSIONS Immediate postoperative jejunal feeding was associated with impaired respiratory mechanics and postoperative mobility and did not influence the loss of muscle strength or the increase in fatigue , which occurred after major surgery . Immediate postoperative enteral feeding should not be routine in well-nourished patients at low risk of nutrition-related complications",
"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",
"BACKGROUND Multimodal postoperative care regimens accelerate recovery after abdominal surgery . The benefit of thoracic epidural ( TE ) analgesia over patient-controlled analgesia ( PCA ) remains unproven when used with a fast-track postoperative care plan . METHODS Fifty-six patients undergoing major intestinal resection , and on a fast-track postoperative care plan , were r and omized to preemptive TE or PCA . Patients were evaluated at st and ard time points for pain score , quality of life ( Short Form-36 ) , and complications . Oral analgesia was substituted for TE and PCA on the second postoperative day . Discharge criteria were identical for both groups . RESULTS Six patients ( 20.6 % ) had a failed epidural . There was no difference in length of stay ( 5.8 versus 6.2 days , TE versus PCA , P = .55 ) , total length of stay ( including readmissions ) , pain scores , quality of life , complications , or hospital costs at any time point . CONCLUSION TE offers no advantage over PCA for patients undergoing major intestinal resections who are on a fast-track postoperative care plan using PCA",
"BACKGROUND Heparin-induced thrombocytopenia , defined by the presence of heparin-dependent IgG antibodies , typically occurs five or more days after the start of heparin therapy and can be complicated by thrombotic events . The frequency of heparin-induced thrombocytopenia and of heparin-dependent IgG antibodies , as well as the relative risk of each in patients given low-molecular-weight heparin , is unknown . METHODS We obtained daily platelet counts in 665 patients in a r and omized , double-blind clinical trial comparing unfractionated heparin with low-molecular-weight heparin as prophylaxis after hip surgery . Heparin-induced thrombocytopenia was defined as a decrease in the platelet count below 150,000 per cubic millimeter that began five or more days after the start of heparin therapy , and a positive test for heparin-dependent IgG antibodies . We also tested a representative subgroup of 387 patients for heparin-dependent IgG antibodies regardless of their platelet counts . RESULTS Heparin-induced thrombocytopenia occurred in 9 of 332 patients who received unfractionated heparin and in none of 333 patients who received low-molecular-weight heparin ( 2.7 percent vs. 0 percent ; P = 0.0018 ) . Eight of the 9 patients with heparin-induced thrombocytopenia also had one or more thrombotic events ( venous in 7 and arterial in 1 ) , as compared with 117 of 656 patients without heparin-induced thrombocytopenia ( 88.9 percent vs. 17.8 percent ; odds ratio , 36.9 ; 95 percent confidence interval , 4.8 to 1638 ; P frequency of heparin-dependent IgG antibodies was higher among patients who received unfractionated heparin ( 7.8 percent , vs. 2.2 percent among patients who received low-molecular-weight heparin ; P = 0.02 ) . CONCLUSIONS Heparin-induced thrombocytopenia , associated thrombotic events , and heparin-dependent IgG antibodies are more common in patients treated with unfractionated heparin than in those treated with low-molecular-weight heparin",
"Background : We have documented that adrenaline 2.0 µg·ml− 1 markedly improves relief of dynamic pain when added to a thoracic epidural analgesic infusion of bupivacaine 1 mg·ml− 1 and fentanyl 2 µg·ml− 1 . Concern about possible adverse effects on spinal cord blood flow , expressed by others , prompted us to find the lowest concentration of adrenaline needed to produce effective and reliable pain relief after major surgery",
"BACKGROUND Bowel preparation prior to colonic surgery usually includes antibiotic therapy together with mechanical bowel preparation ( MBP ) . Mechanical bowel preparation may cause discomfort to the patient , prolonged hospitalization , and water and electrolyte imbalance . It was assumed that with the improvement in surgical technique together with the use of more effective prophylactic antibiotics , it was possible that MBP would no longer be necessary . HYPOTHESIS There is no statistical difference in the postoperative results of patients who undergo elective colon resection with MBP as compared with those who have no MBP . DESIGN AND PATIENTS The study includes all patients who had elective large bowel resection at Campus Golda between April 1 , 1999 , and March 31 , 2002 . Emergency operations were not included . The patients were r and omly assigned to the 2 study groups ( with or without MBP ) according to identification numbers . All patients were treated with intravenous and oral antibiotics prior to surgery . The patients in the MBP group received Soffodex for bowel preparation . RESULTS A total of 329 patients participated in the study , 165 without MBP and 164 with MBP . The 2 groups were similar in age , sex , and type of surgical procedure . Two hundred sixty-eight patients ( 81.5 % ) underwent surgery owing to colorectal cancer and 61 patients ( 18.5 % ) owing to benign disease . The hospitalization period was longer in the bowel-prepared group ( mean + /- SD , 8.2 + /- 5.1 days ) as compared with the nonprepared group ( mean + /- SD , 8.0 + /- 2.7 days ) . However , this difference was not statistically significant . The time until the first bowel movement was similar between the 2 groups : a mean + /- SD of 4.2 + /- 1.3 days in the nonprepared group as compared with a mean + /- SD of 4.3 + /- 1.1 days in the prepared group ( P = NS ) . Four patients ( 1.2 % ) died in the postoperative course owing to acute myocardial infa rct ion and pulmonary embolism . Sixty-two patients ( 37.6 % ) of the non-MBP group suffered from postoperative complications as compared with 77 patients ( 46.9 % ) of the MBP group . CONCLUSION Our results suggest that no advantage is gained by preoperative MBP in elective colorectal surgery",
"BACKGROUND : Previous work has shown that the administration of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinical ly significant short term benefits . AIMS : This study aim ed firstly to re-evaluate these short term effects , and secondly to establish whether there are any long term benefits . SUBJECTS : One hundred patients admitted for elective moderate or major gastrointestinal surgery . METHODS : In the inpatient phase , patients were r and omised to receive a normal ward diet postoperatively , or the same diet supplemented with an oral dietary supplement . In the outpatient phase , patients were further r and omised to receive their home diet , or their home diet supplemented with the oral dietary supplement for four months . RESULTS : During the inpatient phase , patients treated with oral supplements had a significantly improved nutritional intake and lost less weight ( 2.2 , 95 % confidence interval ( 95 % CI ) 0.9 kg ) compared with control patients ( 4.2 ( 0.78 ) kg , p h and grip strength whereas control patients showed a significant reduction in grip strength ( p Subjective levels of fatigue increased significantly above preoperative levels in control patients ( p complications compared with four in the supplemented group ( p nutrient intakes but there were no significant differences in indices of nutritional status or wellbeing between the groups . CONCLUSIONS : The prescription of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinical ly significant benefits . These benefits , however , are restricted to the inpatient phase",
"OBJECTIVE The purpose of this study was to determine the effect of early oral bowel stimulation with osmotic laxatives on gastrointestinal function , postoperative nausea and vomiting ( PONV ) and pain in patients who undergo fast-track abdominal hysterectomy . STUDY DESIGN This was a double-blind , placebo-controlled study of 53 women who were assigned r and omly to either laxative ( magnesium oxide + disodium phosphate ) or placebo that was initiated 6 hours after the operation . Primary outcome was time to first defecation ; the number of vomiting episodes ; nausea and pain score were assessed on a visual analogue scale . RESULTS Time to first postoperative defecation was a median of 45 hours in the laxative group and a median of 69 hours in the placebo group ( P pain scores , PONV and the use of morphine or antiemetics . Postoperative hospitalization was a median of 1 day in the laxative group and of 2 days in the placebo group ( P = .41 ) . CONCLUSION Laxative improves recovery of gastrointestinal function after fast-track hysterectomy but has no significant effect on pain and PONV",
"We have shown that epinephrine markedly improves the analgesic effect of a thoracic epidural infusion of bupivacaine and fentanyl . Ropivacaine has an intrinsic vasoconstrictive effect , and epinephrine may therefore not have the same pharmacokinetic interaction in a ropivacaine-fentanyl infusion ; but a possible spinal cord & agr;2-agonist effect of epinephrine would give the same positive pharmacodynamic interaction with ropivacaine and fentanyl during epidural analgesia . In a prospect i ve , r and omized , crossover study , a thoracic epidural infusion of ropivacaine 1 mg/mL and fentanyl 2 & mgr;g/mL with or without epinephrine 2 & mgr;g/mL was given to 12 patients in a double-blinded manner after major thoracic or upper abdominal surgery . Main outcome measures were pain intensity at rest and when coughing , evaluated on a visual analog scale . Extent of sensory blockade was evaluated by determining dermatomal hypoesthesia to cold . Pain increased ( P hypoesthetic dermatomal segments decreased ( P epinephrine was omitted from the triple epidural infusion . After 3 h without epinephrine , pain intensity when coughing was unacceptable despite rescue analgesia . After restarting the triple epidural mixture with epinephrine , pain was again reduced to mild pain when coughing , and the sensory blockade was restored . The mixture with epinephrine caused less nausea and facilitated mobilization . We conclude that epinephrine improves the pain relief and reduces the side effects of a thoracic epidural infusion of ropivacaine and fentanyl after major thoracic or upper abdominal surgery",
"Background : The debate over the correct perioperative fluid management is unresolved . Methods : The impact of two intraoperative fluid regimes on postoperative outcome was prospect ively evaluated in 152 patients with an American Society of Anesthesiologists physical status of I – III who were undergoing elective intraabdominal surgery . Patients were r and omly assigned to receive intraoperatively either liberal ( liberal protocol group [ LPG ] , n = 75 ; bolus of 10 ml/kg followed by 12 ml · kg−1 · h−1 ) or restrictive ( restrictive protocol group [ RPG ] , n = 77 ; 4 ml · kg−1 · h−1 ) amounts of lactated Ringer 's solution . The primary endpoint was the number of patients who died or experienced complications . The secondary endpoints included time to initial passage of flatus and feces , duration of hospital stay , and changes in body weight , hematocrit , and albumin serum concentration in the first 3 postoperative days . Results : The number of patients with complications was lower in the RPG ( P = 0.046 ) . Patients in the LPG passed flatus and feces significantly later ( flatus , median [ range ] : 4 [ 3–7 ] days in the LPG vs. 3 [ 2–7 ] days in the RPG ; P their postoperative hospital stay was significantly longer ( 9 [ 7–24 ] days in the LPG vs. 8 [ 6–21 ] days in the RPG ; P = 0.01 ) . Significantly larger increases in body weight were observed in the LPG compared with the RPG ( P postoperative days , hematocrit and albumin concentrations were significantly higher in the RPG compared with the LPG . Conclusions : In patients undergoing elective intraabdominal surgery , intraoperative use of restrictive fluid management may be advantageous because it reduces postoperative morbidity and shortens hospital stay ",
"Postoperative convalescence is mainly determined by the extent and duration of postoperative ileus . This r and omized clinical trial evaluated the effects of early oral feeding on functional gastrointestinal recovery and quality of life",
"Recent studies have suggested that MBP does not lower the risk of postoperative septic complications after elective colorectal surgery . This r and omized clinical trial assessed whether preoperative MBP is beneficial in elective colonic surgery",
"Autonomic behavior is subject to direct suggestion . We found that patients undergoing major operations benefit more from instruction than from information and reassurance . We compared the return of intestinal function after intra-abdominal operations in 2 groups of patients : the suggestion group received specific instructions for the early return of gastrointestinal motility , and the control group received an equal-length interview offering reassurance and nonspecific instructions . The suggestion group had a significantly shorter average time to the return of intestinal motility , 2.6 versus 4.1 days . Time to discharge was 6.5 versus 8.1 days . Covariates including duration of operation , amount of intraoperative bowel manipulation , and amount of postoperative narcotics were also examined using the statistical model analysis of covariance . An average savings of $ 1,200 per patient result ed from this simple 5-minute intervention . In summary , the use of specific physiologically active suggestions given preoperatively in a beleivable manner can reduce the morbidity associated with an intra-abdominal operation by reducing the duration of ileus",
" Background : Surgery is succeeded by long‐lasting state of relative peripheral insulin resistance , which is reduced by giving glucose infusion or oral carbohydrate‐rich drinks immediate before operating instead of fasting . The aim of the present study was to investigate whether oral carbohydrate or carbohydrate with peptide drinks preoperatively instead of fasting would improve postoperative voluntary muscle strength , nutritional intake and ambulation , decrease postoperative fatigue , anxiety and discomfort , and reduce the endocrine response to surgery",
"Background : Basic pharmacological research indicates that there are synergistic antinociceptive effects at the spinal cord level between adrenaline , fentanyl and bupivacaine . Our clinical experience with such a mixture in a thoracic epidural infusion after major surgery confirms this . The objectives of the present study were to evaluate the effects on postoperative pain intensity , pain relief and side effects when removing adrenaline from this triple epidural mixture ",
"Summary Oesophageal Doppler monitoring allows non‐invasive estimation of stroke volume and cardiac output . We studied the impact of Doppler guided fluid optimisation on haemodynamic parameters , peri‐operative morbidity and hospital stay in patients undergoing major bowel surgery . Fifty‐seven patients were r and omly assigned to Doppler ( D ) or control ( C ) groups . All patients received intra‐operative fluid therapy at the discretion of the non‐investigating anaesthetist . In addition , Group D were given fluid challenges ( 3 ml.kg−1 ) guided by oesophageal Doppler . Group D received significantly more intra‐operative colloid than Group C ( mean 28 ( SD 16 ) vs. 19.4 ( SD 14.7 ) ml.kg−1 , p = 0.02 ) . Cardiac output increased significantly for Group D whilst that of controls remained unchanged . The mean difference between the groups in final cardiac output was 0.87 l.min−1 ( 95 % confidence interval 0.31–1.43 l.min−1 , p = 0.003 ) . Five control patients required postoperative critical care admission . Fluid titration using oesophageal Doppler during bowel surgery can improve haemodynamic parameters and may reduce critical care admissions postoperatively",
" Preoperative oral carbohydrate ( CHO ) reduces postoperative insulin resistance . In this r and omized trial , the effect of CHO on postoperative whole‐body protein turnover was studied",
"PURPOSE : Despite the universal use of bowel preparation before colonoscopy and colorectal surgery , the physiologic effects have not been described in a st and ardized setting . This study was design ed to investigate the physiologic effects of bowel preparation . METHODS : In a prospect i ve study , 12 healthy volunteers ( median age , 63 years ) underwent bowel preparation with bisacodyl and sodium phosphate . Fluid and food intake were st and ardized according to weight , providing adequate calorie and oral fluid intake . Before and after bowel preparation , weight , exercise capacity , orthostatic tolerance , plasma and extracellular volume , balance function , and biochemical parameters were measured . RESULTS : Bowel preparation led to a significant decrease in exercise capacity ( median , 9 percent ) and weight ( median , 1.2 kg ) . Plasma osmolality was significantly increased from 287 to 290 mmol kg−1 , as well as increased phosphate and urea concentrations , whereas calcium and potassium concentrations decreased significantly after bowel preparation . No differences in plasma or extracellular volumes were seen . Orthostatic tolerance and balance function did not change after bowel preparation . CONCLUSIONS : Bowel preparation has significant adverse physiologic effects , which may be attributed to dehydration . The majority of these findings is small and may not be of clinical relevance in otherwise healthy patients undergoing bowel preparation and following recommendations for oral fluid intake",
"Abstract Objective : To determine the efficacy of antiplatelet therapy as prophylaxis against deep venous thrombosis or pulmonary embolism in surgical and high risk medical patients . Design : Overviews of all r and omised trials of antiplatelet therapy that could have been available by March 1990 and in which deep venous thrombosis was assessed systematic ally . Setting : 53 trials ( total 8400 patients ) of an average of two weeks of antiplatelet therapy versus control in general or orthopaedic surgery ; nine trials ( 600 patients ) of antiplatelet therapy versus control in other types of immobility ; 18 trials ( 1000 patients ) of one antiplatelet regimen versus another . Results : Overall , a few weeks of antiplatelet therapy produced a highly significant ( 2P reduction in deep venous thrombosis . 25 % of patients allocated antiplatelet therapy versus 34 % of appropriately adjusted controls had deep venous thrombosis detected by systematic fibrinogen scanning or venography , representing prevention in about 90 patients per 1000 allocated antiplatelet therapy . There was an even greater proportional reduction in pulmonary embolism : such emboli were detected among 47 ( 1.0 % ) antiplatelet allocated patients versus an adjusted control total of 129 ( 2.7 % ) , representing prevention among about 17 patients per 1000 treated ( 2P reductions were similar and separately significant for nonfatal pulmonary embolism ( 0.7 % antiplatelet therapy upsilion 1.8 % control ; 2P deaths attributed to pulmonary embolism ( 0.2 % upsilion 0.9 % ; 2P = 0.0001 ) . There was a slight but non - significant excess of deaths from other causes ( 1.0 % upsilion 0.7 % ) , which made the difference in total mortality non-significant , though still favourable ( 1.2 % upsilion 1.5 % ) . Information on adding antiplatelet therapy to heparin was limited but , at least for pulmonary embolism , suggested more protection from the combination than from heparin alone . Conclusion : It had previously been supposed that antiplatelet therapy did not influence venous thromboembolism , and many surgeons and physicians do not use it routinely for thromboprophylaxis , even for patients who are at substantial risk of deep venous thrombosis or pulmonary embolism . These results indicate that antiplatelet therapy - either alone or , for greater effect , in addition to other proved forms of thromboprophylaxis ( such as subcutaneous heparin ) - should be considered",
"Postoperative organ dysfunction contributes to morbidity , hospital stay and convalescence . Multimodal rehabilitation with epidural analgesia , early oral feeding , mobilization and laxative use after colonic resection has reduced ileus and hospital stay "
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Introduction : Non-invasive telemonitoring programmes detecting deterioration of heart failure are increasingly used in heart failure care . Aim : The aim of this study was to compare different monitoring algorithms used in non-invasive telemonitoring programmes for patients with chronic heart failure . Methods : We performed a systematic literature review in MEDLINE ( PubMed ) and Embase to identify published reports on non-invasive telemonitoring programmes in patients with heart failure aged over 18 years . Results : Out of 99 studies included in the study , 20 ( 20 % ) studies described the algorithm used for monitoring worsening heart failure or algorithms used for titration of heart failure medication . Most frequently used biometric measurements were bodyweight ( 96 % ) , blood pressure ( 85 % ) and heart rate ( 61 % ) . Algorithms to detect worsening heart failure were based on daily changes in bodyweight in 20 ( 100 % ) studies and /or blood pressure in 12 ( 60 % ) studies . In 12 ( 60 % ) studies patients were contacted by telephone in the case of measurements outside thresholds . Conclusion : Only one in five studies on telemonitoring in chronic heart failure reported the algorithm that was used to detect worsening heart failure . St and ardised description of the telemonitoring algorithm can expedite the identification of key components in telemonitoring algorithms that allow accurate prediction of worsening heart failure | [
"Background Home telemonitoring ( HTM ) of chronic heart failure ( HF ) promises to improve care by timely indications when a patient ’s condition is worsening . Simple rules of sudden weight change have been demonstrated to generate many alerts with poor sensitivity . Trend alert algorithms and bio-impedance ( a more sensitive marker of fluid change ) , should produce fewer false alerts and reduce workload . However , comparisons between such approaches on the decisions made and the time spent review ing alerts has not been studied . Methods Using HTM data from an observational trial of 91 HF patients , a simulated telemonitoring station was created and used to present virtual caseloads to clinicians experienced with HF HTM systems . Clinicians were r and omised to either a simple ( i.e. an increase of 2 kg in the past 3 days ) or advanced alert method ( either a moving average weight algorithm or bio-impedance cumulative sum algorithm ) . Results In total 16 clinicians review ed the caseloads , 8 r and omised to a simple alert method and 8 to the advanced alert methods . Total time to review the caseloads was lower in the advanced arms than the simple arm ( 80 ± 42 vs. 149 ± 82 min ) but agreements on actions between clinicians were low ( Fleiss kappa 0.33 and 0.31 ) and despite having high sensitivity many alerts in the bio-impedance arm were not considered to need further action . Conclusion Advanced alerting algorithms with higher specificity are likely to reduce the time spent by clinicians and increase the percentage of time spent on changes rated as most meaningful . Work is needed to present bio-impedance alerts in a manner which is intuitive for clinicians",
"Background Evidence that home telemonitoring for patients with chronic heart failure ( CHF ) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage . Methods Between January 2010 and June 2013 , patients with a confirmed diagnosis of CHF were enrolled and r and omly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system ( Motiva ® ) . The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio ( ICER ) established by the groups ’ difference in total cost and in the combined clinical endpoint “ days alive and not in hospital nor inpatient care per potential days in study ” within the follow-up of 12 months . Results A total of 621 predominantly male patients were enrolled , whereof 302 patients were assigned to the intervention group and 319 to the control group . Ischemic cardiomyopathy was the leading cause of heart failure . Despite r and omization , subjects of the control group were more often in NYHA functional class III – IV , and exhibited peripheral edema and renal dysfunction more often . Additionally , the control and intervention groups differed in heart rhythm disorders . No differences existed regarding risk factor profile , comorbidities , echocardiographic parameters , especially left ventricular and diastolic diameter and ejection fraction , as well as functional test results , medication and quality of life . While the observed baseline differences may well be a play of chance , they are of clinical relevance . Therefore , the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances . Conclusions CardioBBEAT provides prospect i ve outcome data on both , clinical and health economic impact of home telemonitoring in CHF . The study differs by the use of a high evidence level r and omized controlled trial ( RCT ) design along with actual cost data obtained from health insurance companies . Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care . Overall , it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System . Trial registration Clinical Trials.gov NCT02293252 ; date of registration : 10 November",
"Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203",
"BACKGROUND Because of potential side effects and logistical difficulty of titrating medications , out patients with congestive heart failure rarely receive appropriate doses of carvedilol or other beta-blockers . To address these obstacles , we studied if an automated telemedicine system named TeleWatch ( TW ) could facilitate carvedilol titration in out patients with left ventricular systolic dysfunction . METHODS Forty-nine patients with New York Heart Association class II and III left ventricular systolic dysfunction , who were tolerating appropriate afterload-reducing therapy and not receiving beta-blockers , were enrolled into a 3-month study . Patients were r and omized to have clinic-only ( CO ) ( n = 24 ) carvedilol titration or titrations which combined clinic visits with TW monitoring ( n = 25 ) . All patients were seen in clinic biweekly , and those in the TW group were remotely monitored daily . Using a predefined algorithm , patients in the CO and TW groups were eligible for carvedilol titration on a biweekly or weekly basis , respectively , by physicians blinded to group assignment . RESULTS There was no statistical difference in the mean final daily dose of carvedilol between the CO and TW groups ( 39.4 vs 36.2 mg/d , P = .52 ) . Because remote telemedicine titrations were as successful as titrations in the clinic , the time to reach the final dose of carvedilol was significantly shorter in the TW group ( 33.6 vs 63.7 days , P serious adverse events in the study , 4 of which were in the TW group ( P = .29 ) ; however , TW prospect ively detected 2 adverse events . CONCLUSIONS Remote monitoring with an automated telemedicine system can successfully facilitate titration of carvedilol in out patients with New York Heart Association class II and III congestive heart failure",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"Background — This study was design ed to determine whether physician-led remote telemedical management ( RTM ) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure ( HF ) . Methods and Results — We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35 % and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25 % . Patients were r and omly assigned ( 1:1 ) to RTM or usual care . Remote telemedical management used portable devices for ECG , blood pressure , and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers . The primary end point was death from any cause . The first secondary end point was a composite of cardiovascular death and hospitalization for HF . Baseline characteristics were similar between the RTM ( n=354 ) and control ( n=356 ) groups . Of the patients assigned to RTM , 287 ( 81 % ) were at least 70 % compliant with daily data transfers and no break for > 30 days ( except during hospitalizations ) . The median follow-up was 26 months ( minimum 12 ) , and was 99.9 % complete . Compared with usual care , RTM had no significant effect on all-cause mortality ( hazard ratio , 0.97 ; 95 % confidence interval , 0.67 to 1.41 ; P=0.87 ) or on cardiovascular death or HF hospitalization ( hazard ratio , 0.89 ; 95 % confidence interval , 0.67 to 1.19 ; P=0.44 ) . Conclusions — In ambulatory patients with chronic HF , RTM compared with usual care was not associated with a reduction in all-cause mortality . Clinical Trial Registration : — URL : http://www . Clinical Trials.gov . Unique identifier : NCT00543881",
"Background Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient 's home . The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions . Methods / design A primary care-based r and omised controlled trial will be carried out to assess the impact of a telemonitoring intervention aim ed at home care patients with heart failure ( HF ) and /or chronic lung disease ( CLD ) . The results will be compared with those obtained with st and ard health care practice . The duration of the study will be of one year . Sixty patients will be recruited for the study . In-home patients , diagnosed with HF and /or CLD , aged 14 or above and with two or more hospital admissions in the previous year will be eligible . For the intervention group , telemonitoring will consist of daily patient self- measurements of respiratory-rate , heart-rate , blood pressure , oxygen saturation , weight and body temperature . Additionally , the patients will complete a qualitative symptom question naire daily using the telemonitoring system . Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits . The control group will receive usual care . The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-r and omisation . The secondary outcome measures are : duration of hospital stay , hospital admissions due to HF or CLD , mortality rate , use of health care re sources , quality of life , cost-effectiveness , compliance and patient and health care professional satisfaction with the new technology . Discussion The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting . The study may contribute to enhance the underst and ing of alternative modes of health care provision for medically unstable elderly patients , who bear a high degree of physical and functional deterioration . Trial Registration IS RCT N : IS RCT",
"AIMS This multicentre , r and omized controlled trial hypothesized that daily electronic transmission of body weight to a heart failure ( HF ) clinic will reduce cardiac hospitalization in patients recently hospitalized with HF . METHODS AND RESULTS A total of 344 patients were r and omized to either an intervention group ( IG ) or a control group ( CG ) . Of the 319 patients included in the final analysis , the mean age was 73 years ( SD 10.2 ) , 75 % were males , and 57 % had a left ventricular ejection fraction ( LVEF ) Patients in both groups were recommended to weigh themselves daily and , in the case of sudden weight gain > 2 kg in 3 days , to contact the HF clinic . Patients in the IG were given an electronic scale and the weight was automatically transmitted to and monitored at the HF clinic . No significant differences were found for the primary endpoint , cardiac re-hospitalization [ 70/153 CG , 70/166 IG ; hazard ratio ( HR ) 0.90 , 95 % confidence interval ( CI ) 0.65 - 1.26 , P = 0.54 ] , or for the secondary endpoints , which included all-cause hospitalization ( 84/153 CG , 79/166 IG ; HR 0.83 , 95 % CI 0.61 - 1.13 , P = 0.24 ) , death from any cause ( 8/153 CG , 5/166 IG ; HR 0.57 , 95 % CI 0.19 - 1.73 , P = 0.32 ) , or the composite endpoint of cardiac hospitalization and death from any cause ( 78/153 CG , 75/166 IG ; HR 0.90 , 95 % CI 0.65 - 1.26 , P = 0.54 ) . Subgroup analyses did not show any benefits for patients in the IG despite their more frequent monitoring ; 398 occasions compared with 30 occasions in the CG . CONCLUSION Daily electronic transmission of body weight and monitoring three times a week did not decrease hospitalization or death in HF patients followed up at a HF clinic",
"Objective : We investigated in a pilot study whether telemedicine is beneficial in mild to moderate chronic heart failure . Methods : A total of 128 patients with an ejection fraction ≤60 % and NYHA class II or III chronic heart failure were evaluated . Thirty-two patients were enrolled prospect ively in a staged telemedical service program . Ninety-six controls were matched 3:1 to each telemedicine patient . Results : Median follow-up was 307 days ( range 104–459 ) . All-cause hospitalization duration [ 317 vs. 693 days/100 patient years ; relative risk ( RR ) 0.46 ; 95 % confidence interval ( CI ) 0.37–0.58 ; p as cardiac hospitalization duration ( 49 vs. 379 days/100 patient years ; RR 0.13 ; 95 % CI 0.08–0.23 ; p lower , cardiac hospitalization rate ( 11 vs. 35/100 patient years ; RR 0.31 ; 95 % CI 0.11–1.02 ; p = 0.058 ) tended to be lower in the telemedicine compared with the control group . Conclusion : These preliminary data suggest that telemedical care and monitoring may reduce morbidity in patients with NYHA class II and III chronic heart failure",
"BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL\"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure",
"Background Mobile health ( mHealth ) interventions may improve heart failure ( HF ) self-care , but st and ard models do not address informal caregivers ’ needs for information about the patient ’s status or how the caregiver can help . Objective We evaluated mHealth support for caregivers of HF patients over and above the impact of a st and ard mHealth approach . Methods We identified 331 HF patients from Department of Veterans Affairs outpatient clinics . All patients identified a “ CarePartner ” outside their household . Patients r and omized to “ st and ard mHealth ” ( n=165 ) received 12 months of weekly interactive voice response ( IVR ) calls including questions about their health and self-management . Based on patients ’ responses , they received tailored self-management advice , and their clinical team received structured fax alerts regarding serious health concerns . Patients r and omized to “ mHealth+CP ” ( n=166 ) received an identical intervention , but with automated emails sent to their CarePartner after each IVR call , including feedback about the patient ’s status and suggestions for how the CarePartner could support disease care . Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate . Self-care and symptom data also were collected through the weekly IVR assessment s. Results Participants were on average 67.8 years of age , 99 % were male ( 329/331 ) , 77 % where white ( 255/331 ) , and 59 % were married ( 195/331 ) . During 15,709 call-weeks of attempted IVR assessment s , patients completed 90 % of their calls with no difference in completion rates between arms . At both endpoints , composite quality of life scores were similar across arms . However , more mHealth+CP patients reported taking medications as prescribed at 6 months ( 8.8 % more , 95 % CI 1.2 - 16.5 , P=.02 ) and 12 months ( 13.8 % more , CI 3.7 - 23.8 , P mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up ( P=.048 ) . mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints ( both P taking medications as prescribed during weekly IVR assessment s , and also were less likely to report breathing problems or weight gains ( all P patients with more depressive symptoms at enrollment , those r and omized to mHealth+CP were more likely than st and ard mHealth patients to report excellent or very good general health during weekly IVR calls . Conclusions Compared to a relatively intensive model of IVR monitoring , self-management assistance , and clinician alerts , a model including automated feedback to an informal caregiver outside the household improved HF patients ’ medication adherence and caregiver communication . mHealth+CP may also decrease patients ’ risk of HF exacerbations related to shortness of breath and sudden weight gains . mHealth+CP may improve quality of life among patients with greater depressive symptoms . Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical , infrequent retrospective surveys . Trial Registration Clinical Trials.gov NCT00555360 ; https:// clinical trials.gov/ct2/show/NCT00555360 ( Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B )",
"BACKGROUND Small studies suggest that telemonitoring may improve heart-failure outcomes , but its effect in a large trial has not been established . METHODS We r and omly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring ( 826 patients ) or usual care ( 827 patients ) . Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was review ed by the patients ' clinicians . The primary end point was readmission for any reason or death from any cause within 180 days after enrollment . Secondary end points included hospitalization for heart failure , number of days in the hospital , and number of hospitalizations . RESULTS The median age of the patients was 61 years ; 42.0 % were female , and 39.0 % were black . The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point , which occurred in 52.3 % and 51.5 % of patients , respectively ( difference , 0.8 percentage points ; 95 % confidence interval [ CI ] , -4.0 to 5.6 ; P=0.75 by the chi-square test ) . Readmission for any reason occurred in 49.3 % of patients in the telemonitoring group and 47.4 % of patients in the usual-care group ( difference , 1.9 percentage points ; 95 % CI , -3.0 to 6.7 ; P=0.45 by the chi-square test ) . Death occurred in 11.1 % of the telemonitoring group and 11.4 % of the usual care group ( difference , -0.2 percentage points ; 95 % CI , -3.3 to 2.8 ; P=0.88 by the chi-square test ) . There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components . No adverse events were reported . CONCLUSIONS Among patients recently hospitalized for heart failure , telemonitoring did not improve outcomes . The results indicate the importance of a thorough , independent evaluation of disease-management strategies before their adoption . ( Funded by the National Heart , Lung , and Blood Institute ; Clinical Trials.gov number , NCT00303212 . )",
"BACKGROUND Telemonitoring , the use of communication technology to monitor clinical status , is gaining attention as a strategy to improve the care of patients with heart failure . A system of frequent monitoring could alert clinicians to early heart failure decompensation , providing the opportunity for intervention before patients become severely ill and require hospitalization . Moreover , patients ' participation in a daily monitoring program could have a favorable effect on their health behaviors . The literature on telemonitoring for heart failure , however , is quite limited . METHODS AND MATERIAL S Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) is a r and omized , controlled , trial design ed to compare an automated , daily symptom , and self-reported weight monitoring intervention with usual care in reducing ( all-cause ) hospital readmissions and mortality among patients recently hospitalized with decompensated heart failure . The intervention will be implemented and all outcomes will be assessed over a 6-month period . The purpose of the intervention is to collect information about symptoms , clinical status and weight and to engage participants in their own self-care . Participants are recruited from general cardiology , heart failure specialty , and primary care practice s across the United States . CONCLUSIONS The results of this study may inform future policy decisions regarding implementation of telemonitoring in treatment of heart failure",
"AIMS Electronic health support ( e-health ) may improve self-care of patients with heart failure ( HF ) . We aim to assess whether an adjusted care pathway with replacement of routine consultations by e-health improves self-care as compared with usual care . In addition , we will determine whether the ESC/HFA ( European Society of Cardiology/Heart Failure Association ) website heartfailurematters.org ( HFM website ) improves self-care when added to usual care . Finally , we aim to evaluate the cost-effectiveness of these interventions . METHODS A three-arm parallel r and omized trial will be conducted . Arm 1 consists of usual care ; arm 2 consists of usual care plus the HFM website ; and arm 3 is the adjusted care pathway with an interactive platform for disease management ( e-Vita platform ) , with a link to the HFM website , which replaces routine consultations with HF nurses at the outpatient clinic . In total , 414 patients managed in 10 Dutch HF outpatient clinics or in general practice will be included and followed for 12 months . Participants are included if they have had an established diagnosis of HF for at least 3 months . The primary outcome is self-care as measured by the European Heart Failure Self-care Behaviour scale ( EHFScB scale ) . Secondary outcomes are quality of life , cardiovascular- and HF-related mortality , hospitalization , and its duration as captured by hospital and general practitioner registries , use of and user satisfaction with the HFM website , and cost-effectiveness . PERSPECTIVE This study will provide important prospect i ve data on the impact and cost-effectiveness of an interactive platform for disease management and the HFM website . CLINICAL TRIAL REGISTRATION unique identifier : NCT01755988",
"BACKGROUND Heart failure ( HF ) remains a condition with high morbidity and mortality . We tested a telephone support strategy to reduce major events in rural and remote Australians with HF , who have limited healthcare access . Telephone support comprised an interactive telecommunication software tool ( TeleWatch ) with follow-up by trained cardiac nurses . METHODS Patients with a general practice ( GP ) diagnosis of HF were r and omized to usual care ( UC ) or UC and telephone support intervention ( UC+I ) using a cluster design involving 143 GPs throughout Australia . Patients were followed up for 12 months . The primary endpoint was the Packer clinical composite score . Secondary endpoints included hospitalization for any cause , death or hospitalization , as well as HF hospitalization . RESULTS Four hundred and five patients were r and omized to CHAT . Patients were well matched at baseline for key demographic variables . The primary endpoint of the Packer score was not different between the two groups ( P = 0.98 ) , although more patients improved with UC+I. There were fewer patients hospitalized for any cause ( 74 vs. 114 , adjusted HR 0.67 [ 95 % CI 0.50 - 0.89 ] , P = 0.006 ) and who died or were hospitalized ( 89 vs. 124 , adjusted HR 0.70 [ 95 % CI 0.53 - 0.92 ] , P = 0.011 ) , in the UC+I vs. UC group . HF hospitalizations were reduced with UC+I ( 23 vs. 35 , adjusted HR 0.81 [ 95 % CI 0.44 - 1.38 ] ) , although this was not significant ( P = 0.43 ) . There were 16 deaths in the UC group and 17 in the UC+I group ( P = 0.43 ) . CONCLUSIONS Although no difference was observed in the primary endpoint of CHAT ( Packer composite score ) , UC+I significantly reduced the number of HF patients hospitalized among a rural and remote cohort . These data suggest that telephone support may be an efficacious approach to improve clinical outcomes in rural and remote HF patients",
"AIMS Chronic heart failure ( CHF ) patients are frequently rehospitalized within 6 months after an episode of fluid retention . Rehospitalizations are preventable , but this requires an extensive organization of the healthcare system . In this study , we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners ( GPs ) and a heart failure clinic could reduce mortality and rehospitalization rate . METHODS AND RESULTS One hunderd and sixty CHF patients [ mean age 76 ± 10 years , 104 males , mean left ventricular ejection fraction ( LVEF ) 35 ± 15 % ] were block r and omized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring ( TM ) or usual care ( UC ) . The TM group measured body weight , blood pressure , and heart rate on a daily basis with electronic devices that transferred the data automatically to an online data base . Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded . All-cause mortality was significantly lower in the TM group as compared with the UC group ( 5 % vs. 17.5 % , P = 0.01 ) . The total number of follow-up days lost to hospitalization , dialysis , or death was significantly lower in the TM group as compared with the UC group ( 13 vs. 30 days , P = 0.02 ) . The number of hospitalizations for heart failure per patient showed a trend ( 0.24 vs. 0.42 hospitalizations/patient , P = 0.06 ) in favour of TM . CONCLUSION Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization , death , or dialysis in CHF patients . These findings need confirmation in a large trial",
"BACKGROUND Chronic heart failure ( CHF ) remains a common cause of disability , death and hospital admission . Several investigations support the usefulness of programs of disease management for improving clinical outcomes . However , the effect of home-based telemanagement programs on the rate of hospital readmission is still unclear and the cost-effectiveness ratio of such programs is unknown . The aim of the study was to determine whether a home-based telemanagement ( HBT ) programme in CHF patients decreased hospital readmissions and hospital costs in comparison with the usual care ( UC ) follow-up programme over a one-year period . METHODS AND RESULTS Four hundred-sixty CHF patients ( pts ) , aged 57+/-10 years were r and omised to two management strategies : 230 pts to HBT programme and 230 pts to UC programme . The HBT pts received a portable device , transferring , by telephone , a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation . The UC pts were referred to their primary care physicians and cardiologists . The primary objective of the study was one-year hospital readmission for cardiovascular reasons . During one-year follow-up 55 pts ( 24 % ) in HBT group and 83 pts ( 36 % ) in UC group had at least one readmission ( RR=0.56 ; 95 % CI : 0.38 - 0.82 ; p=0.01 ) . After adjusting for clinical and demographic characteristics , the HBT group had a significantly lower risk of readmission compared with the UC group ( HR=0.50 , 95 % CI : 0.34 - 0.73 ; p=0.01 ) . The intervention was associated with a 36 % decrease in the total number of hospital readmissions ( HBT group : 91 readmissions ; UC group : 142 readmissions ) and a 31 % decrease in the total number of episodes of hemodynamic instability ( 101 in HBT group vs 147 in UC group ) . The rate of hearth failure-related readmission was 19 % ( 43 pts ) in HBT group and 32 % ( 73 pts ) in UC group ( RR=0.49 , 95 % [ CI ] : 0.31 - 0.76 ; p=0.0001 ) . No significant difference was found on cardiovascular mortality between groups . Mean cost for hospital readmission was significantly lower in HBT group ( euro 843+/-1733 ) than in UC group ( euro 1298+/-2322 ) , ( -35 % , p hospital readmissions and costs in CHF patients",
"BACKGROUND Remote monitoring of heart failure ( HF ) patients may help in the early detection of acute decompensation before the onset of symptoms , providing the opportunity for early intervention to reduce HF-related hospitalizations , improve outcomes , and lower costs . METHODS AND RESULTS MUSIC is a multicenter nonr and omized study design ed to develop and vali date an algorithm for prediction of impending acute HF decompensation with the use of physiologic signals obtained from an external device adhered to the chest . A total of 543 HF patients ( 206 development , 337 validation ) with ejection fraction ≤40 % and a recent HF admission were enrolled . Patients were remotely monitored for 90 days using a multisensor device . Accounting for device failure and patient withdrawal , 314 patients ( 114 development , 200 validation ) were included in the analysis . Development patient data were used to develop a multiparameter HF detection algorithm . Algorithm performance in the development cohort had 65 % sensitivity , 90 % specificity , and a false positive rate of 0.7 per patient-year for detection of HF events . In the validation cohort , algorithm performance met the prespecified end points with 63 % sensitivity , 92 % specificity , and a false positive rate of 0.9 per patient-year . The overall rate of significant adverse skin response was 0.4 % . CONCLUSION Using an external multisensor monitoring system , an HF decompensation prediction algorithm was developed that met the prespecified performance end point . Further studies are required to determine whether the use of this system will improve patient outcomes",
"We studied 138 patients admitted for heart failure ( HF ) . Patients were allocated one of three treatment strategies . Group 1 ( G1 , n = 50 ) were given usual care for HF , Group 2 ( G2 , n = 56 ) received a multi-disciplinary team approach , while Group 3 ( G3 , n = 32 ) had home telephone self-monitoring . Telemonitoring was based on the answers to three simple queries about bodyweight change , dyspnoea and general health . The system stratified the HF severity of each patient once a week , and recommended a prompt medical appointment or simple follow-up . Over a 12-month follow-up period , there were 43 adverse events ( cardiovascular deaths and rehospitalizations for HF : G1 = 22 , G2 = 14 , G3 = 7 ) . There was no difference between G2 and G3 ( P = 0.78 ) but there was significant disadvantage with usual care ( P = 0.02 vs. G2 and P = 0.04 vs. G3 ) . Time to re-admission for HF increased in G2 and G3 compared to G1 ( 188 and 198 days vs. 95 days , P = 0.03 and P = 0.02 respectively ) . Automated home telephone self-monitoring reduced rehospitalization in patients with advanced HF"
] | 411665e6-06ff-11f0-808a-c43d1ab1c353 |
A systematic review of published and unpublished data on the use of long-acting medications in ADHD and hyperkinetic disorder is reported , giving effect sizes and numbers-to-treat for extended-release stimulant preparations and atomoxetine ( ATX ) . A panel of experts from several European countries used the review to make recommendations about the use of these drugs in practice , and conclusions are reported : ( 1 ) Long-acting preparations should be available and used ; ( 2 ) They should not replace short-acting drugs ( which will be the initial treatment for many children for reasons of cost and flexibility of dosing ) . Individual clinical choice is needed . ( 3 ) Both ATX and extended-release preparations of stimulants should be available . The choice will depend upon the circumstances , and detailed recommendations are made | [
"Background The treatment of children with attention deficit hyperactivity disorder ( ADHD ) and Tourette syndrome ( TS ) has been problematic because methylpheni date (MPH)—the most commonly used drug to treat ADHD — has been reported to worsen tics and because clonidine (CLON)—the most commonly prescribed alternative — has unproven efficacy . Methods The authors conducted a multicenter , r and omized , double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were r and omly administered CLON alone , MPH alone , combined CLON + MPH , or placebo ( 2 × 2 factorial design ) . Each subject participated for 16 weeks ( weeks 1–4 CLON/placebo dose titration , weeks 5–8 added MPH/placebo dose titration , weeks 9–16 maintenance therapy ) . Results Thirty-seven children were administered MPH alone , 34 were administered CLON alone , 33 were administered CLON + MPH , and 32 were administered placebo . For our primary outcome measure of ADHD ( Conners Abbreviated Symptom Question naire – Teacher ) , significant improvement occurred for subjects assigned to CLON ( p placebo , the greatest benefit occurred with combined CLON + MPH ( p for impulsivity and hyperactivity ; MPH appeared to be most helpful for inattention . The proportion of individual subjects reporting a worsening of tics as an adverse effect was no higher in those treated with MPH ( 20 % ) than those being administered CLON alone ( 26 % ) or placebo ( 22 % ) . Compared with placebo , measured tic severity lessened in all active treatment groups in the following order : CLON + MPH , CLON alone , MPH alone . Sedation was common with CLON treatment ( 28 % reported moderate or severe sedation ) , but otherwise the drugs were tolerated well , including absence of any evident cardiac toxicity . Conclusions Methylpheni date and clonidine ( particularly in combination ) are effective for ADHD in children with comorbid tics . Prior recommendations to avoid methylpheni date in these children because of concerns of worsening tics are unsupported by this trial",
"Objective : To test the hypothesis that atomoxetine does not significantly worsen tic severity relative to placebo in children and adolescents with attention deficit/hyperactivity disorder ( ADHD ) and comorbid tic disorders . Methods : Study subjects were 7 to 17 years old , met Diagnostic and Statistical Manual of Mental Disorders – IV criteria for ADHD , and had concurrent Tourette syndrome or chronic motor tic disorder . Patients were r and omly assigned to double-blind treatment with placebo ( n = 72 ) or atomoxetine ( 0.5 to 1.5 mg/kg/day , n = 76 ) for up to 18 weeks . Results : Atomoxetine treatment was associated with greater reduction of tic severity at endpoint relative to placebo , approaching significance on the Yale Global Tic Severity Scale total score ( –5.5 ± 6.9 vs –3.0 ± 8.7 , p = 0.063 ) and Tic Symptom Self-Report total score ( –4.7 ± 6.5 vs –2.9 ± 5.2 , p = 0.095 ) and achieving significance on the Clinical Global Impressions ( CGI ) tic/neurologic severity scale score ( –0.7 ± 1.2 vs –0.1 ± 1.0 , p = 0.002 ) . Atomoxetine patients also showed greater improvement on the ADHD Rating Scale total score ( –10.9 ± 10.9 vs –4.9 ± 10.3 , p ( –0.8 ± 1.1 vs –0.3 ± 1.0 , p = 0.015 ) . Discontinuation rates were not significantly different between treatment groups . Atomoxetine patients had greater increases in heart rate and decreases of body weight , and rates of treatment-emergent decreased appetite and nausea were higher . No other clinical ly relevant treatment differences were seen in any other vital sign , adverse event , or electrocardiographic or laboratory measures . Conclusions : Atomoxetine did not exacerbate tic symptoms . Rather , there was some evidence of reduction in tic severity with a significant reduction of attention deficit/hyperactivity disorder symptoms . Atomoxetine treatment appeared safe and well tolerated",
"OBJECTIVE Methylpheni date ( MPH ) , the most commonly prescribed drug for attention-deficit/hyperactivity disorder ( ADHD ) , has a short half-life , which necessitates multiple daily doses . The need for multiple doses produces problems with medication administration during school and after-school hours , and therefore with compliance . Previous long-acting stimulants and preparations have shown effects equivalent to twice-daily dosing of MPH . This study tests the efficacy and duration of action , in natural and laboratory setting s , of an extended-release MPH preparation design ed to last 12 hours and therefore be equivalent to 3-times-daily dosing . METHODS Sixty-eight children with ADHD , 6 to 12 years old , participated in a within-subject , double-blind comparison of placebo , immediate-release ( IR ) MPH 3 times a day ( tid ) , and Concerta , a once-daily MPH formulation . Three dosing levels of medication were used : 5 mg IR MPH tid/18 mg Concerta once a day ( qd ) ; 10 mg IR MPH tid/36 mg Concerta qd ; and 15 mg IR MPH tid/54 mg Concerta qd . All children were currently medicated with MPH at enrollment , and each child 's dose level was based on that child 's MPH dosing before the study . The doses of Concerta were selected to be comparable to the daily doses of MPH that each child received . To achieve the ascending rate of MPH delivery determined by initial investigations to provide the necessary continuous coverage , Concerta doses were 20 % higher on a daily basis than a comparable tid regimen of IR MPH . Children received each medication condition for 7 days . The investigation was conducted in the context of a background clinical behavioral intervention in both the natural environment and the laboratory setting . Parents received behavioral parent training and teachers were taught to establish a school-home daily report card ( DRC ) . A DRC is a list of individual target behaviors that represent a child 's most salient areas of impairment . Teachers set daily goals for each child 's impairment targets , and parents provided rewards at home for goal attainment . Each weekday , teachers completed the DRC , and it was used as a dependent measure of individualized medication response . Teachers and parents also completed weekly st and ardized ratings of behavior and treatment effectiveness . To evaluate the time course of medication effects , children spent 12 hours in a laboratory setting on Saturdays and medication effects were measured using procedures and methods adapted from our summer treatment program . Measures of classroom behavior and academic productivity/accuracy were taken in a laboratory classroom setting during which children completed independent math and reading worksheets . Measures of social behavior were taken in structured , small-group board game setting s and unstructured recess setting s. Measures included behavior frequency counts , academic problems completed and accuracy , independent observations , teacher and counselor ratings , and individualized behavioral target goals . Reports of adverse events , sleep quality , and appetite were collected . RESULTS On virtually all measures in all setting s , both drug conditions were significantly different from placebo , and the 2 drugs were not different from each other . In children 's regular school setting s , both medications improved behavior as measured by teacher ratings and individualized target behaviors ( the DRC ) ; these effects were seen into the evening as measured by parent ratings . In the laboratory setting , effects of Concerta were equivalent to tid MPH and lasted at least through 12 hours after dosing . Concerta was significantly superior to tid MPH on 2 parent rating scores , and when asked , more parents preferred Concerta than preferred tid IR MPH or placebo . Side effects on children 's sleep and appetite were similar for the 2 preparations . In the lab setting , both medications improved productivity and accuracy on arithmetic seatwork assignments , disruptive and on-task behavior , and classroom rule following . Both medications improved children 's rule following and negative behavior in small group board games , as well as in unstructured recess setting s. Individual target behaviors also showed significant improvement with medication across domains in the laboratory setting . Children 's behavior across setting s deteriorated across the laboratory day , and the primary effect of medication was to prevent this deterioration as the day wore on . Results support the use of background behavioral treatment in clinical trials of stimulant medication , and illustrate the utility of a measure of individualized daily target goals ( ie , the DRC ) as an objective measure of medication response in both the laboratory and natural school setting s. CONCLUSION This investigation clearly supports the efficacy of the Concerta long-acting formulation of MPH for parents who desire to have medication benefits for their child throughout the day and early evening . ( ABSTRACT TRUNCATED",
"OBJECTIVE . In this study we examined the effectiveness of atomoxetine for the treatment of oppositional defiant disorder comorbid with attention-deficit/hyperactivity disorder . METHODS . Patients were aged 6 to 12 years and met Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , diagnostic criteria for attention-deficit/hyperactivity disorder with a Swanson , Nolan , and Pelham Rating Scale-Revised attention-deficit/hyperactivity disorder subscale score above age and gender norms ; Clinical Global Impressions-Severity Scale score of ≥4 ; and Swanson , Nolan , and Pelham Rating Scale-Revised oppositional defiant disorder subscale score of ≥15 . Patients were r and omly assigned in a 2:1 ratio to receive 1.2 mg/kg per day of atomoxetine ( n = 156 ) or placebo ( n = 70 ) for 8 weeks . Treatment effect on oppositional defiant disorder and attention-deficit/hyperactivity disorder symptoms was measured by using the investigator-rated Swanson , Nolan , and Pelham Rating Scale-Revised . RESULTS . Repeated- measures analysis demonstrated a statistically significant difference favoring atomoxetine over placebo in the reduction of Swanson , Nolan , and Pelham Rating Scale-Revised oppositional defiant disorder total scores . There were significant pairwise treatment differences at weeks 2 and 5 but not at week 8 postbaseline . A last-observation-carried-forward analysis showed Swanson , Nolan , and Pelham Rating Scale-Revised scores at endpoint for the atomoxetine and placebo groups were significantly different for attention-deficit/hyperactivity disorder symptoms but not for oppositional defiant disorder symptoms . Atomoxetine was superior to placebo in a last-observation-carried-forward analysis of Clinical Global Impression-Improvement and Clinical Global Impression-Severity scores . CONCLUSIONS . This study confirms previous findings that patients with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder show statistically and clinical ly significant improvement in attention-deficit/hyperactivity disorder symptoms and global clinical functioning when treated with atomoxetine . It remains uncertain , however , whether atomoxetine exerts a specific and enduring effect on oppositional defiant disorder symptoms",
"OBJECTIVE OROS methylpheni date HCL ( MPH ) is a recently developed long-acting stimulant medication used to treat attention-deficit/hyperactivity disorder ( ADHD ) . This study was conducted to examine dosage effects on ADHD symptoms and stimulant side effects and to explore potential moderating effects of ADHD subtype . METHODS Children with ADHD combined type ( ADHD-CT ) or predominantly inattentive type ( ADHD-PI ; n = 47 ) , ages 5 to 16 years , underwent a placebo-controlled , crossover trial using forced titration with weekly switches at 3 dosage levels . Parent and teacher ratings of ADHD symptoms were used to evaluate efficacy . In addition , vital signs and st and ardized measures of stimulant side effects were obtained weekly . RESULTS Parent ratings were more sensitive to treatment effects than teacher ratings . ADHD symptoms and Clinical Global Impressions Severity Index ratings at each dose condition differed significantly from placebo and baseline ratings , which did not differ from one another . For those with ADHD-CT , there was a clear linear dose-response relationship , with clinical ly significant reductions in ADHD Rating Scale-IV scores occurring in two thirds to three fourths of the subjects during either 36- or 54-mg dose conditions . Children with ADHD-PI , conversely , were more likely to respond optimally to lower doses and derived less benefit from higher doses , with 60 % displaying significant improvement on the ADHD Rating Scale-IV at 36 mg or lower . Mild stimulant side effects were reported during placebo and at all dosage levels . With the exception of insomnia and decreased appetite , which were more common at higher doses , parent report of side effects was not related to dose . In addition , younger and smaller children were more likely to display sleep difficulties and decreased appetite at the higher dose levels Although pulse rate increased slightly with increasing dose , there were no dose effects on blood pressure . CONCLUSIONS In children with ADHD-CT , the most common subtype of ADHD , increasing doses of stimulant medication were associated with increased improvement of inattention and hyperactivity symptoms . In children with ADHD-PI , symptom improvement occurred at lower doses and less benefit was derived from higher doses . In both ADHD subtypes , higher doses were associated with parent ratings of increased insomnia and decreased appetite",
"OBJECTIVES Atomoxetine seems to be as effective for treating attention-deficit/hyperactivity disorder ( ADHD ) when the daily dose is administered once in the morning as when the dose is divided and administered in the morning and evening . In the present study , the efficacy of atomoxetine administered once daily among children with ADHD was assessed throughout the day , including the evening and early morning . Another goal was to determine how early in treatment it was possible to discern a specific effect of the drug on ADHD symptoms . METHODS This study was a r and omized , multicenter , double-blind , placebo-controlled trial conducted at 12 outpatient sites in the United States . A total of 197 children , 6 to 12 years of age , who had been diagnosed as having ADHD , on the basis of the Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ) criteria , were r and omized to receive 8 weeks of treatment with atomoxetine or placebo , dosed once daily in the mornings . ADHD symptoms were assessed with parent and investigator rating scales . The primary outcome measure was the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version : Investigator-Administered and Scored total score . Daily parent assessment s of children 's home behaviors in the evening and early morning were recorded with an electronic data entry system . This instrument measures 11 specific morning or evening activities , including getting up and out of bed , doing or completing homework , and sitting through dinner . RESULTS Seventy-one percent of the children enrolled were male , 69 % met criteria for the combined subtype ( both inattentive and hyperactive/impulsive symptoms ) , and the most common psychiatric comorbidity was oppositional defiant disorder ( 35 % ) . Once-daily atomoxetine ( final mean daily dose of 1.3 mg/kg ) was significantly more effective than placebo in treating core symptoms of ADHD . Mean reductions in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version : Investigator-Administered and Scored total score were significantly greater for patients r and omized to atomoxetine , beginning at the first visit after the initiation of treatment and continuing at all subsequent visits . Both inattentive and hyperactive/impulsive symptom clusters were significantly reduced with atomoxetine , compared with placebo . With continued treatment and dose titrations , core symptoms of ADHD continued to decrease throughout the 8-week study . Mean reductions in the daily parent assessment total scores for patients r and omized to atomoxetine were superior during the first week , beginning with the first day of dosing , and were also superior at endpoint . Efficacy outcomes for the evening hours for atomoxetine-treated patients were superior to those for placebo-treated patients , as assessed with 2 different assessment scales . Decreases in the daily parent assessment morning subscores at endpoint showed a significant reduction in symptoms that lasted into the mornings . Rates of discontinuations attributable to adverse events were atomoxetine were decreased appetite , somnolence , and fatigue . CONCLUSIONS Among children 6 to 12 of age who had been diagnosed as having ADHD , once-daily administration of atomoxetine in the morning provided safe , rapid , continuous , symptom relief that lasted not only into the evening hours but also into the morning hours . Atomoxetine treatment was safe and well tolerated",
"OBJECTIVE The objective of this study was to evaluate differences in the pharmacodynamic ( PD ) profile of 2 second-generation extended-release ( ER ) formulations of methylpheni date ( MPH ) : Meta date CD ( MCD ; methylpheni date HCl , US Pharmacopeia ) extended-release capsules , CII , and Concerta ( CON ; methylpheni date HCl ) extended-release tablets , CII . Little empirical information exists to help the clinician compare the PD effects of the available ER formulations on attention and behavior . Previous studies have shown that the near-equal doses of MCD and CON provide equivalent , total exposure to MPH as measured by area under the plasma concentration time curve , yet their pharmacokinetic ( PK ) plasma concentration versus time profiles are different . We previously offered a theoretical PK/PD account of the similarities and differences among available ER formulations based on the hypothesis that all formulations produce effects related to MPH delivered by 2 processes : 1 ) an initial bolus dose of immediate-release ( IR ) MPH that is expected to achieve peak plasma concentration in the early morning and have rapid onset of efficacy within 2 hours of dosing , which for the MCD capsule is delivered by 30 % of the total daily dose as uncoated beads and for the CON tablet is delivered by an overcoat of 22 % of the total daily dose ; and 2 ) an extended , controlled delivery of ER MPH that is expected to achieve peak plasma concentrations in the afternoon to maintain efficacy for a programmed period of time after the peak of the initial bolus , which for the MCD capsule is delivered by polymer-coated beads and for the CON tablet by an osmotic-release oral system . According to this PK/PD model , clinical superiority is expected at any point in time for the formulation with the highest MPH plasma concentration . METHODS This was a multisite , double-blind , double-dummy , 3-way crossover study of 2 active treatments ( MCD and CON ) and placebo ( PLA ) . Children with confirmed diagnoses of attention-deficit/hyperactivity disorder were stratified to receive bioequivalent doses of MCD and CON that were considered to be low ( 20 mg of MCD and 18 mg of CON ) , medium ( 40 mg of MCD and 36 mg of CON ) , or high ( 60 mg of MCD and 54 mg of CON ) , and in a r and omized order each of the study treatments was administered once daily in the morning for 1 week . On the seventh day of each treatment week , children attended a laboratory school , where surrogate measures of response were obtained by using teacher ratings of attention and deportment and a record of permanent product of performance on a 10-minute math test at each of the 7 classroom sessions spread across the day at 1.5-hour intervals . Safety was assessed by patient reports of adverse events , parent ratings on a stimulant side-effects scale , and measurement of vital signs . RESULTS The analyses of variance revealed large , statistically significant main effects for the within-subject factor of treatment for all 3 outcome measures ( deportment , attention , and permanent product ) . The interactions of treatment x session were also highly significant for all 3 outcome measures . Inspection of the PD profiles for the treatment x session interactions suggested 4 patterns of efficacy across the day : 1 ) PLA > MCD approximately CON ( PLA superiority ) immediately after dosing ; 2 ) MCD > CON > PLA during the morning ( MCD superiority ) ; 3 ) MCD approximately CON > PLA during the afternoon ( PD equivalence of MCD and CON ) ; and 4 ) CON > MCD approximately PLA in the early evening ( CON superiority ) . The effect of site was significant , because some study centers had low and some high scores for behavior in the lab classroom , but both the low- and high-scoring sites showed similar PD patterns across the day . The interaction of dose x treatment was not significant , indicating that the pattern of treatment effects was consistent across each dose level . There were no statistically significant overall differences among the 3 treatments for the frequency of treatment-emergent adverse events , ratings of side effects , or vital signs . Two additional PK/PD questions were addressed : 1 . The a priori hypothesis called for a comparison of the average of sessions ( removing session as a factor ) during a time period that corresponds to the length of a typical school day ( from 1.5 through 7.5 hours after dosing ) . For the planned contrast of the 2 treatment conditions ( MCD versus CON ) , the difference was significant , confirming the a priori hypothesis of superiority of near-equal daily doses of MCD over CON for this predefined postdosing period . 2 . In the design of the study , the dose factor represented the total daily dose , consisting of 2 components : the initial bolus doses of IR MPH , which differ for the near-equal total daily doses of MCD and CON , and the reservoir doses of ER MPH , which were the same for the 2 formulations . To evaluate the moderating effects of the bolus component of dose on outcome , average effect size ( ES ) was calculated for the efficacy outcomes at the time of expected peak PK concentration times of the initial bolus component for each formulation at the 3 dose levels . The correlation ( r ) of ES with IR MPH bolus dose was significant for each of the 3 outcome measures ( r approximately .9 ) , indicating that the magnitude of effects in the early morning may be attributed to the dose administered by the IR MPH bolus of each formulation . For the 2 dose conditions with equal 12-mg IR MPH boluses ( MCD 40 and CON 54 ) , the ESs were large and indistinguishable ( eg , deportment ES approximately 0.75 for both ) . CONCLUSIONS Once-daily doses of MCD and CON produced statistically significantly different PD effects on surrogate measures of behavior and performance among children with attention-deficit/hyperactivity disorder in the laboratory school setting . As predicted by the PK/PD model , superiority at any point in time was achieved by the formulation with the highest expected plasma MPH concentration",
"OBJECTIVE To compare the efficacy , safety , and tolerability of once-daily administration of modified-release methylpheni date ( MPH MR ) with placebo in children with attention-deficit/hyperactivity disorder ( ADHD ) . METHODS The study was a 3-week , double-blind , 32-site , r and omized clinical trial comparing MPH MR with placebo . Children were 6 to 16 years of age , had a diagnosis of ADHD , and had not failed a previous trial of stimulant treatment for ADHD . After a 1-week , single-blind , placebo-washout period , participants received a once-daily dose of MPH MR or placebo , which was started with 1 capsule ( 20 mg ) and individually titrated up to a maximum of 3 capsules ( 60 mg ) . The primary outcome measure was specified as a reduction in ADHD symptom severity from the teacher version of the 10-item Conners ' Global Index . Investigators , teachers , and parents evaluated safety . RESULTS The study r and omized 321 children : 158 to MPH MR and 163 to placebo . Children in the MPH MR group were started on a dose of 20 mg/d and reached a mean dose of 40.7 mg/d ( 1.28 mg/kg/d ) at endpoint . Compared with placebo , MPH MR significantly reduced ADHD symptoms ratings on the teacher version of the 10-item Conners ' Global Index , on the parent version of the Conners ' Global Index , on the parent assessment of global efficacy , and on investigator assessment of global improvement . The most common adverse events in the MPH MR group were headache , anorexia , abdominal pain , and insomnia . Only anorexia occurred at a rate that was significantly greater than placebo . CONCLUSION MPH MR administered once daily in the morning is effective and safe in controlling ADHD symptoms throughout the school day",
"Abstract Objective : To compare the rate and extent of absorption of DL-threo-methylpheni date ( MPH ) from two modified-release MPH formulations at their respective recommended starting doses in healthy adult volunteers . Design : Open-label , r and omised , crossover , bioavailability study . Participants : Twenty healthy adult male and female volunteers . Methods : Subjects received single doses of two modified-release formulations of MPH , a 20 mg capsule ( Ritalin ® LA ) and an 18 mg tablet ( Concerta ® ) . A total of 19 plasma sample s was collected over 24 hours , and MPH plasma concentrations were determined by liquid chromatography-mass spectrometry ( LC-MS/MS ) . These values were used to calculate st and ard noncompartmental pharmacokinetic parameters describing the rate ( peak concentration and time to peak concentration ) and extent ( area under the concentration-time curve , AUC ) of absorption of the two formulations . The relative bioavailability of the two drugs was assessed using a 90 % confidence interval , based on the lower and upper endpoints of the confidence interval for the ratios of the geometric means ( log transformed ) being within the 0.80–1.25 equivalence criterion . Results : Nineteen subjects , ten male and nine female , aged 21–34 years completed both treatment phases of the study . The Ritalin ® LA formulation displayed a distinctly biphasic pharmacokinetic profile , with mean initial peak plasma concentration of 7 µg/L at an average of 2.1 hours after administration and a second peak of 9.3 µg/L occurring at 5.6 hours . In contrast , the profile of the Concerta ® formulation rapidly reached an initial plateau concentration of 3.4 µg/L at 3.3 hours after administration and a second mean plateau concentration of 5.9 µg/L approximately 6 hours after administration . Substantially more MPH was absorbed from Ritalin ® LA than from Concerta ® over the first 4 hours ; the respective AUC4 values were 18.5 and 9.3 µg · h/L ( p The overall extent of absorption of MPH was similar between the two formulations . Oral clearance was identical between the two dosage forms . Conclusion : The Ritalin ® LA formulation exhibited more rapid initial absorption and reached significantly higher peak plasma concentrations compared with the Concerta ® formulation , although the oral bioavailability of MPH was similar between the two formulations . The Ritalin ® LA capsule demonstrated a distinctly bimodal plasma concentration-time profile . MPH plasma concentrations result ing from Concerta ® reached a peak at 6 hours . These results indicate that the recommended starting dose of the Ritalin ® LA 20 mg capsule formulation provides more rapid absorption and higher peak plasma concentrations than the recommended 18 mg starting dose of the Concerta ® formulation",
"BACKGROUND The duration of action of the immediate-release formulation of methylpheni date hydrochloride is short ( 3 to 4 hours ) , and 3 times daily dosing is thought to maximize effectiveness across a 12-hour day . The initial sustained-release formulations of methylpheni date had reduced efficacy compared with immediate-release methylpheni date and were not well accepted . Tachyphylaxis was hypothesized to account for the reduced effects , and an ascending drug delivery pattern was proposed to overcome this acute tolerance . METHODS Children with attention-deficit/hyperactivity disorder were evaluated in a laboratory school to characterize onset and duration of the effect of a variety of methylpheni date regimens . In a proof-of-concept study , an experimental ascending profile was established by an initial bolus followed by small increasing doses of immediate-release methylpheni date in capsules administered every 30 minutes for 8 hours . Two proof-of-product studies of a new oral once-a-day formulation to deliver methylpheni date by an osmotic pump process based on OROS ( ALZA Corp , Mountain View , Calif ) technology ( hereafter referred to \" OROS-methylpheni date \") were conducted : a pharmacokinetic study and a pharmacodynamic study . RESULTS The experimental ascending profile matched the effect of the st and ard regimen of methylpheni date , 3 times daily . In the pharmacokinetic study , OROS-methylpheni date treatment produced a rapid rise followed by increasing plasma concentrations that peaked 7 to 9 hours after administration . In the pharmacodynamic study , OROS-methylpheni date treatment matched the 3 times daily dosing of methylpheni date for onset and duration of efficacy . CONCLUSIONS These studies demonstrate the translation of a basic science finding ( acute tolerance to clinical doses of methylpheni date ) into clinical application ( the selection of a new drug delivery pattern for methylpheni date ) . This approach produced a new product ( OROS-methylpheni date or Concerta ) , which proved to have the predicted rapid onset ( with 1 - 2 hours ) and long duration of efficacy ( 10 - 12 hours ) after a single administration in the morning",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"The rate of onset of a drug 's effect is an important determinant of its abuse potential . This experiment examined the acute behavioral effects of orally administered sustained-release methylpheni date ( SR ; 20 - 40 mg ) , immediate-release methylpheni date ( IR ; 20 - 40 mg ) , and placebo in 10 healthy volunteers . Drug effects were assessed before drug administration and periodically afterwards for 6 hr using drug-effect question naires and performance measures that are sensitive to the acute effects of stimulants . The IR formulation produced stimulant-like drug effects ( e.g. , increased ratings of \" good effects \" ) that generally varied as a function of dose and time . The SR formulation produced only transient effects on these measures . These findings are consistent with previous research on the influence of rate of onset using other drugs and suggest that the abuse potential of IR methylpheni date may be greater than that of SR methylpheni date",
"Background Methylpheni date ( MPH ) is commonly prescribed in the treatment of Attention-Deficit/Hyperactivity Disorder or ADHD . Concerta and Meta date CD are once-daily formulations of MPH using different delivery mechanisms result ing in different pharmacokinetic profiles . A recent study ( COMACS ) showed that for near-milligram ( mg ) equivalent daily doses , Meta date CD provides greater symptom control in the morning ( 1.5 through 4.5 hours post-dose ) , while Concerta provides greater control in the early evening ( 12 hours post-dose ) . Non-inferential comparison of effects for different dose levels of the two formulations suggested that equivalent levels of morning symptom control could be obtained with lower daily doses of Meta date CD than Concerta ; the situation being reversed in the evening . The current paper presents a secondary analysis that provides a statistical test of these observations . Method The COMACS study was a multi-center , double-blind crossover study of Meta date CD , Concerta and placebo with each treatment administered for 1 week . Children were assigned on the basis of their pre-trial dosage to either high ( Meta date CD 60 mg ; Concerta 54 mg ) , medium ( Meta date CD 40 mg ; Concerta 36 mg ) or low doses ( Meta date CD 20 mg ; Concerta 18 mg ) of MPH , and attended a laboratory school on the 7th day for assessment at 7 sessions across the day . For the post-hoc comparisons across dose levels presented here , total SKAMP scores with the active treatments ( adjusted for placebo response ) were analyzed using an analysis of covariance , with a combined measure modeling placebo response across all time period as the covariate . Results Symptom control from 1.5 through 6.0 hours post-dose was as good with lower doses of Meta date CD ( 20 and 40 mg ) as with higher doses of Concerta ( 36 and 54 mg , respectively ) . Lower daily doses of Concerta ( 18 and 36 mg ) and higher doses of Meta date CD ( 40 and 60 mg , respectively ) gave equivalent control at 7.5 and 12 hours with Meta date CD giving better control from1.5 through 6.0 hours post-dose . Conclusions Different delivery profiles of Meta date CD and Concerta can be exploited to limit total daily exposure to MPH while at the same targeting a specific , especially clinical ly significant , period of the day . These results need to be confirmed in a study in which children are r and omly allocated to different dose levels of the two formulations and plasma MPH concentrations are assessed simultaneously",
"BACKGROUND [ corrected ] Attention-deficit/hyperactivity disorder ( ADHD ) has been less studied in adults than in children , and the treatment studies reported to date have been small , single-center trials . To assess the efficacy of atomoxetine , a new and highly selective inhibitor of the norepinephrine transporter , we conducted two large , multicenter treatment trials . METHODS Two identical studies using r and omized , double-blind , placebo-controlled design s and a 10-week treatment period were conducted in adults with DSM-IV-defined ADHD as assessed by clinical history and confirmed by a structured interview ( study I , n = 280 ; study II , n = 256 ) . The primary outcome measure was a comparison of atomoxetine and placebo using repeated measures mixed model analysis of postbaseline values of the Conners ' Adult ADHD Rating Scale . RESULTS In each study , atomoxetine was statistically superior to placebo in reducing both inattentive and hyperactive and impulsive symptoms as assessed by primary and secondary measures . Discontinuations for adverse events among atomoxetine patients were under 10 % in both studies . CONCLUSION Atomoxetine appears to be an efficacious treatment for adult ADHD . Its lack of abuse potential may be an advantage for many patients",
"Abstract Objective : To evaluate the safety and efficacy of extended-release methylpheni date with a bimodal profile using SODAS ™ technology ( Ritalin ® LA ™ ) compared with placebo in children aged 6–14 years with attention deficit hyperactivity disorder ( ADHD ) . Method : This was a multicenter , double-blind , r and omized , placebo-controlled , parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders ( DSM-IV ) criteria for ADHD . Following titration and a 1-week placebo washout period , patients were r and omized to 2 weeks of double-blind treatment with either Ritalin ® LA ™ ( 10–40 ) mg/day ) or placebo . The efficacy assessment s used were the Conners ’ ADHD/DSM-IV Scales for teachers ( CADS-T ) and for parents ( CADS-P ) , and the Clinical Global Impression-Improvement Scale ( CGI-I ) completed by the investigator . The primary efficacy variable was the change from baseline ( end of placebo washout ) to the final rating ( end of 2-week double-blind treatment ) in the CADS-T Total subscale score . Results : One-hundred- and -sixty-one children were treated and 134 responders were included in the intent-to-treat analysis . Ritalin ® LA ™ achieved a mean change from baseline ( ± SD ) on the CADS-T Total subscale of –10.7 ( ±15.68 ) compared with 2.8 ( ±10.59 ) for placebo ( p the CADS-T Total score with Ritalin ® LA ™ was 0.90 . Additionally , 69.8 % of patients in the Ritalin ® LA ™ group were rated as much or very much improved on the CGI-I at final assessment compared with 40 % of patients in the placebo group ( p = 0.0009 ) . The adverse events reported were generally mild or moderate , and were similar in both groups . Conclusion : The results demonstrate that Ritalin ® LA ™ administered once daily for up to 2 weeks achieved outcomes statistically superior to placebo in children with ADHD",
"BACKGROUND Oppositional defiant disorder (ODD)is associated with a high degree of impairment in social skills , family interaction , and academic functioning . Comorbid ODD is reportedly present in 40 % to 70 % of children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) . OBJECTIVE The goal of this study was to assess the efficacy and safety of mixed amphetamine salts extended release ( MAS XR ) for the treatment of ODD in children and adolescents aged 6 to 17 years . METHODS This was a 4-week , multicenter , r and omized , double-blind , parallel-group , placebo-controlled , forced-dose-escalation study . Patients were r and omized to receive active treatment with MAS XR 10 , 20 , 30 , or 40 mg/d or placebo . The primary efficacy end point was the ODD subscale of the Swanson , Nolan , and Pelham-IV ( SNAP-IV ) parent rating . Primary safety measures included adverse events recorded at each visit and for 30 days after study drug discontinuation , and changes in vital signs , 12-lead electrocardiographic ( ECG ) findings , laboratory tests and physical examinations , and body weight . A post hoc efficacy re analysis was completed based on the results for the per- protocol population . For this analysis , patients were divided into high and low baseline severity categories according to the dichotomized baseline ODD parent or teacher score or dichotomized baseline ADHD parent or teacher score ( high defined as scores at the median or greater and low defined as scores less than the median ) . RESULTS A total of 308 children and adolescents ( age range , 6 - 17 years ; 213 males , 95 females ) were r and omized to receive active treatment with MAS XR 10 mg/d ( n = 60 ) 20 mg/d ( n = 58 ) , 30 mg/d ( n = 69 ) , or 40 mg/d ( n = 61 ) or placebo ( n = 60 ) . Of the 308 study patients , 244 ( 79.2 % ) had comorbid ADHD . A significant change from baseline in the ODD symptoms measured with the SNAP-IV parent rating subscale was found for the MAS XR 30-mg/d ( -0.52 ; P MAS XR 30-mg/d group in the intent-to-treat analysis ( -0.42 ; P MAS XR was well tolerated in these children and adolescents with ODD , and most adverse events were mild to moderate in intensity . The most frequently reported adverse events occurring in MAS XR-treated patients were anorexia/decreased appetite ( 25.3 % ) , insomnia ( 19.5 % ) , headache ( 18.5 % ) , and abdominal pain ( 10.7 % ) . Statistically , but not clinical ly , significant decreases in body weight were seen with MAS XR ( range , -1.1 to -3.5 lb ; P ) . Changes in laboratory values , ECG measurements , and physical and other vital signs were also not clinical ly significant . The post hoc re analysis was based on the per- protocol population ( n = 229 ) . An assessment of the high baseline symptom severity subgroups showed a good response to MAS XR treatment for the SNAP-IV parent and teacher rating scales ( both , P XR ( 30 and 40 mg ) were effective and well tolerated in the management of ODD in these school aged children and adolescents in the presence or absence of ADHD",
"BACKGROUND The few controlled studies of methylpheni date ( MPH ) in adults with attention deficit/hyperactivity disorder ( ADHD ) have reported equivocal results . A previous , pilot study by our group suggested that these results were due to inadequate dosing . METHOD We conducted a r and omized , 6-week , placebo-controlled , parallel study of MPH in 146 adult patients with DSM-IV ADHD using st and ardized instruments for diagnosis , separate assessment s of ADHD , depressive and anxiety symptoms , and a robust average oral daily dose of 1.1 mg/kg/day . RESULTS We found a marked therapeutic response for the MPH treatment of ADHD symptoms that exceeded the placebo response ( 76 % vs. 19 % ) . Treatment was safe and well tolerated . Response to MPH was independent of socioeconomic status , gender , and lifetime history of psychiatric comorbidity . CONCLUSIONS These results confirm that robust doses of MPH are effective in the treatment of adult ADHD",
"BACKGROUND The objective of this study was to evaluate the safety and efficacy of once-daily OROS methylpheni date ( MPH ) in the treatment of adults with DSM-IV attention-deficit/hyperactivity disorder ( ADHD ) . METHODS We conducted a r and omized , 6-week , placebo-controlled , parallel- design study of OROS MPH in 141 adult subjects with DSM-IV ADHD , using st and ardized instruments for diagnosis . OROS MPH or placebo was initiated at 36 mg/day and titrated to optimal response , depending on efficacy and tolerability , up to 1.3 mg/kg/day . RESULTS Treatment with OROS MPH was associated with clinical ly and statistically significant reductions in DSM-IV symptoms of inattention and hyperactivity/impulsivity relative to subjects treated with placebo . At endpoint , 66 % of subjects ( n = 44 ) receiving OROS MPH and 39 % of subjects ( n = 29 ) [ corrected ] receiving placebo attained our a priori definition of response of much or very much improved on the Clinical Global Impression-Improvement scale plus a > 30 % reduction in Adult ADHD Investigator System Report Scale score . OROS MPH was associated with small but statistically significant increases in systolic blood pressure ( 3.5 + /- 11.8 mm Hg ) , diastolic blood pressure ( 4.0 + /- 8.5 mm Hg ) , and heart rate ( 4.5 + /- 10.5 bpm ) . CONCLUSIONS These results show that treatment with OROS MPH in daily doses of up to 1.3 mg/kg/day was effective in the treatment of adults with ADHD . Because of the potential for increases in blood pressure and heart rate , subjects receiving treatment with MPH should be monitored for changes in blood pressure parameters during treatment",
"Objective : To compare the safety and efficacy of atomoxetine , a selective inhibitor of the norepinephrine transporter , versus placebo in Attention-Deficit/Hyperactivity Disorder ( ADHD ) patients with comorbid Oppositional Defiant Disorder ( ODD ) . Methods : A subset analysis of 98 children from two identical , multi-site , double-blind , r and omized , placebo-controlled trials involving 9 weeks of treatment with atomoxetine or placebo was conducted . Patients met DSM-IV ADHD criteria . ODD was diagnosed with the Diagnostic Interview for Children and Adolescents-IV ( DICA-IV ; Reich , Welner , & Herjanic , 1997 ) . ADHD severity was assessed with the ADHD Rating Scale-IV-Parent Version : Investigator Administered and Scored ( ADHD-RS-IV-Parent : Inv ; DuPaul , Power , Anastopoulos , & Reid , 1998 ) ; the short version of the Conners ’ Parent Rating Scales-Revised ( CPRS-R : S ; Conners , 2000 ) ; and the Clinical Global Impressions of ADHD Severity ( CGI-ADHD-S ; Guy , 1976 ) . Clinical response was defined as a ≥ 25 % reduction in ADHD-RS-IV-Parent : Inv total score . Results : ADHD-RS-IV-Parent : Inv , CGI-ADHD-S , and three CPRS-R : S subscale scores improved markedly with atomoxetine treatment . However , a decrease in the CPRS-R : S Oppositional subscore for atomoxetine-treated patients was not significantly greater than scores for placebo-treated patients . Clinical response rates were 65.4 % in the atomoxetine group , and 36.4 % in the placebo group ( p = .007 ) . Conclusion : Atomoxetine was effective for the treatment of ADHD in patients with comorbid ODD . It did not significantly reduce the severity of ODD symptoms , and was well tolerated by the patients",
"OBJECTIVES In order to treat children with Attention-deficit/Hyperactivity Disorder ( ADHD ) with a once-a-day stimulant several galenic approaches have been tried . The long acting methylpheni date ( MPH , Medikinet-Retard ) is a preparation with a two-step dynamic to release MPH ( step one : acute ; step two : prolonged ) . The efficacy of Medikinet-Retard , a new long-acting methylpheni date preparation , is analyzed based on the assessment of parents in the afternoon . METHODS In a multicenter drug treatment study ( placebo controlled , r and omized , double-blind ) 85 children ( normal intelligence , age 6 to 16 years , diagnosis of ADHD according to DSM-IV ) were investigated over 4 weeks with weekly visits . Forty-three children received Medikinet-Retard and forty-two children placebo . The weekly dose titration depending on body weight and symptomatology allowed a final maximum of 60 mg . The effects on ADHD as perveived by the parents were assessed weekly with a German symptom checklist for ADHD according to DSM-IV and ICD-10 ( FBB-HKS ) . The differences between baseline and last week of treatment were compared statistically between groups . RESULTS There was a large and statistically significant positive drug effect on ADHD symptomatology . The effect size of these differences was d = 1.2 ( total score ) . Effects were found on inattention , hyperactivity and impulsity on the respective subscales . The efficacy of Medikinet-Retard was evaluated by the parents on an average as good . The rate of responders was four-times higher in the verum-group . The correlations of the changed scores in the parent ratings with the respective change scores in the teacher ratings were in the medium range . CONCLUSION This is the first study with a German long-acting methylpheni date preparation ( Medikinet-Retard ) . According to data based on parents ' assessment s , the drug showed very good clinical efficacy and safety in children with ADHD . Its two step galenic release of methylpheni date seems to be appropriate for a once-a-day ( morning ) stimulant in schoolchildren",
"BACKGROUND The thrice daily dosing regimen of immediate release methylpheni date ( IR-MPH ) for Attention Deficit/Hyperactivity Disorder ( ADHD ) requires in-school dosing , leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school . OROS-methylpheni date ( OROS-MPH ) is a once-daily controlled-release formulation of methylpheni date ( MPH ) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations . R and omized , controlled trials ( RCTs ) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works , but under ideal conditions one can not discount the importance of efficacy study results . However , the most useful information to clinicians comes from an effectiveness study design . OBJECTIVES To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD . METHODS This 8 week , multicentre , open-label study r and omized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH . Subjects were titrated to a clinical ly effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks . The SNAP-IV parent-rating scale was used to assess effectiveness . RESULTS OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms ( p=0.0002 , X2=13.8 , df=1 ) and severity of ADHD and ODD symptoms ( p=0.004 , F=8.4 , df=1,127 ) , as well as on the following secondary assessment s : IOWA Conners , Conners Parent Rating Scale ( short version ) , Parent Stress Index , ( short version ) ; Visual Analogue Scale for social play ; Clinical Global Impression-Severity , Clinical Global Impression-Improvement and Parent Satisfaction with treatment . OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile . CONCLUSIONS Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate",
"OBJECTIVES While stimulants are the recognized first-line choice of pharmacotherapy for ADHD , reports that they may induce or exacerbate tics have tended to limit their use in ADHD children who have a history of tics or a family history of Tourette 's syndrome . This study analyzes the incidence of tics reported across five studies of children with ADHD who received methylpheni date (MPH)-based therapy as part of the clinical development program for once-daily OROS MPH ( CONCERTA McNeil Consumer & Specialty Pharmaceuticals , Fort Washington , PA ) . METHODS Data were analyzed from three placebo-controlled , active-controlled studies ( studies 1 - 3 ) lasting 1 - 4 weeks , and two open-label studies lasting 2 years ( study 4 ) and 9 months ( study 5 ) , respectively . During the course of the studies , parents were asked at the end of each week of treatment ( studies 1 and 2 ) , biweekly ( study 3 ) , or monthly ( for the first year of study 4 , then at 3-month intervals thereafter ) whether their child had experienced tics . Tics could also be reported as adverse events in the two open-label studies . RESULTS Pooled data from the three placebo-controlled studies showed that the incidence of tics was not significantly different across all three treatment groups ( OROS MPH , 4.0 % ; MPH tid , 2.3 % ; placebo , 3.7 % , p = 0.5249 ) . During the first year of the 2-year open-label study , the monthly incidence of tics remained constant , at approximately 5 % . Analysis of tic episodes per patient in this study found no correlation between an OROS MPH dose and the frequency of tic episodes . The risk of tic episodes was higher in patients with a history of tics than in those with no history of tics ( 33 % versus 7 % , p tics . CONCLUSIONS These data suggest that MPH-based therapy does not significantly induce or exacerbate tics in children with ADHD",
"OBJECTIVE Few studies have assessed effectiveness and tolerability of stimulants when used for prolonged periods in children with attention-deficit/hyperactivity disorder ( ADHD ) . This article presents final results from an open-label , multisite study of a once-daily formulation of methylpheni date ( MPH ) , OROS MPH . METHOD Subjects received OROS MPH ( 18 - 54 mg initially , with adjustments based on clinical condition ) for up to 24 months . Multiple measures of ADHD symptoms , vital signs , weight , height , and laboratory results were assessed throughout the study period . RESULTS A total of 407 children enrolled in the open-label study and 229 completed the trial . Effectiveness of OROS MPH therapy was maintained throughout the study as indicated by parent and investigator assessment s. There was a 26 % increase in mean daily dose over the study period , with the majority of the increase occurring during year 1 . In general , treatment was well tolerated , with 31 ( 7.6 % ) of subjects discontinuing because of adverse events . Minimal effects on growth in height and weight were observed during the study . No clinical ly significant effects on vital signs or laboratory test parameters were observed . CONCLUSIONS : Sustained effectiveness of OROS MPH was maintained for up to 24 months with minimal effects on growth , tics , vital signs , or laboratory test values",
"Mixed amphetamine salts extended release ( MAS XR ; Adderall XR ® ) and atomoxetine ( Strattera ® ) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder ( ADHD ) combined or hyperactive/impulsive type in a r and omized , double-blind , multicenter , parallel-group , forced-dose-escalation laboratory school study . Primary efficacy measure was the SKAMP ( Swanson , Kotkin , Agler , M-Flynn , and Pelham ) behavioral rating scale . Changes in mean SKAMP deportment scores from baseline were significantly greater for MAS XR ( n = 102 ) than for atomoxetine ( n = 101 ) overall ( -0.56 and -0.13 , respectively ; p ( p events were similar for both treatment groups . The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than atomoxetine in children with ADHD",
"OBJECTIVE A new once-a-day methylpheni date ( MPH ) formulation , Concerta ( methylpheni date HCl ) extended-release tablets ( OROS MPH ) , has been developed . This study was conducted to determine the safety and efficacy of OROS MPH in a multicenter , r and omized , clinical trial . METHODS Children with attention-deficit/hyperactivity disorder ( ADHD ; n = 282 ) , all subtypes , ages 6 to 12 years , were r and omized to placebo ( n = 90 ) , immediate-release methylpheni date ( IR MPH ) 3 times a day ( tid ; dosed every 4 hours ; n = 97 ) , or OROS MPH once a day ( qd ; n = 95 ) in a double-blind , 28-day trial . Outcomes in multiple domains were assessed , and data were analyzed using analysis of variance and Kaplan Meier product limit estimates for time to study cessation . The primary time point for analysis was the last available patient visit using last observation carried forward . RESULTS Children in the OROS and IR MPH groups showed significantly greater reductions in core ADHD symptoms than did children on placebo . This was true both at the end of week 1 and at the end of treatment on the basis of mean teacher and parent IOWA Conners ratings . IR MPH tid and OROS MPH qd did not differ significantly on any direct comparisons . Forty-eight percent of the placebo group discontinued early compared with 14 % and 16 % in the IR MPH and OROS MPH groups , respectively . CONCLUSIONS For the treatment of core ADHD symptoms , OROS MPH dosed qd and IR MPH dosed tid were superior to placebo and were not significantly different from each other.attention-deficit/hyperactivity disorder , methylpheni date , OROS , Concerta",
"ABSTRACT . Clinical research on attention-deficit hyperactivity disorder ( ADHD ) has begun to integrate measures of health-related quality of life ( HRQL ) as part of the overall assessment of treatment outcomes . This study examines the association between HRQL and measures of clinical symptoms of ADHD . Data were gathered from 297 children and adolescents in an 8-week , r and omized , double-blind , placebo-controlled , clinical trial of atomoxetine treatment for ADHD . HRQL was assessed with the Child Health Question naire 50-item Parent Form . ADHD symptoms were assessed with the ADHD Rating Scale-IV ; Parent Version and Clinical Global Impressions-ADHD-Severity . Associations between HRQL and clinical symptoms were assessed with correlations , analyses of variance with post hoc comparisons , and t tests . The Child Health Question naire 50-item Parent Form scales assessing psychosocial domains of HRQL were significantly negatively correlated with clinical measures . Improvement in clinical symptoms was associated with corresponding improvement in psychosocial aspects of HRQL . The findings suggest that HRQL instruments can add important information to efficacy measures in clinical trials of ADHD treatment",
"Abstract Objectives The primary objective was to compare the differences in clinical efficacy of the starting dose of Ritalin ® LA ™ ( 20 mg ) to the starting dose of Concerta ® ( 18 mg ) , in a laboratory school setting for the duration of an entire school day . Secondary objectives were to compare Ritalin ® LA ™ 20 mg with Concerta ® 36 mg , and Ritalin ® LA ™ and both Concerta ® doses versus placebo across the school day . Methods Thirty-six children ( 29 males , 7 females ) , aged 6–12 years , with attention deficit hyperactivity disorder , previously stabilized on methylpheni date ( MPH ) , completed this four-way , r and omized , single-blind crossover , analog classroom study . Patients were evaluated on day 0 and r and omized to receive treatment on days 7 , 14 , 21 , and 28 ( Ritalin ® LA ™ 20 mg , Concerta ® 18 mg , Concerta ® 36 mg , or placebo ) . Results Swanson , Kotkin , Agler , M-Flynn and Pelham Rating Scale (SKAMP)-attention : The effect of Ritalin ® LA ™ 20 mg across the morning was statistically different from that of Concerta 18 mg and 36 mg , as demonstrated by the change in the area under the curve ( AUC ) during the first 4 hours ( 0–4 ) from pre-dose . AUC(0–4 ) for Ritalin ® LA ™ was −2.48 versus −1.36 for Concerta ® 18 mg ( p = 0.015 ) , and −1.55 for Concerta ® 36 mg ( p = 0.043 ) . AUC(0–8 ) change from pre-dose for Ritalin ® LA ™ was −4.48 versus −2.72 for Concerta ® 18 mg ( p = 0.074 ) , and −3.24 for Concerta ® 36 mg ( p = 0.208 ) . SKAMP-deportment : AUC(0–4 ) for Ritalin ® LA ™ was −1.67 compared with −0.28 for Concerta ® 18 mg ( p ( p = 0.004 ) . AUC(0–8 ) change from pre-dose for Ritalin ® LA ™ was −2.81 compared with −0.82 for Concerta ® 18 mg ( p = 0.018 ) , and −1.34 for Concerta ® 36 mg ( p = 0.078 ) . Combined : Mean AUC(0–4 ) change from pre-dose for Ritalin ® LA ™ was −2.05 compared with −0.78 for Concerta ® 18 mg ( p p = 0.003 ) . The mean AUC(0–8 ) change from pre-dose for Ritalin ® LA ™ was −3.58 compared with −1.70 for Concerta ® 18 mg ( p = 0.010 ) , −2.22 for Concerta ® 36 mg ( p = 0.061 ) . Math test-attempted : Mean pre-dose score for Ritalin ® LA ™ was about 73 compared with 74 , 90 , and 81 for Concerta ® 18 mg , 36 mg , and placebo , respectively . Mean AUC(0–8 ) change from pre-dose for Ritalin ® LA ™ was 202 compared with 115 for Concerta ® 18 mg ( p = 0.135 ) , 137 for Concerta ® 36 mg ( p = 0.265 ) . Math test-correct : Mean pre-dose score for Ritalin ® LA ™ was 68 compared with 64 , 78 , and 76 for Concerta ® 18 mg , 36 mg , and placebo , respectively . Mean AUC(0–8 ) change from pre-dose for Ritalin ® LA ™ was 183 compared with 100 for Concerta ® 18 mg ( p = 0.144 ) , and 117 for Concerta ® 36 mg ( p = 0.245 ) . Safety : One patient from each treatment group experienced a single mild adverse event that included abdominal pain , nausea , and dyspnea . Conclusion While both Ritalin ® LA ™ and Concerta ® were shown to be effective , the different release profiles of each formulation can result in distinct differences between the effects on measures of attention and deportment",
"OBJECTIVES This study examined the prevalence rates and correlates of nonmedical use of prescription opioid analgesics among U.S. college students in terms of student and college characteristics . METHODS This study analyzed data from a nationally representative sample of 10,904 r and omly selected students attending 119 four-year colleges in 2001 . RESULTS The lifetime prevalence of nonmedical prescription opioid use was 12 % and the past year prevalence was 7 % . Approximately one in every four colleges had a prevalence of 10 % or higher for past year nonmedical use of prescription opioids . Multivariate regression analyses indicated nonmedical use was more likely to occur among college students who were white , residents of fraternity and sorority houses , attended more competitive colleges , earned lower grade point averages , and reported higher rates of substance use and other risky behaviors . CONCLUSIONS This study provides evidence that the nonmedical use of prescription opioids represents a problem on college campuses . These findings have important implication s for developing prevention efforts and therapeutic strategies aim ed at reducing the nonmedical use of prescription opioid analgesics among college students while not hindering necessary medication management for pain",
"BACKGROUND Attention-deficit/hyperactivity disorder ( ADHD ) is an early-onset neuropsychiatric disorder that affects 3 % to 7 % of school-age children and 4 % of adults . Its pathophysiology is thought to involve the dopaminergic and nor-adrenergic pathways associated with attention control and impulsivity . These symptoms have largely been defined in the childhood population , but the course of the condition and expression in the adult population are not as well characterized . METHOD This is an ongoing , 3-year , open-label study consisting of adults with DSM-IV ADHD who were previously enrolled in 1 of 2 double-blind , acute-treatment studies of atomoxetine . The results of the interim analysis reported here were derived from the study of 384 patients at 31 sites who had been studied for a period of up to 97 weeks . The primary efficacy measure was the Conners ' Adult ADHD Rating Scale-Investigator Rated : Screening Version ( CAARS-Inv : SV ) total ADHD symptom score . In addition , safety , adverse events , and vital sign measurements were assessed . RESULTS Significant improvement was noted with atomoxetine therapy , with mean CAARS-Inv : SV total ADHD symptom scores decreasing 33.2 % from 29.2 ( baseline of open-label therapy ) to 19.5 ( endpoint of open-label therapy ) ( p secondary efficacy measures . Adverse events consisted primarily of pharmacologically ( noradrenergic ) expected effects , such as increases in heart rate and blood pressure and a slight decrease in weight . CONCLUSION The results of this interim analysis of an ongoing , open-label study of adults with ADHD support the long-term efficacy , safety , and tolerability of atomoxetine for the treatment of adult ADHD",
"OBJECTIVE To examine ( 1 ) moderating effects of oppositional defiant disorder ( ODD ) on attention-deficit/hyperactivity disorder ( ADHD ) treatment response and ( 2 ) responses of ODD symptoms to atomoxetine . METHOD Children and adolescents ( ages 8 - 18 ) with ADHD were treated for approximately 8 weeks with placebo or atomoxetine ( fixed dosing : 0.5 , 1.2 , or 1.8 mg/kg/day , b.i.d . ) under r and omized , double-blind conditions . Among patients with lifetime diagnostic information ( n = 293 ) , 39 % were diagnosed with comorbid ODD and 61 % were not . Treatment-group differences and differences between patients with and without comorbid ODD were examined post hoc for changes on the Attention-Deficit/Hyperactivity Disorder Rating Scale IV-Parent version , investigator-administered and -scored ; Conners ' Parent Rating Scale-Revised Short Form ; Clinical Global Impressions Severity of ADHD Scale ; and the parent-rated Child Health Question naire . RESULTS Youths with ADHD and comorbid ODD showed statistically significant improvement in ADHD , ODD , and quality -of-life measures . Treatment response was similar in youths with and without ODD , except that the comorbid group showed improvement compared with placebo at 1.8 mg/kg/day but not 1.2 mg/kg/day . In contrast , youths without ODD showed improvement at 1.2 mg/kg/day and no incremental benefit at 1.8 mg/kg/day . CONCLUSIONS Atomoxetine treatment improves ADHD and ODD symptoms in youths with ADHD and ODD , although the comorbid group may require higher doses",
"OBJECTIVE The objective of these studies was to compare the rate and extent of absorption of d , l-threo-methylpheni date ( MPH ) from two extended-release products -- a capsule formulation containing coated beads and an OROS tablet formulation -- in healthy male and female subjects under fasted conditions . MATERIAL S Meta date CD ( methylpheni date HCl , USP ) Extended-Release Capsules and Concerta ( methylpheni date hydrochloride ) Extended-Release Tablets . METHODS Two studies were conducted : ( 1 ) A single dose , r and omized , two-way crossover study in 36 adults comparing a 20 mg capsule and an 18 mg tablet , and ( 2 ) a single dose , r and omized , four-way crossover study in 24 adults comparing 2 x 20 mg capsules , one 36 mg tablet , 3 x 20 mg capsules and one 54 mg tablet . Blood sample s were collected over 24 hours and MPH plasma concentrations were used to calculate pharmacokinetic parameters for each treatment . Equivalence of pharmacokinetic parameters for comparable doses of the formulations was concluded if the 90 % confidence intervals ( CI ) for the ratio between test and reference means were within the 80 - 125 % equivalence criterion . RESULTS Both formulations exhibited biphasic plasma concentration-time profiles and were equivalent in terms of total exposure ( AUC(0-last ) and AUC(0-infinity ) ) . However , early exposure ( AUC(0 - 4 ) and AUC(0 - 6 ) , the first maximum measured plasma concentration ( C(max-1 ) , and early plasma MPH concentrations ( 1.5 , 3 and 4 hours ) were greater with the capsule formulation , while later plasma MPH concentrations ( 8 , 10 and 12 hours ) were greater with the tablet formulation ( the CIs were outside the 80 - 125 % required for equivalence and p exposure to MPH and higher MPH concentrations during the first 6 hours following dosing . MPH is frequently used in school children , and this period would correspond to a major part of the school day",
"OBJECTIVE To assess the pharmacokinetic ( PK ) properties of a single daily dose of Adderall ( mixed amphetamine salts ) and the extended-release formulation , SLI381 ( ADDERALL XR ) , in pediatric attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Fifty-one children ( aged 6 - 12 years ) with ADHD participated in a 6-week , seven-visit , PK and pharmacodynamic study . PK sampling occurred during visit 1 and again at visit 7 . At visit 1 , subjects received an initial oral dose of SLI381 , 20 mg . At visit 7 subjects completed 1 week of medication treatment following r and om assignment to once-daily orally dosed SLI381 10 mg , 20 mg , or 30 mg ; Adderall 10 mg ; or placebo . RESULTS PK parameters evidence d substantial intersubject variability ( coefficients of variation = 28 - 56 % ) . Time to maximum concentration ( Tmax ) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine ( t = -2.35 , p = .04 , df = 8.6 ) and 3.2 hours for levoamphetamine ( t = -2.39 , p = .04 , df = 9.2 ) . The d- and l-isomer concentrations were highly correlated and approximated a 3:1 ratio . CONCLUSIONS SLI381 showed extended Tmax values compared with Adderall and appears suitable for once-daily dosing . Intersubject variability underscores the need for individual dose titration",
"OBJECTIVE Five studies have demonstrated the effectiveness of atomoxetine compared with placebo in reducing symptoms of attention-deficit/hyperactivity disorder ( ADHD ) based on parent reports . The primary objective of this clinical trial was to assess the efficacy of once-daily atomoxetine compared with placebo using teacher reports . METHOD One hundred fifty-three patients aged 8 - 12 years were r and omly assigned to receive once-daily atomoxetine or placebo in a 2:1 ratio for 7 weeks . ADHD symptoms at school were primarily assessed by baseline-to-endpoint change on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Teacher Version : Investigator administered and scored ( ADHDRS-IV-Teacher : Inv ) as rated by investigators using teacher reports . RESULTS ADHDRS-IV-Teacher : Inv total scores were significantly lower for children treated with atomoxetine compared with those treated with placebo ( p = .001 ) . Similar results were observed for the inattentive ( p = .016 ) and hyperactive/impulsive ( p .001 ) ADHDRS-IV-Teacher : Inv subscales , the clinician-rated Clinical Global Impressions severity scale ( p = .001 ) , the Conners Global Index-Teacher scale ( p = .008 ) , and the Conners Parent Rating Scale-Revised : Short Form ADHD Index T-Score ( p Discontinuations due to adverse events were low in both groups ( atomoxetine 5.9 % , placebo 0 % , p = .096 ) . CONCLUSIONS This study extends previous results based on parent reports showing that once-daily administration of atomoxetine is safe and effective in improving ADHD symptoms in children and demonstrates that outcomes at school are similar when symptoms are reported by teachers"
] | 4116662c-06ff-11f0-808a-c43d1ab1c353 |
The suboptimal outcomes of atrial fibrillation ( AF ) ablation have been attributed to lack of transmural lesions during pulmonary vein isolation . The advent of contact force ( CF ) sensing technology enables real-time assessment of the applied force at the catheter-tissue interface and increases the chances of transmural lesions . We sought to perform a meta- analysis of data from eligible studies to delineate the true impact of CF technology . Data base search es through April 2015 identified 9 eligible studies ( enrolling 1148 patients ) . The relative risk of AF recurrence at follow-up was used as the primary end point and assessed with r and om-effects meta- analysis . Radiofrequency ( RF ) duration , total procedure length , and fluoroscopy exposure were assessed as secondary outcomes using weighted mean difference with the r and om-effects model . Compared with st and ard technology , the use of CF technology showed a 37 % reduction ( relative risk 0.63 ; 95 % confidence interval 0.44 - 0.91 ; P = .01 ) in AF recurrence at a median follow-up of 12 months and a 7.3-minute reduction ( 95 % confidence interval -14.05 to -0.55 ; P = .03 ) in RF use during ablation . There was no significant difference in total procedure length and fluoroscopy exposure between the 2 groups . In conclusion , this meta- analysis shows that the use of CF technology decreases AF recurrence at a median follow-up of 12 months and also led to decreased use of RF during ablation . There was no difference in total procedure length and fluoroscopy exposure | [
"Background —Atrial fibrillation ( AF ) ablation is increasingly used in clinical practice . We aim ed to study the natural history and long-term outcomes of ablated AF . Methods and Results —We followed 831 patients after pulmonary vein isolation ( PVI ) performed in 2005 . We documented clinical outcomes using our prospect i ve AF registry with most recent up date on this group of patients in October 2009 . In the first year after ablation , 23.8 % had early recurrence . Over long-term follow-up ( 55 months ) , only 8.9 % had late arrhythmia recurrence defined as occurring beyond the first year after ablation . Repeat ablations in patients with late recurrence revealed conduction recovery in at least 1 of the previously isolated PVs in all of them and right-sided triggers with isoproterenol testing in 55.6 % . At last follow-up , clinical improvement was 89.9 % ( 79.4 % arrhythmia-free off antiarrhythmic drugs and 10.5 % with AF controlled with antiarrhythmic drugs ) . Only 4.6 % continued to have drug-resistant AF . It was possible to safely discontinue anticoagulation in a substantial proportion of patients with no recurrence in the year after ablation ( CHADS score ⩽2 , stroke incidence of 0.06 % per year ) . The procedure-related complication rate was very low . Conclusions —Pulmonary vein isolation is safe and efficacious for long-term maintenance of sinus rhythm and control of symptoms in patients with drug-resistant AF . It obviates the need for antiarrhythmic drugs , negative dromotropic agents , and anticoagulants in a substantial proportion of patients",
"BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study",
"BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome ",
"BACKGROUND Electrode-tissue contact is crucial for adequate lesion formation in radiofrequency catheter ablation ( RFCA ) . OBJECTIVE We assessed the impact of direct catheter force measurement on acute procedural parameters during RFCA of atrial fibrillation ( AF ) . METHODS Fifty consecutive patients ( 28 male ) with paroxysmal AF who underwent their first procedure of circumferential pulmonary vein ( PV ) isolation ( PVI ) were assigned to either RFCA using ( 1 ) a st and ard 3.5-mm open-irrigated-tip catheter or ( 2 ) a catheter with contact force measurement capabilities . Using the endpoint of PVI with entry and exit block , acute procedural parameters were assessed . RESULTS Procedural data showed a remarkable decline in ablation time ( radiofrequency time needed for PVI ) from 50.5 ± 15.9 to 39.0 ± 11.0 minutes ( P = 0.007 ) with a reduction in overall procedure duration from 185 ± 46 to 154 ± 39 minutes ( P = 0.022 ) . In parallel , the total energy delivered could be significantly reduced from 70,926 ± 19,470 to 58,511 ± 14,655 Ws ( P = 0.019 ) . The number of acute PV reconnections declined from 36 % to 12 % ( P = 0.095 ) . CONCLUSIONS The use of contact force sensing technology is able to significantly reduce ablation and procedure times in PVI . In addition , energy delivery is substantially reduced by avoiding radiofrequency ablation in positions with insufficient surface contact . Procedural efficacy and safety of this new feature have to be evaluated in larger cohorts",
"INTRODUCTION The additional benefit of contact force ( CF ) technology during pulmonary vein isolation ( PVI ) for paroxysmal atrial fibrillation ( AF ) to improve mid-term clinical outcome is unclear . METHODS AND RESULTS Eligible patients with symptomatic paroxysmal AF were enrolled in this prospect i ve trial , comparing circular antral catheter ablation ( guided by Carto 3 System , Biosense Webster ) using either a new open-irrigated CF catheter ( SmartTouch Thermocool , Biosense Webster ) ( CF group ) or a non-CF open-irrigated catheter ( EZ Steer Thermocool , Biosense Webster ) ( control group ) . Overall , 30 patients were enrolled in each group , with a st and ardized 12-month follow-up , free of antiarrhythmic therapy . Demographic , cardiovascular and anatomic characteristics were similar in both groups . Though complete PVI was eventually achieved in all cases in both groups , success using an exclusive anatomic approach was 80.0 % in CF group versus 36.7 % in control group ( P fluoroscopy exposure ( P radiofrequency time ( P = 0.01 ) . The incidence rates of AF recurrence were 10.5 % ( 95 % CI , 1.38 - 22.4 ) in the CF group , and 35.9 % ( 95 % CI , 12.4 - 59.4 ) in the control group ( log rank test , P = 0.04 ) . After adjustment on potential confounders , the use of CF catheter was found to be associated with a lower AF recurrence ( OR 0.18 , 95 % CI 0.04 - 0.94 , P = 0.04 ) . CONCLUSION Our findings suggest a potential benefit of real-time CF sensing technology , in reducing AF recurrence during the first year after PVI",
"BACKGROUND Contact force ( CF ) sensing catheters provide advantages with regard to safety and efficacy . This study aim ed to evaluate if CF catheters reduce cardiac perforations and other major complications and offer equal safety compared to the magnetic navigation system ( MNS ) . METHODS Data from 1.517 ablation procedures from our prospect i ve registry was analyzed . Ablations were performed using either CF guided catheters ( CF group , n=248 ) , non-CF catheters ( NCF group , n=813 ) , or MNS ( n=456 ) . Four subgroups were analyzed : atrial fibrillation ( AF , n=557 ) , supraventricular tachycardia ( SVT , n=715 ) , ventricular tachycardia ( VT , n=190 ) and patients with congenital heart defects ( CHD , n=55 ) . The primary endpoint of this study was incidence of cardiac perforation . Secondary endpoints were major and minor complications within 30 days of the procedure . RESULTS Complications occurred in 11.3 % ( n=172 ) of the procedures . In 2.8 % ( n=43 ) a major complication occurred , 0.9 % ( n=13 ) had a perforation , 8.5 % ( n=129 ) had a minor complication and 2 patients died ( 0.1 % ) . No cardiac perforation occurred in the CF group , which was significantly different from NCF procedures ( 0.0 % vs. 1.6 % ; relative risk 0.76 , 95 % CI 0.74 - 0.79 , P=0.031 ) and equal to MNS ( 0.0 % ) . This was also observed in the AF subgroup ( 0.0 % vs. 3.3 % ; RR 0.67 , 95 % CI 0.63 - 0.72 , P=0.021 ) , and the occurrence of major complications was lower for CF versus NCF procedures ( 2.1 % vs. 7.8 % , P=0.010 ) . CONCLUSIONS CF-guided catheter ablation is superior to NCF with regard to procedural safety and avoidance of cardiac perforation . This difference is due to a reduction of cardiac perforation and major complications in the AF subgroup"
] | 4116665e-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND AND PURPOSE Recent studies have shown that visit-to-visit blood pressure variability is a powerful risk factor for stroke , is reduced by calcium channel blockers and diuretics , and increased by β-blockers . However , it is unknown whether these effects are dose-dependent and persist in combination with other drugs . METHODS Cochrane and Medline data bases were search ed for systematic review s and r and omized controlled trials of antihypertensive drugs . Eligible trials r and omized all patients to a combination of drug classes or different doses of the same drug . Baseline and follow-up data for mean ( SD ) systolic blood pressure ( SBP ) and diastolic blood pressure were extracted . Differences in interindividual variance ( SD2 ) in blood pressure were expressed as a ratio ( VR ) . Estimates were pooled by r and om-effects meta- analysis . RESULTS Calcium channel blockers reduced interindividual variability in SBP when added to another agent ( VR , 0.75 ; 95 % CI , 0.64 to 0.87 ; P=0.0002 ; 12 trials ; 1565 patients ) with a smaller reduction with diuretics ( VR , 0.85 ; 0.71 to 1.01 ; P=0.07 ; 17 trials ; 3217 patients ) . Adding other agents to calcium channel blockers did not significantly affect SBP variability ( VR , 1.06 ; 0.83 to 1.34 ; P=0.65 ; 12 trials ; 1460 patients ) despite a 5.8-mm Hg reduction in mean SBP . R and omization to a higher dose of calcium channel blockers reduced SBP variability ( VR , 0.84 ; 0.74 to 0.94 ; P=0.004 ; 25 trials ; 2179 patients ) , whereas r and omization to a higher dose of β-blockers increased SBP variability ( VR , 1.31 ; 1.01 to 1.69 ; P=0.034 ; 6 trials ; 486 patients ) . CONCLUSIONS Effects of antihypertensive drugs on SBP variability are dose-dependent and persist when used in combinations . Use of a high dose of a calcium channel blocker alone or in combination with other agents is therefore likely to be particularly effective in prevention of stroke | [
"The antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg , both combined with hydrochlorothiazide ( HCTZ ) 25 mg , were assessed in a pooled analysis from two large trials with identical study design s in patients with stage 1–2 hypertension . The trials were double-blind with a 4:4:1 r and omization scheme to compare once-daily telmisartan 80 mg and HCTZ 25 mg versus once-daily valsartan 160 mg and HCTZ 25 mg versus once-daily placebo on reductions in clinic blood pressure ( BP ) . The primary end point was changes from baseline in BP at the end of 8 weeks . In total , 2121 patients were r and omized ( telmisartan – HCTZ , 942 , valsartan – HCTZ , 952 , and placebo , 227 ) and had baseline seated BPs of 154/102 and 155/102 mm Hg in the two studies , respectively . Changes from baseline in BP after administration of telmisartan – HCTZ ( −24.5/−18.0 mm Hg ) were significantly greater than for both placebo ( −4.1/−6.5 mm Hg ) and valsartan – HCTZ ( −22.3/−16.8 mm Hg ) ( versus placebo , P for systolic and diastolic BP ; versus valsartan – HCTZ , P=0.0004 for systolic BP and P=0.0019 for diastolic BP ) . Adverse event rates were higher in the placebo group than in the active treatment groups ( placebo , 41 % , telmisartan – HCTZ , 30 % , and valsartan – HCTZ , 30 % , P that telmisartan – HCTZ at doses of 80/25 mg lowered systolic and diastolic BP to a greater extent than valsartan – HCTZ at doses of 160/25 mg in stage 1–2 hypertension . The magnitude of the BP-lowering effect provides support for the use of angiotensin receptor blockers with higher doses of a thiazide diuretic ( 25 mg ) to improve hypertension control ",
"Increased arterial stiffness , as estimated from aortic pulse wave velocity ( Ao-PWV ) , and albuminuria are independent predictors for cardiovascular disease in type 2 diabetes mellitus ( T2DM ) . Whether angiotensin receptor blockers ( ARBs ) , drugs with cardio-renal protective effects , improve Ao-PWV to a greater extent than other equipotent antihypertensive medications remains unclear . After a 4-week washout phase , we compared the effects of valsartan ( n=66 ) , an ARB , with that of amlodipine ( n=65 ) , a calcium channel blocker on Ao-PWV in 131 T2DM patients with pulse pressure ( PP ) ≥60 mm Hg and raised albumin excretion rate ( AER ) in a 24-week r and omized , double-blind , parallel group study . Hydrochlorothiazide ( HCTZ ) 25 mg/d was added to valsartan 160 mg and amlodipine 5 mg/od uptitrated to 10 mg/od after 4 weeks to ensure equivalent BP control . After 24 weeks brachial and central aortic PP had fallen to a similar extent with attained mean ( SD ) brachial and central PP of 61.6 ( 13.6 ) and 47.3 ( 14.1 ) mm Hg in the valsartan/HCTZ group and 61.5 ( 12.2 ) and 47.3 ( 9.9 ) mm Hg in the amlodipine group , respectively . Ao-PWV showed a significantly greater reduction , mean ( 95 % CI ) , −0.9 m/s ( −1.4 to −0.3 ) for valsartan/HCTZ compared to amlodipine ( P=0.002 ) . AER fell significantly only with Val/HCTZ from 30.8(20.4 , 46.5 ) to 18.2(12.5 , 26.3 ) mcg/min , ( P=0.01 ) with between treatment difference in favor of Val/HCTZ of −15.3mcg/min ( P were not correlated . Valsartan/HCTZ improves arterial stiffness and AER to a significantly greater extent than amlodipine despite similar central and brachial BP control . These 2 effects , which appear independent of each other , may explain the specific cardio-renal protective properties of ARBs",
"BACKGROUND The aim of the study was to evaluate whether the combined treatment of calcium channel blocker , amlodipine and beta-blocker , betaxolol , favorably affects cardiac autonomic nervous activity ( CANA ) and health-related quality of life ( HRQL ) . METHODS AND RESULTS A total of 65 patients with a poor blood pressure ( BP ) control with a low dose amlodipine therapy were r and omly assigned to the amlodipine dose-up group ( n=21 ) and betaxolol adding group ( n=44 ) . Before and after a 6-month treatment , BP , heart rate variability ( HRV ) , HRQL and blood chemistries were evaluated . Low frequency ( LF ) spectra/high frequency ( HF ) spectra and HF/total power spectra ( TP ) were calculated as indexes of CANA , and HRQL was assessed by the question naire sheets . BP was well controlled in all patients of the present study . In the betaxolol adding group , LF/HF decreased ( 2.1+/-1.9 to 1.3+/-0.9 , p HF/TP reciprocally increased ( 0.41+/-0.17 to 0.52+/-0.18 , p amlodipine dose-up group showed no significant changes in the HRV . HRQL was significantly improved in the betaxolol adding group , whereas it remained unchanged in the amlodipine dose-up group . Blood chemistries remained unchanged except for the slightly increased plasma brain natriuretic peptide concentrations in the betaxolol adding group ( 36+/-47 to 62+/-62 pg/ml , p amlodipine and betaxolol appears to be more useful than amlodipine dose-up therapy , because combined treatment improves CANA and HRQL",
"OBJECTIVE To evaluate the 24 h antihypertensive efficacy and duration of action of felodipine extended release ( ER ) in comparison with two other long acting dihydropyridine calcium antagonists , amlodipine and nifedipine gastrointestinal therapeutic system ( GITS ) , in patients with mild to moderate essential hypertension substantiated by ambulatory blood pressure ( BP ) monitoring . DESIGN R and omized , forced titration , parallel group study . Clinic BP was measured at every patient 's visit , and 24 h ambulatory BP was monitored at baseline and at the end of each dose-titration period . SETTING Single centre : hypertension research unit in Quebec City , Quebec . PATIENTS There were 89 patients enrolled into the study . Eighty-four eligible patients were r and omized , and 83 completed the study and were included in the final efficacy analysis . INTERVENTIONS Following a two-to four-week washout period ( baseline ) , patients were r and omly allocated to receive felodipine ER 5 mg , amlodipine 5 mg or nifedipine GITS 30 mg for four weeks ( low dose ) . All study patients had their daily dose doubled to felodipine ER 10 mg , amlodipine 10 mg or nifedipine GITS 60 mg for a further four weeks ( high dose ) . MAIN RESULTS Significant ( P baseline in clinic BP were observed in all treatment groups for low and high doses . Ambulatory BP profiles showed comparable blood pressure reductions with felodipine ER and amlodipine , and a trend towards a lesser reduction with nifedipine GITS during 24 h , daytime and night-time periods . BP loads were similarly reduced with the three treatments . Trough to peak ratios ( T : Ps ) were calculated from 24 h ambulatory BP curves according to two different approaches : for diastolic and systolic BP , respectively , the global approach produced T : Ps of 0.49 and 0.50 with felodipine ER 5 mg ; 0.50 and 0.34 with felodipine ER 10 mg ; 0.70 and 0.60 with amlodipine 5 mg ; 0.88 and 0.82 with amlodipine 10 mg ; 0.65 and 0.55 with nifedipine GITS 30 mg ; 0.68 and 0.53 with nifedipine GITS 60 mg . T : Ps in the individual approach were 0.07 and 0.10 with felodipine ER 5 mg ; 0.23 and 0.31 with felodipine ER 10 mg ; 0.22 and 0.31 with amlodipine 5 mg ; 0.45 and 0.58 with amlodipine 10 mg ; 0.27 and 0.31 with nifedipine GITS 30 mg ; and 0.24 and 0.40 with nifedipine GITS 60 mg . CONCLUSION There was no evidence in this study of a difference among felodipine ER , amlodipine and nifedipine GITS in lowering ambulatory or clinic BP . Treatment based on ambulatory BP may be preferable to treatment guided by T : Ps because ambulatory BP is firmly established as a predictor of cardiovascular risk . Furthermore , there is no consensus on how to calculate T : Ps , and different methods of calculation may give divergent results",
"OBJECTIVE --To assess the effectiveness of angiotensin converting enzyme inhibition in preventing the development of diabetic nephropathy ( albuminuria greater than 300 mg/24h ) . DESIGN --Open r and omised controlled study of four years ' duration . SETTING --Outpatient diabetic clinic in tertiary referral centre . PATIENTS --44 normotensive ( mean blood pressure 127/78 ( SD 12/10 ) mm Hg ) insulin dependent diabetic patients with persistent microalbuminuria ( 30 - 300 mg/24h ) . INTERVENTIONS --The treatment group ( n = 21 ) was initially given captopril ( 25 mg/24 h ) . The dose was increased to 100 mg/24 h during the first 16 months and thiazide was added after 30 months . The remaining 23 patients were left untreated . MAIN OUTCOME MEASURES --Albuminuria , kidney function , development of diabetic nephropathy ( albuminuria greater than 300 mg/24 h ) , and arterial blood pressure . RESULTS -- Clinical and laboratory variables were comparable at baseline . Urinary excretion of albumin was gradually reduced from 82 ( 66 - 106 ) to 57 ( 39 - 85 ) mg/24 h ( geometric mean ( 95 % confidence interval ) ) in the captopril treated group , whereas an increase from 105(77 - 153 ) to 166 ( 83 - 323 ) mg/24 h occurred in the control group ( p less than 0.05 ) . Seven of the untreated patients progressed to diabetic nephropathy , whereas none of the captopril treated patients developed clinical overt diabetic nephropathy ( p less than 0.05 ) . Systemic blood pressure , glomerular filtration rate , haemoglobin A1c concentration , and urinary excretion of sodium and urea remained practically unchanged in the two groups . CONCLUSIONS --The findings suggest that angiotensin converting enzyme inhibition postpones the development of clinical overt diabetic nephropathy in normotensive insulin dependent diabetic patients with persistent microalbuminuria",
"The efficacy of once-a-day cilazapril ( a new long acting converting enzyme inhibitor ) therapy for the 24 h control of hypertension and its effects on the renin-angiotensin axis were investigated . Twenty-four uncomplicated hypertensive patients whose sitting diastolic blood pressures remained within 94 to 114 mmHg after four weeks of placebo were r and omly assigned on a double-blind basis to receive either continued placebo or cilazapril therapy at a single dose of 1.25 , 2.5 or 5.0 mg/day for a further four weeks . At the end of weeks 4 and 8 , systolic and diastolic blood pressures and heart rates were recorded , supine and st and ing , at 0 , 2 , 4 , 6 , 9 , 12 and 24 h following a single dose of drug . At the same times , blood was withdrawn for determination of plasma renin activity and aldosterone . Supine and erect systolic and diastolic blood pressures were lowered to normotensive levels with an optimal response being achieved at a dose of 2.5 mg/day . Supine and erect heart rates were unchanged with respect to drug dosage , and the reflex increase in heart rate and diastolic blood pressure on changing from supine to erect posture was maintained in all groups . Maximum antihypertensive efficacy was from 2 to 6 h after drug ingestion . There were no changes in resting aldosterone , but plasma renin activity was increased at all drug dosages . A single 2.5 mg dose of cilazapril provides blood pressure control for a 24 h period . Cilazapril does not appear to interfere with the reflex autonomic responses to postural change",
" Perindopril erbumine , a new long‐acting , non‐sulfhydryl‐containing angiotensin converting enzyme inhibitor , was evaluated in 289 patients with hypertension in a 16‐week , double‐blind , placebo‐controlled dose‐ranging study . After 4 weeks of single‐blind placebo treatment , patients with supine diastolic arterial pressures from 95 to 114 mm Hg were r and omized to receive placebo , 4 mg perindopril once daily , or 2 mg perindopril twice daily . The daily dose of perindopril was increased by 4 mg every 4 weeks to a maximum of 16 mg per day . Mean decreases in systolic and diastolic arterial pressure were greater with perindopril than with placebo ( p in arterial pressure reduction or in the percentage of responders between once‐ and twice‐daily administration of perindopril . Adverse reactions with perindopril were generally mild and , with the exception of cough , were similar with placebo . The findings of this study indicate that perindopril is effective , well tolerated , and suitable for once‐daily administration for the treatment of hypertension",
"The aim of this study was to compare the effect of valsartan/amlodipine and atenolol/amlodipine combination in preventing the recurrence of atrial fibrillation ( AF ) in hypertensive diabetic patients with a history of recent paroxysmal atrial fibrillation . Two hundred ninty-six hypertensive patients with well-controlled type 2 diabetes in sinus rhythm but with at least 2 ECG-documented episodes of AF in the previous 6 months were r and omized to 160 mg of valsartan plus amlodipine ( titrated from 2.5 to 10 mg ) or to 100 mg of atenolol plus amlodipine ( 2.5 to 10 mg ) in addition to their previous antiarrhythmic treatment ( if any ) and were followed up for 1 year . Blood pressure ( BP ) and a 24-hour ECG were evaluated monthly . The patients were asked to report any episode of symptomatic AF and to perform an ECG as early as possible . SBP/DBP values were significantly reduced after 12 months with valsartan/amlodipine ( from 150.4/93.5 to 126.37/7.4 mm Hg , P atenolol/amlodipine ( from 151.1/94.2 to 127.1/77.9 mm Hg , P ECG-documented episode of AF was reported in 20.3 % of the patients treated with valsartan/amlodipine and in 34.1 % of those treated with atenolol/amlodipine , with a significant difference between treatments ( P valsartan/amlodipine combination on AF recurrence was more evident in patients treated with amiodarone or propafenone than in patients treated with other antiarrhythmic drugs or without antiarrhythmic treatment . Despite similar BP reduction , valsartan/amlodipine combination was more effective in patients treated with amiodarone or propafenone than atenolol/amlodipine in preventing new episodes of AF in hypertensive diabetic patients",
"Background and Aim . Endothelial dysfunction in hypertensive type-2 diabetic patients is associated with increased levels of circulating soluble adhesion molecules ( SAM ) . SAM participate in the development of diabetic macroangiopathy and microangiopathy . The aim of this study was to compare the effect of tr and olapril ( T ) and its fixed-dose combination with verapamil ( FDTV ) on SAM levels in hypertensive type-2 diabetic patients . Methods . Forty type-2 diabetic patients with never-treated hypertension were r and omly assigned to two groups . One group ( FDTV ) received 2/180 mg once a day ; the other group received T 2 mg once a day . Study drugs were administered for three months in both groups . VCAM-1 , ICAM , and E-selectin were measured by ELISA at the beginning and end of the study . Patients were evaluated monthly for blood pressure , fasting serum glucose , and adverse events . Statistical analysis was performed with ANOVA . Results . Both therapeutics regimens reduced significantly the levels of the SAM tested . When both groups were compared , we did not find a significant difference in ICAM and E-selectin reduction . However , VCAM-1 presented a significantly greater reduction ( p = 0.022 ) in the tr and olapril-verapamil group . No patient suffered adverse events . Conclusion . Our results show that FDTV produces a greater reduction of VCAM-1 circulating levels than tr and olapril alone . This may explain some of the beneficial effects of this fixed dosed combination that are non-related to its antihypertensive effects",
"BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors or angiotensin II receptor blockers ( ARB ) have been shown to delay the progression to proteinuria and kidney failure in hypertensive type 2 diabetic patients with diabetic nephropathy . Further synergistic effect may be obtained by combined therapy with both ARB and ACE inhibitors . OBJECTIVE To evaluate the effect of dual blockage of the renin-angiotensin system by adding maximal recommended dose of ARB with maximal recommended dose of ACE inhibitors in type 2 diabetic patients with diabetic nephropathy . MATERIAL AND METHOD Type 2 diabetic patients with urine protein/creatinine ( UPCr ) > 0.5 gm/gm and hypertension who received maximal recommended dose of ACE inhibitors ( Enalapril 40 mg/day ) over three months were r and omized to two groups . ARB group received adding maximal recommended dose of ARB ( Telmisartan 80 mg/day ) and control group received previous ACE inhibitors only for 24 weeks . RESULTS Eighty patients were enrolled . ARB group led to significantly reduced UPCr from baseline at week 8 , 12 , and 24 ( 2.65 + /- 1.81 , 2.24 + /- 1.85 , 2.24 + /- 1.88 and 1.98 + /- 1.73 gm/gm respectively , p UPCr in the control group was unchanged ( 1.97 + /- 1.56 , 1.85 + /- 1.27 , 1.97 + /- 1.11 and 1.96 + /- 1.42 gm/gm respectively , p > 0.05 ) . ARB group induced an additional reduction in proteinuria of 29.25 % ( 95 % CI 9.68 - 48.82 ) compared with control group . By the end of the present study , glomerular filtration rate had fallen from 41.76 + /- 12.16 to 37.84 + /- 13.59 ml/min/1.73 m2 in ARB group and 50.89 + /- 29.43 to 49.41 + /- 29.85 ml/min/1.73 m2 in control group ( p > 0.05 ) . Serum potassium had changed from 4.51 + /- 0.48 to 4.58 + /- 0.13 mEq/L in ARB group and 4.60 + /- 0.58 to 4.40 + /- 0.13 mEq/L in the control group ( p > 0.05 ) . No other serious adverse effects were reported during treatment . CONCLUSION Adding maximal recommended dose of ARB with maximal recommended dose of ACE inhibitors in type 2 diabetic patients can reduce proteinuria more than ACE inhibitors alone . This treatment is safe and well tolerated ",
"Since there is concern that the potentially useful antihypertensive combination of verapamil and propranolol might lead to adverse cardiovascular responses , we have investigated its effects , not only on blood pressure , but also on electrocardiographic and echocardiographic variables . Fourteen hypertensive patients participated in a double-blind , r and omized , crossover comparison of verapamil 360 mg , propranolol 240 mg , verapamil 360 mg + propranolol 240 mg , and placebo , each given for 4 weeks . The antihypertensive effect of verapamil + propranolol was greater than that of either drug alone . Pulse rate was reduced by propranolol but not verapamil . However , addition of verapamil to propranolol led to further reduction in pulse rate . The PR interval was prolonged by verapamil + propranolol when compared with all other treatments . The active drugs increased ventricular dimensions and the effect of the combination was statistically significant . Thus , verapamil + propranolol is an effective antihypertensive combination , but heart rate , atrio-ventricular conduction and left ventricular function may be affected adversely , necessitating careful monitoring of therapy",
"In a double-blind study , 128 patients with essential hypertension , refractory to beta-blocker monotherapy , were r and omised to 1 of 4 treatment groups . Felodipine 2.5 mg twice daily , 5 mg twice daily , 10 mg twice daily or matched placebo twice daily were administered in addition to the beta-blocker for 4 weeks . Mean supine blood pressure before r and omisation to treatment was 167/104 + /- 20/7 mm Hg . After 4 weeks of treatment , supine blood pressures 2 hours after dose were 161/98 + /- 20/10 mm Hg ( P ) , 152/92 + /- 23/8 mm Hg ( felodipine 2.5 mg ) , 142/87 + /- 18/7 mm Hg ( felodipine 5 mg ) and 142/86 + /- 17/7 mm Hg ( felodipine 10 mg ) . The falls in systolic and diastolic blood pressures were significantly greater for all 3 felodipine groups than for placebo . Blood pressure reductions were less marked 14 hours after dosage : 161/100 + /- 20/9 mm Hg ( P ) , 160/97 + /- 24/9 mm Hg ( felodipine 2.5 mg ) , 153/97 + /- 21/11 mm Hg ( felodipine 5 mg ) , and 157/94 + /- 19/9 mm Hg ( felodipine 10 mg ) ; but the two higher doses of felodipine produced a significantly greater sustained fall in blood pressure than placebo . There was a correlation between the dose of felodipine and its antihypertensive effect . St and ing blood pressures were reduced to the same extent as supine measurements . Heart rate was not significantly affected . Bodyweight did not increase during the study . Side effects of felodipine therapy were minor , and mostly attributable to the vasodilatory properties of the drug . Only 4 patients withdrew because of side effects . It is concluded that felodipine is an effective and well tolerated antihypertensive drug , and that 5 mg twice daily is a suitable starting dose in hypertensive patients refractory to beta-blocker monotherapy . It may be necessary to increase this dose to 10 mg twice daily in selected patients",
"This study was conducted to determine the effects of a tablet combining losartan/hydrochlorothiazide ( L/HCTZ ) in comparison with losartan alone in Japanese diabetic patients with hypertension . Thirty consecutive Japanese diabetic patients with hypertension were r and omly assigned to group A , receiving losartan alone for the first 3 months , then L/HCTZ for the next 3 months , or group B , receiving L/HCTZ for the first 3 months , then losartan alone for the next 3 months . Clinical and biological parameters were obtained before , and 3 and 6 months after the start of this study . The decreases in systolic and diastolic blood pressure ( BP ) during treatment with L/HCTZ were significantly greater than in treatment with losartan alone . Both treatments significantly and similarly decreased urinary albumin excretion , the cardio-ankle vascular index ( CAVI ) and augmentation index ( AI ) . There was no significant difference in metabolic change during both the mono- and combination pharmacotherapies . The tablet combining L/HCTZ significantly reduced systolic and diastolic BP compared with the losartan monotherapy , and offered benefits similar to losartan monotherapy for albuminuria , arterial stiffness assessed by the CAVI and AI , and metabolic effects . Thus , the L/HCTZ tablet could be a useful drug for Japanese diabetic patients with hypertension",
"OBJECTIVE --To assess whether angiotensin converting enzyme inhibition reduces proteinuria in diabetic nephropathy more than blood pressure reduction with other antihypertensive treatment . DESIGN -- Prospect i ve , open r and omised study lasting eight weeks in patients with diabetic nephropathy . SETTING --Outpatient nephrology clinics . PATIENTS --40 Patients with type I diabetes and diabetic nephropathy with reduced renal function . INTERVENTION -- Antihypertensive treatment with enalapril or metoprolol , usually combined with frusemide . MAIN OUTCOME MEASURES --Arterial blood pressure and urinary excretion of albumin and protein . RESULTS --Arterial blood pressure after eight weeks was 135/82 ( SD 13/7 ) mm Hg in the group given enalapril and 136/86 ( 16/12 ) mm Hg in the group given metoprolol . Proteinuria and albuminuria were similar in both groups before r and omisation . After eight weeks ' treatment , the geometric mean albumin excretion was 0.7 ( 95 % confidence interval 0.5 to 1.2 ) g/24 h in the patients given enalapril and 1.6 ( 1.1 to 2.5 ) g/24 h in the patients given metoprolol ( p less than 0.02 ) . The proteinuria was 1.1 ( 0.7 to 1.7 ) and 2.4 ( 1.6 to 3.6 ) g/24 h respectively ( p less than 0.02 ) . CONCLUSIONS --Antihypertensive treatment with enalapril reduced proteinuria in patients with diabetic nephropathy more than an equally effective antihypertensive treatment with metoprolol . This points to a specific antiproteinuric effect of the angiotensin converting enzyme inhibitor independent of the effect on systemic blood pressure",
"Background —Activation of the renin-angiotensin-aldosterone system and oxidative modification of LDL cholesterol play important roles in atherosclerosis . The Study to Evaluate Carotid Ultrasound changes in patients treated with Ramipril and vitamin E ( SECURE ) , a sub study of the Heart Outcomes Prevention Evaluation ( HOPE ) trial , was a prospect i ve , double-blind , 3 × 2 factorial design trial that evaluated the effects of long-term treatment with the angiotensin-converting enzyme inhibitor ramipril and vitamin E on atherosclerosis progression in high-risk patients . Methods and Results —A total of 732 patients ≥55 years of age who had vascular disease or diabetes and at least one other risk factor and who did not have heart failure or a low left ventricular ejection fraction were r and omly assigned to receive ramipril 2.5 mg/d or 10 mg/d and vitamin E ( RRR-&agr;-tocopheryl acetate ) 400 IU/d or their matching placebos . Average follow-up was 4.5 years . Atherosclerosis progression was evaluated by B-mode carotid ultrasound . The progression slope of the mean maximum carotid intimal medial thickness was 0.0217 mm/year in the placebo group , 0.0180 mm/year in the ramipril 2.5 mg/d group , and 0.0137 mm/year in the ramipril 10 mg/d group ( P = 0.033 ) . There were no differences in atherosclerosis progression rates between patients on vitamin E and those on placebo . Conclusions —Long-term treatment with ramipril had a beneficial effect on atherosclerosis progression . Vitamin E had a neutral effect on atherosclerosis progression ",
"In guidelines , a combination therapy of two or more antihypertensives is recommended for treatment of hypertension where monotherapy is ineffective . Although diuretics or calcium channel blockers are commonly used as add-ons to angiotensin receptor blocker ( ARB ) , the most effective and safe combination has not been established . In this r and omized 4-month study , the efficacy and safety were compared between an ARB/diuretics ( losartan/hydrochlorothiazide [ HCTZ ] ) combination and the most prescribed combination , ARB/calcium channel blocker ( c and esartan/amlodipine ) in hypertensive patients for whom 8 mg/day of c and esartan proved ineffective . After 36 patients were recruited and allocated into two groups , changes in blood pressure ( BP ) and laboratory values were analyzed in 31 patients : 16 patients received losartan ( 50 mg/day)/HCTZ ( 12.5 mg/day ) ( L/H group ) , and 15 patients received c and esartan ( 8 mg/day)/amlodipine ( 5 mg/day ) ( C/A group ) after 5 patients were withdrawn . After 4 months , L/H significantly ( p reduced mean systolic BP (SBP)/diastolic BP ( DBP ) from baseline 160/89±13/11 mmHg to 140/80±9/8 mmHg , and C/A reduced BP from 161/90±10/11 mmHg to 141/79±10/7 mmHg . The efficacy in reducing BP was similar between the two combination therapies . L/H significantly reduced serum potassium , but within the normal range , and did not increase serum uric acid or serum triglyceride . With L/H , the percentage of patients who attained the BP goal in SBP was higher in elderly patients than in younger patients . As L/H is more cost-effective than c and esartan/amlodipine and has fewer adverse effects on uric acid and other metabolic parameters than diuretic monotherapy , it is concluded to be useful for the management of hypertension",
"The antihypertensive efficacy of the new dihydro-pyridine derivative nilvadipine given once daily was compared in two r and omized , double-blind studies with that of hydrochlorothiazide/triamterene ( HCT/T ) and of enalapril . In the first study , arterial pressures were compared after 4 weeks of therapy with nilvadipine ( 16 mg q.d . ) or HCT/T ( 25/50 mg q.d . ) in patients with mild-to-moderate hypertension in a parallel-group design . The combination of both treatments was administered after 4 weeks if diastolic arterial pressures were mm Hg . The blood pressure ( BP ) in the nilvadipine group ( n = 125 ) was 161/102 ± 17/7 ( mean ± SD ) mm Hg after a 2-week placebo period and decreased after 4 weeks by – 16/– 13 ± 22/12 mm Hg . The BP decreased in the HCT/T group ( n = 124 ) compared to the nilvadipine group to a similar degree ( p = 0.91 , n.s . ) from 160/103 ± 17/8 mm Hg by −17/-13 ± 18/11 mm Hg . A combination therapy was started after 4 weeks in 39 patients in the nilvadipine group and in 34 patients in the HCT/T group . This led independently of the treatment sequence , to a similar decrease in BP in the nilvadipine group ( – 17/7 ± 16/10 mm Hg ) and in the HCT/T group ( -12/9 ± 16/9 mm Hg ) . In the second study , the antihypertensive effect of nilvadipine ( 1 x 8 mg ) was compared with that of enalapril ( 1x10 mg ) in a r and omized , double-blind , crossover design . Sixty-one patients with essential hypertension ( WHO I – II ) were treated over two 4-week periods following placebo periods of 2 weeks . Nonresponders ( BP dosage . The BP decreased to a similar degree after 4 weeks on nilvadipine from 175/108 ± 13/7 mm Hg by −19/-13 mm Hg and from 176/107 ± 13/6 mm Hg by −21/-13 mm Hg after 4 weeks on enalapril to 156/95 + 14/ 9 mm Hg and 155/94 ± 16/10 mm Hg , respectively . Goal diastolic BPs of nilvadipine and enalapril with diastolic BPs mm Hg . Combination therapy caused a decrease in the diastolic BP of −14/-13 mm Hg . In conclusion , nilvadipine administered once daily was as effective as hydrochlorothiazide or enalapril in lowering the BP . In combination with a diuretic , the sequence of treatments , i.e. , diuretic first or nilvadipine first , had no influence on antihypertensive efficacy . The combination of calcium antagonist and diuretic was as effective as that of the calcium antagonist with enalapril",
"BACKGROUND Blood pressure is a determinant of the risk of stroke among both hypertensive and non-hypertensive individuals with cerebrovascular disease . However , there is uncertainty about the efficacy and safety of blood-pressure-lowering treatments for many such patients . The perindopril protection against recurrent stroke study ( PROGRESS ) was design ed to determine the effects of a blood-pressure-lowering regimen in hypertensive and non-hypertensive patients with a history of stroke or transient ischaemic attack . METHODS 6105 individuals from 172 centres in Asia , Australasia , and Europe were r and omly assigned active treatment ( n=3051 ) or placebo ( n=3054 ) . Active treatment comprised a flexible regimen based on the angiotensin- converting-enzyme inhibitor perindopril ( 4 mg daily ) , with the addition of the diuretic indapamide at the discretion of treating physicians . The primary outcome was total stroke ( fatal or non-fatal ) . Analysis was by intention to treat . FINDINGS Over 4 years of follow up , active treatment reduced blood pressure by 9/4 mm Hg . 307 ( 10 % ) individuals assigned active treatment suffered a stroke , compared with 420 ( 14 % ) assigned placebo ( relative risk reduction 28 % [ 95 % CI 17 - 38 ] , p risk of total major vascular events ( 26 % [ 16 - 34 ] ) . There were similar reductions in the risk of stroke in hypertensive and non-hypertensive subgroups ( all p perindopril plus indapamide reduced blood pressure by 12/5 mm Hg and stroke risk by 43 % ( 30 - 54 ) . Single-drug therapy reduced blood pressure by 5/3 mm Hg and produced no discernable reduction in the risk of stroke . INTERPRETATION This blood-pressure-lowering regimen reduced the risk of stroke among both hypertensive and non-hypertensive individuals with a history of stroke or transient ischaemic attack . Combination therapy with perindopril and indapamide produced larger blood pressure reductions and larger risk reductions than did single drug therapy with perindopril alone . Treatment with these two agents should now be considered routinely for patients with a history of stroke or transient ischaemic attack , irrespective of their blood pressure",
"Summary 116 patients from 4 clinics participated in a double blind study to assess the efficacy of ( BAYl 5240 ) , a nifedipine-acebutolol fixed combination ( 10 mg+100 mg ) , as compared to nifedipine 20 mg in essential hypertension . During the 10 week study , the mean recumbent blood pressure decreased 1 to 3 h after treatment from 175.5/105.2 to 148.3/88.0 mmHg in the BAY1 5240 group and from 174.3/102.9 to 150.3/86.5 mmHg in the nifedipine group . The results also showed a comparable decrease in the mean systolic ( SBP ) and diastolic ( DBP ) blood pressures before treatment ( 24 h after last tablet ) and after physical exertion before and after either drug given for 4 weeks . Doubling of the dose for 4 additional weeks produced a moderate and similar additional decrease in blood pressure . The results show the possibility of treating essential hypertension with a low dose of a beta-adrenergic blocking agent in combination with 10 mg nifedipine . Both regimens were well tolerated . One patient in the BAYl 5240 group and 2 in the nifedipine group , all treated by the same investigator , were withdrawn from the study because of headache during the nifedipine pre-period",
"BACKGROUND Proteinuria predicts renal disease progression , and its reduction by angiotensin-converting enzyme inhibitors ( ACEi ) or angiotensin II receptor antagonists ( ARA ) is renoprotective . METHODS In this prospect i ve , r and omized , cross-over study of 24 patients with nondiabetic , chronic nephropathies , we compared the effects on proteinuria , renal hemodynamics , and glomerular permselectivity of 8 weeks with comparable blood pressure control achieved by benazepril ( 10 mg/day ) and valsartan ( 80 mg/day ) combined therapy with those achieved by benazepril ( 20 mg/day ) or valsartan ( 160 mg/day ) alone . RESULTS Despite comparable changes in blood pressure and glomerular filtration rate ( GFR ) , combined therapy decreased proteinuria more than benazepril ( -56 % vs. -45.9 % , P=0.02 ) and valsartan ( -41.5 % , P=0.002 ) . Changes in urinary protein to creatinine ratio followed the same trend . Filtration fraction and renal vascular resistances ( RVR ) decreased more with combined ( -14.7%,-23.7 % ) or benazepril ( -12.4 % , -20.5 % ) than with valsartan ( -2.7 % , -12.5 % , P RVR changes , adjusted for GFR changes , were associated with those in proteinuria ( P Changes in glomerular permeability were comparable and did not predict different changes in proteinuria in the three groups . CONCLUSION At comparable blood pressure , combined ACEi and ARA decreased proteinuria better than ACEi and ARA . The greater antiproteinuric effect most likely depended on an ACEi-related hemodynamic effect , in addition to glomerular size selectivity amelioration . Long-term combined ACEi and ARA therapy may be more renoprotective than treatment with each agent alone",
"This double-blind , placebo-controlled , four-way balanced design crossover study included hypertensive patients aged 60–85 years with mean office-measured sitting systolic blood pressure ( SBP ) 160–179 mm Hg and daytime SBP ⩾135 mm Hg . After a 2-week run-in period , during which previous medications were discontinued , each patient received the following four treatments in r and omized order for 4 weeks each : lercanidipine 10 mg ( L ) , enalapril 20 mg ( E ) , lercanidipine 10 mg plus enalapril 20 mg ( L/E ) and placebo ( P ) . At the end of each treatment period , office trough blood pressure ( BP ) was measured and a 24-h Ambulatory Blood Pressure Monitoring ( ABPM ) was performed . Seventy-five patients ( mean age 66 years , office BP 168/92 mm Hg , daytime SBP 151 mm Hg ) were r and omized and 62 completed the study with four valid post-baseline ABPMs . The administration of P , L , E and L/E was associated with a mean 24-h SBP of 144 , 137 , 133 and 127 mm Hg , respectively . All active treatments significantly reduced the mean 24-h SBP in comparison with placebo , but L/E was significantly more effective than L and E alone . Similarly , office SBP was significantly more reduced with L/E ( −16.9 mm Hg ) than with L ( −5.0 mm Hg ) or E ( −5.9 mm Hg ) . A BP mm Hg was recorded in 18 % of patients with L , 19 % with E and 45 % with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events . In conclusion , combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated",
"BACKGROUND The effect on endothelium-dependent and independent vasodilation of 24-week treatment with a fixed-dose combination of perindopril/indapamide ( 2/0.625 mg , daily ) and atenolol ( 50 mg , daily ) , was evaluated in 62 untreated essential hypertensive patients according a double-blind , parallel group , r and omized study . METHODS Brachial artery flow-mediated dilation ( FMD ) , response to sublingual glyceril trinitrate ( GTN , 25 microg ) and to cold pressor test ( CPT ) were measured at baseline and after treatments at 12 and 24 weeks , as change in diameter from ultrasound scans by a computerized system . RESULTS Blood pressure ( BP ) was ( P perindopril/indapamide group . After 24 weeks , FMD was significantly increased ( P perindopril/indapamide ( from 5.0 + /- 2.1 to 6.0 + /- 1.7 % ) but not by atenolol ( from 5.1 + /- 1.8 to 5.5 + /- 1.8 % ) . Improvement in FMD was not statistically related to BP reduction . Response to GTN was also significantly ( P perindopril/indapamide ( from 6.2 + /- 1.9 to 6.9 + /- 1.7 % ) , but not by atenolol ( from 6.1 + /- 2.8 to 6.6 + /- 2.6 % ) . Improvement in GTN response was significantly ( P BP reduction . Response to CPT was significantly increased ( P perindopril/indapamide after 12 and 24 weeks , whereas atenolol significantly ( P perindopril/indapamide improves endothelium-dependent vasodilation in comparison with atenolol . This improvement was observed without significant relations with BP changes , suggesting a pressure-independent effect . Improvement in endothelium-independent and sympathetic-associated vasodilation was also observed . These results suggests that long term therapy with a fixed-dose combination of perindopril/indapamide affords vascular protection in hypertensive patients",
"Objective : To see whether low dose thiazide diuretics given to patients with essential hypertension might avoid the adverse metabolic consequences seen with conventional doses . Design : Double blind r and omised crossover study of two 12 week treatment periods with either low dose ( 1.25 mg ) or conventional dose ( 5.0 mg ) bendrofluazide given after a six week placebo run in period . Setting : Outpatient clinics serving the greater Belfast area . Subjects : 16 white non-diabetic patients ( 9 male ) under 65 with essential hypertension recruited from general practice s within the greater Belfast area . Main outcome measures : Systolic and diastolic blood pressure and peripheral and hepatic insulin action . Results : One man failed to complete the study . There were no differences between doses in their effects on systolic and diastolic blood pressure . Bendrofluazide 1.25 mg had substantially less effect20on serum potassium concentration than the 5.0 mg dose . There were no intertreatment differences in fasting glucose , insulin , cholesterol , and triglyceride concentrations . Bendrofluazide 5.0 mg significantly increased postabsorptive endogenous glucose production compared with baseline ( mean 10.9 ( SD 1.2 ) v 10.0 ( 0.8 ) μmol/kg/min ) , whereas bendrofluazide 1.25 mg did not . Postabsorptive endogenous glucose20production was significantly higher with bendrofluazide 5.0 mg compared with 1.25 mg ( 10.9 ( 1.2 ) v 9.9 ( 0.8 ) μmol/kg/min ) but was suppressed to a similar extent after insulin ( bendrofluazide 5.0 mg202.8 ( 1.5 ) μmol/kg/min v bendrofluazide 1.25 mg 2.2 ( 1.5 ) μmol/kg/min ) . Exogenous glucose infusion rates required to maintain euglycaemia were not significantly different between doses and were20similar to baseline . Conclusions : Bendrofluazide 1.25 mg is as effective as conventional doses but has less adverse metabolic effect . In contrast with conventional doses , how dose bendrofluazide has no effect on hepatic insulin action . There is no difference between low and conventional doses of bendrofluazide in their effect on peripheral insulin sensitivity",
"BACKGROUND The objective of this prospect i ve , r and omized , open-label , blinded-endpoint study was to compare the antihypertensive efficacy of valsartan 80 mg v irbesartan 150 mg when combined with hydrochlorothiazide ( HCTZ ) 12.5 mg . METHODS Untreated or uncontrolled hypertensive adults ( n = 800 ) were enrolled by primary care physicians . After a 5-week open-label lead-in phase in which all patients received 12.5 mg HCTZ once daily , subjects whose blood pressure ( BP ) remained uncontrolled were r and omized ( n = 464 ) to valsartan/HCTZ ( 80/12.5 mg ) or irbesartan/HCTZ ( 150/12.5 mg ) for 8 weeks . Home BP monitoring ( HBPM ) was performed in the morning and in the evening for 5 days , at baseline , and after 8 weeks . Office BP measurements were obtained at baseline and after 8 weeks . RESULTS Irbesartan/HCTZ produced greater reductions in average systolic BP ( SBP ) and diastolic BP ( DBP ) measured by HBPM than valsartan/HCTZ ( SBP : -13.0 v -10.6 mm Hg , P = .0094 ; DBP : -9.5 v -7.4 mm Hg , P = .0007 ) . These differences were more pronounced in the morning ( trough ) than in the evening . Office BP measurements also showed greater reductions in trough seated SBP and DBP with irbesartan/HCTZ compared with valsartan/HCTZ . Normalization rates observed with HBPM ( SBP overall safety was similar in the two groups . CONCLUSIONS The superior BP-lowering potency of the fixed combination irbesartan/HCTZ ( 150/12.5 mg ) over valsartan/HCTZ ( 80/12.5 mg ) , evidence d independently from the investigators by HBPM , supports the use of this technique in trials with prospect i ve , r and omized , open-label , blinded-endpoint design",
"BACKGROUND Antihypertensive agents differentially influence the plasma adiponectin concentration and the effects of fixed-dose combination regimens remain unclear . The influence of a combination of an angiotensin-converting enzyme inhibitor ( ACEI ) and a thiazide-type diuretic or an ACEI alone on plasma adiponectin concentrations in patients with essential hypertension was evaluated in the present study . METHODS AND RESULTS After a 2-week placebo run-in phase , 30 patients with essential hypertension were r and omized to receive preterax ( 2 mg perindopril/0.625 mg indapamide ) or cilazapril ( 2.5 mg ) once daily for 12 weeks . Plasma adiponectin and insulin concentrations were measured before and after treatment . Insulin resistance was measured by homeostasis assessment index ( HOMA-IR ) . Treatment with preterax ( P=0.003 ) and cilazapril ( P=0.031 ) significantly reduced systolic blood pressure ( BP ) , but only preterax reduced diastolic BP ( P=0.024 ) . Cilazapril treatment significantly increased the plasma adiponectin concentration ( P=0.025 ) and reduced plasma triglycerides ( P=0.041 ) , whereas preterax treatment increased the plasma insulin concentration ( P=0.041 ) and tended to increase HOMA-IR . CONCLUSIONS The combination of an ACEI and indapamide improved BP control , but attenuated the beneficial effects of ACE inhibition on plasma adiponectin in patients with essential hypertension . Such a combination may be best reserved for improved BP control rather than for metabolic protection in clinical hypertension",
"OBJECTIVE To study whether administration of 1.25 and 5.0 mg ramipril daily , compared with placebo treatment , reduces the urinary albumin excretion rate ( UAER ) in normotensive patients with type 1 diabetes . RESEARCH DESIGN AND METHODS Ramipril was administered double blind at two different doses ( 1.25 [ n = 19 ] and 5.0 mg [ n = 18 ] ) , and compared with placebo ( n = 18 ) after a single-blind placebo period of 1 - 4 weeks . The patients ( total , n = 55 ; women , n = 14 ) were followed for 2 years . To document an effect on the renin-angiotensin system , ACE activity and plasma-renin activity ( PRA ) were measured . In addition , 24-h ambulatory blood pressure ( BP ) was recorded at baseline and repeated after 1 and 2 years using a Spacelab 90207 ambulatory BP recording device ( Spacelab , Redmont , CA ) . RESULTS Both doses of ramipril were sufficient to reduce ACE activity and to increase PRA significantly as compared with placebo ( P ambulatory nor clinic BP was affected by either dose of ramipril compared with the placebo group . There was no progression of UAER in the placebo group during the 2 years of the study . Analysis of covariance showed no differences in UAER between the three treatment groups at year 1 ( P = 0.94 ) or year 2 ( P = 0.97 ) , after adjusting for baseline . Furthermore , there were no statistically significant changes from baseline UAER within any of the three treatment groups . CONCLUSIONS Treatment with ramipril did not affect microalbuminuria or clinic or ambulatory BP in this study . On the basis of the present study , we question the clinical use of ACE inhibitors in stably normotensive patients with type 1 diabetes and microalbuminuria in whom a concomitant reduction in BP is not demonstrated",
"The objective of this Phase III double-blind parallel-group controlled study was to examine the superiority of amlodipine 10 mg once daily ( the amlodipine 10 mg group ) to amlodipine 5 mg once daily ( the amlodipine 5 mg group ) in 305 Japanese out patients with essential hypertension whose systolic blood pressure ( SBP ) had not reached the therapeutic target levels ( amlodipine 5 mg once daily . This study consisted of the 1-week prescreening , 8-week screening and 8-week double-blind periods . Changes in trough SBP from baseline at week 8 of the double-blind period ( week 8) were −7.0 mm Hg and −13.7 mm Hg in the amlodipine 5 and 10 mg groups , respectively ; a significant difference ( P groups . Changes in trough diastolic blood pressure ( DBP ) from baseline at week 8 were −2.7 mm Hg and −6.8 mm Hg in the amlodipine 5 and 10 mg groups , respectively , with a significant difference ( P , responder rates were 28.5 and 44.0 % in the amlodipine 5 mg and 10 mg groups , respectively , with a significant difference ( P=0.002 ) between the two groups . The amlodipine 10 mg group showed no significant difference in the incidences of adverse events against the amlodipine 5 mg group . The incidence of mild peripheral oedema was 4 % only in the amlodipine 10 mg group . In conclusion , amlodipine 10 mg once daily was found to be superior to amlodipine 5 mg once daily , safe , well tolerated and useful for the relevant subjects",
"Anti-hypertensive medication with an angiotensin II receptor blocker ( ARB ) is effective in slowing the progression of chronic kidney disease . The present study was design ed to investigate whether calcium channel blockers ( CCBs ) in combination with an ARB differentially affect kidney function . Elderly hypertensive patients with chronic kidney disease ( n = 17 , 72 ± 6 years old ) were instructed to self-measure blood pressure . They were r and omly assigned to receive either benidipine ( 4–8 mg/day ) or amlodipine ( 5–10 mg/day ) combined with olmesartan ( 10 mg/day ) . After 3 months , CCBs were switched in each patient and the same protocol was applied for another 3 months . At baseline , significant correlation was obtained between urine albumin ( 22.8 ± 16.7 ( median ± median absolute deviation ) mg/g creatinine ) and self-measured blood pressure ( 170 ± 23/87 ± 10 ( mean ± SD ) mmHg , r = 0.65 , p regimens reduced blood pressure to a similar extent ( 139 ± 22/75 ± 11 mmHg and 133 ± 17/72 ± 10 mmHg , respectively ; both p ) , while urine albumin decreased only after combination therapy including benidipine ( 11.7 ± 6.1 mg/g creatinine , p , but not amlodipine , in combination with olmesartan , reduced urinary albumin excretion in elderly hypertensive patients with chronic kidney disease . The results suggest the importance of selecting medications used in combination with ARB in hypertensive patients with chronic kidney disease",
"Objective To compare the incidence of stroke and other cardiovascular events in hypertensive patients receiving a low-dose diuretic and low-dose calcium antagonist combination with those receiving low-dose diuretic monotherapy , and assess the effects of a small blood pressure difference at achieved levels lower than those achieved in previous placebo-controlled trials . Methods The Felodipine Event Reduction ( FEVER ) trial was an investigator- design ed , prospect i ve , multicentre , double-blind , r and omized , placebo-controlled , parallel group trial . It enrolled 9800 Chinese patients , of either sex , aged 50–79 years , with one or two additional cardiovascular risk factors or disease , whose blood pressure , 6 weeks after switching from previous antihypertensive therapy to low-dose ( 12.5 mg a day ) hydrochlorothiazide , was in the range 140–180 mmHg ( systolic ) or 90–100 mmHg ( diastolic ) . These patients were r and omly assigned either to low-dose felodipine extended release or placebo , and followed at 3-month intervals for an average of 40 months . Results The intention-to-treat analysis included 9711 r and omly selected patients with only 30 ( 0.3 % ) lost to follow-up . A total of 31 842 patient-years of follow-up were accumulated , with 85.9 % of patients remaining on blinded r and omized treatment . Add-on therapy was given to 33.9 % of the hydrochlorothiazide – felodipine patients and to 42.3 % of the hydrochlorothiazide – placebo patients . In the felodipine group , systolic blood pressure (SBP)/diastolic blood pressure ( DBP ) decreased ( from r and omization to study end ) from 154.2/91.0 to 137.3/82.5 mmHg , and in the placebo group from 154.4/91.3 to 142.5/85.0 mmHg , with an average difference throughout the trial of 4.2/2.1 mmHg . In the felodipine group , the primary endpoint ( fatal and non-fatal stroke ) was reduced by 27 % ( P = 0.001 ) . Among secondary endpoints , all cardiovascular events were reduced by 27 % ( P by 35 % ( P = 0.012 ) , death by any cause by 31 % ( P = 0.006 ) , coronary events by 32 % ( P = 0.024 ) , heart failure by 30 % ( P = 0.239 ) , cardiovascular death by 33 % ( P = 0.019 ) , cancer by 36 % ( P = 0.017 ) in the felodipine group . No significant differences were found in new-onset diabetes . Both treatments were very well tolerated . Conclusions In moderately complicated hypertensive patients from China even a difference in SBP/DBP as small as 4/2 mmHg , such as that induced by adding low-dose felodipine to low-dose hydrochlorothiazide , is associated with very substantial reductions in the incidence of most types of cardiovascular events . As the SBP achieved in the felodipine group was below the recommended goal of less than 140 mmHg , and SBP in the placebo group was slightly above that level , FEVER provides the required evidence in support of the guidelines recommended goal , even for a hypertensive population not entirely consisting of patients with diabetes or previous cardiovascular events ",
"Angiotensin converting enzyme inhibitors ( ACE-Is ) and angiotensin II receptor blockers ( ARBs ) are frequently used for the treatment for glomerulonephritis and diabetic nephropathy because of their albuminuria- or proteinuria-reducing effects . To many patients who are nonresponsive to monotherapy with these agents , combination therapy appears to be a good treatment option . In the present study , we examined the effects of the addition of an ARB ( losartan ) followed by titration upon addition and at 3 and 6 months ( n=14 ) and the addition of an ACE-I followed by titration upon addition and at 3 and 6 months ( n=20 ) to the drug regimen treatment protocol in type 2 diabetic patients with nephropathy for whom more than 3-month administration of an ACE-I or the combination of an ACE-I plus a conventional antihypertensive was ineffective to achieve a blood pressure ( BP ) of 130/80 mmHg and to reduce urinary albumin to losartan or addition of an ACE-I to the treatment protocol reduced systolic blood pressure ( SBP ) by 10 % and 12 % , diastolic blood pressure ( DBP ) by 7 % and 4 % , and urinary albumin excretion by 38 % and 20 % of the baseline value , respectively . However , the effects on both BP and urinary albumin were not significantly different between the two therapies . In conclusion , addition of losartan or an ACE-I to an ongoing treatment with an ACE-I , or addition of an ACE-I to ongoing treatment with a conventional antihypertensive were equally effective at reducing the urinary albumin excretion and BP , and provided renal protection in patients with type-2 diabetic nephropathy",
"The blood pressure response to a new sustained-release formulation of nifedipine was evaluated in an 8-week , double-blind , placebo-controlled study . Twenty-nine patients with mild essential hypertension were r and omized to receive placebo ( N = 9 ) , 30 mg nifedipine ( N = 10 ) , or 60 mg nifedipine ( N = 10 ) . During treatment , 30-mg and 60-mg doses of nifedipine administered once daily decreased office blood pressures from 137/98 + /- 8/2 mm Hg and 141/98 + /- 15/2 mm Hg at baseline , respectively , to 126/89 + /- 9/7 mm Hg and 126/86 + /- 6/7 mm Hg ( P less than .005 ) . Noninvasive automatic ambulatory blood pressure monitoring demonstrated a marginally significant ( P less than .10 ) reduction in the mean 24-hour blood pressure of 2/6 + /- 8/8 mm Hg and 5/6 + /- 9/9 mm Hg for patients taking 30 mg and 60 mg nifedipine once daily , respectively . Diastolic blood pressure load ( the percentage of ambulatory diastolic blood pressure readings greater than 90 mm Hg ) during 24 hours was decreased by 41 % and 35 % , with 30 mg and 60 mg nifedipine administered once daily , respectively . No significant dose response to nifedipine at these dose levels was observed . Although the once-daily formulation of nifedipine achieved effective control of office blood pressure , similar control was not observed in awake and 24-hour periods in all patients",
"Summary General well-being , adverse effects and antihypertensive efficacy have been investigated in a double blind , parallel-group , dose-response multicentre study of diltiazem and metoprolol monotherapy for hypertension . 128 patients with primary hypertension were included from 10 participating centres . The patients were r and omized to receive oral diltiazem 120–240–360 mg/day or metoprolol 50–100–200 mg/day . Each dose was given for a 4-week period as a forced titration regime . In all 119 patients , 59 and 60 , respectively , on diltiazem and metoprolol completed the study protocol . There were dose-dependent reductions in supine and st and ing blood pressures ( BP ) after both diltiazem and metoprolol therapy . In the diltiazem group , supine BP was reduced by 10 (11)/10 ( 6 ) mm Hg ( SBP/DBP ) at the highest dose level , and the corresponding values for the metoprolol group were 7 (16)/8 ( 9 ) mm Hg ( SBP/DBP ) . Target pressures ( DBP ≤ 90 mm Hg and /or a reduction in DBP of ≥ 10 % ) were reached in 63 % and 48 % of the patients , respectively . The incidence and severity of dose-dependent adverse effects , as evaluated by spontaneous reports or open and direct question ing , did not differ between treatments . Subjective well-being , evaluated by a self-administered question naire , the MSE-profile , did not differ significantly between diltiazem and metoprolol therapy . However , after an initial slight deterioration , contentment and vitality tended to improve with increasing doses of diltiazem , while a dose-related deterioration in these variables was observed on metoprolol therapy . At the highest dose levels , contentment and vitality tended to be better in the diltiazem than the metoprolol group . Thus , diltiazem and metoprolol in daily doses of 120–360 mg and 50–200 mg , respectively , produce comparable and parallel reductions in supine and st and ing BP . However , while subjective well-being tended to improve with increasing doses of diltiazem , there was a negative trend for metoprolol . It is concluded that diltiazem , given as monotherapy to hypertensive patients , does not impair subjective well-being ",
"Abstract We compared the efficacy of treatment protocol s with an angiotensin converting enzyme ( ACE ) inhibitor alone ( enalapril , 5 mg ) or angiotensin II ( ATII ) receptor blocker ( losartan , 50 mg ) or both enalapril plus losartan in patients with microalbuminuria in a prospect i ve , r and omized clinical trial . Normotensive type 2 diabetic patients with microalbuminuria documented by at least 3 consecutive urinary albumin excretion analyses were recruited for the study . Patients were grouped r and omly into one of the protocol s which consisted of treatment with 5 mg enalapril daily ( group 1 ; n=12 ) , 50 losartan daily ( group 2 ; n=12 ) or both drugs ( group 3 ; n=10 ) . They were reevaluated with regard to HbA1c levels , lipid profiles , blood pressure and urinary albumin excretion rates ( UAER ) at 3-month intervals for 12 months . Mean age , duration of diabetes , body mass index , plasma lipid profiles and blood pressure levels were similar at the initial visit . In group 1 , UAER returned to normal levels in 10 patients . Normalization of UAER occurred in 8 and 7 patients in groups 2 and 3 , respectively . Percentage of reduction in UAERs at the end of 12 months were 58 % , 59 % and 60 % ( p=0.0001 ; p=0.0002 ; p=0.0003 , respectively ) . The amount of reduction in UAER did not differ significantly among the three groups ( p=0.346 ) . ACE inhibitors and angiotensin II receptor blockers have similar efficacy in treating diabetic microalbuminuria , and the combination of the two drugs does not add any further benefit",
"A large proportion of patients with hypertension need a second drug to reach satisfactory control of blood pressure ( BP ) , but there are few well- design ed controlled trials comparing the efficacy of drugs added as a second option . In a double-blind r and omized clinical trial , 82 patients with uncontrolled BP , receiving hydrochlorothiazide 25 mg daily , were selected to receive amiloride 2.5–5 mg/day ( n = 39 ) or enalapril 10–20 mg/day ( n = 43 ) . Ambulatory blood pressure monitoring ( ABPM ) was done before and after 12-weeks of treatment . Office BP was measured in the 4th , 8th , and 12th weeks . The doses of amiloride and enalapril were doubled in the fourth week , and propranolol was added in the 8th week if office BP was above 140/90 mm Hg . There was a greater BP reduction in patients treated with enalapril . The ABPM δ values between the groups were 3.6 ± 2.2 , 3.9 ± 2.2 , and 1.1 ± 2.7 mmHg for 24-h , daily , and nightly systolic blood pressure , respectively , favoring enalapril . For diastolic blood pressure ( DBP ) , the deltas were 1.7 ± 2.0 , 3.2 ± 1.5 , and 1.2 ± 1.9 mmHg , respectively ( p = 0.039 for daily DBP ) . Office SBP decreased more and sooner in patients allocated to enalapril ( p = 0.003 ) . More patients taking amiloride required propranolol to control BP ( p = 0.035 ) . Potassium increased 0.3 mEq/L on the average in both groups . Cough , albeit predominantly mild , was reported more frequently by participants treated with enalapril . We conclude that enalapril is more effective than amiloride to lower BP of patients on hydrochlorothiazide with uncontrolled BP . Trial registration : Clinical Trials.gov identifier : NCT00394394",
"Aim : To review the efficacy and safety of losartan and hydrochlorothiazide compared to losartan alone , hydrochlorothiazide alone or placebo in the treatment of mild to moderate hypertension in a clinical trial Patients and methods : A r and omly allocated , placebo-controlled , double-blind parallel study was performed in 40 clinical centers throughout the United States . A total of 703 males and females aged 18–75 years with a sitting diastolic blood pressure of 95–115 mmHg entered the trial and 604 completed the 12-week protocol . The participants were r and omly assigned to concomitant therapy once a day with : ( 1 ) 50 mg losartan and 6.25 mg hydrochlorothiazide , ( 2 ) 50 mg losartan and 12.5 mg hydrochlorothiazide , ( 3 ) 50 mg losartan alone , ( 4 ) 12.5 mg hydrochlorothiazide alone or ( 5 ) placebo . All participants were followed for 12 weeks Results : At baseline , mean trough sitting diastolic blood pressure was 100.9 - 101.7 mmHg , with no significant difference between treatment groups . Sitting diastolic blood pressure fell 4.0 mmHg with placebo , 7.2 mmHg with 12.5 mg hydrochlorothiazide , 7.2 mmHg with 50 mg losartan , 9.3 mmHg with 50 mg losartan + 6.25 mg hydrochlorothiazide , and 13.2 mmHg with 50 mg losartan + 12.5 mg hydrochlorothiazide . The fall in mean trough sitting systolic blood pressure was 2.4 , 9.3 , 10.7 , 12.0 and 17.9 mmHg for the respective groups . After subtracting the placebo effect , the reductions in blood pressure induced by losartan and hydrochlorothiazide were additive for both sitting diastolic and systolic blood pressures and approximately equaled the reduction seen with the combination of losartan and hydrochlorothiazide . There were no significant differences in adverse events between treatment groups Conclusions : The concomitant administration of 50 mg losartan + 12.5 mg hydrochlorothiazide produced additive falls in sitting diastolic and systolic blood pressures which were greater than that achieved with either drug alone . On the basis of the adverse effects reported , the combination was well",
"The antihypertensive effect of doxazosin 1 - 16 mg once-daily was compared with that of atenolol 50 - 100 mg once-daily , and placebo , utilizing a double-blind parallel group ( 12 patients each ) design . Blood pressure ( BP ) and pulse rate were determined in out- patients who returned for clinic visits every 2 weeks for 14 weeks . During the first 4 weeks , all patients received single-blind placebo therapy . During the subsequent 10 weeks , patients were r and omized to placebo , atenolol or doxazosin treatment . After 2 weeks of doxazosin therapy 16 mg daily , there was a significant decrease from baseline ( single-blind placebo period ) in supine diastolic BP ( P less than 0.01 ) and st and ing diastolic BP ( P less than 0.001 ) . The decreases in supine and st and ing diastolic BPs in the doxazosin 16 mg daily group were significantly ( P less than 0.01 ) different from the corresponding BPs of the placebo group . At weeks 12 and 14 , heart rates in the doxazosin group were not significantly different from baseline or from those in the placebo group . After 4 and 6 weeks of atenolol 100 mg daily , there was a significant decrease from baseline in both supine ( P less than 0.001 and P less than 0.05 ) and st and ing ( P less than 0.05 ) diastolic BPs and heart rates ( P less than 0.05 ) . However , when the atenolol group was compared with the placebo group , a significant decrease occurred only with supine diastolic BP at week 12 ( P less than 0.01 ) and not at week 14 ; but significant decreases occurred in supine and st and ing heart rates at weeks 12 and 14 ( P less than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"To achieve the target blood pressure recommended by the latest guidelines , multiple antihypertensive drugs are needed in most patients . In this study , the efficacy of treatment using an angiotensin II receptor antagonist ( ARB ) combined with a calcium channel blocker ( CCB ) or a diuretic was compared from multiple perspectives in patients with hypertension . Twenty-nine patients with essential hypertension , who had failed to achieve their target blood pressure ( ARB olmesartan at 20 mg day−1 , were additionally given 8–16 mg day−1 of the CCB azelnidipine or 1–2 mg day−1 of trichlormethiazide ( a thiazide diuretic ) in a r and omized crossover manner for 4 months each . At the end of each combination therapy period , blood and urine sample s were collected and arterial stiffness was evaluated by measuring the cardio-ankle pulse wave velocity . Compared with monotherapy , the blood pressure was reduced similarly by adding azelnidipine ( −12/−10 mm Hg ) or trichlormethiazide ( −14/−9 mm Hg ) . The heart rate was decreased with the CCB by 4 b.p.m . ( P . Serum K , lipids and blood glucose were not significantly changed with either combination , whereas serum uric acid was increased with the thiazide ( P with azelnidipine . Plasma levels of renin , angiotensin II and aldosterone were also increased with the thiazide period , whereas high-sensitivity C-reactive protein and oxidized low-density lipoprotein were decreased with azelnidipine . In addition , the cardio-ankle vascular index , a parameter of arterial stiffness , was decreased with the azelnidipine period but was unchanged with the thiazide period ( P of olmesartan and azelnidipine has advantages over the combination of olmesartan and a thiazide with respect to avoiding hyperuricemia , sympathetic activation , renin – angiotensin-aldosterone system stimulation , inflammation , oxidative stress , and increased arterial stiffness in patients with moderate hypertension . These properties may provide cardiovascular protection in addition to the hypotensive effect",
"The effect of nicardipine hydrochloride , a calcium-channel blocking agent , was studied in 46 patients with stable angina in a double-blind , placebo-controlled , r and omized , repeated cross-over protocol , using a 30 or 40 mg dose of nicardipine or placebo three times a day . Mean resting heart rate and blood pressure did not change significantly with 30 mg nicardipine ; heart rate increased from 81 + /- 10 to 88 + /- 13 beats min-1 , systolic blood pressure decreased from 129 + /- 18 to 119 + /- 16 mmHg , and diastolic blood pressure from 81 + /- 12 to 74 + /- 11 mmHg ( P less than 0.01 for all three variables ) with a 40 mg dose . Using a treadmill exercise protocol , mean exercise duration increased from 5.4 + /- 1.8 to 6.0 + /- 1.8 min ( P less than 0.01 ) with 30 mg nicardipine , and from 5.8 + /- 1.7 to 6.6 + /- 1.9 min ( P less than 0.01 ) with 40 mg . Time to onset of angina increased from 4.6 + /- 1.9 to 5.2 + /- 1.7 min ( P less than 0.05 ) with 30 mg and from 5.1 + /- 1.8 to 5.7 + /- 1.8 min ( P = NS ) with 40 mg . Mean anginal frequency and sublingual nitroglycerin consumption were low during the cross-over placebo period and did not change significantly during therapy with nicardipine . Non-cardiac side-effects were mild and required the withdrawal of only one patient from the study . However , during nicardipine therapy four patients had unstable angina and two developed a non-Q wave myocardial infa rct ion . Of these patients , five were receiving a beta-adrenergic blocker that was discontinued prior to the study . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In 2004–2005 , the antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg combined with hydrochlorothiazide 25 mg were assessed in a large placebo-controlled trial in patients with stages 1 and 2 hypertension and demonstrated that both agents were highly effective in lowering blood pressure ( BP ) compared with placebo and that telmisartan lowered BP significantly greater than valsartan . To confirm this finding according to Food and Drug Administration guidelines , we performed a second large trial using the same design in an entirely separate patient population . The trial was double-blind with a 4 : 4 : 1 r and omization scheme to compare once daily telmisartan 80 mg plus hydrochlorothiazide 25 mg versus once daily valsartan 160 mg plus hydrochlorothiazide 25 mg versus once daily placebo on reductions in seated clinic BP in patients with stages 1 and 2 hypertension . The primary endpoints were the changes from baseline in seated diastolic and systolic BP at the end of the 8-week treatment period . Safety endpoints included adverse events , changes in laboratory parameters and pulse rate . In total , 1185 patients were r and omized ( of which 1181 were treated and included in the primary analysis : 528 in the telmisartan-hydrochlorothiazide group , 523 in the valsartan-hydrochlorothiazide group , and 130 in the placebo group ) , changes from baseline in BP following telmisartan-hydrochlorothiazide ( −24.6/−18.2 mmHg ) were significantly greater than both placebo ( −4.1/−6.1 mmHg ) and valsartan-hydrochlorthiazide ( −22.5/−17.0 mmHg ) ( versus placebo , P for systolic and diastolic BP ; versus valsartan-hydrochlorothiazide , P=0.017 for systolic BP and P=0.025 for diastolic BP ) . The total number of patients with at least one adverse event reported was similar among the three treatment groups ( placebo , 42 % , telmisartan-hydrochlorothiazide , 36 % , and valsartan-hydrochlorothiazide , 37 % ) . Thus , this large , second trial confirms that telmisartan-hydrochlorothiazide at doses of 80/25 mg lowered both systolic and diastolic BP to a greater extent than valsartan-hydrochlorothiazide at doses of 160/25 mg in stages 1–2 hypertension . Although these are not the highest doses of these agents at present , at the time that the studies were conducted , they were the maximally approved dosages . Both studies support the strategy of using angiotensin receptor blockers with a higher dose of a thazide diuretic ( 25 mg ) for enhancing the control of hypertension",
"Summary The effect of beta-adrenergic blockade on blood pressure variation was studied in ten patients with moderate hypertension . Supine systolic and diastolic blood pressures were measured every 5 min during six hours sessions , using an ultrasonic method . Systolic and diastolic variation in each six hour session was defined as the st and ard deviation of the mean of systolic and diastolic readings made in that period . After 3 weeks of single-blind placebo , a 12 week double-blind r and omized crossover study was initiated with placebo ( 6 weeks ) and atenolol ( 100 mg b. i. d. for 3 weeks and 200 mg b. i. d. for 3 weeks ) . Systolic and diastolic blood pressure and heart rate decreased significantly ( p atenolol treatment . Diastolic variation did not change significantly , whereas systolic variation decreased slightly but significantly ( p systolic blood pressure . It is concluded that beta-adrenergic blockade decreases blood pressure and heart rate without causing significant changes in spontaneous systolic or diastolic",
"Our previous studies have shown that blood pressure variability is not linked to activity of the adrenergic nervous system but that a small part of the variation is due to vagal nervous tone . The present work investigates whether myogenic activity of blood vessels could be responsible for the blood pressure variations . To test this hypothesis , variability was measured before and after administration of nifedipine , known to decrease spontaneous vascular contractions . In 17 patients with moderate essential hypertension , blood pressure was measured every 30 min for 12 h with a device recording Korotkoff 's sounds on tape . Blood pressure variability was defined as the st and ard deviation of the mean of all readings . Placebo , nifedipine ( 20 mg b.i.d . in a slow-release formulation ) alone and in combination with atenolol ( 50 mg b.i.d . ) , and atenolol alone were given double-blind for 3 weeks each . At the end of each period , a 12 h blood pressure profile was recorded . Systolic blood pressure significantly decreased with any of the drugs used ; the combination of nifedipine and atenolol caused a greater decrease than that of any of the drugs alone . Diastolic blood pressure only decreased with the combination of nifedipine and atenolol . Nifedipine did not cause significant changes in systolic or diastolic variability ; a small but nonsignificant decrease in diastolic variability was seen with atenolol and the combination of atenolol and nifedipine . The present data do not support the hypothesis that blood pressure variability is linked to myogenic vascular activity because no decrease in blood pressure variability was seen with nifedipine",
"Objectives : To determine the blood pressure lowering effect and safety of losartan potassium 50 mg once or twice daily , or l00 mg once daily , using 24-h ambulatory blood pressure monitoring and conventional trough clinic blood pressure Design : Multicenter , double-blind , r and omized , parallel , placebo-controlled trial Setting : Nine sites in university hospitals and urban centers in the United States Patients : 122 mild to moderate hypertensive adult non-black men and women , 21 years of age and older , who were within 30 % of their ideal body weight Intervention : Qualification required a mean 24-h ambulatory blood pressure measurement of > 85 mmHg and a sitting diastolic blood pressure of 95–115 mmHg . Subjects were then r and omized to placebo or losartan potassium in three different dose regimens Clinic blood pressure evaluations : Trough blood pressure was measured by trained observers using st and ardized methods , and ambulatory blood pressure measurements were obtained for 26 h using a SpaceLabs Model 90207 monitor Results : All doses of losartan potassium significantly decreased mean systolic 24-h ambulatory blood pressure ( range –9.4 to –14.2 mmHg ; P and mean diastolic 24-h ambulatory blood pressure ( range –5.6 to –9.0 mmHg ; P blood pressure profiles revealed a smooth , sustained antihypertensive effect of losartan potassium at all doses . Similar reductions in blood pressure were observed using trough clinic measurements . There were no significant differences in overall clinical adverse experiences between treatment groups . There were no significant changes in heart rate , body weight , electrocardiograms or mean laboratory measurements Conclusions : Losartan potassium , the first of a new class of potent and specific AT1-selective , non-peptide , angiotensin II antagonists , significantly reduces mean 24-h ambulatory blood pressure and trough clinic sitting blood pressure , and is well",
"Background : Combined regimen may be superior to monotherapy in blood pressure ( BP ) control . Since BP control is crit‐ically related to cardiovascular mortality and morbidity in hypertensive patients , this study aim ed to evaluate the efficacy and safety of a low‐dose combined regimen of preterax compared with cilazapril monotherapy for better BP control in treated hypertensive patients . Methods : Stable hypertensive patients were evaluated if their systolic BP ( SBP ) was > 130 mmHg and /or diastolic BP ( DBP ) was > 85 mmHg even with up to 2 antihypertensive drugs . Patients were excluded if they were on angiotensin‐converting enzyme inhibitors , angiotensin II receptor blockers or a diuretic . They were then r and omized to receive either preterax ( perindopril 2 mg and indapamide 0.625 mg ) or cilazapril 2.5 mg once daily in a double‐blind fashion for a period of 12 weeks after a 2‐week placebo run‐in phase . Sitting BP was recorded and the safety and efficacy were evaluated at each visit every 4 weeks . Response was defined as positive if SBP was ≤140 mmHg and DBP was ≤90 mmHg at the last visit or there was > 20 mmHg reduction in SBP and /or > 10 mmHg reduction in DBP using either treatment . Plasma biochemical analysis was performed both before and after the treatment . Results : Among the 47 patients initially enrolled , 41 completed the study ( 21 in the preterax group , 20 in the cilazapril group ) . There was no difference in the number of adverse events between the 2 groups . SBP was significantly reduced by preterax ( 13.43 ±12.48 mmHg , p and cilazapril ( 9.00 ±13.75 mmHg , p DBP was significantly reduced only by preterax ( 7.67 ±9.40 mmHg , p = 0.0009 ) but not by cilazapril ( 3.60 ±8.37 mmHg , p > 0.05 ) . The response rate was significantly higher to preterax ( 100 % ) than to cilazapril ( 70 % ) ( p = 0.0086 ) . Conclusion : Though similar in safety , combined regimen preterax was more effective than cilazapril to facilitate adequate BP control in already‐treated hypertensives . It can be added on to other antihypertensives for better BP control in clinical hypertension . [ J Chin Med Assoc 2008;71(5):247–253",
"Objective To determine the long-term efficacy and safety of a fixed , very-low-dose tablet combining one-half the st and ard dose of perindopril with one-quarter the st and ard dose of indapamide as first-line treatment in elderly patients . Design Double-blind , r and omized , placebo-controlled study in an outpatient setting . Patients and interventions Following a single-blind , placebo run-in period of 4 weeks , patients [ 65–85 years , with mild-to-moderate essential hypertension or isolated systolic hypertension ( ISH ) ] were r and omized to receive one tablet of perindopril 2 mg/indapamide 0.625 mg ( Per/ Ind ) ( n = 193 ) or placebo ( n = 190 ) , daily for 12 weeks . After this first 12-week period , all patients on Per/Ind ( n = 138 ) and patients responding to placebo ( n = 61 ) were maintained on their previous regimen for a further 48 weeks . Patients in the placebo group whose blood pressure was not normalized , were switched to Per/Ind ( n = 60 ) . Main outcome measure The primary endpoint was the proportion of patients with blood pressure that normalized between weeks 0 and 60 . Results After 1 year of treatment ( intention-to-treat ) supine systolic and diastolic blood pressure decreased by 23.0 ± 15.3 mmHg and 13.3 ± 9.4 mmHg with Per/Ind ( n = 253 : 193 from r and omized Per/Ind group and 60 from the placebo group switched at week 12 ) . The mean decreases in systolic blood pressure were similar in essential hypertension and ISH ( systolic blood pressure 23.2 versus 22.7 mmHg , respectively ) . Per/Ind treatment ( n = 253 ) achieved an initial normalization of blood pressure in 96.2 % [ 95 % confidence interval ( CI ) 93.6–98.9 % ; Kaplan-Meier estimate ] of Per/Ind-treated patients ; 79.8 % ( 95 % CI 74.1–85.5 % ) of these maintained a normalized blood pressure throughout the 1-year follow-up . The incidence of adverse events was similarly low in the placebo and active therapy groups . Efficacy and safety results for the over 75 years subgroup were similar to those for the younger elderly subjects Conclusions The fixed , very low-dose combination of perindopril 2 mg/indapamide 0.625 mg results in sustained blood pressure control when used as first line treatment of elderly hypertensive patients over 1-year , and is well-tolerated",
"The purpose of this trial was to evaluate the antihypertensive efficacy of the concomitant administration of selected doses of hydrochlorothiazide ( HCTZ ) on a background of losartan potassium ( losartan ) 50 mg , a selective angiotensin II receptor antagonist . Patients with essential hypertension ( > or = 95 mmHg inclusion criteria ) with a mean sitting diastolic blood pressure ( SiDBP ) of 105 + /- 0.4 ( S.E. ) mmHg entered a 4-week , single-blind monotherapy period of losartan 50 mg once daily . At the end of the monotherapy period , patients whose blood pressure was adequately controlled were discontinued . Patients whose blood pressure was partially controlled based on a SiDBP > 92 mmHg entered a 12 week double-blind period and were r and omly assigned to either receive placebo ( n = 80 ) , HCTZ 6.25 mg ( n = 80 ) , HCTZ 12.5 mg ( n = 72 ) or HCTZ 25 mg ( n = 80 ) in addition to losartan 50 mg . During the losartan monotherapy period , there was a 4 mmHg fall in SiDBP with a further fall of 5 mmHg after 12 weeks of double-blind therapy in the losartan/placebo control group . Based on the between group differences in BP change from the end of the losartan monotherapy period ( baseline ) to end of 12 weeks of double-blind , the concomitant administration of a very low dose of HCTZ ( 6.25 mg ) with losartan did not significantly decrease SiDBP compared with the fall in blood pressure in the losartan/placebo control group ( diff . between groups = -2 ( 95 % C.I.[-4.1 , + 0.9 ] mmHg ) ) . However , the concomitant administration of HCTZ 12.5 or 25 mg with losartan 50 mg result ed in significantly different ( p diastolic blood pressure compared to the losartan/placebo group ( diff . between groups = -4 ( 95 % C.I. [ -6.3 , -1.1 ] mmHg ) for 12.5 mg combination group ; -6 ( 95 % C.I. [ -8.3 , -3.3 ] ) mmHg for the HCTZ 25 mg combination group ) . The proportions of patients treated with losartan plus HCTZ 12.5 mg or 25 mg that achieved a trough SiDBP trough SiDBP > or = 88 mmHg but with a decrease of at least 5 mmHg were 71 % and 83 % , respectively . The percentage of clinical adverse experiences that were considered drug-related as assessed by the investigator were generally similar across all treatment groups . There were no reports of orthostatic hypotension in any of the treatment groups . Changes in serum glucose , potassium and uric acid were not appreciably different amongst the treatment groups . In summary , in patients with predominantly moderate to severe essential hypertension , the addition of HCTZ 12.5 mg or 25 mg to losartan 50 mg produced effective control of blood pressure in a substantial majority of patients who only partially responded to losartan monotherapy . There were no differences amongst the treatment groups with respect to drug-related adverse experiences in this trial",
"A two-centre , double-blind , placebo controlled , r and omized 3-way crossover study was undertaken to assess the efficacy , tolerability and safety of celiprolol in mild to moderate essential hypertension . A 4-week single-blind placebo run-in/screening period , during which no antihypertensive medication was given , was followed by 3 consecutive 4-week treatment periods with placebo or celiprolol ( 200 mg or 400 mg daily ) . At the end of the 4-week placebo run-in/screening period , 26 hospital out- patients with a seated mean blood pressure ( systolic/diastolic ) of 161.4/101.7 mmHg and a mean pulse rate of 75 beats/min entered the double-blind crossover phase of the study . Results showed that there was no significant difference in seated mean systolic or diastolic blood pressure between 200 mg celiprolol daily ( 149.2/92.3 mmHg ) and 400 mg celiprolol daily ( 149.1/92.5 mmHg ) . However , mean seated systolic and diastolic blood pressures were significantly ( p less than 0.05 ) lower on celiprolol than on placebo ( 157.1/98.2 mmHg ) . Neither dose of celiprolol had a significant effect on seated pulse rate . No patient was withdrawn due to an adverse event and no laboratory assessment outside the normal range was reported to be of any clinical significance . It is concluded that oral celiprolol , 200 mg or 400 mg daily , is effective and well tolerated for controlling mild to moderate essential hypertension . Since both doses had very similar effects on blood pressure there is no advantage in this group of patients for the 400 mg daily dose of celiprolol",
"BACKGROUND Patients ( pts ) with stable coronary artery disease ( CAD ) can benefit from a decrease in the blood pressure ( BP ) , according to recent studies . OBJECTIVE To evaluate the efficacy and tolerability of the fixed combination : amlodipine + enalapril , when compared to amlodipine in the normalization of the diastolic arterial pressure ( DAP ) ( pts with CAD and systemic arterial hypertension ( SAH ) . METHODS Double-blind and r and omized study , with two groups of pts with DAP > or = 90 and or = 110 mmHg during the four-week wash-out with atenolol treatment alone , were excluded . After the wash-out , pts were r and omly distributed for the use of the combination ( A ) or amlodipine ( B ) and were followed every four weeks up to 98 days . The initial doses ( in mg ) were , respectively : A- 2.5/10 and B- 2.5 ; the doses were increased when DAP > 85mmHg , at the visits . Statistical analysis was carried out with chi2 , Fischer and analysis of variance , for p 110 selected pts , 72 ( A= 32 , B= 40 ) were r and omized . The decreases in DAP and systolic arterial pressure ( SAP ) were significant ( p mmHg : SAP , A ( 127.7 + /- 13.4 ) and B ( 125.3 + /- 12.6 ) ( p= 0.45 ) and DAP , A ( 74.5 + /- 6.7 mmHg ) and B ( 75.5 + /- 6.7 mmHg ) ( p= 0.32 ) . Group A presented a lower incidence of lower-limb edema : ( 7.1 % vs 30.6 % , p=0.02 ) on the 98th day of follow-up . CONCLUSION The fixed combination of enalapril and amlodipine , as well as isolated amlodipine , was effective in the normalization of BP in pts with CAD and SAH stages I and II , adding blockage of the renin-angiotensin system",
"Angiotensin-converting enzyme inhibitors and calcium antagonists are 2 classes of antihypertensive agents frequently used either as monotherapy or in combination . A 6-week , multicenter , r and omized , double-blind , placebo-controlled trial was conducted in essential hypertensive patients ( diastolic blood pressures [ BP ] when seated , 95 - 115 mm Hg ) to evaluate the efficacy , dose response , and safety profiles of enalapril combined with a new once-daily formulation of diltiazem . BP and heart rate were measured at 5 ( peak ) and 24 ( trough ) hours after dose to assess the efficacy and pharmacodynamic profile of the combination given once daily . There were 336 patients r and omly assigned to either enalapril 5 mg plus 1 of 4 dose levels of diltiazem ER ( 60 , 120 , 180 , or 240 mg ) , enalapril 5 mg alone , or placebo . Each combination dose level produced statistically significant reductions ( p trough diastolic BP when seated , compared with placebo ( -6.8 , -8.3 , -10.1 , and -10.3 mm Hg for the diltiazem ER doses of 60 , 120 , 180 , and 240 mg , respectively ) . The 3 highest combination dose levels result ed in statistically significant ( p trough diastolic BP when seated , compared with placebo . There was a significant ( p relation . A trough-to-peak ratio > or = 0.5 was shown for the 3 highest combination doses . Drug-related adverse events were seen in 8.9 % to 19 % of the combination patients , 14.3 % of the enalapril patients , and 8.6 % of the placebo patients . The frequency and type of adverse events were those currently noted with each drug studied when used as monotherapy",
"High levels of proteinuria predict renal deterioration , suggesting that interventions to reduce proteinuria may postpone the development of severe renal impairment . This multicenter Canadian trial evaluated whether supramaximal dosages of c and esartan would reduce proteinuria to a greater extent than the maximum approved antihypertensive dosage . The authors r and omly assigned 269 patients who had persistent proteinuria ( > or = 1 g/d ) despite 7 wk of treatment with the highest approved dosage of c and esartan ( 16 mg/d ) to 16 , 64 , or 128 mg/d c and esartan for 30 wk . The median serum creatinine level was 130.0 micromol/L ( 1.47 mg/dl ) , and the median urinary protein excretion was 2.66 g/d ; most ( 53.9 % ) patients had diabetic nephropathy . The mean difference of the percentage change in proteinuria for patients receiving 128 mg/d c and esartan compared with those receiving 16 mg/d c and esartan was -33.05 % ( 95 % confidence interval -45.70 to -17.44 ; P Reductions in BP were not different across the three treatment groups . Elevated serum potassium levels ( K+ > 5.5 mEq/L ) led to the early withdrawal of 11 patients , but there were no dosage-related increases in adverse events . In conclusion , proteinuria that persists despite treatment with the maximum recommended dosage of c and esartan can be reduced by increasing the dosage of c and esartan further , but serum potassium levels should be monitored during treatment",
"STUDY OBJECTIVE To compare the renoprotective and blood pressure-lowering effects of combination losartan-low-dose hydrochlorothiazide with losartan alone in hypertensive patients with stage 3 chronic kidney disease ( CKD ) . DESIGN Prospect i ve , open-label , r and omized , controlled study . SETTING Outpatient clinic at a university-affiliated hospital in Japan . PATIENTS Sixty adults ( mean age 67 yrs ) with stage 3 CKD who had been receiving losartan 50 mg/day and had not achieved their target blood pressure of 130/80 mm Hg . INTERVENTION Patients were r and omly assigned to receive combination losartan 50 mg-hydrochlorothiazide 12.5 mg/day in addition to losartan 50 mg/day ( combination therapy group , 30 patients ) or to receive losartan 100 mg/day ( control group , 30 patients ) over a 24-week period . MEASUREMENTS AND MAIN RESULTS Efficacy was determined by monitoring clinical and laboratory parameters . Mean baseline systolic and diastolic blood pressures were 158/90 mm Hg in both groups ; at 24 weeks of treatment , these blood pressures significantly decreased to 133/79 mm Hg in the combination therapy group compared with both baseline and the values in the control group ( 145/83 mm Hg ) . Although serum creatinine concentration increased and the estimated glomerular filtration rate decreased significantly in both groups , the urinary protein : creatinine ratio was significantly lower in the combination therapy group . With stratification of patients on the basis of whether they had diabetes mellitus , we found that the reduction in the urinary protein : creatinine ratio was more evident in the combination therapy group . No significant increase in the occurrence of adverse metabolic effects was noted in either group . CONCLUSION In these hypertensive patients with stage 3 CKD , combination therapy with the maximum recommended daily dose of losartan of 100 mg and a low dose of hydrochlorothiazide of 12.5 mg ameliorated proteinuria and reduced blood pressure more effectively than treatment with losartan 100 mg alone , irrespective of whether the patients had diabetes",
"The objective of the present study was to assess the efficacy of bisoprolol in migraine prophylaxis . A double-blind placebo-controlled study was conducted in 226 patients with migraine with or without aura , a migraine history of at least 2 years and at least 3 documented attacks during the 28 days run-in period . The duration of treatment was 12 weeks following an initial 28 days ' run-in period . Patients reported the number of attacks and their severity in a diary . Treatment with bisoprolol 5 mg result ed in a significant reduction in the frequency of migraine attacks ( 39 % vs 22 % ) compared to placebo treatment ( p duration and severity of the attacks . Bisoprolol was well tolerated",
"A multi-centre study was carried out to examine the antihypertensive effect and adverse event profile of felodipine in an extended-release ( ER ) formulation given once daily as monotherapy . Doses of 5 mg , 10 mg or 20 mg felodipine ER were compared with placebo in 183 patients with mild or moderate hypertension . All antihypertensive medication was discontinued on entering a 4-week placebo run-in period . If , at the end of the run-in period , supine diastolic blood pressure was in the range greater than 95 less than 120 mmHg , patients were r and omly allocated to double-blind treatment with felodipine , 5 mg , 10 mg or 20 mg , or placebo , to be taken once daily for 4 weeks . Supine and st and ing blood pressure , heart rate and body weight were measured every 2 weeks during the trial . Assessment s were made 24 hours after intake of the study drug . Adverse events were recorded at each review . Over the 4-week treatment period , a dose-related decrease in supine diastolic blood pressure was observed , this reduction occurring already during the first 2 weeks of active treatment . In the placebo group and the felodipine 5 mg , 10 mg and 20 mg groups , supine blood pressure ( systolic/diastolic ) decreased by 7/6 mmHg , 9/8 mmHg , 12/10 mmHg and 14/11 mmHg , respectively . Supine diastolic blood pressure reduction in the felodipine 10 mg group and both systolic and diastolic blood pressure reductions in the 20 mg group were significantly greater than with placebo . St and ing diastolic blood pressure reduction was significantly greater in all three dose groups on felodipine compared with placebo . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The study compared valsartan/amlodipine combination with irbesartan/hydrochlorothiazide ( HCTZ ) combination in very elderly hypertensives . After a 4-week placebo period , 94 hypertensives , aged 75 - 89 years were r and omized to valsartan 160mg/amlodipine 5 mg or irbesartan 300mg/HCTZ 12.5 mg for 24 weeks according to a prospect i ve , parallel group study . After 4 weeks amlodipine or HCTZ was doubled in non-responders . Patients were checked every 4 weeks . At each visit clinical sitting , lying and st and ing blood pressure ( BP ) , systolic BP ( SBP ) and diastolic BP ( DBP ) were evaluated , and an electrocardiogram was performed . At the end of the placebo period and of the treatment period a non-invasive 24-h ambulatory BP monitoring ( ABPM ) was performed and electrolytes and uric acid were evaluated . Both combinations significantly reduced ambulatory BP . In the valsartan/amlodipine group the mean reduction ( -29.9/-15.6 for 24h , -28.6/-14.5mmHg for day-time and -26.2/-17.4mmHg for night-time SBP/DBP ) was similar to that of the irbesartan/HCTZ group ( -29.6/-15.4 for 24h , -29.3/-14.9mmHg for day-time and -25.4/-16.9mmHg for night-time SBP/DBP ) . Both combinations significantly reduced clinical sitting and lying BP values with no difference between treatments . BP changes from lying to st and ing position were significantly greater in the irbesartan/HCTZ group ( -17.2/-9.1mmHg ) than in the valsartan/amlodipine group ( -10.1/-1.9mmHg , p Potassium significantly decreased and uric acid significantly increased ( -0.4mmol/l , p irbesartan/HCTZ group . In conclusion , both combinations were similarly effective in reducing ambulatory and clinical BP in very elderly hypertensives . However , valsartan/amlodipine offered some advantages in terms of less pronounced BP orthostatic changes and absence of metabolic adverse effects ",
"A total of 203 patients with hypertension ( supine diastolic blood pressure of 100 - 119 mm Hg ) from six centers entered into a 3-week placebo baseline followed by 5 weeks of active treatment ( either placebo or isradipine 2.5 , 5 , 7.5 , or 10 mg BID ) to determine the effectiveness of isradipine on blood pressure control . Electrocardiographic criteria for left-ventricular ischemia were coded blindly using the Minnesota Codes 4 - 1 to 4 - 4 and 5 - 1 to 5 - 3 at the end of baseline and active treatment periods . One hundred seventy patients with hypertension and matching and complete electrocardiograms completed the study for analysis : 63 ( 37 % ) were white and 117 ( 69 % ) were men . They were 52.1 + /- 10.3 years old mean + /- SD ; range : 22 - 77 years ) . No myocardial infa rct ion occurred during the active phase . Fifty-eight of 170 ( 34 % ) at baseline and 54 of 116 ( 32 % ) at week 5 had left atrial enlargement . Romhilt-Estes left-ventricular hypertrophy was not significantly different at baseline versus active treatment : 14 of 170 ( 8.2 % ) versus 15 of 170 ( 8.8 % ) . At baseline , the rate of active ischemia was 28.2 % ( 48/170 ) : 27.8 % ( 10/36 ) were r and omized to receive placebo during active treatment and 28.4 % ( 38/134 ) were given isradipine ( P = NS ) . For those without ischemia at baseline , the rate of change to electrocardiographic ischemia during active treatment was 0 % ( 0/26 ) for those receiving placebo and 3.1 % ( 3/96 ) for those taking isradipine ( P = NS ) . For those with ischemia at baseline , the rate of change to no ischemia during active treatment was 20 % ( 2/10 ) for those receiving placebo and 10.5 % ( 4/38 ) for those taking isradipine ( P = NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"This multicentre study compared the antihypertensive effect and tolerability of the novel angiotensin II antagonist c and esartan cilexetil with those of losartan and placebo . Men and women aged 20 - 80 years , with primary hypertension and sitting diastolic blood pressure ( DBP ) 95 - 114 mm Hg after a 4-week placebo run-in period , were r and omized to once daily double-blind treatment with c and esartan cilexetil 8 mg ( n=82 ) , c and esartan cilexetil 16 mg ( n=84 ) , losartan 50 mg ( n=83 ) or placebo ( n=85 ) for 8 weeks . Blood pressure was measured 6 and 24 h after dose , i.e. at peak and trough . Differences between treatments were analysed by analysis of covariance , and the primary effect variable was reduction in trough sitting DBP . Compared with placebo treatment , trough DBP was significantly reduced by a mean ( 95 % CI ) of 8.9 ( 6.0 ; 11.8 ) mm Hg with 8 mg and 10.3 ( 7.4 ; 13.2 ) mm Hg with 16 mg c and esartan cilexetil . The 8 mg dose was as effective as losartan 50 mg , while 16 mg c and esartan cilexetil was significantly more effective , with a difference between treatments of 3.7 ( 0.8 ; 6.7 ) mm Hg ( p=0.013 ) . The placebo corrected trough/peak ratio was 0.9 - 1.1 with c and esartan cilexetil and 0.7 with losartan . C and esartan cilexetil was similarly well tolerated as placebo . In conclusion , c and esartan cilexetil 8 mg or 16 mg once daily is an effective and well tolerated antihypertensive treatment . C and esartan cilexetil 16 mg is significantly more effective than losartan 50 mg once daily",
"A r and omized , double-blind , placebo-controlled , parallel-group multicenter study was conducted to evaluate the antihypertensive efficacy and safety of 8-week treatment with one of three fixed-dose combinations — losartan 50 mg plus hydrochlorothiazide 12.5 mg , losartan 50 mg plus hydrochlorothiazide 6.25 mg , or losartan 25 mg plus hydrochlorothiazide 6.25 mg — in comparison with those of hydrochlorothiazide 12.5 mg alone , losartan 50 mg alone , or placebo in Japanese patients with essential hypertension . Significant reductions in sitting diastolic blood pressure ( DBP ) and systolic blood pressure ( SBP ) were seen in all three combination groups compared with the placebo group ( each p DBP and SBP were observed in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group ( 12.7 and 18.0 mmHg , respectively ) . The reductions in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group were significantly greater ( each p incidences of clinical and laboratory drug-related adverse events between any of the combination groups and the placebo group . All combination groups showed improved hypokalemia and hyperuricemia compared to the hydrochlorothiazide 12.5 mg group . These results demonstrated that once-daily , fixed-dose combination therapy with losartan 50 mg plus hydrochlorothiazide 12.5 mg is well tolerated and more efficacious in lowering DBP and SBP than monotherapy in Japanese hypertensive patients",
"BACKGROUND The Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension ( ACCOMPLISH ) trial showed that initial antihypertensive therapy with benazepril plus amlodipine was superior to benazepril plus hydrochlorothiazide in reducing cardiovascular morbidity and mortality . We assessed the effects of these drug combinations on progression of chronic kidney disease . METHODS ACCOMPLISH was a double-blind , r and omised trial undertaken in five countries ( USA , Sweden , Norway , Denmark , and Finl and ) . 11 506 patients with hypertension who were at high risk for cardiovascular events were r and omly assigned via a central , telephone-based interactive voice response system in a 1:1 ratio to receive benazepril ( 20 mg ) plus amlodipine ( 5 mg ; n=5744 ) or benazepril ( 20 mg ) plus hydrochlorothiazide ( 12.5 mg ; n=5762 ) , orally once daily . Drug doses were force-titrated for patients to attain recommended blood pressure goals . Progression of chronic kidney disease , a prespecified endpoint , was defined as doubling of serum creatinine concentration or end-stage renal disease ( estimated glomerular filtration rate benazepril plus amlodipine compared with benazepril plus hydrochlorothiazide . At trial completion , vital status was not known for 143 ( 1 % ) patients who were lost to follow-up ( benazepril plus amlodipine , n=70 ; benazepril plus hydrochlorothiazide , n=73 ) . All r and omised patients were included in the ITT analysis . There were 113 ( 2.0 % ) events of chronic kidney disease progression in the benazepril plus amlodipine group compared with 215 ( 3.7 % ) in the benazepril plus hydrochlorothiazide group ( HR 0.52 , 0.41 - 0.65 , p adverse event in patients with chronic kidney disease was peripheral oedema ( benazepril plus amlodipine , 189 of 561 , 33.7 % ; benazepril plus hydrochlorothiazide , 85 of 532 , 16.0 % ) . In patients with chronic kidney disease , angio-oedema was more frequent in the benazepril plus amlodipine group than in the benazepril plus hydrochlorothiazide group . In patients without chronic kidney disease , dizziness , hypokalaemia , and hypotension were more frequent in the benazepril plus hydrochlorothiazide group than in the benazepril plus amlodipine group . INTERPRETATION Initial antihypertensive treatment with benazepril plus amlodipine should be considered in preference to benazepril plus hydrochlorothiazide since it slows progression of nephropathy to a greater extent . FUNDING Novartis",
"OBJECTIVE To assess if low ( 1.25 mg ) and /or st and ard ( 5 mg ) doses of the ACE inhibitor ramipril could prevent progression of microalbuminuria ( incipient diabetic nephropathy ) in normotensive type 1 diabetic patients . RESEARCH DESIGN AND METHODS This study , using a multicenter r and omized placebo-controlled double-blind parallel group , was conducted over 2 years in 28 outpatient diabetic clinics in the U.K. and Irel and . We screened 334 type 1 diabetic patients with suspected microalbuminuria and normal blood pressure ; of these , 140 patients 18 - 65 years of age with a diagnosis of type 1 diabetes and persistent microalbuminuria , defined as urinary albumin excretion rate ( AER ) of 20 - 200 microg/min , were enrolled in the study . RESULTS The proportion of patients progressing to macroalbuminuria was reduced in the ramipril groups but did not reach statistical significance over 2 years . AER was significantly lower at year 2 in the combined ramipril-treated patients versus placebo ( P = 0.013 ) . More patients on ramipril regressed to normoalbuminuria ( ramipril , 20 % for 5 mg ramipril , and 4 % for placebo ( P = 0.053 ) . Blood pressure was significantly reduced to a similar extent with both 1.25 and 5 mg ramipril . Supine systolic blood pressure increased from 130 to 134 mmHg in the placebo group and fell in the 1.25 mg ramipril group ( from 132 to 129 mmHg ) and in the 5 mg ramipril group ( from 134 to 130 mmHg ) ( P = 0.003 , compared with placebo ) . No statistically significant changes were observed in glomerular filtration rate ( GFR ) between the placebo- and ramipril-treated groups during the 2-year period . CONCLUSIONS Microalbuminuria is reduced significantly by ramipril treatment in type 1 diabetic patients without hypertension . Although the magnitude of the response was greater , there is no significant difference between responses to 1.25 or 5 mg ramipril . Small but highly significant reductions in systolic and mean arterial pressures occur in ramipril-treated patients . GFR is stable at this stage of the evolution of diabetic nephropathy and is unaffected by ramipril treatment for 2 years",
"OBJECTIVES The objective of this study was to evaluate the effects of losartan + /- hydrochlorothiazide ( HCTZ ) versus placebo in obese patients with systolic and diastolic hypertension . RESEARCH DESIGN AND METHODS R and omized patients ( n = 261 ) were non-diabetic with systolic blood pressure ( SBP ) > or = 140 and or = 95 and 30 kg/m(2 ) , and waist circumference > 40 (males)/ > 35 ( females ) inches . Patients were r and omized to placebo or a forced titration of losartan 50 mg titrated at 4-week intervals to losartan 100 mg , losartan 100 mg/HCTZ 12.5 mg , and losartan 100 mg/HCTZ 25 mg . Primary efficacy measurements were change from baseline in SBP and DBP at 12 weeks . Secondary measurements were change from baseline in BPs at 8 and 16 weeks , percent responders at 12 and 16 weeks , and safety/tolerability . Post-hoc analyses were BP at 4 weeks and achievement of controlled BP ( SBP Losartan 50 mg reduced BP from 151.6/99.2 mmHg at baseline to 140.1/89.8 mmHg at week 4 ( post hoc ) , 139.5/89.6 mmHg with losartan 100 mg at week 8 ( secondary ) , 134.3/85.9 mmHg with losartan 100 mg/HCTZ 12.5 mg at week 12 ( primary ) , and 132.1/84.9 mmHg with losartan 100 mg/HCTZ 50 mg at week 16 ( secondary ) ( all p Rates of clinical adverse experiences were similar between treatment groups . A limitation of these analyses is the relatively rapid rate of study drug titration , which may not have allowed for the evaluation of the full treatment effect at each titration step . CONCLUSIONS We conclude that losartan alone or in combination with HCTZ was generally well tolerated and effective in the treatment of elevated systolic and diastolic BP in obese patients with hypertension",
" Hypertensive patients whose BP was uncontrolled despite the use of antihypertensive agents , including an ARB ( c and esartan 8 mg/day or valsartan 80 mg/day ) , were enrolled . The patients were r and omly assigned to combination therapy with telmisartan 40 mg/day ( changed from current ARB ) and hydrochlorothiazide ( HCTZ ) 12.5 mg/day ( T + H , n = 32 ) or to no change in their current drug regimen ( CTL , n = 32 ) . The observation period was 12 weeks . The office and home BPs were significantly reduced in the T + H compared to those in the CTL . A sufficient and long-acting BP lowering effect , as reflected in decreased early morning BP , was obtained with the combination of low-dose HCTZ and telmisartan without apparent metabolic deterioration",
"The antihypertensive efficacy and tolerability of the new calcium antagonist isradipine was assessed in 86 hypertensive patients who had pretreatment diastolic blood pressures ( DBP ) ± 105 mm Hg and who were r and omly allocated to a double-blind comparison of three different dosage regimens : 1.25 mg , 2.5 mg , and 5 mg b.i.d . , and placebo . A 2-week run-in period was followed by a 4-week course of treatment . Isradipine reduced systolic and diastolic blood pressures dose-dependently : the normalization rate ( DBP ± 90 mm Hg ) was 5 % with placebo and 29 , 55 , and 64 % , with isradipine 1.25 , 2.5 , and 5 mg b.i.d . , respectively . The proportion of patients experiencing at least a 10 mm Hg reduction in sitting DBP was 29 , 67 , 86 , and 91 % , respectively . All three dosages proved to he significantly effective compared to placebo . Neither heart rate nor blood pressure regulation in orthostasis were influenced . The main side effects were headache , dizziness , and flushing : isradipine 1.25 and 2.5 mg b.i.d . were well tolerated ( not significantly different from placebo ) . In conclusion , isradipine 2.5 mg h.i.d . appears to he the potential dose of first choice , exhibiting a favorable benefit-risk profile",
"OBJECTIVE The aim of this study was to evaluate the efficacy and tolerability of a new fixed-dose combination ( FDC ) of telmisartan 40 mg + amlodipine 5 mg ( T+A ) compared with amlodipine 5-mg monotherapy ( A ) in adult Indian patients with stage II hypertension . METHODS This comparative , Phase III , 12-week , multicenter , prospect i ve , r and omized , double-blind study was conducted in Indian patients aged 18 to 65 years with established stage II hypertension . Patients were treated with oral FDC of T+A or A QD before breakfast for 12 weeks ; blood pressure ( BP ) and heart rate were measured in the sitting position . Primary efficacy end points were reduction in clinical systolic BP (SBP)/ diastolic BP ( DBP ) from baseline to study end and number of responders ( ie , patients who achieved target SBP/ DBP Tolerability was assessed by treatment-emergent adverse events , identified using physical examination , laboratory analysis , and electrocardiography . RESULTS A total of 210 patients were enrolled in the study ; 203 patients ( 143 men , 60 women ) completed the study while 7 were lost to follow-up ( 4 patients in the T+A group and 3 in the A group ) and considered with-drawn . At study end , statistically significant percentage reductions from baseline within groups and between groups were observed in SBP ( T+A [ -27.4 % ] ; A [ -16.6 % ] ) and DBP ( T+A [ -20.1 % ] ; A [ -13.3 % ] ) ( all , P Response rates were 87.3 % ( 89/102 ) in the T+A group and 69.3 % ( 70/101 ) in the A group ( P adverse events were not significantly different between the 2 treatment groups ( T+A , 16.0 % [ 17/106 ] ; A , 15.4 % [ 16/104 ] ) . Peripheral edema was reported in 8.5 % patients ( 9/106 ) in the T+A group compared with 13.5 % ( 14/104 ) in the A group , and cough was reported in 3.8 % patients ( 4/106 ) in the T+A group and 1.0 % ( 1/104 ) patients in the A group ; these differences did not reach statistical significance . The incidences of headache , dizziness , and diarrhea were similar between the 2 groups . CONCLUSIONS Among these Indian patients with stage II hypertension , the FDC of T+A was found to be significantly more effective , with regard to BP reductions , than A , and both treatments were well tolerated ",
"In a double blind placebo controlled r and omised parallel study the antihypertensive activity and adverse biochemical effects of three doses of cyclopenthiazide were evaluated in patients with mild essential hypertension that had been recently diagnosed or was being treated with a single drug . After a four week placebo washout period 53 patients with diastolic blood pressures between 90 - 110 mm Hg were r and omly assigned to 50 , 125 , or 500 micrograms cyclopenthiazide or matching placebo for an eight week period of treatment . Blood pressure was measured in the patients ' homes by the same observer every two weeks . Serum urea , electrolytes , urate , and creatinine concentrations and 24 hour urinary sodium excretion were monitored every four weeks and serum magnesium concentration and plasma renin activity at the end of the washout and treatment periods . After eight weeks of treatment systolic and diastolic blood pressures were significantly reduced in patients taking 125 and 500 micrograms cyclopenthiazide when compared with those taking placebo . The decrement in serum potassium concentration ( 0.6 mmol/l ) and increase in serum urate concentration 0.06 mmol/l ) were greatest with the 500 micrograms dose , the increase in serum urate concentration alone being significant . No change in serum magnesium concentration or 24 hour urinary sodium excretion was noted with any dose of cyclopenthiazide . Only the 500 micrograms dose of cyclopenthiazide significantly increased the mean plasma renin activity ( 1.8 ( 95 % confidence interval 0.2 to 3.4)-5.4 ( 3.9 to 6.8 ) nmol angiotensin I/l/h ) ; the other doses like the placebo had no effect . Cyclopenthiazide 125 micrograms , a dose lower than is currently marketed , produced a similar hypotensive response to 500 micrograms of the drug without up setting the biochemical profile",
"AIM The aim of the present study is to evaluate the effect of treatment with verapamil , tr and olapril and their combination on peripheral microcirculation vasoreactivity . METHODS Twenty hypertensive patients were r and omized to receive oral tr and olapril ( 4 mg oid ; TRA ) or verapamil ( 240 mg oid ; VER ) for 6 months and then the combination of the two drugs for additional 6 months . At baseline , 6 months and 12 months , peripheral microcirculation vasoreactivity was evaluated by forearm blood flow technique ( venous plethysmography ) , as vasodilation to an endothelium-dependent ( acetylcholine ) and an endothelium-independent stimulus ( sodium nitroprusside , SNP ) ; minimal forearm vascular resistances ( MFVR ) were also evaluated . RESULTS Blood pressure decreased similarly and progressively in both groups throughout the study period . In VER , 6-month verapamil treatment significantly increased vasodilation to acetylcholine , but not to SNP . The superimposition of tr and olapril increased the response to SNP , and less to acetylcholine . In TRA group , 6-month treatment with tr and olapril improved the response to SNP , but not to acetylcholine . In this group , the superimposition of verapamil caused a significant improvement in the response to acetylcholine , but not to SNP . At the end of the study , MFVR were significantly reduced in both groups , but to a greater extent in TRA . CONCLUSION The present study demonstrates that chronic treatment with verapamil ameliorates endothelial function in the forearm microcirculation of essential hypertensive patients , while tr and olapril protects microcirculation from structural alterations . The combination of the two drugs is potentially a powerful tool to counteract hypertension-related microvascular dysfunction and damage"
] | 4116669a-06ff-11f0-808a-c43d1ab1c353 |
Background Cardiovascular risk management ( CVRM ) is notoriously difficult because of multi-morbidity and the different phenotypes and severities of cardiovascular disease . Computerized decision support systems ( CDSS ) enable the clinician to integrate the latest scientific evidence and patient information into tailored strategies . The effect on cardiovascular risk factor management is yet to be confirmed . Methods We performed a systematic review and meta- analysis evaluating the effects of CDSS on CVRM , defined as the change in absolute values and attainment of treatment goals of systolic blood pressure ( SBP ) , low density lipoprotein cholesterol ( LDL-c ) and HbA1c . Also , CDSS characteristics related to more effective CVRM were identified . Eligible articles were method ologically appraised using the Cochrane risk of bias tool . We calculated mean differences , relative risks , and if appropriate ( I2 14,335 studies identified , 22 were included . Four studies reported on SBP , 3 on LDL-c , 10 on CVRM in patients with type II diabetes and 5 on guideline adherence . The CDSSs varied considerably in technical performance and content . Heterogeneity of results was such that quantitative pooling was often not appropriate . Among CVRM patients , the results tended towards a beneficial effect of CDSS , but only LDL-c target attainment in diabetes patients reached statistical significance . Prompting , integration into the electronical health record , patient empowerment , and medication support were related to more effective CVRM . Conclusion We did not find a clear clinical benefit from CDSS in cardiovascular risk factor levels and target attainment . Some features of CDSS seem more promising than others . However , the variability in CDSS characteristics and heterogeneity of the results – emphasizing the immaturity of this research area - limit stronger conclusions . Clinical relevance of CDSS in CVRM might additionally be sought in the improvement of shared decision making and patient empowerment | [
"RATIONALE , AIMS AND OBJECTIVES To assess the outcomes of a clinical decision support ( CDS ) intervention design ed for home care patients with high medication regimen complexity ( MRC ) and to examine correlates of CDS use . METHOD The CDS consisted of a computerized algorithm that identified high MRC patients , electronic alerts and a care management module . Nurses were r and omized upon identification of an eligible patient . Full intention to treat and intervention group-only analyses were completed . Regression-adjusted outcomes were hospitalization , emergency department use and reduction in MRC . RESULTS Five hundred nurses were r and omized with 7919 of their patients . Approximately 20 % of the intervention group was hospitalized versus 21 % in the control group ; 16.5 % versus 16.7 % had an emergency department visit ; and 6 % in each group dropped below the high MRC threshold . No statistically significant differences were found in the intention to treat analysis . Eighty-two percent of intervention nurses used the CDS but for only 42 % of their patients . Among intervention patients , CDS use ( vs. non-use ) was associated with reduced MRC and hospitalization . CDS use was associated with various clinician and patient characteristics . CONCLUSION CDS use was limited , negating the impact of the intervention overall . Findings on correlates of CDS use and the relationship between CDS use and positive outcomes suggest that CDS use and outcomes could be enhanced by avoiding short patient lengths of stay , improving continuity of care , increasing reliance on salaried nurses and /or increasing per diem nurses ' incentives to use CDS",
"This study was aim ed to investigate the effects of computerized decision support system in improving the prescription of drugs for cardiovascular prevention . A total of 197 Italian general practitioners were r and omly allocated to receive either the alerting computerized decision support system integrated into st and ard software ( intervention arm ) or the st and ard software alone ( control arm ) . Data on 21230 patients with diabetes , 3956 with acute myocardial infa rct ion , and 2158 with stroke were analysed . The proportion of patients prescribed with cardiovascular drugs and days of drug – drug interaction exposure were evaluated . Computerized decision support system significantly increased the proportion of patients with diabetes prescribed with antiplatelet drugs ( intervention : + 2.7 % vs. control : + 0.15 % ; p lipidlowering drugs ( + 4.2 % vs. + 2.8 % ; p = 0.001 ) . A statistically significant decrease in days of potential interactions has been observed only among patients with stroke ( −1.2 vs. −0.5 days/person-year ; p = 0.001 ) . In conclusion , computerized decision support system significantly increased the use of recommended cardiovascular drugs in diabetic patients , but it did not influence the exposure to potential",
"Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners",
"OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 ( 64 % ) at the comparison sites participated ; 83 of 103 ( 81 % ) of the intervention-site subjects returned for follow-up at year 2 . Performance of the six recommended assessment s improved in intervention-site subjects at year 2 compared with year 1 ( 5.8 vs. 4.3 , P = 0.0001 ) and compared with comparison-site subjects at year 2 ( 4.2 , P = 0.014 ) . No significant changes were noted in intermediate outcomes . CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes . Additional interventions are needed to improve intermediate outcomes ",
"PURPOSE Dyslipidemia treatment dramatically decreases coronary heart disease risk in diabetes , yet only a minority of these patients are screened or achieve optimal low-density lipoprotein ( LDL ) cholesterol levels . Our aim was to increase the percentage of diabetic patients in whom lipid management was achieved through electronic and direct educational detailing . METHODS The study cohort comprised 884 diabetic patients at 12 primary care practice s. Practice sites were r and omized to one of three intervention groups : electronic educational detailing , direct ( face-to-face ) educational detailing , or control . Direct and electronic detailing were performed over a 12-month period . All sites were notified of our goal to enhance lipid testing among diabetic patients . Chart abstract ion was performed 15 months after the start of the intervention . For the entire population ( n=884 ) , the proportion of patients with lipid testing was calculated , and changes from pre- to postintervention were compared across groups . We compared pre- and postintervention LDL-cholesterol changes between groups using least square means to account for site variation . RESULTS Favorable provider actions increased significantly with the intervention ( + 22 % compared with + 6 % in controls , P=.01 ) . By logistic regression , electronic detailing increased the likelihood of lipid testing ( odds ratio 3.0 , confidence interval 1.6 - 5.7 ) , as did direct detailing ( odds ratio 1.8 , confidence interval 0.9 - 3.7 ) in patients with no preintervention LDL test ( n=432 ) . Lipid testing tended to increase to a greater extent at intervention sites ( + 23 % for the combination of electronic and direct detailing vs + 11 % for controls , P=.06 ) . CONCLUSIONS Brief educational detailing either through direct or electronic communication favorably impacts provider behavior regarding dyslipidemia care for diabetic patients",
"Background Very few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world . The potential role of decision support system for the management of blood pressure among Indian hypertensives remains unclear . We propose a cluster r and omised trial that aims to test the effectiveness and cost effectiveness of DSS among Indian hypertensive patients . Methods The trial design is a cluster r and omised community intervention trial , in which the participants would be adult male and female hypertensive patients , in the age group of 35 to 64 years , reporting to the Primary Health Care centres of Mahabubnagar district , And hra Pradesh , India . The objective of the study is to test the effectiveness and compare the cost effectiveness and cost utility among hypertensive subjects r and omized to receive either decision support system or a chart based algorithmic support system in urban and rural areas of a district in the state of And hra Pradesh , India ( baseline versus 12 months follow up ) . The primary outcome would be a comparison of the systolic blood pressure at 0 and 12 months among hypertensive patients r and omized to receive the decision support system or the chart based algorithmic support system . Computer generated r and omisation and an investigator and analyser blinded method would be followed . 1600 participants ; 800 to each arm ; each arm having eight clusters of hundred participants each have been recruited between 01 August 2011 - 01 March 2012 . A twelve month follow up will be completed by March 2013 and results are expected by April 2013 . Discussion This cluster r and omized community intervention trial on DSS will enable policy makers to find out the effectiveness , cost effectiveness and cost utility of decision support system for management of blood pressure among hypertensive patients in India . Most of the previous studies on decision support system have focused on physician performance , adherence and on preventive care reminders . The uniqueness of the proposed study lies in finding out the effectiveness of a decision support system on patient related outcomes .Trial registration CTRI/2012/03/002476 , Clinical Trial Registry - India",
"Background Electronic guideline -based decision support systems have been suggested to successfully deliver the knowledge embedded in clinical practice guidelines . A number of studies have already shown positive findings for decision support systems such as drug-dosing systems and computer-generated reminder systems for preventive care services . Methods A systematic literature search ( 1990 to December 2008 ) of the English literature indexed in the Medline data base , Embase , the Cochrane Central Register of Controlled Trials , and CRD ( DARE , HTA and NHS EED data bases ) was conducted to identify evaluation studies of electronic multi-step guideline implementation systems in ambulatory care setting s. Important inclusion criterions were the multidimensionality of the guideline ( the guideline needed to consist of several aspects or steps ) and real-time interaction with the system during consultation . Clinical decision support systems such as one-time reminders for preventive care for which positive findings were shown in earlier review s were excluded . Two comparisons were considered : electronic multidimensional guidelines versus usual care ( comparison one ) and electronic multidimensional guidelines versus other guideline implementation methods ( comparison two ) . Results Twenty-seven publications were selected for analysis in this systematic review . Most design s were cluster r and omized controlled trials investigating process outcomes more than patient outcomes . With success defined as at least 50 % of the outcome variables being significant , none of the studies were successful in improving patient outcomes . Only seven of seventeen studies that investigated process outcomes showed improvements in process of care variables compared with the usual care group ( comparison one ) . No incremental effect of the electronic implementation over the distribution of paper versions of the guideline was found , neither for the patient outcomes nor for the process outcomes ( comparison two ) . Conclusions There is little evidence at the moment for the effectiveness of an increasingly used and commercialised instrument such as electronic multidimensional guidelines . After more than a decade of development of numerous electronic systems , research on the most effective implementation strategy for this kind of guideline -based decision support systems is still lacking . This conclusion implies a considerable risk towards inappropriate investments in ineffective implementation interventions and in suboptimal care",
"BACKGROUND Optimal care for patients with diabetes is difficult to achieve in clinical practice . OBJECTIVE To evaluate the impact of a registry and decision support system on processes of care , and physiologic control . PARTICIPANTS R and omized trial with clustering at the practice level , involving 7,412 adults with diabetes in 64 primary care practice s in the Northeast . INTERVENTIONS Provider decision support ( reminders for overdue diabetes tests , alerts regarding abnormal results , and quarterly population reports with peer comparisons ) and patient decision support ( reminders and alerts ) . MEASUREMENTS AND MAIN RESULTS Process and physiologic outcomes were evaluated in all subjects . Functional status was evaluated in a r and om patient sample via question naire . We used multiple logistic regression to quantify the effect , adjusting for clustering and potential confounders . Intervention subjects were significantly more likely to receive guideline -appropriate testing for cholesterol ( OR = 1.39 ; [ 95%CI 1.07 , 1.80 ] P = 0.012 ) , creatinine ( OR = 1.40 ; [ 95%CI 1.06 , 1.84 ] P = 0.018 ) , and proteinuria ( OR = 1.74 ; [ 95%CI 1.13 , 1.69 ] P = 0.012 ) , but not A1C ( OR = 1.17 ; [ 95 % CI 0.80 , 1.72 ] P = 0.43 ) . Rates of control of A1C and LDL cholesterol were similar in the two groups . There were no differences in blood pressure , body mass index , or functional status . CONCLUSIONS A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers . This system improved the process of laboratory monitoring in primary care , but not physiologic control",
"Abstract Objectives : To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk , blood pressure , and prescribing of cardiovascular drugs in hypertensive patients . Design : Cluster r and omised controlled trial . Setting : 27 general practice s in Avon . Participants : 614 patients aged between 60 and 79 years with high blood pressure . Interventions : Patients were r and omised to computer based clinical decision support system plus cardiovascular risk chart ; cardiovascular risk chart alone ; or usual care . Main outcome measures : Percentage of patients in each group with a five year cardiovascular risk≥10 % , systolic blood pressure , diastolic blood pressure , prescribing of cardiovascular drugs . Results : Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10 % than patients receiving usual care . Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10 % than chart only patients , odds ratio 2.3 ( 95 % confidence interval 1.1 to 4.8 ) . The chart only group had significantly lower systolic blood pressure compared with the usual care group ( difference in means−4.6 mm Hg ( 95 % confidence interval−8.4 to−0.8 ) . Reduction of diastolic blood pressure did not differ between the three groups . The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups . Conclusions : The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended . Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure ",
"BACKGROUND Computerized decision support systems ( CDSSs ) linked with electronic medical records ( EMRs ) are promoted as an effective means of improving patient care . However , very few high- quality studies are set in routine , community-based clinical care , and no consistent evidence of an effect on patient outcomes has been found . METHODS A r and omized controlled trial among EMR-using primary care practice s in Ontario , Canada . Patients 55 years or older with previous vascular events , diabetes mellitus , hypertension , or hypercholesterolemia were r and omized to the Computerization of Medical Practice s for the Enhancement of Therapeutic Effectiveness ( COMPETE III ) CDSS intervention or to usual care . The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient , risk calculation , and a clinical re source . The primary outcome was a composite score of 8 recommended process outcomes at 1 year . Data collectors were blinded to group allocation . Analysis used the intention-to-treat principle with multiple imputation for missing data . RESULTS We r and omized and included in the analysis 1102 patients in 49 community-based physician practice s ( 53.4 % female ; mean age , 69.1 years ; 28.0 % with a previous vascular event ) . The intervention group ( 545 [ 49.5 % ] ) had a significantly greater improvement in mean process composite , with a difference of 4.70 ( P continuity of care ( 4.18 ; P ability to improve their vascular health ( 3.07 ; P -vascular events , clinical variables , and quality of life-were not improved . CONCLUSION Despite favorable review s and important improvements in the complex processes required to reduce vascular risk , clinical outcomes remain unchanged",
"OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients",
"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 Management of diabetes is frequently suboptimal in primary care setting s , where providers often fail to intensify therapy when glucose levels are high , a problem known as clinical inertia . We asked whether interventions targeting clinical inertia can improve outcomes . RESEARCH DESIGN AND METHODS A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center . We studied all patients ( 4,138 ) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were r and omized to be control subjects or to receive one of three interventions . Instead of consultative advice , the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient 's visit , individual face-to-face feedback on performance for 5 min every 2 weeks , or both . RESULTS Over an average patient follow-up of 15 months within the intervention site , improvements in and final HbA1c ( A1C ) with feedback + reminders ( deltaA1C 0.6 % , final A1C 7.46 % ) were significantly better than control ( deltaA1C 0.2 % , final A1C 7.84 % , P systolic blood pressure ( sBP ) and LDL cholesterol . Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP . Over a 2-year period , overall glycemic control improved in the intervention site but did not change in other primary care sites ( final A1C 7.5 vs. 8.2 % , P internal medicine resident primary care providers improves glycemic control . Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care setting",
"Objective To determine the effectiveness of a patient decision aid ( PDA ) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster r and omised controlled trial ( RCT ) . Design A cluster RCT . Setting 49 general practice s in UK r and omised into intervention ( n=25 ) and control ( n=24 ) . Participants General practice s Inclusion criteria : > 4 medical partners ; list size > 7000 ; and a diabetes register with > 1 % of practice population . 191 practice s assessed for eligibility , and 49 practice s r and omised and completed the study . Patients People with type 2 diabetes mellitus ( T2DM ) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin ( HbA1c ) greater than 7.4 % ( IFCC HbA1c > 57 mmol/mol ) or advised in the preceeding 6 months to add or consider changing to insulin therapy . Exclusion criteria : currently using insulin therapy ; difficulty reading or underst and ing English ; difficulty in underst and ing the purpose of the study ; visual or cognitive impairment or mentally ill . A total of 182 assessed for eligibility , 175 r and omised to 95 intervention and 80 controls , and 167 completion and analysis . Intervention Brief training of clinicians and use of PDA with patients in single consultation . Primary outcomes Decision quality ( Decisional Conflict Scores , knowledge , realistic expectations and autonomy ) and glycaemic control ( glycosolated haemoglobin , HbA1c ) . Secondary outcomes Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications . Results Intervention group : lower total Decisional Conflict Scores ( 17.4 vs 25.2 , p better knowledge ( 51.6 % vs 28.8 % , p realistic expectations ( risk of ‘ hypo ’ , ‘ weight gain ’ , ‘ complications ’ ; 81.0 % vs 5.2 % , 70.5 % vs 5.3 % , 26.3 % vs 5.0 % respectively , p more autonomous in decision-making ( 64.1 % vs 42.9 % , p=0.012 ) . No significant difference in the glycaemic control between the two groups . Conclusions Use of the P AND As decision aid reduces decisional conflict , improves knowledge , promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice . IS RCT N Trials Register Number 14842077",
"OBJECTIVES This study aim ed to assess the uptake and effect in primary care of a computerized decision support system ( DSS ) for the management of hyperlipidaemia . METHOD A prospect i ve controlled trial was conducted in 25 practice s covering a population of 150,000 in the city of Birmingham . The Primed system , a specialist developed , rule based DSS for general practice , was introduced prospect ively after a 3-month baseline data collection . The main outcome measures were nine months ' data on prescribing of lipid lowering agents ; use of laboratory tests ; and referrals to secondary care for the investigation of hyperlipidaemia . RESULTS System use was lower than expected . A shift was observed towards requests for appropriate follow-up of previously abnormal lipid results and a greater emphasis on full lipid profiles , in line with the DSS guidelines . Referrals showed a 55 % decrease on those expected ( NS ) . The prescribing evaluation revealed a large variation between practice s , but no significant alteration following system use . Views of users favoured decision support as a concept , but criticised technical problems with the system . CONCLUSIONS Greater integration of DSS software and practice based data h and ling systems is needed . The mode of data capture , and hence both the content and form of knowledge representation , in DSS must take greater account of the primary care consultation process if such systems are to be of use to practitioners",
"BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848",
"Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice",
"Background R and omized control trials from the developed world report that clinical decision support systems ( DSS ) could provide an effective means to improve the management of hypertension ( HTN ) . However , evidence from developing countries in this regard is rather limited , and there is a need to assess the impact of a clinical DSS on managing HTN in primary health care center ( PHC ) setting s. Methods and Results We performed a cluster r and omized trial to test the effectiveness and cost‐effectiveness of a clinical DSS among Indian adult hypertensive patients ( between 35 and 64 years of age ) , wherein 16 PHC clusters from a district of Telangana state , India , were r and omized to receive either a DSS or a chart‐based support ( CBS ) system . Each intervention arm had 8 PHC clusters , with a mean of 102 hypertensive patients per cluster ( n=845 in DSS and 783 in CBS groups ) . Mean change in systolic blood pressure ( SBP ) from baseline to 12 months was the primary endpoint . The mean difference in SBP change from baseline between the DSS and CBS at the 12th month of follow‐up , adjusted for age , sex , height , waist , body mass index , alcohol consumption , vegetable intake , pickle intake , and baseline differences in blood pressure , was −6.59 mm Hg ( 95 % confidence interval : −12.18 to −1.42 ; P=0.021 ) . The cost‐effective ratio for CBS and DSS groups was $ 96.01 and $ 36.57 per mm of SBP reduction , respectively . Conclusion Clinical DSS are effective and cost‐effective in the management of HTN in re source ‐constrained PHC setting s. Clinical Trial Registration URL : http://www.ctri.nic.in . Unique identifier : CTRI/2012/03/002476",
"Background Electronic medical records ( EMRs ) have the potential to facilitate the design of large cluster-r and omized trials ( CRTs ) . Objective To describe the design of a CRT of clinical decision support to improve diabetes care and outcomes . Methods In the Diabetes Improvement Group-Intervention Trial ( DIG-IT ) , we identified and balanced preassignment characteristics of 12,675 diabetic patients cared for by 147 physicians in 24 practice s of 2 systems using the same vendor ’s EMR . EMR-facilitated disease management was system A ’s experimental intervention ; system B interventions involved patient empowerment , with or without disease management . For our sample , we : ( 1 ) identified characteristics associated with response to interventions or outcomes ; ( 2 ) summarized feasible partitions of 10 system A practice s ( 2 groups ) and 14 system B practice s ( 3 groups ) using intra-cluster correlation coefficients ( ICCs ) and st and ardized differences ; ( 3 ) selected ( blinded ) partitions to effectively balance the characteristics ; and ( 4 ) r and omly assigned groups of practice s to interventions . Results In System A , 4,306 patients , were assigned to 2 groups of practice s ; 8,369 patients in system B were assigned to 3 groups of practice s. Nearly all baseline outcome variables and covariates were well-balanced , including several not included in the initial design . DIG-IT ’s balance was superior to alternative partitions based on volume , geography or demographics alone . Conclusions EMRs facilitated rigorous CRT design by identifying large numbers of patients with diabetes and enabling fair comparisons through preassignment balancing of practice sites . Our methods can be replicated in other setting s and for other conditions , enhancing the power of other translational investigations",
"PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines . METHODS A 1-year cluster r and omized controlled trial was performed using 30 primary care practice s ( 4,105 patients ) in southeastern New Engl and . The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein ( LDL ) and non – high-density lipoprotein ( HDL ) cholesterol goals . RESULTS After 1 year of intervention , both r and omized practice groups improved screening ( 89 % screened ) , and 74 % of patients in both groups were at their LDL and non-HDL cholesterol goals ( P screening or percentage of patients who achieved LDL and non-HDL cholesterol goals . Post hoc analysis showed practice s who made high use of the patient activation kiosk were more likely to have patients screened ( odds ratio [ OR ] = 2.54 ; 95 % confidence interval [ CI ] , 1.97–3.27 ) compared with those who made infrequent or no use . Additionally , physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals ( OR = 1.27 ; 95 % CI , 1.07–1.50 ) and non-HDL goals ( OR = 1.23 ; 95 % CI , 1.04–1.46 ) than low-use or no-use physicians . CONCLUSION This study showed None results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practice s. Post hoc analysis showed a potential benefit in practice s that used the e-health tools more frequently in screening and management of dyslipidemia . Further research on how to incorporate and increase adoption of user-friendly , patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted",
"OBJECTIVE : 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",
"PURPOSE Clinical guidelines are design ed to assist in the management of specific diseases ; however , these guidelines are often neglected in the delivery of care . The purpose of this study was to determine whether clinician use of an clinical practice guideline would increase in response to having , at the patient visit , a decision support system based on a practice guideline that generates a customized management protocol for the individual patient using data from the patient 's electronic medical record . SUBJECTS AND METHODS In a 6-month controlled trial at a primary care clinic , 58 primary care clinicians were r and omized to receive either a special encounter form with the computer-generated guideline recommendations or a st and ard encounter form . The effect of computer-generated advice on clinician behavior was measured as rate of compliance with guideline recommendations . Data from 30 clinicians were analyzed ; data from 28 clinicians were excluded because these clinicians did not meet predefined criteria for minimum exposure to diabetic patient care . RESULTS Availability of patient management recommendations generated by the decision support system result ed in a two-fold increase in clinician compliance with care guidelines for diabetes mellitus ( P = 0.01 ) . Median compliance for the group receiving the recommendations was 32.0 % versus 15.6 % for the control group . CONCLUSION Decision support based on a clinical practice guideline is an effective tool for assisting clinicians in the management of diabetic patients . This decision support system provides a model for how a clinical practice guideline can be integrated into the care process by computer to assist clinicians in managing a specific disease through helping them comply with care st and ards . Use of decision support systems based on clinical practice guidelines could ultimately improve the quality of medical care",
"Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 .",
"In a distributed information search task , data representation and cognitive distribution jointly affect user search performance in terms of response time and accuracy . Guided by UFuRT ( User , Function , Representation , Task ) , a human-centered framework , we proposed a search model and task taxonomy . The model defines its application in the context of healthcare setting . The taxonomy clarifies the legitimate operations for each type of search task of relational data . We then developed experimental prototypes of hyperlipidemia data displays . Based on the displays , we tested the search tasks performance through two experiments . The experiments are of a within-subject design with a r and om sample of 24 participants . The results support our hypotheses and vali date the prediction of the model and task taxonomy . In this study , representation dimensions , data scales , and search task types are the main factors in determining search efficiency and effectiveness . Specifically , the more external representations provided on the interface the better search task performance of users . The results also suggest the ideal search performance occurs when the question type and its corresponding data scale representation match . The implication s of the study lie in contributing to the effective design of search interface for relational data , especially laboratory results , which could be more effectively design ed in electronic medical records",
"Purpose To assess the impact of personalised physician learning ( PPL ) interventions using simulated learning cases on control of hypertension and dyslipidaemia in primary care setting s. Methods A total of 132 primary care physicians , 4568 eligible patients with uncontrolled hypertension , and 15 392 eligible patients with uncontrolled dyslipidaemia were cluster-r and omised to one of three conditions : ( a ) no intervention , ( b ) PPL-electronic medical record ( EMR ) intervention in which 12 PPL cases were assigned to each physician based on observed patterns of care in the EMR in the previous year , or ( c ) PPL-ASSESS intervention in which 12 PPL cases were assigned to each physician based on their performance on four st and ardised assessment cases . General and generalised linear mixed models were used to account for clustering and to model differences in patient outcomes in the study arms . Results Among patients with uncontrolled hypertension at baseline , 49.1 % , 46.6 % and 47.3 % ( p=0.43 ) achieved blood pressure ( BP ) targets at follow-up . Among patients with uncontrolled dyslipidaemia at baseline , 37.5 % , 37.3 % and 38.1 % ( p=0.72 ) achieved low density lipoprotein cholesterol targets at follow-up in PPL-EMR , PPL-ASSESS and the control group , respectively . Although systolic ( BP ) ( p lipid ( p systolic BP values ( p=0.51 ) or lipid values ( p=0.61 ) among the three study arms . No difference in intervention effect was noted when comparing the PPL-EMR with the PPL-ASSESS intervention ( p=0.47 ) . Conclusions The two PPL interventions tested in this study did not lead to improved control of hypertension or dyslipidaemia in primary care clinics during a mean 14-month follow-up period . This None result may have been due in part to substantial overall improvement in BP and lipid control at the study sites during the study . Trial registration number NCT00903071",
"Computerized reminder systems have been shown to be effective in improving physician compliance with preventive services guidelines . Very little has been published about the use of computerized reminders for preventive care in diabetes . We implemented a computer-generated reminder system for diabetes care guidelines in a r and omized controlled study in the outpatient clinics of 35 internal medicine residents at the University of Utah and Salt Lake Veterans Affairs Hospitals . After a six month study period , compliance with the recommended care significantly improved in both the intervention group that received patient-specific reminders about the guidelines ( 38.0 % at baseline , 54.9 % at follow-up ) and the control group that received a nonspecific report ( 34.6 % at baseline , 51.0 % at follow-up ) . There was no significant difference between the two groups . Both clinic sites showed similar improvement over baseline levels of compliance . Residents who completed encounter forms used by the system showed a significantly greater improvement in compliance than those who did not complete encounter forms ( 19.7 % vs. 7.6 % , p = 0.006 ) . The improvements in guideline compliance were seen in all areas of diabetes preventive care studied , and significant improvements were seen with recommended items from the medical history , physical exam , laboratory testing , referrals , and patient education . The use of encounter forms by the providers significantly improved documented compliance with the guidelines in almost all categories of preventive care . These results suggest that computerized reminder systems improve compliance with recommended care more by facilitating the documentation of clinical findings and the ordering of recommended procedures than by providing the clinician with patient-specific information about guideline compliance status . Further study is needed to underst and the implication s of these findings to the development of future computerized reminder systems for chronic diseases such as diabetes",
"BACKGROUND Achievement of diabetes care goals is suboptimal globally . Diabetes-focused quality improvement ( QI ) is effective but remains untested in South Asia . OBJECTIVE To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes . DESIGN Parallel , open-label , pragmatic r and omized , controlled trial . ( Clinical Trials.gov : NCT01212328 ) . SETTING Diabetes clinics in India and Pakistan . PATIENTS 1146 patients ( 575 in the intervention group and 571 in the usual care group ) with type 2 diabetes and poor cardiometabolic profiles ( glycated hemoglobin [ HbA1c ] level ≥8 % plus systolic blood pressure [ BP ] ≥140 mm Hg and /or low-density lipoprotein cholesterol [ LDLc ] level ≥130 mg/dL ) . INTERVENTION Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records . MEASUREMENTS Proportions achieving HbA1c level less than 7 % plus BP less than 130/80 mm Hg and /or LDLc level less than 100 mg/dL ( primary outcome ) ; mean risk factor reductions , health-related quality of life ( HRQL ) , and treatment satisfaction ( secondary outcomes ) . RESULTS Baseline characteristics were similar between groups . Median diabetes duration was 7.0 years ; 6.8 % and 39.4 % of participants had preexisting cardiovascular and microvascular disease , respectively ; mean HbA1c level was 9.9 % ; mean BP was 143.3/81.7 mm Hg ; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months , a greater percentage of intervention participants achieved the primary outcome ( 18.2 % vs. 8.1 % ; relative risk , 2.24 [ 95 % CI , 1.71 to 2.92 ] ) . Compared with usual care , intervention participants achieved larger reductions in HbA1c level ( -0.50 % [ CI , -0.69 % to -0.32 % ] ) , systolic BP ( -4.04 mm Hg [ CI , -5.85 to -2.22 mm Hg ] ) , diastolic BP ( -2.03 mm Hg [ CI , -3.00 to -1.05 mm Hg ] ) , and LDLc level ( -7.86 mg/dL [ CI , -10.90 to -4.81 mg/dL ] ) and reported higher HRQL and treatment satisfaction . LIMITATION Findings were confined to urban specialist diabetes clinics . CONCLUSION Multicomponent QI improves achievement of diabetes care goals , even in re source -challenged clinics . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute and UnitedHealth Group",
"PURPOSE Recent efforts to encourage meaningful use of electronic health records ( EHRs ) assume that widespread adoption will improve the quality of ambulatory care , especially for complex clinical conditions such as diabetes . Cross-sectional studies of typical uses of commercially available ambulatory EHRs provide conflicting evidence for an association between EHR use and improved care , and effects of longer-term EHR use in community-based primary care setting s on the quality of care are not well understood . METHODS We analyzed data from 16 EHR-using and 26 non – EHR-using practice s in 2 northeastern states participating in a group-r and omized quality improvement trial . Measures of care were assessed for 798 patients with diabetes . We used hierarchical linear models to examine the relationship between EHR use and adherence to evidence -based diabetes care guidelines , and hierarchical logistic models to compare rates of improvement over 3 years . RESULTS EHR use was not associated with better adherence to care guidelines or a more rapid improvement in adherence . In fact , patients in practice s that did not use an EHR were more likely than those in practice s that used an EHR to meet all of 3 intermediate outcomes targets for hemoglobin A1c , low-density lipoprotein cholesterol , and blood pressure at the 2-year follow-up ( odds ratio = 1.67 ; 95 % CI , 1.12–2.51 ) . Although the quality of care improved across all practice s , rates of improvement did not differ between the 2 groups . CONCLUSIONS Consistent use of an EHR over 3 years does not ensure successful use for improving the quality of diabetes care . Ongoing efforts to encourage adoption and meaningful use of EHRs in primary care should focus on ensuring that use succeeds in improving care . These efforts will need to include provision of assistance to longer-term EHR users",
"AIMS To evaluate the effectiveness of a multifaceted intervention to improve the clinical decision making of general practitioners ( GPs ) for patients with diabetes . To identify practice characteristics which predict success . METHODS Cluster r and omized controlled trial with 124 practice s and 185 GPs in The Netherl and s. The intervention group received feedback reports and support from a facilitator ; the control group received no special attention . Outcome measures were the compliance rates with evidence -based recommendations pertaining to discussion of body weight control , discussion of problems with medication , blood pressure measurement , foot examination , eye examination , initiating anti-diabetic medication or increasing the dosage in cases of uncontrolled blood glucose , and scheduling a follow-up appointment . RESULTS The GPs reported on their clinical decision making in 1410 consultations with Type 2 diabetic patients at baseline and 1449 consultations after the intervention period . The intervention result ed in statistically significant improvement for two of the seven outcome measures : foot examination ( odds ratio 1.68 ; 95 % confidence interval 1.19 - 2.39 ) and eye examination ( 1.52 ; 1.07 - 2.16 ) . Discussion of problems with medication showed a near significant trend towards increased benefit for the intervention group ( 1.52 ; 0.99 - 2.32 ) . Practice characteristics were not found to be related to the success of the intervention . CONCLUSIONS Feedback reports with support from facilitators appear to increase rates of foot examination and eye examination in general practice . Alternative interventions should be explored to improve the pursuit of metabolic control by GPs",
"Background : Achieving optimum blood glucose control in patients with type 2 diabetes mellitus ( T2DM ) is difficult . Some primary care physicians ( PCPs ) delay the start of insulin use because of the uncertainty in intensifying insulin therapy . The objective was to develop and vali date a computer application ( CA ) that helps PCPs to make decisions about insulin therapy in order to achieve a significant improvement in glycated hemoglobin ( HbA1c ) . Methods : This was a cluster-r and omized clinical trial . Fourteen primary care centers ( PCCs ) in Madrid with 66 PCPs and 697 T2DM patients on insulin therapy were r and omly divided into two groups of seven PCCs each . In the intervention group , seven PCCs included 39 PCPs and 365 T2DM patients on insulin therapy . These PCPs were free to use the CA . A further seven PCCs were assigned to the control group with 27 PCPs and 332 T2DM patients on insulin therapy . The control group did not use the CA . The duration of the trial was 18 months to vali date the CA . The outcome was a change in HbA1c from baseline . Results : In the intervention group , the final HbA1c was 7.19 % ( st and ard deviation [ SD ] ± 0.93 ) , with a difference from the start of −0.69 % ( p = .001 ) . In the control group , it was 7.71 % ( SD ± 1.37 ) , with a difference from the start of −0.09 % ( p not significant ) . Conclusions : This CA helps to improve HbA1c figures of T2DM patients with insulin when it is used by PCPs to make decisions when starting , continuing , or changing insulin and its dosage",
"OBJECTIVE To evaluate whether a new documentation-based clinical decision support system ( CDSS ) is effective in addressing deficiencies in the care of patients with coronary artery disease ( CAD ) and diabetes mellitus ( DM ) . STUDY DESIGN Controlled trial r and omized by physician . METHODS We assigned primary care physicians ( PCPs ) in 10 ambulatory practice s to usual care or the CAD/DM Smart Form for 9 months . The primary outcome was the proportion of deficiencies in care that were addressed within 30 days after a patient visit . RESULTS The Smart Form was used for 5.6 % of eligible patients . In the intention-to-treat analysis , patients of intervention PCPs had a greater proportion of deficiencies addressed within 30 days of a visit compared with controls ( 11.4 % vs 10.1 % , adjusted and clustered odds ratio = 1.14 ; 95 % confidence interval , 1.02 - 1.28 ; P = .02 ) . Differences were more pronounced in the \" on-treatment \" analysis : 17.0 % of deficiencies were addressed after visits in which the Smart Form was used compared with 10.6 % of deficiencies after visits in which it was not used ( P documentation of smoking status and prescription of antiplatelet agents when appropriate . CONCLUSIONS Overall use of the CAD/DM Smart Form was low , and improvements in management were modest . When used , documentation-based decision support shows promise , and future studies should focus on refining such tools , integrating them into current electronic health record platforms , and promoting their use , perhaps through organizational changes to primary care practice",
"OBJECTIVE There is a well-documented gap between diabetes care guidelines and the services received by patients in most health care setting s. This report presents 12-month follow-up results from a computer-assisted , patient-centered intervention to improve the level of recommended services patients received from a variety of primary care setting s. RESEARCH DESIGN AND METHODS A total of 886 patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program . Physicians were stratified and r and omized to intervention or control conditions and evaluated on two primary outcomes : number of recommended laboratory screenings and recommended patient-centered care activities completed from the National Committee on Quality Assurance/American Diabetes Association Provider Recognition Program ( PRP ) . Secondary outcomes were evaluated using the Problem Areas in Diabetes 2 quality of life scale , lipid and HbA1c levels , and the Patient Health Question naire-9 depression scale . RESULTS The program was well implemented and significantly improved both the number of laboratory assays and patient-centered aspects of diabetes care patients received compared with those in the control condition . There was overall improvement on secondary outcomes of lipids , HbA1c , quality of life , and depression scores ; between-condition differences were not significant . CONCLUSIONS Staff in small , mixed-payer primary care offices can consistently implement a patient-centered intervention to improve PRP measures of quality of diabetes care . Alternative explanations for why these process improvements did not lead to improved outcomes , and suggested directions for future research are discussed",
"BACKGROUND Web-based personal health records ( PHRs ) have been advocated as a means to improve type 2 diabetes mellitus ( DM ) care . However , few Web-based systems are linked directly to the electronic medical record ( EMR ) used by physicians . METHODS We r and omized 11 primary care practice s. Intervention practice s received access to a DM-specific PHR that imported clinical and medications data , provided patient-tailored decision support , and enabled the patient to author a \" Diabetes Care Plan \" for electronic su bmi ssion to their physician prior to upcoming appointments . Active control practice s received a PHR to up date and su bmi t family history and health maintenance information . All patients attending these practice s were encouraged to sign up for online access . RESULTS We enrolled 244 patients with DM ( 37 % of the eligible population with registered online access , 4 % of the overall population of patients with DM ) . Study participants were younger ( mean age , 56.1 years vs 60.3 years ; P ( median income , $ 53,784 vs $ 49,713 ; P baseline glycemic control compared with non participants . More patients in the intervention arm had their DM treatment regimens adjusted ( 53 % vs 15 % ; P DM-related medication adjustment . Low rates of online patient account registration and good baseline control among participants limited the intervention 's impact on overall risk factor control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00251875",
"BACKGROUND : Electronic information systems have been proposed as one means to reduce medical errors of commission ( doing the wrong thing ) and omission ( not providing indicated care ) . OBJECTIVE : To assess the effects of computer-based cardiac care suggestions . DESIGN : A r and omized , controlled trial targeting primary care physicians and pharmacists . SUBJECTS : A total of 706 out patients with heart failure and /or ischemic heart disease . INTERVENTIONS : Evidence -based cardiac care suggestions , approved by a panel of local cardiologists and general internists , were displayed to physicians and pharmacists as they cared for enrolled patients . MEASUREMENTS : Adherence with the care suggestions , generic and condition-specific quality of life , acute exacerbations of their cardiac disease , medication compliance , health care costs , satisfaction with care , and physicians ’ attitudes toward guidelines . RESULTS : Subjects were followed for 1 year during which they made 3,419 primary care visits and were eligible for 2,609 separate cardiac care suggestions . The intervention had no effect on physicians ’ adherence to the care suggestions ( 23 % for intervention patients vs 22 % for controls ) . There were no intervention-control differences in quality of life , medication compliance , health care utilization , costs , or satisfaction with care . Physicians viewed guidelines as providing helpful information but constraining their practice and not helpful in making decisions for individual patients . CONCLUSIONS : Care suggestions generated by a sophisticated electronic medical record system failed to improve adherence to accepted practice guidelines or outcomes for patients with heart disease . Future studies must weigh the benefits and costs of different ( and perhaps more Draconian ) methods of affecting clinician behavior",
"BACKGROUND We conducted a cluster r and omized controlled trial to examine the effectiveness of computerized decision support ( CDS ) design ed to improve hypertension care and outcomes in a racially diverse sample of primary care patients . METHODS We r and omized 2,027 adult patients receiving hypertension care in 14 primary care practice s to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group . We assessed prescribing of guideline -recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients ’ race/ethnicity using interaction terms . MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42 % at baseline and 46 % at the outcome visit with no significant differences between groups . After adjustment for patients ’ demographic and clinical characteristics , number of prior visits , and levels of baseline blood pressure control , there were no differences between intervention groups in the odds of outcome blood pressure control . The use of CDS to providers significantly improved Joint National Committee ( JNC ) guideline adherent medication prescribing compared to usual care ( 7 % versus 5 % , P overall blood pressure control . Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed",
"OBJECTIVE : To describe the effect of the Vermont Diabetes Information System ( VDIS ) on hospital and emergency room use DATA SOURCE : Statewide discharge data base STUDY DESIGN : R and omized controlled trial of a decision support system for 7,412 adults with diabetes and their 64 primary care providers . DATA COLLECTION / DATA EXTRACTION : Charges and date s for hospital admissions and emergency room care in Vermont during an average of 32 months of observation . Data from New York hospitals were not available . PRINCIPAL FINDINGS : Patients r and omized to VDIS were admitted to the hospital less often than control subjects ( 0.17 admissions vs. 0.20 ; P=0.01 ) and generated lower hospital charges ( $ 3,113 vs. $ 3,480 ; P=0.019 ) . VDIS patients also had lower emergency room utilization ( 0.27 visits vs. 0.36 ; P charges ( $ 304 vs. $ 414 ; P men and in older subjects . CONCLUSIONS : In spite of data limitations that tended to reduce the apparent effect of the system ; this r and omized , controlled trial showed that VDIS reduces hospitalization and emergency room utilization and expenses",
"BACKGROUND The success of guidelines depends largely on effective implementation and uptake in clinical practice . The Optimal Renal Anemia Management Assessment ( ORAMA ) study investigated the impact of European Best Practice Guideline ( EBPG ) prompting on patient outcomes . METHODS ORAMA was a prospect i ve , international , multicenter , cluster-r and omized study . Fifty-three centers in eight European countries enrolled patients with chronic kidney disease stage V receiving chronic dialysis . Patients were either anemic ( hemoglobin [ Hb ] erythropoiesis stimulating agents and /or iron supplementation . Centers were r and omized to two groups , with or without access to a computerized clinical decision support ( CDS ) system . In a post hoc analysis , patients were further subdivided into adherence or non-adherence of investigators to the EBPG regardless of CDS usage . Primary endpoint was the proportion of patients with Hb > 11 g/ dL ( 110 g/L ) , reflecting hematological targets in the revised EPBG . RESULTS In this population of 599 dialysis patients , hematological targets did not differ in the presence or absence of a CDS system . There was a general shift towards improved patient distribution by Hb categories while the width of the distribution curves remained unchanged . The proportion of patients with Hb > 11 g/dL ( 110 g/L ) was higher among adherers ( 79 % and 84 % with or without CDS use , respectively ) than non-adherers ( 59 % and 57 % , respectively ) . CONCLUSIONS ORAMA is the first international study to show that adherence to EBPG improved attainment of anemia indices . The availability of a CDS system did not affect anemia management",
"STUDY OBJECTIVE To assess the effects of evidence -based treatment suggestions for hypertension made to physicians and pharmacists using a comprehensive electronic medical record system . DESIGN R and omized controlled trial with a 2 x 2 factorial design of physician and pharmacist interventions , which result ed in four groups of patients : physician intervention only , pharmacist intervention only , intervention by physician and pharmacist , and intervention by neither physician nor pharmacist ( control ) . SETTING Academic primary care internal medicine practice . SUBJECTS Seven hundred twelve patients with uncomplicated hypertension . MEASUREMENTS AND MAIN RESULTS Suggestions were displayed to physicians on computer workstations used to write outpatient orders and to pharmacists when filling prescriptions . The primary end point was generic health-related quality of life . Secondary end points were symptom profile and side effects from antihypertensive drugs , number of emergency department visits and hospitalizations , blood pressure measurements , patient satisfaction with physicians and pharmacists , drug therapy compliance , and health care charges . In the control group , implementation of care changes in accordance with treatment suggestions was observed in 26 % of patients . In the intervention groups , compliance with suggestions was poor , with treatment suggestions implemented in 25 % of patients for whom suggestions were displayed only to pharmacists , 29 % of those for whom suggestions were displayed only to physicians , and 35 % of the group for whom both physicians and pharmacists received suggestions ( p=0.13 ) . Intergroup differences were neither statistically significant nor clinical ly relevant for generic health-related quality of life , symptom and side-effect profiles , number of emergency department visits and hospitalizations , blood pressure measurements , charges , or drug therapy compliance . CONCLUSION Computer-based intervention using a sophisticated electronic physician order-entry system failed to improve compliance with treatment suggestions or outcomes of patients with uncomplicated hypertension ",
"Electronic decision-support tools may help to improve management of hyperlipidemia and other chronic diseases . This study examined the impact of lipid management tools integrated into an electronic medical record ( EMR ) in primary care practice s. This r and omized controlled trial was conducted in a national network of physicians who use an outpatient EMR . Adult primary care physicians were r and omized by office to receive an electronic form that was embedded in the EMR . The form contained prompts regarding suboptimal care based on Adult Treatment Panel-III ( ATP-III ) guidelines , as well as reporting tools to identify patients outside of office visits whose lipid management was suboptimal . All active patients , ages 20 - 79 years , whose physicians participated in the study , were categorized as high , moderate , or low cardiovascular risk , and the proportion who were tested for hyperlipidemia , at lipid goal , and on lipid-lowering medications if not at goal were measured according to ATP-III guidelines . A total of 105 physicians from 25 offices and 64,150 patients were included in the study . Outcomes improved for most measures from before to 1 year after the intervention ( November 1 , 2005 to October 31 , 2006 ) . However , after controlling for confounding variables and for clustering in multilevel modeling , only up-to- date lipid testing for high-risk patients was statistically better in the intervention group as compared to the control group ( adjusted odds ratio 15.0 , P quality of lipid management after implementing an EMR-based disease management intervention in primary care setting s. Future studies may need to examine more comprehensive interventions that include office staff in a team approach to care",
"OBJECTIVES To explore changes in mortality and hospital usage for chronically ill seniors enrolled in a multidisease care management program , Care Management Plus ( CMP ) . DESIGN Controlled clinical trial with seven intervention and six control clinics with additional patient-level matching . SETTING Intermountain Health Care , a large health system in Utah ; seven intervention and six control clinics . PARTICIPANTS Three thous and four hundred thirty-two senior patients ( > or=65 ) enrolled in Medicare . INTERVENTION The intervention employed nurse care managers supported by specialized information technology in primary care to manage chronically ill patients ( 2002 - 2005 ) . MEASUREMENTS Mortality and hospitalization data were collected from clinical records and Medicare billing . RESULTS One thous and one hundred forty-four intervention patients were matched to 2,288 controls . Average age was 76.2 ; average comorbidity score was 2.3+/-1.1 ; 75 % of patients had two or more chronic diseases . Survival analyses showed lower mortality and slightly more emergency department visits for care managed patients than for controls . In patients with diabetes mellitus , the intervention result ed in significantly lower mortality at 1 year ( 6.2 % , vs 10.6 % for controls ) and at 2 years ( 12.9 % vs 18.2 % ) . Hospitalization rate was lower ( 21.0 % , vs. 24.2 % for controls ) at 1 year and substantially more so at the 2-year follow-up . CONCLUSION CMP was successful in reducing death for all patients . For complex patients with diabetes mellitus in the intervention group , death and hospital usage were lower . Per clinic , hypothesized savings from decreased hospitalizations was $ 17,384 to $ 70,349",
"PURPOSE We wanted to assess the impact of an electronic health record – based diabetes clinical decision support system on control of hemoglobin A1c ( glycated hemoglobin ) , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels in adults with diabetes . METHODS We conducted a clinic-r and omized trial conducted from October 2006 to May 2007 in Minnesota . Included were 11 clinics with 41 consenting primary care physicians and the physicians ’ 2,556 patients with diabetes . Patients were r and omized either to receive or not to receive an electronic health record (EHR)–based clinical decision support system design ed to improve care for those patients whose hemoglobin A1c , blood pressure , or LDL cholesterol levels were higher than goal at any office visit . Analysis used general and generalized linear mixed models with repeated time measurements to accommo date the nested data structure . RESULTS The intervention group physicians used the EHR-based decision support system at 62.6 % of all office visits made by adults with diabetes . The intervention group diabetes patients had significantly better hemoglobin A1c ( intervention effect −0.26 % ; 95 % confidence interval , −0.06 % to −0.47 % ; P=.01 ) , and better maintenance of systolic blood pressure control ( 80.2 % vs 75.1 % , P=.03 ) and borderline better maintenance of diastolic blood pressure control ( 85.6 % vs 81.7 % , P = .07 ) , but not improved low-density lipoprotein cholesterol levels ( P = .62 ) than patients of physicians r and omized to the control arm of the study . Among intervention group physicians , 94 % were satisfied or very satisfied with the intervention , and moderate use of the support system persisted for more than 1 year after feedback and incentives to encourage its use were discontinued . CONCLUSIONS EHR-based diabetes clinical decision support significantly improved glucose control and some aspects of blood pressure control in adults with type 2 diabetes"
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The present study used a systematic review approach to identify relevant r and omised control trials ( RCT ) with vitamin D and then apply meta-regression to explore the most appropriate model of the vitamin D intake-serum 25-hydroxyvitamin D ( 25(OH)D ) relationship to underpin setting reference intake values . Methods included an up date d structured search on Ovid MEDLINE ; rigorous inclusion /exclusion criteria ; data extraction ; and meta-regression ( using different model constructs ) . In particular , priority was given to data from winter-based RCT performed at latitudes > 49·5 ° N ( n 12 ) . A combined weighted linear model meta-regression analyses of natural log ( Ln ) total vitamin D intake ( i.e. diet and supplemental vitamin D ) v. achieved serum 25(OH)D in winter ( that used by the North American Dietary Reference Intake Committee ) produced a curvilinear relationship ( mean ( 95 % lower CI ) serum 25(OH)D ( nmol/l ) = 9·2 ( 8·5 ) Ln ( total vitamin D ) ) . Use of non-transformed total vitamin D intake data ( maximum 1400 IU/d ; 35 μg/d ) provided for a more linear relationship ( mean serum 25(OH)D ( nmol/l ) = 0·044 × ( total vitamin D)+33·035 ) . Although inputting an intake of 600 IU/d ( i.e. the RDA ) into the 95 % lower CI curvilinear and linear models predicted a serum 25(OH)D of 54·4 and 55·2 nmol/l , respectively , the total vitamin D intake that would achieve 50 ( and 40 ) nmol/l serum 25(OH)D was 359 ( 111 ) and 480 ( 260 ) IU/d , respectively . Inclusion of 95 % range in the model to account for inter-individual variability increased the predicted intake of vitamin D needed to maintain serum 25(OH)D ≥ 50 nmol/l to 930 IU/d . The model used to describe the vitamin D intake-status relationship needs to be considered carefully when setting new reference intake values in the Europe | [
"INTRODUCTION A high peak bone mass may be essential for reducing the risk of osteoporosis later in life and a sufficient vitamin D level during puberty may be necessary for optimal bone accretion and obtaining a high peak bone mass . Dietary intake and synthesis during winter of vitamin D might be limited but the effect of vitamin D supplementation in adolescence on bone mass is not well established . OBJECTIVE To investigate the effect of supplementation with 5 and 10 microg/day vitamin D(3 ) for 12 months in 11- to 12-year-old girls on bone mass and bone turnover as well as the possible influence of VDR and ER genotype on the effect of the supplementation . METHODS The girls ( n=221 ) were r and omized to receive either 5 microg or 10 microg vitamin D(3 ) supplementation per day or placebo for 12 months . Whole body and lumbar spine bone mass measured by DXA and pubertal status were determined at baseline and after 12 months whereas physical activity and dietary intake of calcium and vitamin D were assessed at baseline . Serum ( S ) 25-hydroxyvitamin D ( 25OHD ) , S-osteocalcin , S-parathyroid hormone , S-calcium , S-inorganic phosphate , urinary ( U ) pyridinoline ( Pyr ) and deoxpyridinoline ( Dpyr ) were measured at baseline and after 6 and 12 months . RESULTS The S-25OHD concentration increased ( p vitamin D-supplementation on biomarkers for bone turnover or on whole body or spine bone mineral augmentation . However , vitamin D supplementation increased whole body bone mineral density ( BMD ) ( p=0.007 ) and bone mineral content ( BMC ) ( p=0.048 ) in the FF VDR genotype but not in the Ff or ff VDR genotypes . CONCLUSION Supplementation with vitamin D ( 5 or 10 microg/day ) over 12 months increased the S-25OHD concentration but there was no effect on indices of bone health in the entire group of girls . However , there was an effect on BMD for a subgroup with the FF VDR genotype indicating an influence of genotype",
"Objective : To assess the vitamin D status of healthy young people living in Northern Irel and and the effect of vitamin D supplementation on vitamin D status and bone turnover . Design : Double-blinded r and omised controlled intervention study . Setting : University of Ulster , Coleraine , Northern Irel and .Subjects : In total , 30 apparently healthy students ( 15 male and 15 female subjects ) , aged 18–27 years , were recruited from the university , with 27 completing the intervention . Interventions : Subjects were r and omly assigned , to receive either 15 μg ( 600 IU ) vitamin D3 and 1500 mg calcium/day ( vitamin D group ) , or 1500 mg calcium/day ( control group ) for 8 weeks between January and March . Vitamin D status , bone turnover markers , serum calcium and parathyroid hormone concentrations were measured at baseline and post intervention . Results : At baseline , vitamin D status was low in both the vitamin D group ( 47.9 ( s.d . 16.0 ) ) and the control group ( 55.5 ( s.d . 18.6 ) nmol/l 25(OH)D ) . Post intervention vitamin D status was significantly higher in the vitamin D-treated group ( 86.5 ( s.d . 24.5 ) ) compared to the control group ( 48.3 ( s.d . 16.8 ) nmol/l ) ( P supplementation on bone turnover markers or PTH concentrations . Conclusions : This study suggests that young adults in Northern Irel and do not consume an adequate daily dietary intake of vitamin D to maintain plasma vitamin D concentrations in the wintertime . A daily supplement of 15 μg vitamin D3 significantly increased vitamin D status in these individuals to levels of sufficiency . Achievement of an optimum vitamin D status among young adults may have future positive health implication",
"The necessity and safety of an oral calcium ( Ca ) and vitamin D regimen was evaluated in a population of 66 independently living and 73 institutionalized elderly women over an 11-week winter period . The members of both groups were r and omly assigned into trial and control groups . Serum Ca , creatinine , and calcidiol levels were measured before and after the trial . The regimen consisted of 1.558 g of Ca and 45 micrograms ( equal to 1,800 IU ) of vitamin D administered daily in addition to the normal diet . The controls received no treatment . A majority of the elderly subjects living independently had ensured their Ca , and a quarter of them also their vitamin D intake on their own initiative . The mean serum calcidiol concentration before the trial was 24.1 nmol/L in the institutionalized and 38.5 nmol/L in the elderly subjects living independently ( P less than .001 ) . After the trial , serum calcidiol was 10.4 nmol/L in the institutionalized control subjects and had decreased ( P less than .001 ) in both control groups , but increased ( P less than .001 ) in both treatment groups . The safety indicators , serum Ca , creatinine , and calcidiol , did not indicate any group or individual side effect",
"BACKGROUND Numerous observational studies have found supplemental calcium and vitamin D to be associated with reduced risk of common cancers . However , interventional studies to test this effect are lacking . OBJECTIVE The purpose of this analysis was to determine the efficacy of calcium alone and calcium plus vitamin D in reducing incident cancer risk of all types . DESIGN This was a 4-y , population -based , double-blind , r and omized placebo-controlled trial . The primary outcome was fracture incidence , and the principal secondary outcome was cancer incidence . The subjects were 1179 community-dwelling women r and omly selected from the population of healthy postmenopausal women aged > 55 y in a 9-county rural area of Nebraska centered at latitude 41.4 degrees N. Subjects were r and omly assigned to receive 1400 - 1500 mg supplemental calcium/d alone ( Ca-only ) , supplemental calcium plus 1100 IU vitamin D3/d ( Ca + D ) , or placebo . RESULTS When analyzed by intention to treat , cancer incidence was lower in the Ca + D women than in the placebo control subjects ( P unadjusted relative risks ( RR ) of incident cancer in the Ca + D and Ca-only groups were 0.402 ( P = 0.01 ) and 0.532 ( P = 0.06 ) , respectively . When analysis was confined to cancers diagnosed after the first 12 mo , RR for the Ca + D group fell to 0.232 ( CI : 0.09 , 0.60 ; P treatment and serum 25-hydroxyvitamin D concentrations were significant , independent predictors of cancer risk . CONCLUSIONS Improving calcium and vitamin D nutritional status substantially reduces all-cancer risk in postmenopausal women . This trial was registered at clinical trials.gov as NCT00352170",
"BACKGROUND Elevated circulating concentrations of proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure ( CHF ) . In vitro studies suggest that vitamin D suppresses proinflammatory cytokines and increases antiinflammatory cytokines . OBJECTIVE We evaluated the effect of vitamin D supplementation on the survival rate and different biochemical variables in patients with CHF . DESIGN One hundred twenty-three patients r and omly received either 50 mug vitamin D(3)/d plus 500 mg Ca/d [ D(+ ) group ] or placebo plus 500 mg Ca/d [ D(- ) group ] for 9 mo . Biochemical variables were assessed at baseline and after 9 mo . The survival rate was calculated for a follow-up period of 15 mo . RESULTS Ninety-three patients completed the study . Significant treatment effects were observed on logarithmic-transformed serum concentrations of 25-hydroxyvitamin D ( P = 0.001 ) , parathyroid hormone ( P = 0.007 ) , tumor necrosis factor alpha ( P = 0.006 ) , and interleukin 10 ( P = 0.042 ) . 25-Hydroxyvitamin D increased by 26.8 ng/mL in the D(+ ) group but increased only by 3.6 ng/mL in the D(- ) group . Compared with baseline , parathyroid hormone was significantly lower and the antiinflammatory cytokine interleukin 10 was significantly higher in the D(+ ) group after 9 mo . The proinflammatory cytokine tumor necrosis factor alpha increased in the D(- ) group but remained constant in the D(+ ) group . The survival rate did not differ significantly between the study groups during the follow-up period . CONCLUSIONS Vitamin D(3 ) reduces the inflammatory milieu in CHF patients and might serve as a new antiinflammatory agent for the future treatment of the disease . Our data provide evidence for the involvement of an impaired vitamin D-parathyroid hormone axis in the progression of CHF",
"BACKGROUND Indirect evidence suggests that optimal vitamin D status is achieved with a serum 25-hydroxyvitamin D [ 25(OH)D ] concentration > 75 nmol/L. OBJECTIVE We aim ed to determine the intake of vitamin D(3 ) needed to raise serum 25(OH)D to > 75 nmol/L. DESIGN The design was a 6-mo , prospect i ve , r and omized , double-blinded , double-dummy , placebo-controlled study of vitamin D(3 ) supplementation . Serum 25(OH)D was measured by radioimmunoassay . Vitamin D(3 ) intake was adjusted every 2 mo by use of an algorithm based on serum 25(OH)D concentration . RESULTS A total of 138 subjects entered the study . After 2 dose adjustments , almost all active subjects attained concentrations of 25(OH)D > 75 nmol/L , and no subjects exceeded 220 nmol/L. The mean ( + /-SD ) slope at 9 wk [ defined as 25(OH)D change/baseline dose ] was 0.66 + /- 0.35 (nmol/L)/(microg/d ) and did not differ statistically between blacks and whites . The mean daily dose was 86 microg ( 3440 IU ) . The use of computer simulations to obtain the most participants within the range of 75 - 220 nmol/L predicted an optimal daily dose of 115 microg/d ( 4600 IU ) . No hypercalcemia or hypercalciuria was observed . CONCLUSIONS Determination of the intake required to attain serum 25(OH)D concentrations > 75 nmol/L must consider the wide variability in the dose-response curve and basal 25(OH)D concentrations . Projection of the dose-response curves observed in this convenience sample onto the population of the third National Health and Nutrition Examination Survey suggests a dose of 95 microg/d ( 3800 IU ) for those above a 25(OH)D threshold of 55 nmol/L and a dose of 125 microg/d ( 5000 IU ) for those below that threshold",
"Abstract : Supplementation of elderly institutionalized women with vitamin D and calcium decreased hip fractures and increased hip bone mineral density . Quantitative ultrasound ( QUS ) measurements can be performed in nursing homes , and easily repeated for follow-up . However , the effect of the correction of vitamin D deficiency on QUS parameters is not known . Therefore , 248 institutionalized women aged 62–98 years were included in a 2-year open controlled study . They were r and omized into a treated group ( n = 124 ) , receiving 440 IU of vitamin D3 combined with 500 mg calcium ( 1250 mg calcium carbonate , Novartis ) twice daily , and a control group ( n = 124 ) . One hundred and three women ( 42 % ) , aged 84.5 ± 7.5 years , completed the study : 50 in the treated group , 53 in the controls . QUS of the calcaneus , which measures BUA ( broadb and ultrasound attenuation ) and SOS ( speed of sound ) , and biochemical analysis were performed before and after 1 and 2 years of treatment . Only the results of the women with a complete follow-up were taken into account . Both groups had low initial mean serum 25-hydroxyvitamin D levels ( 11.9 ± 1.2 and 11.7 ± 1.2 mg/l ; normal range 6.4–40.2 mg/l ) and normal mean serum parathyroid hormone ( PTH ) levels ( 43.1 ± 3.2 and 44.6 ± 3.5 ng/l ; normal range 10–70 ng/l , normal mean 31.8 ± 2.3 ng/l ) . The treatment led to a correction of the metabolic disturbances , with an increase in 25-hydroxyvitamin D by 123 % ( p50.01 ) and a decrease in PTH by 18 % ( p50.05 ) and of alkaline phosphatase by 15 % ( p50.01 ) . In the controls there was a worsening of the hypovitaminosis D , with a decrease of 25-hydroxyvitamin D by 51 % ( p50.01 ) and an increase in PTH by 51 % ( p50.01 ) , while the serum calcium level decreased by only 2 % ( p5 0.01 ) . After 2 years of treatment BUA increased significantly by 1.6 % in the treated group ( p50.05 ) , and decreased by 2.3 % in the controls ( p50.01 ) . Therefore , the difference in BUA between the treated subjects and the controls ( 3.9 % ) was significant after 2 years ( p50.01 ) . However , SOS decreased by the same amount in both groups ( approximately 0.5 % ) . In conclusion , BUA , but not SOS , reflected the positive effect on bone of supplementation with calcium and vitamin D3 in a population of elderly institutionalized women",
"BACKGROUND The cholecalciferol inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known , particularly within ranges comparable to the probable physiologic supply of the vitamin . OBJECTIVES The objectives were to establish the quantitative relation between steady state cholecalciferol input and the result ing serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores . DESIGN Cholecalciferol was administered daily in controlled oral doses labeled at 0 , 25 , 125 , and 250 micro g cholecalciferol for approximately 20 wk during the winter to 67 men living in Omaha ( 41.2 degrees N latitude ) . The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment . RESULTS From a mean baseline value of 70.3 nmol/L , equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose , with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input . The calculated oral input required to sustain the serum 25-hydroxycholecalciferol concentration present before the study ( ie , in the autumn ) was 12.5 micro g ( 500 IU)/d , whereas the total amount from all sources ( supplement , food , tissue stores ) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g ( approximately 3800 IU)/d . By difference , the tissue stores provided approximately 78 - 82 micro g/d . CONCLUSIONS Healthy men seem to use 3000 - 5000 IU cholecalciferol/d , apparently meeting > 80 % of their winter cholecalciferol need with cutaneously synthesized accumulations from solar sources during the preceding summer months . Current recommended vitamin D inputs are inadequate to maintain serum 25-hydroxycholecalciferol concentration in the absence of substantial cutaneous production of vitamin",
"The effect of small calcium and vitamin D supplements on mineral metabolism in normal persons is unclear . To investigate the biochemical response to these medications , we administered 1000 mg Ca and 25 micrograms cholecalciferol per day or a placebo to 92 normal men for 1 y. The Ca and cholecalciferol were tolerated well . 25-Hydroxycholecalciferol [ 25-(OH)D ] and 24,25-dihydroxycholecalciferol [ 24,25-(OH)2D ] levels rose in treated subjects ; there was no definite change in 1,25-(OH)2D concentrations . The average difference in 25-(OH)D levels between treated and untreated subjects was 30 nmol/L at 1 y. Fasting serum Ca , alkaline phosphatase , creatinine , and parathyroid hormone levels and the fasting urinary excretion of Ca , phosphorus and cAMP , were not affected . However , 24-h urinary Ca excretion was higher in the supplemented group ( 3.5 + /- 1.9 vs 4.7 + /- 1.7 mmol/d , p = 0.006 ) . Serum P concentrations were slightly higher in the supplemented group at 1 y. In normal men small calcium and cholecalciferol supplements are safe , provide adequate vitamin D nutrition and apparently increase net gastrointestinal Ca absorption",
"Vitamin D metabolism in elderly individuals can be compromised by several mechanisms . We previously described reduced concentrations of 1,25-dihydroxyvitamin D [ 1,25(OH)2D ] in 30 % of elderly nursing home residents . The present study assesses the effect of vitamin D supplementation on 25-hydroxyvitamin D [ 25(OH)D ] and 1,25(OH)2D . We performed a double-blind study in which 30 elderly nursing home residents were r and omly given either 50 micrograms vitamin D or a placebo daily for 6 wk . Vitamin D metabolites , immunometrically assayed parathyroid hormone ( IRMA-PTH ) , ionized calcium , and bone Gla hormone ( BGP ) were measured in serum at baseline and biweekly for 6 wk . Serum 25(OH)D concentrations increased significantly ( P less than 0.0001 ) over the 6 wk in the treatment group but were unchanged in the placebo group . Serum 1,25(OH)2D , ionized calcium , BGP , and PTH were not significantly altered by the supplement . We conclude that vitamin D supplementation results in an increase in circulating 25(OH)D but not 1,25(OH)2D ; however , the long-term effect on bone mineral metabolism remains unclear",
"BACKGROUND Vitamin D has been added to calcium-fortified orange juice . It is unknown whether vitamin D is as bioavailable from orange juice as it is from supplements . OBJECTIVES The objective was to compare the bioavailability of vitamin D(2 ) and vitamin D(3 ) from orange juice with that from vitamin D(2 ) and vitamin D(3 ) supplements . A secondary aim was to determine which form of vitamin D is more bioavailable in orange juice . DESIGN A r and omized , placebo-controlled , double-blind study was conducted in healthy adults aged 18 - 84 y ( 15 - 20/group ) who received 1000 IU vitamin D(3 ) , 1000 IU vitamin D(2 ) , or placebo in orange juice or capsule for 11 wk at the end of winter . RESULTS A total of 64 % of subjects began the study deficient in vitamin D ( ie , 25-hydroxyvitamin D [ 25(OH)D ] ) concentrations serum 25(OH)D between subjects who consumed vitamin D-fortified orange juice and those who consumed vitamin D supplements ( P = 0.084 ) . No significant difference in serum 25(OH)D(3 ) was observed between subjects who consumed vitamin D(3)-fortified orange juice and vitamin D(3 ) capsules ( P > 0.1 ) . Similarly , no significant difference in serum 25(OH)D(2 ) was observed between subjects who consumed vitamin D(2)-fortified orange juice and vitamin D(2 ) capsules ( P > 0.1 ) . No significant overall difference in parathyroid hormone concentrations was observed between the groups ( P = 0.82 ) . CONCLUSION Vitamin D(2 ) and vitamin D(3 ) are equally bioavailable in orange juice and capsules",
"BACKGROUND Knowledge gaps have contributed to considerable variation ( between 0 and 15 μg/d ) in international dietary recommendations for vitamin D in adolescents . OBJECTIVE We aim ed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above several proposed cutoffs ( 25 , 37.5 , 40 , and 50 nmol/L ) during wintertime in adolescent white girls . DESIGN Data ( baseline and 6 mo ) from 2 r and omized , placebo-controlled , double-blind , 12-mo intervention studies in Danish ( 55 ° N ) and Finnish ( 60 ° N ) girls ( n = 144 ; mean age : 11.3 y ; mean vitamin D intake : 3.7 μg/d ) at vitamin D(3 ) supplementation amounts of 0 , 5 , and 10 μg/d were used . Serum 25(OH)D was measured with an HPLC assay in a central ized laboratory . RESULTS Clear dose-related increments ( P serum 25(OH)D with increasing supplemental vitamin D(3 ) were observed . The slope of the relation between vitamin D intake and serum 25(OH)D at the end of winter was 2.43 nmol ⋅ L(-1 ) ⋅ μg intake(-1 ) , and no difference in the slopes between Finnish and Danish girls was observed . The vitamin D intakes that maintained serum 25(OH)D concentrations at > 25 , > 37.5 , and > 50 nmol/L in 97.5 % of the sample were 8.3 , 13.5 , and 18.6 μg/d , respectively , whereas an intake of 6.3 μg/d maintained a serum 25(OH)D concentration > 40 nmol/L in 50 % of the sample . CONCLUSION The vitamin D intakes required to ensure that adequate vitamin D status [ defined variably as serum 25(OH)D > 25 and > 50 nmol/L ] is maintained during winter in the vast majority ( > 97.5 % ) of adolescent girls ( mean age : 11.3 y ) at northern latitudes ( > 55 ° N ) are 8.3 and 18.6 μg/d , respectively . This trial was registered at clinical trials.gov as NCT00267540",
"UNLABELLED This study of 9605 community-dwelling residents supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in elderly in a northern European region known to be deficient in vitamin D , especially during winter periods . INTRODUCTION We evaluated the effect of two programs for the prevention of osteoporotic fractures leading to acute hospital admission in a population of elderly community-dwelling residents . MATERIAL S AND METHODS This was a factorial , cluster-r and omized , pragmatic , intervention study . We included 9605 community-dwelling residents aged 66 + years . We offered a prevention program of a daily supplement of 1000 mg of elemental calcium as calcium carbonate and 400 IU ( 10 microg ) of vitamin D3 to a total of 4957 participants . Another program with evaluation and suggestions for the improvement of the domestic environment was offered to a total of 5063 participants . Both programs included revision of the resident 's current pharmaceutical treatment . We achieved information on osteoporotic fractures in the study population from the Danish Hospital Registration Data base . We defined osteoporotic fractures as low energy fractures of the proximal humerus , distal forearm , vertebral column , pelvis , cervical femur , and intertrochanteric femur . RESULTS Active participation was 50.3 % in the Calcium and Vitamin D Program and 46.4 % in the Environmental and Health Program . We observed a 16 % reduction in fracture incidence rate ( relative risk [ RR ] , 0.84 ; CI , 0.72 - 0.98 ; p female residents offered the Calcium and Vitamin D Program ( intention-to-prevent analysis ) . CONCLUSIONS This study supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in community-dwelling elderly people in a northern European region known to be deficient in vitamin D , especially during winter periods",
"ABSTRACT . Fifty‐one healthy prepubertal schoolchildren were followed for 13 months in a double blind study . Twenty‐four of them were supplemented with 400 IU of vitamin D2 5–7 times weekly , while 27 received a placebo . The children were examined in winter both at the beginning and at the end of the study , and in the middle of the study in autumn . Mean 25‐hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter , when the study ended . The vitamin D supplementation did not , however , affect other vitamin D metabolites , serum calcium , albumin , inorganic phosphorus , parathyroid hormone concentrations or alkaline phosphatase activity . Moreover , the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children , and thus sub clinical rickets could not be shown",
"Background : Vitamin D insufficiency is prevalent in the northeast United States . Since vitamin D insufficiency is readily amenable to supplementation , it is important to underst and what factors are associated with serum 25 hydroxy vitamin D ( 25(OH)D ) response to vitamin D supplementation . Objective : In this study we examined the association of serum 25(OH)D response to vitamin D supplementation with body size in a population of elderly subjects . Methods : 257 healthy , ambulatory men and women 65 years of age or older were r and omly assigned to treatment with either 700 IU/day ( 17.5 μg/d ) of supplemental vitamin D3 and 500 mg/day ( 12.5 mmol/d ) of supplemental calcium , or to placebo . Results : In multivariate regression analyses , after adjusting for baseline 25(OH)D , season , and sex , we found change in 25(OH)D to be inversely associated with baseline BMI ( p = 0.01 ) in subjects treated with supplements for one year . Change in 25(OH)D was also negatively associated with other baseline anthropometric measurements in these subjects . Conclusion : Our study implies that body size should be taken into account when estimating the amount of vitamin D intake needed to raise 25(OH)D to the desired level",
"Objective : Improvement of vitamin D and K status of about 60 -y-old postmenopausal Dutch women . Design : In a r and omized study postmenopausal women with normal ( T-score > −1 ; n=96 ) and low ( T-score≤−1 ; n=45 ) bone mineral density ( BMD ) of the lumbar spine , were supplemented with 350–400 IU vitamin D3 , 80 μg vitamins K1 , vitamins K1+D3 , or placebo for 1 y. Serum 25-hydroxyvitamin D [ 25(OH)D ] and percentage carboxylated osteocalcin ( % carbOC ) were measured at baseline and after 3 , 6 and 12 months . Results : Baseline % carbOC of the entire study population was positively correlated with BMD of the lumbar spine and femoral neck . Correspondingly , women with low BMD had lower % carbOC at baseline than women with normal BMD but this difference disappeared after 1 y of supplementation with vitamin K1 ( ( mean±s.d . ) 68±11 % ( 95 % CI , 64.5–71.2 % ) vs 72±6 % ( 95 % CI , 70.1–72.9 % ) , respectively ) . One year of supplementation with vitamin D3 showed maximum increases in 25(OH)D of 33±29 % ( 95 % CI , 24.8–41.8 % ) and 68±58 % ( 95 % CI , 50.1–84.6 % ) in women with normal and low BMD , respectively . During winter , however , a 29 % decline in maximum 25(OH)D levels was not prevented in women with low BMD . Conclusion : Daily supplementation of Dutch postmenopausal women with > 400 IU vitamin D3 is indicated to prevent a winter decline in 25(OH)D and to control serum parathyroid hormone levels . Daily supplementation with 80 μg vitamin K1 seems to be necessary to reach premenopausal % carbOC levels . A stimulatory effect of calcium and /or vitamin D on % carbOC can not be excluded . European Journal of Clinical Nutrition ( 2000 ) 54 , 626–631",
"Summary The Osteoporosis Risk Factor and Prevention-Fracture Prevention Study ( OSTPRE-FPS ) was a r and omized population -based open trial ( n = 593 ) . The supplementation group ( n = 287 ) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group ( n = 306 ) received neither supplementation nor placebo . Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women . Introduction Vitamin D deficiency is common in the elderly , and vitamin D levels are associated with low bone mineral density ( BMD ) . The working hypothesis was that vitamin D and calcium supplementation could prevent bone loss in ambulatory postmenopausal women . Methods The OSTPRE-FPS was a r and omized population -based open trial with a 3-year follow-up in 3,432 women ( aged 66 to 71 years ) . A r and omly selected sub sample of 593 subjects underwent BMD measurements . The supplementation group ( n = 287 ) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group ( n = 306 ) received neither supplementation nor placebo . Results In the intention-to-treat analysis , total body BMD ( n = 362 ) increased significantly more in the intervention group than in the control group ( 0.84 % vs. 0.19 % , p = 0.011 ) . The BMD change differences at the lumbar spine ( p = 0.372 ) , femoral neck ( p = 0.188 ) , trochanter ( p = 0.085 ) , and total proximal femur ( p = 0.070 ) were statistically nonsignificant . Analyses in compliant women ( ≥80 % of use ) result ed in stronger and statistically significant effects at the total body and femoral regions . Conclusion Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women with adequate nutritional calcium intake",
"Summary The effect of equivalent oral doses of vitamin D3 600 IU/day , 4200 IU/week and 18,000 IU/month on vitamin D status was compared in a r and omized clinical trial in nursing home residents . A daily dose was more effective than a weekly dose , and a monthly dose was the least effective . Introduction It is assumed that equivalent daily , weekly or monthly doses of vitamin D3 equally influence vitamin D status . This was investigated in a r and omized clinical trial in nursing home residents . Methods The study was performed in ten nursing homes including 338 subjects ( 76 male and 262 female ) , with a mean age of 84 ( ± SD 6.3 years ) . They received oral vitamin D3 either 600 IU/day , or 4200 IU/week , or 18,000 IU/month or placebo . After 4 months , calcium was added during 2 weeks , 320 mg/day or 640 mg/day or placebo . Outcome : serum levels of 25-hydroxyvitamin D ( 25(OH)D ) , parathyroid hormone ( PTH ) and bone turnover markers . Statistical approach : linear multilevel analysis . Results At baseline , mean serum 25(OH)D was 25.0 nmol/L ( SD 10.9 ) , and in 98 % , it was lower than 50 nmol/L. After 4 months , mean serum 25(OH)D levels increased to 62.5 nmol/L ( after daily vitamin D3 69.9 nmol/L , weekly 67.2 nmol/L and monthly 53.1 nmol/L , P groups ) . Median serum PTH levels decreased by 23 % ( p 0.001 ) . Bone turnover markers did not decrease . Calcium supplementation had no effect on serum PTH and bone turnover . Conclusion Daily vitamin D was more effective than weekly , and monthly administration was the least effective",
"To investigate the potential efficacy of calcium and vitamin D in reducing risk for colorectal neoplasms and to develop “ treatable ” phenotypic biomarkers of risk for colorectal neoplasms , we conducted a pilot , r and omized , double-blind , placebo-controlled , 2 × 2 factorial clinical trial to test the effects of these agents on cell cycle markers in the normal colorectal mucosa . Ninety-two men and women with at least one pathology-confirmed colorectal adenoma were treated with 2 g/day calcium and /or 800 IU/day vitamin D3 versus placebo over 6 months . Overall expression and distributions of p21waf1/cip1 ( marker of differentiation ) , MIB-1 ( marker of short-term proliferation ) , and hTERT ( marker of long-term proliferation ) in colorectal crypts in the normal-appearing rectal mucosa were detected by automated immunohistochemistry and quantified by image analysis . In the calcium , vitamin D , and calcium plus vitamin D groups relative to the placebo , p21 expression increased by 201 % ( P = 0.03 ) , 242 % ( P = 0.005 ) , and 25 % ( P = 0.47 ) , respectively , along the full lengths of colorectal crypts after 6 months of treatment . There were no statistically significant changes in the expression of either MIB-1 or hTERT in the crypts overall ; however , the proportion of hTERT , but not MIB-1 , expression that extended into the upper 40 % of the crypts was reduced by 15 % ( P = 0.02 ) in the vitamin D plus calcium group relative to the placebo . These results indicate that calcium and vitamin D promote colorectal epithelial cell differentiation and may “ normalize ” the colorectal crypt proliferative zone in sporadic adenoma patients , and support further investigation of calcium and vitamin D as chemopreventive agents against colorectal neoplasms . ( Cancer Epidemiol Biomarkers Prev 2009;18(11):2933–41",
"The serum 25-hydroxyvitamin D [ 25(OH)D ] response to daily supplementation with 20 microg cholecalciferol ( D3 ) during winter in predominantly white premenopausal women living in Maine was measured and the effects of body composition and hormonal contraceptive use on baseline serum 25(OH)D concentrations and the response to supplementation were examined . A total of 112 women ( 22.2 + /- 3.7 y old ) received placebo from March 2005 until September 2005 when they were r and omized to receive either placebo or 20 microg/d D3 through February 2006 . Eighty-six women completed the study . Actual mean D3 content of the supplements was 22 microg per capsule . In February 2005 the serum 25(OH)D concentration was 62.0 + /- 23.4 nmol/L ( mean + /- SD ) . Serum 25(OH)D concentrations increased by 35.3 + /- 23.2 nmol/L from February 2005 to February 2006 in the treatment group , significantly more than the 10.9 + /- 16.9 nmol/L increase in the placebo group . Treatment group , magnitude of summer increase in 25(OH)D , estrogen dose , and baseline serum 25(OH)D concentrations , but not body fat , were significant predictors of the 1-y change in 25(OH)D concentrations used to assess the magnitude of the response to supplementation . Daily supplementation with 20 microg D3 during winter achieved optimal 25(OH)D concentrations ( > or = 75 nmol/L ) in 80 % of participants , indicating that this dose is adequate to optimize vitamin D status in most young women in Maine",
"UNLABELLED Dietary supplementation with vitamin K(1 ) , with vitamin D(3 ) and calcium or their combination , was examined in healthy older women during a 2-year , double-blind , placebo-controlled trial . Combined vitamin K with vitamin D plus calcium was associated with a modest but significant increase in BMC at the ultradistal radius but not at other sites in the hip or radius . INTRODUCTION The putative beneficial role of high dietary vitamin K(1 ) ( phylloquinone ) on BMD and the possibility of interactive benefits with vitamin D were studied in a 2-year double-blind , placebo-controlled trial in healthy Scottish women > or = 60 years of age . MATERIAL S AND METHODS Healthy , nonosteoporotic women ( n = 244 ) were r and omized to receive either ( 1 ) placebo , ( 2 ) 200 microg/day vitamin K(1 ) , ( 3 ) 10 microg ( 400 IU ) vitamin D(3 ) plus 1000 mg calcium/day , or ( 4 ) combined vitamins K(1 ) and D(3 ) plus calcium . Baseline and 6-month measurements included DXA bone mineral scans of the hip and wrist , markers of bone turnover , and vitamin status . Supplementation effects were tested using multivariate general linear modeling , with full adjustment for baseline and potential confounding variables . RESULTS Significant bone mineral loss was seen only at the mid-distal radius but with no significant difference between groups . However , women who took combined vitamin K and vitamin D plus calcium showed a significant and sustained increase in both BMD and BMC at the site of the ultradistal radius . Serum status indicators responded significantly to respective supplementation with vitamins K and D. Over 2 years , serum vitamin K(1 ) increased by 157 % ( p percentage of undercarboxylated osteocalcin ( % GluOC ) decreased by 51 % ( p serum 25-hydroxyvitamin D [ 25(OH)D ] increased by 17 % ( p PTH decreased by 11 % ( p = 0.049 ) . CONCLUSIONS These results provide evidence of a modest synergy in healthy older women from nutritionally relevant intakes of vitamin K(1 ) together with supplements of calcium plus moderate vitamin D(3 ) to enhance BMC at the ultradistal radius , a site consisting of principally trabecular bone . The substantial increase in gamma-carboxylation of osteocalcin by vitamin K may have long-term benefits and is potentially achievable by increased dietary intakes of vitamin K rather than by supplementation",
"UNLABELLED Bone metabolism follows a seasonal pattern with high bone turnover and bone loss during the winter . In a r and omized , open-label 2-year sequential follow-up study of 55 healthy adults , we found that supplementation with oral vitamin D3 and calcium during winter abolished seasonal changes in calciotropic hormones and markers of bone turnover and led to an increase in BMD . Supplementation with oral vitamin D3 and calcium during the winter months seems to counteract the effects of seasonal changes in vitamin D and thus may be beneficial as a primary prevention strategy for age-related bone loss . INTRODUCTION Bone metabolism follows a seasonal pattern characterized by high bone turnover and bone loss during winter . We investigated whether wintertime supplementation with oral vitamin D3 and calcium had beneficial effects on the circannual changes in bone turnover and bone mass . MATERIAL S AND METHODS This prospect i ve study comprised an initial observation period of 12 months ( \" year 1 \" ) , followed by an intervention during parts of year 2 . Fifty-five healthy subjects living in southwestern Germany ( latitude , 49.5 degrees N ) were r and omized into two groups : 30 subjects were assigned to the treatment group and received oral cholecalciferol ( 500 IU/day ) and calcium ( 500 mg/day ) during the winter months of year 2 ( October-April ) , while 25 subjects assigned to the control group obtained no supplements . Primary endpoints were changes in calciotropic hormones [ serum 25(OH)D , 1,25(OH)2D , and parathyroid hormone ] , markers of bone formation ( serum bone-specific alkaline phosphatase ) and of bone resorption ( urinary pyridinoline and deoxypyridinoline ) , and changes in lumbar spine and femoral neck BMD . RESULTS Forty-three subjects completed the study . During year 1 , calciotropic hormones , markers of bone turnover , and BMD varied by season in both groups . During the winter months of year 1 , bone turnover was significantly accelerated , and lumbar spine and femoral BMD declined by 0.3 - 0.9 % . In year 2 , seasonal changes in calciotropic hormones and markers of bone turnover were either reversed or abolished in the intervention group while unchanged in the control cohort . In the subjects receiving oral vitamin D3 and calcium , lumbar and femoral BMD increased significantly ( lumbar spine : + 0.8 % , p = 0.04 versus year 1 ; femoral neck : + 0.1 % , p = 0.05 versus year 1 ) , whereas controls continued to lose bone ( intervention group versus control group : lumbar spine , p = 0.03 ; femoral neck , p = 0.05 ) . CONCLUSIONS Supplementation with oral vitamin D3 and calcium during winter prevents seasonal changes in bone turnover and bone loss in healthy adults . It seems conceivable that annually recurring cycles of low vitamin D and mild secondary hyperparathyroidism during the winter months contributes , at least in part and over many years , to age-related bone loss . Supplementation with low-dose oral vitamin D3 and calcium during winter may be an efficient and inexpensive strategy for the primary prevention of bone loss in northern latitudes",
"Abstract : Vitamin D status is known to be an important determinant of bone mineral density ( BMD ) . There is a significant seasonal variation in serum vitamin D , and some studies have reported an associated seasonal variation in BMD . The present study was devised to investigate whether a seasonal variation in BMD could be detected in healthy normal subjects , along with associated variations in serum parathyroid hormone ( PTH ) , intestinal calcium absorption and biochemical markers of bone turnover . A second aim was to investigate whether , if such variations were identified , they could be suppressed by vitamin D supplementation . The subjects were 70 healthy female volunteers ( mean age 47.2 years , range 24–70 years ) recruited into a double-masked crossover study and followed over 2 years . During the first year 35 subjects received a daily oral supplement containing 800 IU ( 20 mg ) cholecalciferol ( group 1 ) and 35 subjects received a placebo preparation ( group 2 ) . During the second year the treatment each group received was reversed . Lumbar spine ( L1–L4 ) , left proximal femur and total body BMD were measured by DXA at 3-month intervals . Serum 25-hydroxyvitamin D ( 25-OHD ) , serum PTH , bone markers ( bone-specific ALP ( BSAP ) and urinary crosslinks ( DYPD/creatinine ) ) and calcium absorption were also measured at each visit . Cholecalciferol treatment increased serum 25-OHD by 25.4 nmol/l ( p serum PTH of 6.6 ng/l ( p = 0.011 ) was seen in subjects in the lowest quartile of baseline serum 25-OHD . The treatment had no significant effect on spine , femur or total body BMD , calcium absorption or bone markers . When Fourier analysis was used to analyze the data for seasonal effect ( defined as twice the amplitude of the 1-year period variation ) a highly significant effect for 25-OHD of 18 nmol/l ( p for BMD , PTH , calcium absorption or bone markers . The analysis set a 95 % confidence limit to the seasonal effect of less than 0.6 % for spine , total hip and total body BMD . It was concluded that in the population of healthy women studied there was no evidence of seasonal variation in spine , femur or total body BMD , serum PTH , calcium absorption or bone markers . Vitamin D supplementation was found to have no effect on BMD ",
"Abstract . The effects of postmenopausal hormone replacement therapy ( HRT ) and vitamin D3 on vitamin D metabolites ( 25OHD and 1,25(OH)2D ) were studied in a population -based prospect i ve 1-year study . The serum concentrations of intact parathyroid hormone ( PTH ) , calcium , and phosphate were also studied . A total of 72 women were r and omized into four treatment groups : HRT group ( sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate ) , Vit D3 group ( vitamin D3 300 IU/day + calcium lactate 500 mg/day ) , HRT + Vit D3 group ( both above ) and placebo group ( calcium lactate 500 mg/day ) . Serum sample s were taken in March – April , when vitamin D formation from sunlight in Finl and is minimal after the dark winter . Serum concentrations of 25OHD increased in the Vit D3 group ( 33.5 % , P HRT + Vit D3 group ( 38.2 % , P HRT and placebo groups at the 1-year follow-up examination . Serum concentrations of calcitriol ( 1,25(OH)2D ) increased , however , only in the HRT group ( 23.7 % , P Serum concentrations of PTH decreased by 23.2 % ( P placebo group , but did not change significantly in the other three groups . The concentrations of serum calcium increased in the nonhormone groups ( P serum phosphate concentrations decreased in the hormone groups ( P HRT on serum calcitriol . Vitamin D3 supplementation increased 25OHD concentrations , but did not affect calcitriol concentrations even though the initial levels were low . Interestingly , the combination of HRT and vitamin D3 did not increase serum calcitriol concentrations as much as HRT alone",
"Background : The deceleration of longitudinal growth in children during winter occurs simultaneously with a decrease in the number of daylight hours and a reduction in vitamin D status . Due to worries about deleterious effects on bone of a relative insufficiency , vitamin D supplementation to healthy children has been suggested . Aim : To see whether supplementation of vitamin D to healthy children during winter affects seasonal growth . Subjects and methods : Twelve girls and eight boys aged 6.2 - 13.7 ( mean 9.8 ) years , all healthy , were enrolled in a double-blind , r and omized , placebo-controlled cross-over study with two 4-week treatment periods and 2-week run-in and wash-out periods . Vitamin D 3 600 IU was given in one tablet ABCDin ® daily . Knemometry of the right lower leg was performed on the first and last day of each period . Results : Lower leg growth rates ( mean - SEM ) during placebo and vitamin D 3 administration were identical : 0.28 - 0.04 mm per week ( p = 0.94 , t = 0.1 , 95 % CI : m 0.12 - 0.13 mm per week ) . Conclusion : Supplementation with vitamin D 3 600 IU day m 1 to healthy children during winter may not improve seasonal growth . Therefore , supplementation may not be recommended on the grounds of concerns about growth ; however firm conclusions await r and omized long-term studies",
"Objective : Vitamin D supplementation may be required for certain subgroups in the United States in whom status and intake are inadequate , but the impact of various doses , and whether calcium administration jointly or independently influences vitamin D metabolite levels , is unclear . Methods : In a pilot chemoprevention trial of biomarkers of risk for colorectal adenoma , we measured the impact of vitamin D supplementation and /or calcium supplementation on plasma vitamin D metabolite concentrations . Ninety-two adult men and women living in the southeastern United States were r and omized to 800 IU vitamin D3 , 2000 mg elemental calcium , both , or placebo daily for 6 months . We examined vitamin D status at baseline and postintervention and compared the change in plasma 25-hydroxyvitamin D ( 25(OH)D ) and 1,25(OH)2D levels by intervention group using general linear models . Results : Eighty-two percent of the study population had insufficient plasma 25(OH)D concentrations ( African American participants . Vitamin D supplements , with or without calcium supplementation , raised plasma 25(OH)D concentrations , on average , by 25 to 26 nmol/L. Half of the study participants were classified as having sufficient 25(OH)D status after 6 months of 800 IU of vitamin D3 daily . Calcium alone did not influence 25(OH)D concentrations . Conclusion : In this southeastern U.S. population , half of the study participants receiving 800 IU vitamin D3 daily had blood 25(OH)D concentrations of ≤75 nmol/L after a 6-month intervention period , supporting higher vitamin D dose requirements estimated by some groups . More research is needed to identify the optimal vitamin D dose to improve 25(OH)D status in various at-risk population",
"OBJECTIVES To determine whether relative vitamin D deficiency during the winter months contributes to age-related bone loss and whether rates of change in hard- and soft-tissue mass vary during the year . DESIGN Double-blind , placebo-controlled , 1-year trial in 249 women in which equal numbers of women were r and omized to either placebo or 400 IU of vitamin D daily . All women received 377 mg/d of supplemental calcium largely as calcium citrate malate . PATIENTS Healthy , ambulatory postmenopausal women with usual intakes of vitamin D of 100 IU/d . MEASUREMENTS Duplicate spine and whole-body scans were done by dual energy x-ray absorptiometry at 6-month intervals that were timed to periods when 25-hydroxyvitamin D levels were highest and lowest . Period 1 was June-July to December-January and period 2 was December-January to the next June-July . Serum parathyroid hormone and plasma 25-hydroxyvitamin D levels were measured during periods 1 and 2 . MAIN RESULTS In the placebo group , spinal bone mineral density increased in period 1 , decreased in period 2 , and sustained no net change . Women treated with vitamin D had a similar spinal increase in period 1 ( 1.46 % compared with 1.40 % in placebo ) , less loss in period 2 ( -0.54 % compared with -1.22 % , CI for the difference , 0.05 % to 1.31 % , P = 0.032 ) and a significant overall benefit ( 0.85 % compared with 0.15 % , CI for the difference , 0.03 % to 1.37 % , P = 0.04 ) . In period 2 , 25-hydroxyvitamin D levels were lower and parathyroid hormone levels were higher in the placebo than in the vitamin D group . Whole-body lean and fat tissue and bone mineral density varied during the year but did not change overall . CONCLUSIONS At latitude 42 degrees , healthy postmenopausal women with vitamin D intakes of 100 IU daily can significantly reduce late wintertime bone loss and improve net bone density of the spine over one year by increasing their intake of vitamin D to 500 IU daily . A long-term benefit of preventing vitamin D insufficiency in the winter seems likely although it remains to be shown . Observed changes in bone as well as in fat and lean tissue appear to be related to season",
"Calcium supplementation is effective in reducing blood pressure in various states of hypertension , including pregnancy-induced hypertension and preeclampsia . In addition , calcitropic hormones are associated with blood pressure . The hypothesis is that short-term therapy with calcium and vitamin D(3 ) may improve blood pressure as well as secondary hyperparathyroidism more effectively than calcium monotherapy . The effects of 8 weeks of supplementation with vitamin D(3 ) ( cholecalciferol ) and calcium on blood pressure and biochemical measures of bone metabolism were studied . The sample consisted of 148 women ( mean + /- SD age , 74 + /- 1 yr ) with a 25-hydroxycholecalciferol ( 25OHD(3 ) ) level below 50 nmol/L. They received either 1200 mg calcium plus 800 IU vitamin D(3 ) or 1200 mg calcium/day . We measured intact PTH , 25OHD(3 ) , 1,25-dihydroxyvitamin D(3 ) , blood pressure , and heart rate before and after treatment . Compared with calcium , supplementation with vitamin D(3 ) and calcium result ed in an increase in serum 25OHD(3 ) of 72 % ( P serum PTH of 17 % ( P = 0.04 ) , a decrease in systolic blood pressure ( SBP ) of 9.3 % ( P = 0.02 ) , and a decrease in heart rate of 5.4 % ( P = 0.02 ) . Sixty subjects ( 81 % ) in the vitamin D(3 ) and calcium group compared with 35 ( 47 % ) subjects in the calcium group showed a decrease in SBP of 5 mm Hg or more ( P = 0.04 ) . No statistically significant difference was observed in the diastolic blood pressures of the calcium-treated and calcium- plus vitamin D(3)-treated groups ( P = 0.10 ) . Pearson coefficients of correlation between the change in PTH and the change in SBP were 0.49 ( P vitamin D(3 ) plus calcium group and 0.23 ( P calcium group . A short-term supplementation with vitamin D(3 ) and calcium is more effective in reducing SBP than calcium alone . Inadequate vitamin D(3 ) and calcium intake could play a contributory role in the pathogenesis and progression of hypertension and cardiovascular disease in elderly women",
"UNLABELLED The effect of vitamin D supplementation on bone mineral augmentation in 212 adolescent girls with adequate calcium intake was studied in a r and omized placebo-controlled setting . Bone mineral augmentation determined by DXA increased with supplementation both in the femur and the lumbar vertebrae in a dose-responsive manner . Supplementation decreased the urinary excretion of resorption markers , but had no impact on formation markers . INTRODUCTION Adequate vitamin D intake protects the elderly against osteoporosis , but there exists no indisputable evidence that vitamin D supplementation would benefit bone mineral augmentation . The aim of this 1-year study was to determine in a r and omized double-blinded trial the effect of 5 and 10 microg vitamin D3 supplementation on bone mineral augmentation in adolescent girls with adequate dietary calcium intake . MATERIAL S AND METHODS Altogether , 228 girls ( mean age , 11.4 + /- 0.4 years ) participated . Their BMC was measured by DXA from the femur and lumbar spine . Serum 25-hydroxyvitamin D [ S-25(OH)D ] , intact PTH ( S-iPTH ) , osteocalcin ( S-OC ) , and urinary pyridinoline ( U-Pyr ) and deoxypyridinoline ( U-Dpyr ) were measured . Statistical analysis was performed both with the intention-to-treat ( IT ) and compliance-based ( CB ) method . RESULTS In the CB analysis , vitamin D supplementation increased femoral BMC augmentation by 14.3 % with 5 microg and by 17.2 % with 10 microg compared with the placebo group ( ANCOVA , p = 0.012 ) . A dose-response effect was observed in the vertebrae ( ANCOVA , p = 0.039 ) , although only with the highest dose . The mean concentration of S-25(OH)D increased ( p S-iPTH or S-OC , but it decreased U-DPyr ( p = 0.042 ) . CONCLUSIONS Bone mineral augmentation in the femur was 14.3 % and 17.2 % higher in the groups receiving 5 and 10 microg of vitamin D , respectively , compared with the placebo group , but only 10 mug increased lumbar spine BMC augmentation significantly . Vitamin D supplementation decreased the concentration of bone resorption markers , but had no impact on bone formation markers , thus explaining increased bone mineral augmentation . However , the positive effects were noted with the CB method but not with IT",
"Specific receptors for vitamin D have been identified in human muscle tissue . Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls . We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls . In a double-blind r and omized controlled trial , we studied 122 elderly women ( mean age , 85.3 years ; range , 63 - 99 years ) in long-stay geriatric care . Participants received 1200 mg calcium plus 800 IU cholecalciferol ( Cal+D-group ; n = 62 ) or 1200 mg calcium ( Cal-group ; n = 60 ) per day over a 12-week treatment period . The number of falls per person ( 0 , 1 , 2 - 5 , 6 - 7 , > 7 falls ) was compared between the treatment groups . In an intention to treat analysis , a Poisson regression model was used to compare falls after controlling for age , number of falls in a 6-week pretreatment period , and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations . Among fallers in the treatment period , crude excessive fall rate ( treatment - pretreatment falls ) was compared between treatment groups . Change in musculoskeletal function ( summed score of knee flexor and extensor strength , grip strength , and the timed up&go test ) was measured as a secondary outcome . Among subjects in the Cal+D-group , there were significant increases in median serum 25-hydroxyvitamin D ( + 71 % ) and 1,25-dihydroxyvitamin D ( + 8 % ) . Before treatment , mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group . In the 12-week treatment period , mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group . After adjustment , Cal+D-treatment accounted for a 49 % reduction of falls ( 95 % CI , 14 - 71 % ; p crude average number of excessive falls was significantly higher in the Cal-group ( p = 0.045 ) . Musculoskeletal function improved significantly in the Cal+D-group ( p = 0.0094 ) . A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49 % compared with calcium alone . Over this short-term intervention , recurrent fallers seem to benefit most by the treatment . The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function",
"Vitamin D deficiency is common in elderly persons , especially those with hip fracture [ 1 , 2 ] . It is caused by low exposure to sunshine , decreased synthesis of vitamin D3 in the aging skin , and a diet low in vitamin D [ 3 , 4 ] . The mean vitamin D intake in elderly persons in the Netherl and s is about 100 IU/d , half that of elderly persons in the United States [ 5 ] . Most of this vitamin D comes from margarine , which is the only vitamin D-supplemented food in the Netherl and s ( 3 IU/g ) . In vitamin D deficiency , the low serum concentration of 25-hydroxyvitamin D [ 25(OH)D ] leads to a low 1,25-dihydroxyvitamin D [ 1,25(OH)2D ] concentration and then to a higher serum parathyroid hormone concentration , especially in the winter [ 6 - 10 ] . Histologically , the increased parathyroid activity is associated with high bone turnover , leading to cortical bone loss and low density bone [ 5 , 11 ] , which may lead to hip fracture . We previously studied the effects of vitamin D supplementation in residents of a home for the elderly and residents of a nursing home [ 10 ] . Vitamin D3 , 400 IU/d , led to an adequate increase of the serum 25(OH)D concentration , to a small but significant increase of the serum 1,25(OH)2D concentration , and to a decrease of the serum concentration of intact parathyroid hormone . It was recently observed [ 12 , 13 ] that bone mineral density at the hip is positively related to serum 25(OH)D concentration in postmenopausal and elderly women . Therefore , it might be expected that vitamin D supplementation would increase bone mineral density in elderly persons deficient in vitamin D. In line with this expectation , it was shown that vitamin D supplementation prevented bone loss from the spine during the winter in postmenopausal women [ 14 ] . These results suggest that vitamin D supplementation may reduce the incidence of hip fractures , because bone strength shows a strong correlation with bone mineral density [ 15 ] . However , increasing bone mineral density through a therapeutic intervention does not necessarily lead to increased bone strength , as has been shown with sodium fluoride [ 16 ] . Bone structure and bone quality are also determinants of bone strength [ 17 ] , and falls are a risk factor for hip fractures [ 18 ] . Therefore , hip fracture should be the outcome criterion in studies on the effect of vitamin D supplementation . Intervention studies on the prevention of osteoporotic fractures necessitate large numbers of patients , because the outcome has an annual incidence of 0.5 % to 4 % in the elderly population [ 19 ] . We report the results of a large-scale , prospect i ve study on the effect of vitamin D supplementation on the incidence of hip and other osteoporotic fractures . Methods Participants The study included 2578 persons ( 1916 women and 662 men ) 70 years of age and older ( mean age SD , 80 6 years ; range , 70 to 97 years ) . Participants were recruited from general practitioners , from apartment houses for elderly persons , and from homes for elderly persons in Amsterdam and its vicinity . Persons recruited from practitioners were living independently ; those recruited from apartment houses and homes were receiving some care , but less than they would have received in a nursing home . Participants had to be reasonably healthy and able to give informed consent . Persons with a history of hip fracture or total hip arthroplasty , known hypercalcemia , sarcoidosis , or recent urolithiasis ( were not excluded . The spontaneous use of vitamin D supplements and multivitamins was discouraged , but the prescription practice s of the general practitioners were not altered . All vitamin use was carefully documented . The study was approved by the Ethical Review Board of the Vrije Universiteit Hospital , and all participants gave informed consent . Study Design After checking the inclusion and exclusion criteria and obtaining informed consent , the participants were r and omly assigned to receive either active treatment with vitamin D3 or placebo . The study was double-blind , and r and omization was done in blocks of 10 per general practice , apartment house , or home . R and omization lists were made using a computerized r and om-number generator . Lists in sealed envelopes were sent to the hospital pharmacy for assignment . Each participant took either one tablet per day that contained vitamin D3 , 400 IU , or one placebo tablet per day that was identical in appearance and taste to the vitamin tablet . After enrollment , the participants received the first container of tablets ( 210 tablets ) . The container was replaced every 6 months with a full container . All participants were also advised in writing to consume at least three servings of dairy products per day ( for example , 1 glass of milk , 1 cup of yogurt , and 1 slice of cheese ) to ensure a calcium intake of at least 800 to 1000 mg/d . The study was started in August 1988 . The last participant was enrolled in December 1990 , and all participants had stopped using study medication by December 1993 . The follow-up period had been planned to last no more than 3 years , but because the number of hip fractures during the study was lower than expected , a 6-month extension was planned . The study participants thus received medication for 3 to 3.5 years ; those who received it for 3.5 years were those who consented to the 6-month extension . Total follow-up was to a maximum of 4 years . Data collected at baseline included an outdoor activity score ( 1 equals going outdoors less than once a week ; 2 equals going outdoors 1 or 2 times per week ; and 3 equals going outdoors 3 times per week or more ) and a score for sunshine exposure ( when outside : 1 equals in the shade as much as possible ; 2 equals sometimes in sunshine ; 3 equals much exposure to sunshine ) . These scores show a positive relation with serum 25(OH)D concentration [ 3 ] . Mobility was estimated by a walking score that ranged from 1 ( unable to walk ) to 5 ( walks independently a fair distance on any surface ) [ 20 ] . The dietary calcium intake from dairy products was estimated in a subset of 348 women by using a question naire , as described previously [ 21 ] . The participants were evaluated annually with a question naire on hip fractures , other peripheral fractures , outdoor score , sunshine exposure score , use of vitamin supplements , and walking score . Each general practitioner or caretaker was asked to immediately report change of address , hip fracture , or death . Hip fracture and death were verified by the general practitioner . All participants were followed for the maximal period of 4 years if possible , even if they had stopped using the trial medication , had sustained a fracture , or had moved to another city . To investigate possible selection bias , 267 potential participants in a home for the elderly and its adjunct apartments ( all residents of the institution ) were studied for baseline characteristics , including age , sex , sunshine exposure score , outdoor score , walking score , and reasons for nonparticipation . Compliance was checked when the tablet containers were replaced ( every 6 months ) , by question naire ( every year ) , and by measurement of the serum 25(OH)D concentration . Serum 25(OH)D concentration was measured at baseline and after 1 year in 270 persons who participated in a sub study investigating the effect of vitamin D supplementation on bone mineral density and bone turnover variables . This sub study included a nonr and om sample of participants from several apartment houses and homes for the elderly and is described in detail elsewhere [ 21 ] . In the same sub study , dietary calcium intake from diary products was assessed . Serum 25(OH)D concentration was also estimated during the third year of the study in February and March in a r and om sample of 96 participants drawn from the remaining study population . These participants received a letter giving them an appointment within 10 days ; the blood sample s were drawn at home . Serum 25(OH)D concentration was measured by competitive protein binding assay after being purified by gradient high-pressure liquid chromatography . The intra- and interassay coefficients of variation were 5 % and 6 % , respectively [ 22 ] . Statistical Analysis Baseline data of the vitamin D group and the placebo group were compared using t-tests ( age , calcium intake ) , chi-square tests ( sex , residence ) , and Wilcoxon rank-sum tests ( scores ) . The serum 25(OH)D concentrations of both groups were compared using t-tests . Data on fractures and mortality were analyzed by survival analysis using log-rank tests , Cox proportional-hazards regression , and hazard rate ratios [ 23 ] . Hip fractures are presented using the Kaplan-Meier method . All participants were kept in the study as long as possible . The data were analyzed in two ways . The intention-to-treat analysis included all r and omly assigned participants for either the total follow-up period or until fracture , death , or loss to follow-up . The active treatment analysis included the participants as long as they stated that they were using the trial medication . Thus , the participants were included in the active treatment analysis until they stopped using the trial medication , regardless of whether a fracture occurred after they had stopped . Age , sex , and residence were added in both analyses as covariates to the Cox regression model . Because outdoor score , sunshine score , and walking score were interrelated ( correlation coefficients ranging from 0.21 to 0.59 ) and were likely to indicate general health or mobility , they were averaged over the years and added up to a sum score . For this purpose , the walking score was simplified ( 1 , 2 , or 3 equals 1 ; 4 equals 2 ; 5 equals 3 ) , because the lower walking scores applied to a few participants only . The result ing total score , ranging from 3 to 9 , was entered as a covariate in the model . The level of compliance ( weekly intake as reported on",
"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",
"Vitamin D has been shown to be an important immune system regulator . Vitamin D insufficiency during winter may cause increased susceptibility to upper respiratory tract infections ( URIs ) . To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms , 162 adults were r and omized to receive 50 microg vitamin D3 ( 2000 IU ) daily or matching placebo for 12 weeks . A bi-weekly question naire was used to record the incidence and severity of URI symptoms . There was no difference in the incidence of URIs between the vitamin D and placebo groups ( 48 URIs vs. 50 URIs , respectively , P=0.57 ) . There was no difference in the duration or severity of URI symptoms between the vitamin D and placebo groups [ 5.4+/-4.8 days vs. 5.3+/-3.1 days , respectively , P=0.86 ( 95 % CI for the difference in duration -1.8 to 2.1 ) ] . The mean 25-hydroxyvitamin D level at baseline was similar in both groups ( 64.3+/-25.4 nmol/l in the vitamin D group ; 63.0+/-25.8 nmol/l in the placebo group ; n.s . ) . After 12 weeks , 25-hydroxyvitamin D levels increased significantly to 88.5+/-23.2 nmol/l in the vitamin D group , whereas there was no change in vitamin D levels in the placebo group . There was no benefit of vitamin D3 supplementation in decreasing the incidence or severity of symptomatic URIs during winter . Further studies are needed to determine the role of vitamin D in infection",
"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",
"To examine the relation of the vitamin D status and the remaining estrogen activity with bone turnover and bone mineral density ( BMD ) in elderly women , BMD was measured at both hips using dual-energy X-ray absorptiometry and at the distal radius using single photon absorptiometry , in 330 healthy women aged 70 and over . Vitamin D metabolites , sex hormone binding globulin ( SHBG ) , PTH(1 - 84 ) , osteocalcin , alkaline phosphatase , and hydroxyproline and calcium excretion in 2 h fasting urine were measured . Multiple linear regression was used to adjust for potential confounders . In 65 % of the women , serum 25(OH)D was below 30 nmol/l . Only values below a threshold for 25(OH)D were negatively related to serum PTH(1 - 84 ) ( p = 0.02 , threshold at 25 nmol/l ) and to osteocalcin levels ( p = 0.04 , threshold at 30 nmol/l ) . BMD of the femoral neck and trochanter was positively related to serum 25(OH)D ( left neck p = 0.001 ) with thresholds at 30 nmol/l whereas the distal radius was not ( p = 0.32 ) . Serum PTH was negatively related to BMD at all measurement sites ( all p Serum SHBG , an inverse measure of estrogen activity , was positively related to osteocalcin levels ( p = 0.004 ) and the urinary hydroxyproline/creatinine ratio ( p = 0.002 ) and negatively related to the BMD of the trochanter ( left trochanter p = 0.02 ) and the distal radius ( p = 0.001 ) . We conclude that in elderly women , serum 25(OH)D levels below 30 nmol/l are associated with secondary hyperparathyroidism and increased bone turnover . SHBG is positively related to bone turnover . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVES To determine the prevalence of hypovitaminosis D ( serum 25-hydroxyvitamin D population of elderly veterans and conduct a preliminary assessment of the efficacy of supplementation with cholecalciferol in correcting HVD . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Geriatric clinic at the Bruce W. Carter Veterans Affairs Medical Center , Miami , Florida . PARTICIPANTS Veterans aged 70 and older . INTERVENTION Oral cholecalciferol 2,000 IU daily or placebo for 6 months . MEASUREMENTS Serum calcium , 25-hydroxyvitamin D , parathyroid hormone , and 24-hour urinary calcium . RESULTS Of the 34 participants who completed the study , 62 % had HVD at baseline . In the treatment group , mean serum 25-hydroxyvitamin D level rose from 28.4±7.9 ng/mL at baseline to 42.7±10.5 ng/mL at the end of the trial , but levels remained less than 32 ng/mL in three of 17 ( 18 % ) of the participants . In the placebo group , the baseline level of 27.7±8.3 ng/mL remained unchanged ( 28.8±8.7 ng/mL ) . Supplementation did not alter serum or urinary calcium levels and did not result in any adverse events . CONCLUSION These initial observations suggest that , in older veterans , cholecalciferol 2,000 IU daily for 6 months is generally safe and corrects HVD in most but not all individuals",
"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",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
"BACKGROUND Elderly people who have a fracture are at high risk of another . Vitamin D and calcium supplements are often recommended for fracture prevention . We aim ed to assess whether vitamin D3 and calcium , either alone or in combination , were effective in prevention of secondary fractures . METHODS In a factorial- design trial , 5292 people aged 70 years or older ( 4481 [ 85 % ] of whom were women ) who were mobile before developing a low-trauma fracture were r and omly assigned 800 IU daily oral vitamin D3 , 1000 mg calcium , oral vitamin D3 ( 800 IU per day ) combined with calcium ( 1000 mg per day ) , or placebo . Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months . Analysis was by intention-to-treat and the primary outcome was new low-energy fractures . FINDINGS 698 ( 13 % ) of 5292 participants had a new low-trauma fracture , 183 ( 26 % ) of which were of the hip . The incidence of new , low-trauma fractures did not differ significantly between participants allocated calcium and those who were not ( 331 [ 12.6 % ] of 2617 vs 367 [ 13.7 % ] of 2675 ; hazard ratio ( HR ) 0.94 [ 95 % CI 0.81 - 1.09 ] ) ; between participants allocated vitamin D3 and those who were not ( 353 [ 13.3 % ] of 2649 vs 345 [ 13.1 % ] of 2643 ; 1.02 [ 0.88 - 1.19 ] ) ; or between those allocated combination treatment and those assigned placebo ( 165 [ 12.6 % ] of 1306 vs 179 [ 13.4 % ] of 1332 ; HR for interaction term 1.01 [ 0.75 - 1.36 ] ) . The groups did not differ in the incidence of all-new fractures , fractures confirmed by radiography , hip fractures , death , number of falls , or quality of life . By 24 months , 2886 ( 54.5 % ) of 5292 were still taking tablets , 451 ( 8.5 % ) had died , 58 ( 1.1 % ) had withdrawn , and 1897 ( 35.8 % ) had stopped taking tablets but were still providing data for at least the main outcomes . Compliance with tablets containing calcium was significantly lower ( difference : 9.4 % [ 95 % CI 6.6 - 12.2 ] ) , partly because of gastrointestinal symptoms . However , potentially serious adverse events were rare and did not differ between groups . INTERPRETATION The findings do not support routine oral supplementation with calcium and vitamin D3 , either alone or in combination , for the prevention of further fractures in previously mobile elderly people",
"Objectives : This study was conducted to determine whether there are age differences in the plasma parent vitamin D and 25-hydroxyvitamin D ( 25OHD ) responses to eight weeks of supplementation with 20 μg/day of vitamin D3 . Methods : Twenty-five healthy young men ( age 18–35 ) and 25 healthy older men ( 62–79 ) were r and omly assigned to supplementation with 20 μg/day of vitamin D3 or to no intervention and followed for eight weeks . Plasma vitamin D3 was measured by high performance liquid chromatography and 25OHD was measured by competitive protein binding . Results : Both young and old men in the supplemented group had pronounced , rapid and similar increases in plasma vitamin D3 , whereas vitamin D3 concentrations were stable in the control group . By the end of the eight-week adaptation period , plasma vitamin D3 of young and old men had increased by 4.3 and 6.2 nmol/L respectively . In the supplemented group , mean 25OHD concentrations of both the young and old men increased during the study , and the magnitude of the change after eight weeks was nearly identical in the two age groups ( 22.5 and 22.1 nmol/L in the young and the old men , respectively ) . In the control group there was a modest decrease in 25OHD of both the young and old men . Conclusions : There appears to be no age-related impairment among men in the absorption or metabolism of 20 μg/day of vitamin D3 taken orally for at least eight weeks",
"OBJECTIVE The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level . STUDY DESIGN The OSTPRE-FPS was a r and omized population -based open-trial with 3-year follow-up . The supplementation group ( n=1566 ) received daily cholecalciferol 800IU+calcium carbonate 1000 mg , while the control group ( n=1573 ) received no supplementation or placebo . A r and omly selected sub sample of 593 subjects underwent a detailed measurement program including serum 25(OH)D measurements . MAIN OUTCOME MEASURE The occurrence of falls was the primary outcome of the study . The participants in the sub sample were telephoned at 4 months intervals and the rest of the trial population was interviewed by phone once a year . RESULTS In the entire trial population ( ETP ) , there were 812 women with 1832 falls in the intervention group and 833 women with 1944 falls in the control group ( risk ratio was 0.98 , 95 % CI 0.92 - 1.05 , P=0.160 ) . The supplementation was not associated with single or multiple falls in the ETP . However , in the sub sample , multiple fall incidence decreased by 30 % ( odds ratio ( OR ) 0.70 , 95 % CI 0.50 - 0.97 , P=0.034 ) in the supplementation group . Further , the supplementation decreased the incidence of multiple falls requiring medical attention ( OR 0.72 , 95 % CI 0.53 - 0.97 , P=0.031 ) in the ETP . The mean compliance in the entire trial population was 78 % and in the sub sample 79 % . DISCUSSION Overall , the primary analysis showed no association between calcium and vitamin D supplementation and risk of falls . However , the results of a post hoc analysis suggested that there was a decreased risk of multiple falls requiring medical attention : this finding requires confirmation",
"The aim of this study was to determine whether early changes in bone markers could predict long-term response in bone mineral density ( BMD ) after calcium ( 500 mg ) and vitamin D ( 400 IU ) supplementation twice daily in ambulatory elderly women with vitamin D insufficiency ( 25-hydroxyvitamin D , to receive either the supplementation ( n = 95 ) or a placebo ( n = 97 ) in a double-blind , controlled clinical trial for 1 yr . In comparison with the placebo group , supplementation significantly increased BMD , normalized 25-hydroxyvitamin D and significantly decreased intact PTH and bone remodeling markers . The initial values of telopeptide cross-links were correlated with improvement in total body BMD [ urinary N-telopeptides ( NTX ) , r = 0.38 ; C-telopeptides ( CTX ) , r = 0.32 ; serum CTX , r = 0.28 ] , and the 3-month changes in the same markers were correlated with improvement in total body ( urinary N-telopeptides , r = -0.29 ; serum CTX , r = -0.26 ) and vertebral BMD ( CTX , r = -0.26 ; all P BMD in elderly women with vitamin D insufficiency receiving calcium and vitamin D supplementation",
"Background : Vitamin D insufficiency poses a problem in many parts of the world , the elderly being an especially vulnerable group . This insufficiency results from an inadequate amount of sunshine and a low dietary intake of vitamin D. Typically , insufficiency is accompanied with high intact parathyroid hormone , ( S-iPTH ) concentrations . Aims of the Study : We studied how serum 25-hydroxy vitamin D ( S-25-OHD ) concentrations respond to different doses of vitamin D3 supplementation . Secondly to determine the smallest efficient dose to maintain serum 25-OHD concentration above the insufficiency level . We also studied which dose would be efficient in decreasing S-iPTH concentration in these subjects . Subjects and Methods : Forty-nine 65- to 85-year-old women participated . The women were r and omly assigned into one of four groups receiving 0 ( placebo ) , 5 , 10 or 20 μg of vitamin D3 daily for 12 weeks . Fasting morning blood was drawn at the beginning of the study , and thereafter every second week . Calciotropic variables were assessed from serum and urine sample s. Results : The S-25-OHD concentration increased significantly ( p Equilibrium in S-25-OHD concentration was reached in all groups after 6 weeks of supplementation at 57.7 ( 8.9 ) nmol/L , 59.9 ( 8.9 ) nmol/L and 70.9 ( 8.9 ) nmol/L in the groups with increasing vitamin D supplementation . The dose-response to supplementation decreased with increasing vitamin D status at baseline , r = −0.513 , p = 0.002 . S-iPTH tended to decrease in those with highest dose response to supplementation . Conclusions : A clear dose response was noted in S-25-OHD to different doses of vitamin D3 . The recommended dietary intake of 15 μg is adequate to maintain the S-25-OHD concentration around 40–55 nmol/L during winter , but if the optimal S-25-OHD is higher than that even higher vitamin D intakes are needed . Interestingly , subjects with lower vitamin D status at baseline responded more efficiently to supplementation than those with more adequate status",
"BACKGROUND Knowledge gaps have contributed to considerable variation among international dietary recommendations for vitamin D. OBJECTIVE We aim ed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above several proposed cutoffs ( ie , 25 , 37.5 , 50 , and 80 nmol/L ) during wintertime after adjustment for the effect of summer sunshine exposure and diet . DESIGN A r and omized , placebo-controlled , double-blind 22-wk intervention study was conducted in men and women aged 20 - 40 y ( n = 238 ) by using different supplemental doses ( 0 , 5 , 10 , and 15 microg/d ) of vitamin D(3 ) throughout the winter . Serum 25(OH)D concentrations were measured by using enzyme-linked immunoassay at baseline ( October 2006 ) and endpoint ( March 2007 ) . RESULTS There were clear dose-related increments ( P serum 25(OH)D with increasing supplemental vitamin D(3 ) . The slope of the relation between vitamin D intake and serum 25(OH)D was 1.96 nmol x L(-1 ) x microg(-1 ) intake . The vitamin D intake that maintained serum 25(OH)D concentrations of > 25 nmol/L in 97.5 % of the sample was 8.7 microg/d . This intake ranged from 7.2 microg/d in those who enjoyed sunshine exposure , 8.8 microg/d in those who sometimes had sun exposure , and 12.3 microg/d in those who avoided sunshine . Vitamin D intakes required to maintain serum 25(OH)D concentrations of > 37.5 , > 50 , and > 80 nmol/L in 97.5 % of the sample were 19.9 , 28.0 , and 41.1 microg/d , respectively . CONCLUSION The range of vitamin D intakes required to ensure maintenance of wintertime vitamin D status [ as defined by incremental cutoffs of serum 25(OH)D ] in the vast majority ( > 97.5 % ) of 20 - 40-y-old adults , considering a variety of sun exposure preferences , is between 7.2 and 41.1 microg/d"
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BACKGROUND The contribution of fructose consumption in Western diets to overweight and obesity in population s remains uncertain . PURPOSE To review the effects of fructose on body weight in controlled feeding trials . DATA SOURCES MEDLINE , EMBASE , CINAHL , and the Cochrane Library ( through 18 November 2011 ) . STUDY SELECTION At least 3 review ers identified controlled feeding trials lasting 7 or more days that compared the effect on body weight of free fructose and nonfructose carbohydrate in diets providing similar calories ( isocaloric trials ) or of diets supplemented with free fructose to provide excess energy and usual or control diets ( hypercaloric trials ) . Trials evaluating high-fructose corn syrup ( 42 % to 55 % free fructose ) were excluded . DATA EXTRACTION The review ers independently review ed and extracted relevant data ; disagreements were reconciled by consensus . The Heyl and Method ological Quality Score was used to assess study quality . DATA SYNTHESIS Thirty-one isocaloric trials ( 637 participants ) and 10 hypercaloric trials ( 119 participants ) were included ; studies tended to be small ( , short ( , and of low quality . Fructose had no overall effect on body weight in isocaloric trials ( mean difference , -0.14 kg [ 95 % CI , -0.37 to 0.10 kg ] for fructose compared with nonfructose carbohydrate ) . High doses of fructose in hypercaloric trials ( + 104 to 250 g/d , + 18 % to 97 % of total daily energy intake ) lead to significant increases in weight ( mean difference , 0.53 kg [ CI , 0.26 to 0.79 kg ] with fructose ) . LIMITATIONS Most trials had method ological limitations and were of poor quality . The weight-increasing effect of fructose in hypercaloric trials may have been attributable to excess energy rather than fructose itself . CONCLUSION Fructose does not seem to cause weight gain when it is substituted for other carbohydrates in diets providing similar calories . Free fructose at high doses that provided excess calories modestly increased body weight , an effect that may be due to the extra calories rather than the fructose . PRIMARY FUNDING SOURCE Canadian Institutes of Health Research . ( Clinical Trials.gov registration number : NCT01363791 ) | [
"BACKGROUND Previous short-term studies ( energy expenditure ( EE ) and macronutrient oxidation in response to overfeeding with different types of dietary carbohydrate . This finding could have implication s for obesity . OBJECTIVE We used 96-h continuous whole-body calorimetry in 8 lean and 5 obese women to assess metabolic disposal ( energy dissipation and glycogen or fat storage ) of a controlled excess of dietary energy supplied as different carbohydrate sources or as fat . DESIGN Five dietary treatments were applied in r and om order : energy balance ( control ) and overfeeding by 50 % of energy requirements with fat ( O(fat ) ) or predominantly with glucose , fructose , or sucrose ( O(cho ) ) . Macronutrient oxidation rates were assessed from nonprotein gaseous exchanges . Net macronutrient balances were calculated as cumulative differences between intake and oxidation . RESULTS Increased EE in response to overfeeding dissipated 7.9 % of the energy excess with a variation in EE of EE during the O(fat ) treatment significantly exceeded that during the control treatment in the lean but not in the obese women . There were no significant differences between lean and obese women in macronutrient oxidation or balances , so data were pooled . O(cho ) induced glycogen storage on day 1 ( approximately 100 g ) but thereafter progressively stimulated carbohydrate oxidation so that balance was reached on days 3 and 4 . Fat oxidation was proportionately suppressed . Of the excess carbohydrate , 74 % was oxidized ; there were no significant differences between the various O(cho ) treatments . O(fat ) stimulated fat oxidation by 18 % and suppressed carbohydrate oxidation . On average , 12 % of the excess energy was stored as glycogen and 88 % as fat ; there was no significant difference between overfeeding treatments . CONCLUSION There was no significant difference in fat balance during controlled overfeeding with fat , fructose , glucose , or sucrose",
"We have studied whether the sucrose-induced reduction of insulin sensitivity and cellular insulin binding in normal man is related to the fructose or the glucose moiety . Seven young healthy subjects were fed their usual diets plus 1000 kcal extra glucose per day and eight young healthy subjects were fed their usual diets with addition of 1000 kcal extra fructose per day . The dietary regimens continued for 1 week . Before change of diet there were no statistically significant differences between body weight and fasting plasma concentrations of glucose , insulin , and ketone bodies in the two groups studied . High-glucose feeding caused no significant changes in insulin binding or insulin sensitivity whereas high-fructose feeding was accompanied by a significant reduction both of insulin binding ( P less than 0.05 ) and insulin sensitivity ( P less than 0.05 ) . The changes in insulin binding and insulin sensitivity correlated linearly ( r = 0.52 , P less than 0.01 ) . We conclude that fructose seems to be responsible for the impaired insulin binding and insulin sensitivity induced by sucrose",
"BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar",
"CONTEXT Sugar-sweetened beverages like soft drinks and fruit punches contain large amounts of readily absorbable sugars and may contribute to weight gain and an increased risk of type 2 diabetes , but these relationships have been minimally addressed in adults . OBJECTIVE To examine the association between consumption of sugar-sweetened beverages and weight change and risk of type 2 diabetes in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort analyses conducted from 1991 to 1999 among women in the Nurses ' Health Study II . The diabetes analysis included 91,249 women free of diabetes and other major chronic diseases at baseline in 1991 . The weight change analysis included 51,603 women for whom complete dietary information and body weight were ascertained in 1991 , 1995 , and 1999 . We identified 741 incident cases of confirmed type 2 diabetes during 716,300 person-years of follow-up . MAIN OUTCOME MEASURES Weight gain and incidence of type 2 diabetes . RESULTS Those with stable consumption patterns had no difference in weight gain , but weight gain over a 4-year period was highest among women who increased their sugar-sweetened soft drink consumption from 1 or fewer drinks per week to 1 or more drinks per day ( multivariate-adjusted means , 4.69 kg for 1991 to 1995 and 4.20 kg for 1995 to 1999 ) and was smallest among women who decreased their intake ( 1.34 and 0.15 kg for the 2 periods , respectively ) after adjusting for lifestyle and dietary confounders . Increased consumption of fruit punch was also associated with greater weight gain compared with decreased consumption . After adjustment for potential confounders , women consuming 1 or more sugar-sweetened soft drinks per day had a relative risk [ RR ] of type 2 diabetes of 1.83 ( 95 % confidence interval [ CI ] , 1.42 - 2.36 ; P fruit punch was associated with increased diabetes risk ( RR for > or = 1 drink per day compared with sugar-sweetened beverages is associated with a greater magnitude of weight gain and an increased risk for development of type 2 diabetes in women , possibly by providing excessive calories and large amounts of rapidly absorbable sugars",
"Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field",
"BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between baseline and change in consumption of sugar-sweetened drinks ( the independent variables ) , and difference in measures of obesity , with linear and logistic regression analyses adjusted for potentially confounding variables and clustering of results within schools . FINDINGS For each additional serving of sugar-sweetened drink consumed , both body mass index ( BMI ) ( mean 0.24 kg/m2 ; 95 % CI 0.10 - 0.39 ; p=0.03 ) and frequency of obesity ( odds ratio 1.60 ; 95 % CI 1.14 - 2.24 ; p=0.02 ) increased after adjustment for anthropometric , demographic , dietary , and lifestyle variables . Baseline consumption of sugar-sweetened drinks was also independently associated with change in BMI ( mean 0.18 kg/m2 for each daily serving ; 95 % CI 0.09 - 0.27 ; p=0.02 ) . INTERPRETATION Consumption of sugar-sweetened drinks is associated with obesity in children",
"The effect of dietary fructose ( 20 % of carbohydrate calories , 45 - 65 g day-1 for 4 weeks ) on glycaemic control , serum lipid , lipoprotein and apoprotein A-I and A-II concentrations and on insulin sensitivity was studied in 10 type 2 diabetic patients . The study was done in a r and omized , double-blind fashion with crystalline fructose or placebo administered evenly during 4 meals or snacks per day . The patients were hospitalized throughout the study periods . The fasting plasma glucose concentration decreased during the fructose ( from 10.7 + /- 1.4 mmol l-1 to 8.0 + /- 0.8 mmol l-1 , P control diet ( from 10.1 + /- 0.9 mmol l-1 to 8.0 + /- 0.7 mmol l-1 , P mean diurnal blood glucose concentration also fell both during the fructose ( from 10.8 + /- 0.5 mmol l-1 to 8.4 + /- 0.3 mmol l-1 , P HbA1 concentration improved ( P Insulin sensitivity increased by 34 % ( P Serum insulin , triglyceride , apoprotein A-I and A-II concentrations , body weight , blood pressure and blood lactate remained unchanged during both diets . In conclusion , substitution of moderate amounts of fructose for complex carbohydrates can improve glycaemic control and insulin sensitivity in patients with type 2 diabetes",
"Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P IHCL ( HFrD : + 52 % , P HGO increased after both diets ( HFrD : + 5 % , P fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose",
"OBJECTIVE . The role of sugar-sweetened beverages ( SSBs ) in promoting obesity is controversial . Observational data link SSB consumption with excessive weight gain ; however , r and omized , controlled trials are lacking and necessary to resolve the debate . We conducted a pilot study to examine the effect of decreasing SSB consumption on body weight . METHODS . We r and omly assigned 103 adolescents aged 13 to 18 years who regularly consumed SSBs to intervention and control groups . The intervention , 25 weeks in duration , relied largely on home deliveries of noncaloric beverages to displace SSBs and thereby decrease consumption . Change in SSB consumption was the main process measure , and change in body mass index ( BMI ) was the primary end point . RESULTS . All of the r and omly assigned subjects completed the study . Consumption of SSBs decreased by 82 % in the intervention group and did not change in the control group . Change in BMI , adjusted for gender and age , was 0.07 ± 0.14 kg/m2 ( mean ± SE ) for the intervention group and 0.21 ± 0.15 kg/m2 for the control group . The net difference , −0.14 ± 0.21 kg/m2 , was not significant overall . However , baseline BMI was a significant effect modifier . Among the subjects in the upper baseline- BMI tertile , BMI change differed significantly between the intervention ( −0.63 ± 0.23 kg/m2 ) and control ( + 0.12 ± 0.26 kg/m2 ) groups , a net effect of −0.75 ± 0.34 kg/m2 . The interaction between weight change and baseline BMI was not attributable to baseline consumption of SSBs . CONCLUSIONS . A simple environmental intervention almost completely eliminated SSB consumption in a diverse group of adolescents . The beneficial effect on body weight of reducing SSB consumption increased with increasing baseline body weight , offering additional support for American Academy of Pediatrics guidelines to limit SSB consumption",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
"BACKGROUND Both nutritional and genetic factors are involved in the pathogenesis of nonalcoholic fatty liver disease and insulin resistance . OBJECTIVE The aim was to assess the effects of fructose , a potent stimulator of hepatic de novo lipogenesis , on intrahepatocellular lipids ( IHCLs ) and insulin sensitivity in healthy offspring of patients with type 2 diabetes (OffT2D)--a subgroup of individuals prone to metabolic disorders . DESIGN Sixteen male OffT2D and 8 control subjects were studied in a crossover design after either a 7-d isocaloric diet or a hypercaloric high-fructose diet ( 3.5 g x kg FFM(-1 ) x d(-1 ) , + 35 % energy intake ) . Hepatic and whole-body insulin sensitivity were assessed with a 2-step hyperinsulinemic euglycemic clamp ( 0.3 and 1.0 mU x kg(-1 ) x min(-1 ) ) , together with 6,6-[2H2]glucose . IHCLs and intramyocellular lipids ( IMCLs ) were measured by 1H-magnetic resonance spectroscopy . RESULTS The OffT2D group had significantly ( P IHCLs ( + 94 % ) , total triacylglycerols ( + 35 % ) , and lower whole-body insulin sensitivity ( -27 % ) than did the control group . The high-fructose diet significantly increased IHCLs ( control : + 76 % ; OffT2D : + 79 % ) , IMCLs ( control : + 47 % ; OffT2D : + 24 % ) , VLDL-triacylglycerols ( control : + 51 % ; OffT2D : + 110 % ) , and fasting hepatic glucose output ( control : + 4 % ; OffT2D : + 5 % ) . Furthermore , the effects of fructose on VLDL-triacylglycerols were higher in the OffT2D group ( group x diet interaction : P 7-d high-fructose diet increased ectopic lipid deposition in liver and muscle and fasting VLDL-triacylglycerols and decreased hepatic insulin sensitivity . Fructose-induced alterations in VLDL-triacylglycerols appeared to be of greater magnitude in the OffT2D group , which suggests that these individuals may be more prone to developing dyslipidemia when challenged by high fructose intakes . This trial was registered at clinical trials.gov as NCT00523562"
] | 4116674e-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE to present recommendations based on the ACERTO Project ( Acceleration of Total Post-Operative Recovery ) and supported by evidence related to perioperative nutritional care in General Surgery elective procedures . METHODS review of relevant literature from 2006 to 2016 , based on a search conducted in the main data bases , with the purpose of answering guiding questions previously formulated by specialists , within each theme of this guideline . We preferably used r and omized controlled trials , systematic review s and meta-analyzes but also selected some cohort studies . We context ualized each recommendation -guiding question to determine the quality of the evidence and the strength of this recommendation ( GRADE ) . This material was sent to authors using an open online question naire . After receiving the answers , we formalized the consensus for each recommendation of this guideline . RESULTS the level of evidence and the degree of recommendation for each item is presented in text form , followed by a summary of the evidence found . CONCLUSION this guideline reflects the recommendations of the group of specialists of the Brazilian College of Surgeons , the Brazilian Society of Parenteral and Enteral Nutrition and the ACERTO Project for nutritional interventions in the perioperative period of Elective General Surgery . The prescription of these recommendations can accelerate the postoperative recovery of patients su bmi tted to elective general surgery , with decrease in morbidity , length of stay and rehospitalization , and consequently , of costs | [
"CONTEXT Postoperative enteral nutrition is thought to reduce complications and speed recovery after pancreatic resection . There is little evidence on the best route for delivery of enteral nutrition . Currently we use percutaneous transperitoneal jejunostomy or percutaneous transperitoneal gastrojejunostomy , or the nasojejunal route to deliver enteral nutrition , according to surgeon preference . OBJECTIVE To compare morbidity , efficiency , and safety of these three routes for enteral nutrition following pancreaticoduodenectomy . PATIENTS Data were obtained from a prospect ively maintained data base , for all patients undergoing pancreatic resection between January 2007 and June 2008 . One-hundred pancreatic resected patients underwent enteral nutrition : 93 had Whipple 's operations and 7 had total pancreatectomies . INTERVENTION Enteral nutrition was delivered by agreed protocol , starting within 24 h of operation and increasing over 2 - 3 days to meet full nutritional requirement . RESULTS Delivery route of enteral nutrition was : percutaneous transperitoneal jejunostomy in 25 ( 25 % ) , percutaneous transperitoneal gastrojejunostomy in 32 ( 32 % ) and nasojejunal in 43 ( 43 % ) . The incidence of catheter-related complications was higher in percutaneous techniques : 24 % in percutaneous transperitoneal jejunostomy and 34 % in percutaneous transperitoneal gastrojejunostomy as compared to nasojejunal technique ( 12 % ) . Median time to complete establishment of oral intake was 14 , 14 and 10 days in percutaneous transperitoneal jejunostomy , percutaneous transperitoneal gastrojejunostomy , and nasojejunal groups , respectively . Nasojejunal tubes were removed at median 11 days ( mean 11.5 days ) compared to 5 - 6 weeks for percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy . Commonest catheter-related complication in the percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy was blockage ( n=6 ; 10.5 % ) , followed by pain after removal of feeding tube at 5 - 6 weeks ( n=5 ; 8.8 % ) , whereas in the nasojejunal group it was blockage ( n=3 ; 7.0 % ) , followed by displacement ( n=2 ; 4.7 % ) . Two patients died postoperatively in this cohort , however , there were no catheter-related mortalities . CONCLUSION Enteral nutrition following pancreatic resection can be delivered in different ways . Nasojejunal feeding was associated with fewest and less serious complications . On current evidence surgeon preference is a reasonable way to decide enteral nutrition but a r and omized controlled trial is needed to address this issue",
"Background Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients . The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre r and omised controlled trial to evaluate routine home enteral nutrition in these patients . Methods Patients undergoing oesophagectomy or total gastrectomy were r and omised to either six weeks of home feeding through a jejunostomy ( intervention ) , or treatment as usual ( control ) . Intervention comprised overnight feeding , providing 50 % of energy and protein requirements , in addition to usual oral intake . Primary outcome measures were recruitment and retention rates at six weeks and six months . Nutritional intake , nutritional parameters , quality of life and healthcare costs were also collected . Interviews were conducted with a sample of participants , to ascertain patient and carer experiences . Results Fifty-four of 112 ( 48 % ) eligible patients participated in the study over the 20 months . Study retention at six weeks was 41/54 patients ( 76 % ) and at six months was 36/54 ( 67 % ) . At six weeks , participants in the control group had lost on average 3.9 kg more than participants in the intervention group ( 95 % confidence interval [ CI ] 1.6 to 6.2 ) . These differences remained evident at three months ( mean difference 2.5 kg , 95 % CI −0.5 to 5.6 ) and at six months ( mean difference 2.5 kg , 95 % CI −1.2 to 6.1 ) . The mean values observed in the intervention group for mid arm circumference , mid arm muscle circumference , triceps skin fold thickness and right h and grip strength were greater than for the control group at all post hospital discharge time points . The economic evaluation suggested that it was feasible to collect re source use and EQ-5D data for a full cost-effectiveness analysis . Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial : 1 ) a positive experience , 2 ) the reasons for taking part , and 3 ) uncertainty of the study process . Conclusions This study demonstrated that home enteral feeding by jejunostomy was feasible , safe and acceptable to patients and their carers . Whether home enteral feeding as ’ usual practice ’ is a cost-effective therapy would require confirmation in an appropriately powered , multi-centre study .Trial registration UK Clinical Research Network ID 12447 ( main trial , first registered 30 May 2012 ) ; UK Clinical Research Network ID 13361 ( qualitative sub study , first registered 30 May 2012 ) ; Clinical Trials.gov NCT01870817 ( first registered 28 May 2013",
"ABSTRACT Objective : To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting . Methods : R and omized prospect i ve clinical trial , with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting . The variables measured were the peak expiratory flow , forced expiratory volume in the first second , forced vital capacity , dominant h and grip strength , and non-dominant h and grip strength . Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation . Results : The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics , as well as for all variables . However , postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow ( 128.7±62.5 versus 115.7±59.9 ; p=0.040 ) , forced expiratory volume in the first second ( 1.5±0.6 versus 1.2±0.5 ; p=0.040 ) , forced vital capacity ( 2.3±1.1 versus 1.8±0.9 ; p=0.021 ) , and for muscle function tests dominant h and grip strength ( 24.9±6.8 versus 18.4±7.7 ; p=0.001 ) and non-dominant h and grip strength ( 22.9±6.3 versus 17.0±7.8 ; p=0.0002 ) . In the intragroup evaluation , there was a decrease in preoperative compared with postoperative values , except for dominant h and grip strength ( 25.2±6.7 versus 24.9±6.8 ; p=0.692 ) , in the shortened fasting group . Conclusion : Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant h and grip strength ",
"BACKGROUND Patients undergoing upper gastrointestinal surgery often eat poorly post-operatively , despite dietetic input . A pilot study was conducted to examine the benefit of a 6 week nutritional supplementation via a feeding jejunostomy on fatigue , quality of life and independent living . METHODS A feeding jejunostomy was placed routinely at oesophagectomy or total gastrectomy for cancer . At discharge , patients were r and omised to nutritional supplementation ( 600 kcal/day ) via their feeding jejunostomies or no jejunal supplement . Patients were assessed at discharge and 3 , 6 , 12 and 24 weeks following discharge for fatigue ( MFI-20 ) , quality of life ( QLQ-OES18 ) , health economic analysis ( EQ5D ) as well as completing a two-day dietary diary . RESULTS 44 patients ( M : F , 29:15 ) were r and omised , 23 received jejunal supplements . There were no differences between the groups . Percentage of calculated energy requirement received was greater in the supplemented group at weeks 3 and 6 ( p Oral energy intake was not different between the groups at any time period . After hospital discharge , there were no differences in MFI-20 , EQ5D and QLQ-OES18 scores at any time point . From hospital discharge fatigue improved and plateaued at 6 weeks ( p quality of life until 24 weeks in the active group alone ( p jejunal feeding is effective in providing patients with an adequate energy intake . Increased energy intake however , produced no obvious improvement in measures of fatigue , quality of life or health economics",
"This document represents the first collaboration between 2 organizations — the American Society for Parenteral and Enteral Nutrition and the Society of Critical Care Medicine — to describe best practice s in nutrition therapy in critically ill children . The target of these guidelines is intended to be the pediatric critically ill patient ( > 1 month and 2–3 days in a PICU admitting medical , surgical , and cardiac patients . In total , 2032 citations were scanned for relevance . The PubMed / MEDLINE search result ed in 960 citations for clinical trials and 925 citations for cohort studies . The EMBASE search for clinical trials culled 1661 citations . In total , the search for clinical trials yielded 1107 citations , whereas the cohort search yielded 925 . After careful review , 16 r and omized controlled trials and 37 cohort studies appeared to answer 1 of the 8 preidentified question groups for this guideline . We used the GRADE criteria ( Grading of Recommendations , Assessment ,",
"Objective : To determine whether glutamine (GLN)-supplemented parenteral nutrition ( PN ) improves clinical outcomes in surgical intensive care unit ( SICU ) patients . Summary Background Data : GLN requirements may increase with critical illness . GLN-supplemented PN may improve clinical outcomes in SICU patients . Methods : A parallel-group , multicenter , double-blind , r and omized , controlled clinical trial in 150 adults after gastrointestinal , vascular , or cardiac surgery requiring PN and SICU care . Patients were without significant renal or hepatic failure or shock at entry . All received isonitrogenous , isocaloric PN [ 1.5 g/kg/d amino acids ( AAs ) and energy at 1.3 × estimated basal energy expenditure ] . Controls ( n = 75 ) received st and ard GLN-free PN ( STD-PN ) ; the GLN group ( n = 75 ) received PN containing alanyl-GLN dipeptide ( 0.5 g/kg/d ) , proportionally replacing AA in PN ( GLN-PN ) . Enteral nutrition ( EN ) was advanced and PN weaned as indicated . Hospital mortality and infections were primary endpoints . Results : Baseline characteristics , days on study PN and daily macronutrient intakes via PN and EN , were similar between groups . There were 11 hospital deaths ( 14.7 % ) in the GLN-PN group and 13 deaths in the STD-PN group ( 17.3 % ; difference , −2.6 % ; 95 % confidence interval , −14.6 % to 9.3 % ; P = 0.66 ) . The 6-month cumulative mortality was 31.4 % in the GLN-PN group and 29.7 % in the STD-PN group ( P = 0.88 ) . Incident bloodstream infection rate was 9.6 and 8.4 per 1000 hospital days in the GLN-PN and STD-PN groups , respectively ( P = 0.73 ) . Other clinical outcomes and adverse events were similar . Conclusions : PN supplemented with GLN dipeptide was safe , but did not alter clinical outcomes among SICU patients",
"The benefits of early enteral feeding ( EEN ) have been demonstrated in gastrointestinal surgery . But , the impact of EEN has not been eluci date d yet . We assessed the postoperative nutritional status of patients who had undergone pancreaticoduodenectomy ( PD ) according to the postoperative nutritional method and compared the clinical outcomes of two methods . A prospect i ve r and omized trial was undertaken following PD . Patients were r and omly divided into two groups ; the EEN group received the postoperative enteral feed and the control group received the postoperative total parenteral nutrition ( TPN ) management . Thirty-eight patients were included in our analyses . The first day of bowel movement and time to take a normal soft diet was significantly shorter in EEN group than in TPN group . Prealbumin and transferrin were significantly reduced on post-operative day ( POD ) 7 and were slowly recovered until POD 90 in the TPN group than in the EEN group . EEN group rapidly recovered weight after POD 21 whereas it was gradually decreased in TPN group until POD 90 . EEN after PD is associated with preservation of weight compared with TPN and impact on recovery of digestive function after PD",
"BACKGROUND Enteral nutrition ( EN ) is now used more frequently than total parenteral nutrition ( TPN ) for nutritional support after resection for esophageal cancer . But consensus regarding which type of nutrition should be used does not exist . We studied the effect of TPN and EN on patients ' nutritional status and immune function in the immediate postoperative period after esophageal cancer resection . METHODS We enrolled 30 patients ( 27 men and 3 women ) who underwent subtotal esophagectomy . The patients were r and omly assigned to TPN or EN group . Either TPN or EN was begun on postoperative day 1 . On postoperative days 1 , 3 , and 7 , three endpoints were measured : albumin , C-reactive protein , and Th1/Th2 balance . RESULTS All patients completed the study . Anastomotic leaks occurred in 6 patients in the TPN group and 7 patients in the EN group . Albumin , Th1/Th2 balance , and C-reactive protein did not differ between the groups . Th1/Th2 balance was not different regardless of the preoperative treatment or complications . CONCLUSIONS No differences in immune function , nutritional state , or inflammatory response were seen between patients supported with TPN and those supported with EN . The results of our study suggest that perioperative nutritional support can be safely performed either with TPN or EN",
"Background This review aims to present a consensus for optimal perioperative care in rectal/pelvic surgery , and to provide grade d recommendations for items for an evidence d-based enhanced recovery protocol . Methods Studies were selected with particular attention paid to meta-analyses , r and omized 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 ( evidence grade : high or moderate ) . Conclusions Based on the evidence available for each item of the multimodal perioperative care pathway , the Enhanced Recovery After Surgery ( ERAS ) Society , European Society for Clinical Nutrition and Metabolism ( ESPEN ) and International Association for Surgical Metabolism and Nutrition ( IASMEN ) present a comprehensive evidence -based consensus review of perioperative care for rectal surgery",
"Background Nutrients such as ω-3 fatty acids including fish oil components eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) suppress the growth and promote apoptosis of tumor cells , improve immune function and reduce the effects of systemic inflammatory response syndrome . We sought to investigate the effect of ω-3 fish oil fat emulsion-based parenteral nutrition ( PN ) on nutritional state , immune function , inflammatory reaction , expression of tumor factors and complication incidence in patients after surgical resection of gastric cancer . Methods Forty-eight patients after surgical operation of gastric tumor in hospital were r and omly divided into the control group and intervention group . Patients in both groups were treated with iso-nitrogen and iso-caloric parenteral nutrition support . In addition , the intervention group received ω-3 fish oil fat emulsion and the control group received soybean oil . The indicators of nutrition , immune function and inflammation in the two groups were detected on the day before the operation and postoperative day 6 . The rate of complication was compared between the two groups . Results There was no significant difference in nutritional state , liver function and renal function between the two groups ( P > 0.05 ) . However , the levels of inflammatory markers were significantly decreased ( P the rate of complication was also decreased in the intervention group as compared with the control group . Conclusions ω-3 fish oil fat emulsion-based parenteral nutrition alleviates the inflammatory reaction and reduces the rate of inflammatory complications ",
"Background Postoperative nausea and vomiting is the most common cause for unexpected hospital admission of patients undergoing day care surgery . Overnight fasting changes patient metabolic state and influences their perioperative stress response . Preoperative carbohydrate loading may have accelerated recovery and better overall outcome after major abdominal surgery . The aim of the study was to investigate the effects of preoperative carbohydrate-rich drinks on postoperative nausea and vomiting and pain after day care laparoscopic cholecystectomy . Methods A total of 120 patients posted for day care laparoscopic cholecystectomy were included in the study and were r and omized into three groups . Group A (Cases)—receiving the carbohydrate-rich drink before surgery ( CHO ) , group B (placebo)—receiving the placebo drink before surgery and group C (controls)—fasting from midnight before surgery . Postoperative nausea and vomiting and visual analogue score for pain were noted and analyzed for 24 h. Results Mean score of nausea in 0–4 h in group A was significantly lower as compared to group B and group C ( p = 0.001 ) . Difference in mean score of nausea in 4–12 and 12–24 h between groups was not significant ( p = 0.066 ) , ( p = 0.257 ) . Mean score of vomiting in 0–4 and 4–12 h in group A was significantly less than that of group B and group C ( p = 0.004 ) , ( p = 0.001 ) . Mean score of pain in group A was significantly less when compared to group B and group C in 0–4 h ( p = 0.001 ) and 4–12 h ( 0.005 ) . Conclusion Perioperative consumption of a carbohydrate-rich drink can minimize postoperative nausea , vomiting and pain in patients undergoing outpatient cholecystectomy . Consumption of carbohydrate drinks up to 2 h prior to surgery is not associated with additional complications",
"Background Patients undergoing colorectal cancer resections are at risk for delayed recovery . Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery . The authors previously demonstrated the limited impact of a prehabilitation program using exercise alone . They propose an exp and ed trimodal prehabilitation program that adds nutritional counseling , protein supplementation , and anxiety reduction to a moderate exercise program . This study aim ed to estimate the impact of this trimodal program on the recovery of functional capacity compared with st and ard surgical care . Methods Consecutive patients were enrolled in this pre- and postintervention study over a 23-month period . The postoperative recovery for 42 consecutive patients enrolled in the prehabilitation program was compared with that of 45 patients assessed before the intervention began . The primary outcome was functional walking capacity ( 6-min walk test [ 6MWT ] ) . The secondary outcomes included self-reported physical activity ( CHAMPS question naire ) and health-related quality of life ( SF-36 ) . Data are expressed as mean ± st and ard deviation or median ( interquartile range [ IQR ] ) and were analyzed using Chi-square and Student ’s t test . All p values lower than 0.05 were considered significant . Results The prehabilitation and control groups were comparable in terms of age , gender , body mass index ( BMI ) and American Society of Anesthesiology ( ASA ) class . There was no difference in walking capacity at the first assessment ( 6MWT distance , 422 ± 87 vs 402 ± 57 m ; p = 0.21 ) . During the prehabilitation period lasting a median of 33 days ( range , 21–46 days ) , functional walking capacity improved by 40 ± 40 m ( p were similar . The patients in the prehabilitation program had better postoperative walking capacity at both 4 weeks ( mean difference , 51.5 ± 93 m ; p = 0.01 ) and 8 weeks ( mean difference , 84.5 ± 83 m ; p levels of physical activity before and after surgery . Conclusion In this pilot study , a 1-month trimodal prehabilitation program improved postoperative functional recovery . A r and omized trial is ongoing ( NCT01356264 )",
"Abstract Background Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality . In general , the patients are already malnourished , and early postoperative enteral nutrition is recommended . However , there is no consensus concerning the best enteral access route in these cases . Methods A prospect i ve r and omized trial was performed from 2008 to 2012 with 59 patients who underwent esophagectomy , total gastrectomy , or pancreaticoduodenectomy . In all , 4 patients declined to participate , and 13 did not meet the inclusion criteria and were excluded . Of the 42 included patients , 21 had nasoenteric tubes , and 21 had a jejunostomy . Results The two groups were similar in demographic and clinical aspects . The nasoenteric ( NE ) and jejunostomy groups underwent early enteral therapy in 71 and 62 % of cases ( p > 0.05 ) , respectively . The median length of enteral therapy use was less in the NE group ( 5.0 vs. 8.5 days ) , but the difference was not statistically significant . The NE group required introduction of parenteral therapy more frequently than the jejunostomy group ( p Complications related to the enteral route occurred in 38.0 and 28.5 % of patients ( p > 0.05 ) in the NE and jejunostomy groups , respectively . In the NE group , there were four losses and four tube obstructions . In the jejunostomy group , there were two losses , four obstructions , and two cases of leakage around the tube . In the latter group , patients who underwent therapy for a longer time had tubal complications ( p intensive care unit and hospital stays ( p number of complications . However , the presence of a jejunostomy allowed enteral therapy for longer periods , especially in patients with complications , thus avoiding the need for parenteral nutrition",
"Abstract Background Preoperative education is a key point in multimodal protocol s of perioperative care . We investigated whether preoperative education for patients undergoing open cholecystectomy would reduce the incidence of perioperative symptoms . Methods This was a r and omized , single-blinded , clinical trial that included adult ( 18–65 years old ) c and i date s for elective open cholecystectomy . All patients took part in the ERAS/ACERTO protocol of perioperative care except that only the intervention group received preoperative education . The main endpoints of the study were the presence and intensity of postoperative symptoms ( e.g. , nausea , vomiting , pain ) measured by a visual analogue scale , 24 h after the operation . Results A total of 74 patients ( 34 in the intervention group , 40 in the control group ) completed the study . The intervention group had significantly lower median ( interquartile range ) scores for nausea [ 0 ( 4 ) vs. 2.5 ( 5.8 ) , p = 0.04 ] and pain [ 0.2 ( 2.3 ) vs. 3.1 ( 3.45 ) , p . High well-being ( score ≥6 ) was reported by 79.4 % ( 27 patients ) of the intervention group in contrast to 57.5 % ( 23 patients ) of the controls ( p = 0.04 ) . Conclusions Preoperative education is highly effective in the context of a multimodal protocol for enhancing the recovery of patients su bmi tted to open cholecystectomy",
"Purpose Preoperative nutrition is beneficial for malnourished cancer patients . Yet , there is little evidence whether or not it should be given to nonmalnourished patients . The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery . Methods This was a prospect i ve , two-arm , r and omized , controlled , open-label study . Patients in interventional group received nutritional supplementation for 14 days before surgery , while control group kept on to their everyday diet . Each patient ’s nutritional status was assessed twice — at qualification ( weight loss in 6 months , laboratory parameters : albumin , total protein , transferrin , and total lymphocyte count ) and 1 day before surgery ( change in body weight and laboratory parameters ) . After surgery , all patients were followed up for 30 days for postoperative complications . Results Fifty-four patients in interventional and 48 in control group were analyzed . In postoperative period , patients in control group suffered from significantly higher ( p number of serious complications compared with patients receiving nutritional supplementation . Moreover , levels of all laboratory parameters declined significantly ( p ( albumin and total protein ) or raised ( transferrin and total lymphocyte count ) . Conclusions Preoperative nutritional support should be introduced for nonmalnourished patients as it helps to maintain proper nutritional status and reduce number and severity of postoperative complications compared with patients without such support",
"Background Prolonged preoperative fasting increases insulin resistance and current evidence recommends carbohydrate ( CHO ) drinks 2 hours before surgery . Our hypothesis is that the addition of whey protein to a CHO-based drink not only reduces the inflammatory response but also diminish insulin resistance . Methods Seventeen patients scheduled to cholecystectomy or inguinal herniorraphy were r and omized and given 474 ml and 237 ml of water ( CO group ) or a drink containing CHO and milk whey protein ( CHO-P group ) respectively , 6 and 3 hours before operation . Blood sample s were collected before surgery and 24 hours afterwards for biochemical assays . The endpoints of the study were the insulin resistance ( IR ) , the prognostic inflammatory and nutritional index ( PINI ) and the C-reactive protein (CRP)/albumin ratio . A 5 % level for significance was established . Results There were no anesthetic or postoperative complications . The post-operative IR was lower in the CHO-P group when compared with the CO group ( 2.75 ± 0.72 vs 5.74 ± 1.16 ; p = 0.03 ) . There was no difference between the two groups in relation to the PINI . The CHO-P group showed a decrease in the both CRP elevation and CRP/albumin ratio ( p showed CRP/albumin ratio considered normal was significantly greater ( p the CHO-P group ( 87.5 % ) than in the CO group ( 33.3 % ) . Conclusions Shortening the pre-operative fasting using CHO and whey protein is safe and reduces insulin resistance and postoperative acute phase response in elective moderate operations . Trial registration Clinical Trail.gov",
"Introduction It is generally believed that resumption of feeding after colorectal resection is indicated only after recovery of bowel function . This study was design ed to verify safety , feasibility , and tolerance of early oral postoperative feeding ( EOF ) outside an enhanced recovery after surgery ( ERAS ) program . Material s and methods One hundred patient c and i date s to elective colorectal resection were prospect ively enrolled in an EOF program . Feeding was started on postoperative day ( POD ) 1 with oral nutritional supplement ( ONS ) . On POD 2 , patients had normal food plus ONS to reach 1,000–1,200 kcal/day with progressive increase until 1,800–2,000 kcal/day . Results were compared with historical controls ( n = 100 ) in whom oral feeding was allowed only after full bowel function recovery . The ERAS program was not applied in both groups . Results The EOF group had a better recovery of short half-life protein synthesis compared with the control group ( P ) . Stool canalization occurred after a median of 3 days ( range , 1–6 days ) in the EOF group versus 5 days ( range , 2–8 days ) in the control group ( P = 0.001 ) . The feeding protocol was completed in 89 patients within POD 5 . Tolerance to resumption of feeding was similar in the two groups . The overall rate of postoperative complication was 22 % in the EOF group vs. 27 % in the control group ( P = 0.51 ) . The median length of hospitalization was 9 days ( range , 6–25 days ) in the EOF group vs. 12 days ( range , 6–31 days ) in controls ( P = 0.01 ) . Conclusions EOF after colorectal operations is feasible and safe outside an ERAS program",
"BACKGROUND / AIMS Fasting period before surgery may change metabolic status of the patient and have influence on perioperative stress response . The aim of the study was to investigate effects of preoperative carbohydrate-rich beverage on stress response after laparoscopic cholecystectomy . METHODOLOGY Patients admitted for laparoscopic cholecystectomy were included into study and they were r and omized into a group that was fed prior to surgery and in a group that was in the regime of nothing by mouth from the evening one day before surgery . Concentrations of C-reactive protein and cortisol , were measured before and subsequently up to 48 h postoperatively . RESULTS Postoperative serum C-reactive protein increased significantly in both groups , but the increase was more evident in the group with fasting protocol both 24 and 48 hours postoperatively . In fed patients cortisol concentration measured in the afternoon immediately after the operation showed physiological decline . In patients with fasting protocol postoperative cortisol values rise above the values measured in the morning . CONCLUSIONS Preoperative feeding has advantage over overnight fasting by reducing preoperative discomfort in patients after laparoscopic cholecystectomy . In fed patients , smaller increase in C-reactive protein and better regulation of cortisol levels are an indicator of decreased perioperative stress response",
"OBJECTIVE To investigate the efficacy and safety of alvimopan , 12 mg , administered orally 30 to 90 minutes preoperatively and twice daily postoperatively in conjunction with a st and ardized accelerated postoperative care pathway for managing postoperative ileus after bowel resection . DESIGN , SETTING , AND PATIENTS This multicenter , r and omized , placebo-controlled , double-blind , phase 3 trial enrolled adult patients undergoing partial bowel resection with primary anastomosis by laparotomy and scheduled to receive intravenous , opioid-based , patient-controlled analgesia . A st and ardized accelerated postoperative care pathway including early ambulation , oral feeding , and postoperative nasogastric tube removal was used to facilitate gastrointestinal ( GI ) tract recovery in all of the patients . MAIN OUTCOME MEASURES The primary end point was time to GI-2 recovery ( toleration of solid food and first bowel movement ) . Secondary end points included time to GI-3 recovery ( toleration of solid food and first flatus or bowel movement ) , hospital discharge order written , and actual hospital discharge . Postoperative length of hospital stay based on calendar day of hospital discharge order written , opioid consumption , and overall postoperative ileus-related morbidity were recorded . RESULTS Alvimopan , 12 mg , was well tolerated and significantly accelerated GI-2 recovery , GI-3 recovery , and actual hospital discharge compared with a st and ardized accelerated postoperative care pathway alone ( hazard ratio = 1.5 , 1.5 , and 1.4 , respectively ; P Time to hospital discharge order written as measured by hazard ratio ( 1.4 ) and by postoperative calendar days ( mean for alvimopan , 5.2 days ; mean for placebo , 6.2 days ) was also accelerated . Opioid consumption was comparable between groups , and alvimopan was associated with reduced postoperative ileus-related morbidity compared with placebo . CONCLUSIONS Alvimopan , 12 mg , administered 30 to 90 minutes before and twice daily after bowel resection is well tolerated , accelerates GI tract recovery , and reduces postoperative ileus-related morbidity without compromising opioid analgesia",
"OBJECTIVE : This prospect i ve r and omized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations . METHODS : A total of 199 patients underwent colorectal surgery and were r and omly assigned to early feeding ( n = 99 ) or a regular diet ( n = 100 ) . Patients ' characteristics , diagnoses , surgical procedures , comorbidity , bowel movements , defecation , nasogastric tube reinsertion , time of tolerance of solid diet , complications , and length of hospitalization were assessed . RESULTS : The two groups were similar in terms of gender , age , diagnosis , surgical procedures , and comorbidity . In the early feeding group , 85.9 % of patients tolerated the early feeding schedule . Bowel movements ( 1.7±0.89 vs. 3.27±1.3 ) , defecation ( 3.4±0.77 vs. 4.38±1.18 ) and time of tolerance of solid diet ( 2.48±0.85 vs. 4.77±1.81 ) were significantly earlier in the early feeding group . There was no change between the groups in terms of nasogastric tube reinsertion , overall complication or anastomotic leakage . Hospitalization ( 5.55±2.35 vs. 9.0±6.5 ) was shorter in the early feeding group . CONCLUSIONS : The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively . Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions",
"Purpose In many countries , patients are generally allowed to have clear fluids until 2–3 h before surgery . In Japan , long preoperative fasting is still common practice . To shorten the preoperative fasting period in Japan , we tested the safety and efficacy of oral rehydration therapy until 2 h before surgery . Methods Three hundred low-risk patients scheduled for morning surgery in six university-affiliated hospitals were r and omly assigned to an oral rehydration solution ( ORS ) group or to a fasting group . Patients in the ORS group consumed up to 1,000 ml of ORS containing balanced glucose and electrolytes : 500 ml between 2100 the night before surgery and the time they woke up the next morning and 500 ml during the morning of surgery until 2 h before surgery . Patients in the fasting group started fasting at 2100 the night before surgery . Primary endpoints were gastric fluid volume and pH immediately after anesthesia induction . Several physiological measures of hydration and electrolytes including the fractional excretion of sodium ( FENa ) and the fractional excretion of urea nitrogen ( FEUN ) were also evaluated . Results Mean ( SD ) gastric fluid volume immediately after anesthesia induction was 15.1 ( 14.0 ) ml in the ORS group and 17.5 ( 23.2 ) ml in the fasting group ( P = 0.30 ) . The mean difference between the ORS group and fasting group was −2.5 ml . The 95 % confidence interval ranged from −7.1 to + 2.2 ml and did not include the noninferior limit of + 8 ml . Mean ( SD ) gastric fluid pH was 2.1 ( 1.9 ) in the ORS group and 2.2 ( 2.0 ) in the fasting group ( P = 0.59 ) . In the ORS group , mean FENa and FEUN immediately after anesthesia induction were both significantly greater than those in the fasting group ( P less thirsty and hungry before surgery ( P Conclusions Oral rehydration therapy until 2 h before surgery is safe and feasible in the low-risk Japanese surgical population . Physicians are encouraged to use this practice to maintain the amount of water in the body and electrolytes and to improve the patient ’s comfort",
"INTRODUCTION No study so far has tested a beverage containing glutamine 2 h before anesthesia in patients undergoing surgery . OBJECTIVES The aim of the study was to investigate : 1 ) the safety of the abbreviation of preoperative fasting to 2 h with a carbohydrate-L-glutamine-rich drink ; and 2 ) the residual gastric volume ( RGV ) measured after the induction of anesthesia for laparoscopic cholecystectomies . METHODS R and omized controlled trial with 56 women ( 42 ( 17 - 65 ) years-old ) su bmi tted to elective laparoscopic cholecystectomy . Patients were r and omized to receive either conventional preoperative fasting of 8 hours ( fasted group , n = 12 ) or one of three different beverages drunk in the evening before surgery ( 400 mL ) and 2 hours before the initiation of anesthesia ( 200 mL ) . The beverages were water ( placebo group , n = 12 ) , 12.5 % ( 240 mOsm/L ) maltodextrine ( carbohydrate group , n = 12 ) or the latter in addition to 50 g ( 40 g in the evening drink and 10 g in the morning drink ) of L-glutamine ( glutamine group , n = 14 ) . A 20 F nasogastric tube was inserted immediately after the induction of general anesthesia to aspirate and measure the RGV . RESULTS Fifty patients completed the study . None of the patients had either regurgitation during the induction of anesthesia or postoperative complications . The median ( range ) of RGV was 6 ( 0 - 80 ) mL. The RGV was similar ( p = 0.29 ) between glutamine group ( 4.5 [ 0 - 15 ] mL ) , carbohydrate group ( 7.0 [ 0 - 80 ] mL ) , placebo group ( 8.5 [ 0 - 50 ] mL ) , and fasted group ( 5.0 [ 0 - 50 ] mL ) . CONCLUSION The abbreviation of preoperative fasting to 2 h with carbohydrate and L-glutamine is safe and does not increase the RGV during induction of anesthesia",
"BACKGROUND The aim of this study was to evaluate whether a single preoperative limited oral intake of a carbohydrate drink could improve perioperative patient comfort and satisfaction with anesthesia care in elective day-stay ophthalmologic surgery . METHODS A single-center , prospect i ve , r and omized clinical trial was conducted in a university hospital . The study included ASA I-III patients undergoing ophthalmologic surgery . Patients undergoing both general anesthesia and local anesthesia were included in the study . The control group fasted in accordance to nil per os after midnight , while patients in the experimental group received 200 mL of a carbohydrate drink 2 h before the operation . Both groups were allowed to drink and eat until midnight ad libitum . Patient characteristics , subjective perceptions , taste of the drink , and satisfaction with anesthesia care were ascertained using a question naire administered three times : after the anesthesiologist 's visit , before surgery and before discharge from the ward to assess patient comfort . An analysis of variance and the Mann-Whitney U-test were used for statistical analysis . RESULTS A total of 123 patients were included and 109 patients were r and omly assigned to one of two preoperative fasting regimens . Patients drinking 200 mL 2 h before surgery were not as hungry ( P thirsty preoperatively ( P thirsty after surgery ( P postoperative satisfaction with anesthesia care ( P patient comfort and satisfaction with anesthesia care and should be a part of modern day-stay ophthalmologic surgery",
"ABSTRACT The aim of this study was to investigate the effects of oral carbohydrate solution ( CHO ) on perioperative discomfort , biochemistry , hemodynamics , and patient satisfaction in elective surgery patients under general anesthesia . Sixty cases in ASA I-II group who were planned to have operation under general anesthesia were included in the study . The cases were r and omly divided into two groups having 30 subjects in each . The patients in the study group were given CHO in the evening prior to the surgery and 2–3 hr before the anesthesia while routine fasting was applied in the control group . In the study group ; 2–3 hr before the surgery ; malaise , thirst , hunger , and weakness ; just before the surgery malaise , thirst , hunger , and fatigue ; 2 hr after the operation thirst , hunger , weakness , and concentration difficulty ; 24 hr after the operation malaise and weakness were found significantly lower . Fasting blood glucose ( FBG ) level was found to be higher in the control group at the 90th min of the operation . Gastric volumes were higher in the control group ; gastric pH values were found significantly higher in the study group . The level of anxiety and depression risk rate were found lower in the study group . In conclusion , preoperative CHO reduces perioperative discomfort and improves perioperative well being when compared to overnight fasting",
"Background Studies showing the improvement of insulin sensitivity by reducing the term of preoperative fasting are mostly done in patients undergoing major operations . More information about the role of shortened preoperative fasting in perioperative metabolism is needed for such elective minor/moderate abdominal procedures as laparoscopic cholecystectomy . We investigated the influence of a carbohydrate-rich drink given 2 h before laparoscopic cholecystectomy on insulin resistance and the metabolic response to trauma . Methods A group of 21 female c and i date s ( 18–65 years old ) for elective laparoscopic cholecystectomy were r and omized to either an 8 h fasting group ( control group : n = 10 ) or to a group receiving 200 ml of a carbohydrate beverage containing 12.5 % ( 25 g , 50 kcal per 100 ml and approximately 285 mOsm ) of maltodextrine 2 h before operation ( CHO group : n = 11 ) . Blood sample s for various biochemical assays were collected both at induction of anesthesia and after the 10th postoperative hour . Insulin resistance was assessed by the HOMA-IR equation ( Insulin ( μU/ml ) × blood glucose (mg/dl)/405 ) . Results There were no postoperative complications . Seventy percent ( 7/10 ) of the controls and 27.3 % ( 3/11 ) of the CHO group experienced at least one episode of vomiting ( RR = 2.42 , 95 % Confidence Interval [ CI ] = 0.88–6.68 ; P = 0.08 ) . Biochemical analysis showed that serum glucose ( P , insulin ( P , lactate/pyruvate ratio ( P = 0.03 ) , and triglycerides ( P The value of HOMA-IR was significantly greater ( P = 0.03 ) in the conventionally fasted patients than in the CHO group . Conclusions Abbreviation of the period of preoperative fasting and administration of a carbohydrate beverage diminishes insulin resistance and the organic response to trauma",
"BACKGROUND Direct experimental evidence suggests that total enteral nutrition ( TEN ) reduces septic morbidity compared with bowel rest and total parenteral nutrition ( TPN ) and that mucosal support and maintenance of gut barrier function is a key mechanism . This effect is supported indirectly by clinical studies , but this question has not previously been investigated directly in the postoperative patient . This study examined the hypothesis that early enteral feeding after major upper gastrointestinal surgery may modulate gut barrier function and decrease the risk of major infective complications compared with bowel rest and parenteral nutrition . METHODS A r and omized clinical trial of 67 patients ( TPN = 34 ; TEN = 33 ) fed postoperatively for 7 days was performed . Thirty-day major morbidity and mortality were monitored . Intestinal permeability was measured using the lactulose/mannitol test preoperatively and on postoperative days 1 and 7 . Systemic anti-endotoxin core immunoglobulin G and M antibodies and serum albumin and C-reactive protein were quantified at these time points . RESULTS No clinical benefit was observed in patients fed enterally compared with the parenterally fed group . Intestinal permeability was increased on the 1st postoperative day in association with evidence of endotoxin exposure . By day 7 , enteral feeding compared with parenteral feeding had failed to significantly influence any of the gut barrier or systemic parameters . CONCLUSIONS This r and omized controlled trial of TEN vs TPN after major upper gastrointestinal surgery failed to show a clinical benefit for the enteral route . Moreover , enteral nutrition did not modulate gut barrier function postoperatively",
"Background Many patients experience postoperative nausea and vomiting ( PONV ) . Preoperative treatment with carbohydrate solutions seems to improve the course after different types of surgery . This study was undertaken to investigate the potential value of different models for preoperative hydration/nutrition , in addition to our ERAS ( enhanced recovery after surgery ) protocol . Methods Ninety non-diabetic women planned for elective laparoscopic gastric bypass and aged 18–65 years were included . All were on preoperative low-calorie diet ( LCD ) . They were r and omized into three arms , either a carbohydrate-rich drink , a protein-enriched drink , or tap water and instructed to drink 800 and 200 mL 16 and 2 h , respectively , prior to operation . Risk factors for PONV were recorded preoperatively . All patients were operated before lunch and received 1500–2000 mL of Ringer-Acetate solution during the 24–30-h postoperative hospital time . Four variables ( nausea , pain , tiredness , and headache ) were registered on 100-mm visual analog scales six times over 22 h. The need for additional medication was registered . Results Out of 90 patients , 73 complete data sets were obtained . Nausea peaked at 7 p.m. but with no statistically significant differences between groups for any of the variables . Pain peaked the first 2 h postoperatively , remained longer , and had not returned to baseline values at 6 a.m. the morning after surgery but with no difference between groups . Conclusions Inside our ERAS protocol , additional preoperative carbohydrate- or protein-enriched fluid treatment did not further reduce immediate patient discomfort in laparoscopic gastric bypass surgery",
"BACKGROUND Prolonged preoperative fasting increases insulin resistance ( IR ) . The authors investigated whether an abbreviated preoperative fast with glutamine ( GLN ) plus a carbohydrate (CHO)-based beverage would improve the organic response after surgery . METHODS Forty-eight female patients ( 19 - 62 years ) were r and omized to either st and ard fasting ( control group ) or to fasting with 1 of 3 different beverages before video-cholecystectomy . Beverages were consumed 8 hours ( 400 mL ; placebo group : water ; GLN group : water with 50 g maltodextrine plus 40 g GLN ; and CHO group : water with 50 g maltodextrine ) and 2 hours ( 200 mL ; placebo : water ; GLN : water with 25 g maltodextrine plus 10 g GLN ; and CHO : water with 25 g maltodextrine ) before anesthesia . Blood sample s were collected pre- and postoperatively . RESULTS The mean ( SEM ) postoperative homeostasis model assessment -insulin resistance was greater ( P ( placebo , 1.6 [ 0.3 ] ; CHO , 2.3 [ 0.4 ] ; and GLN , 1.5 [ 0.1 ] ) . Glutathione was significantly higher ( P Interleukin-6 increased in all groups except the GLN group . The C-reactive protein/albumin ratio was higher ( P nitrogen balance was less negative in GLN ( -2.5 [ 0.8 ] gN ) than in both placebo ( -9.0 [ 2 ] gN ; P = .001 ) and control ( -6.6 [ 0.4 ] gN ; P = .04 ) groups . CONCLUSIONS Preoperative intake of a GLN-enriched CHO beverage appears to improve IR and antioxidant defenses and decreases the inflammatory response after video-cholecystectomy",
"Objectives Nutritional deficiencies and immune dysfunction in cancer patients may contribute to postoperative septic morbidity . This trial compared the effects of perioperative enteral immunonutrition ( EIN ) versus st and ard enteral nutrition ( SEN ) on systemic and mucosal immunity in patients undergoing pancreaticoduodenectomy for periampullary cancer . Methods Thirty-seven patients were r and omized ( EIN , n = 17 ; SEN , n = 20 ) to receive feed for 14 days preoperatively and 7 days postoperatively . Mediators of systemic immunity ( interleukin 1&agr ; , tumor necrosis factor & agr ; , lymphocytes subsets , and complement components ) and of mucosal immunity in duodenal biopsies , nutritional markers and parameters were evaluated . Results The groups were comparable for demographics , the concentrations of mediators of systemic and mucosal immunity at time of recruitment , and for the duration and amount of feed received . Preoperative EIN rather than SEN was associated with significant reductions in plasma tumor necrosis factor & agr ; and total hemolytic complement . Enteral immunonutrition – fed patients had significantly higher total lymphocyte count on the third postoperative day and significantly greater rise in CD4/CD8 ratio from day 3 to day 7 postoperatively compared with SEN-fed patients . Conclusions The perioperative administration of EIN rather than SEN is associated with a favorable modulation of the inflammatory response and enhancement of systemic immunity in patients undergoing pancreaticoduodenectomy for periampullary cancer",
"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 The efficacy and feeding-related complications of a nasojejunal feeding tube and jejunostomy after pancreaticoduodenectomy ( PD ) was investigated with a r and omized , controlled clinical trial at the Affiliated Drum Tower Hospital . METHODS Sixty-eight patients who underwent PD in the Department of Hepatobiliary Surgery were r and omly divided into 2 groups : 34 patients received enteral feeding via a nasojejunal tube ( NJT group ) and 34 patients received enteral feeding via a jejunostomy tube ( JT group ) . The assessment of clinical outcome was based on postoperative investigation of complications . The second part of the assessment included tube related complications and an index on catheter efficiency . RESULTS There were 15 cases with infectious complications in the JT group and 13 cases in the NJT group , and there was no significant difference in the rate of infectious complications between the 2 groups . The rate of intestinal obstruction and delayed gastric emptying was significantly decreased in the NJT group ( P Catheter-related complications were more common in the JT group as compared with the NJT group ( 35.3 % vs 20.6 % , P time for removal of the feeding tube and nasogastric tube was significantly decreased in the NJT group . The postoperative hospital stay in the NJT group was significantly decreased ( P hospital mortality in this study . CONCLUSION Nasojejunal feeding is safer than jejunostomy , and it is associated with only minor complications . Nasojejunal feeding can significantly decrease the incidence of delayed gastric emptying and shorten the postoperative hospital stay",
"OBJECTIVE This multicenter , prospect i ve cohort study evaluated the effect of preoperative nutritional support in abdominal surgical patients at nutritional risk as defined by the Nutritional Risk Screening Tool 2002 ( NRS-2002 ) . METHODS A consecutive series of patients admitted for selective abdominal surgery in the Peking Union Medical College Hospital and the Beijing University Third Hospital in Beijing , China were recruited from March 2007 to July 2008 . Data were collected on the nutritional risk screening ( NRS-2002 ) , the application of perioperative nutritional support , surgery , complications , and length of stay . A minimum of 7 d of parenteral nutrition or enteral nutrition before surgery was considered adequate preoperative nutritional support . RESULTS In total 1085 patients were recruited , and 512 of them were at nutritional risk . Of the 120 patients with an NRS score at least 5 , the complication rate was significantly lower in the preoperative nutrition group compared with the control group ( 25.6 % versus 50.6 % , P = 0.008 ) . The postoperative hospital stay was significantly shorter in the preoperative nutrition group than in the control group ( 13.7 ± 7.9 versus 17.9 ± 11.3 d , P = 0.018 ) . Of the 392 patients with an NRS score from 3 to 4 , the complication rate and the postoperative hospital stay were similar between patients with and those without preoperative nutritional support ( P = 1.0 and 0.770 , respectively ) . CONCLUSION This finding suggests that preoperative nutritional support is beneficial to patients with an NRS score at least 5 by lowering the complication rate ",
"Background We have proposed a simplified perioperative rehabilitation program for elective colonic surgery that is focused on early oral nutrition and that could reduce hospital stay and postoperative ileus time without raising complications and readmission rates . Patients and methods Fifty-four patients admitted for elective colonic surgery were prospect ively r and omized into two groups : ( 1 ) an early feeding group (EFG)—on the first postoperative day , patients initially received a oral liquid diet and were advanced to a regular diet within the next 24 h as tolerated and at their discretion ; ( 2 ) a traditional care group— patients were managed by nothing per orus until the elimination of the first flatus and then su bmi tted to an oral liquid diet , followed by a regular diet within the next 24 h as described for the EFG . All patients followed a well-defined , simplified rehabilitation program . Results Patients ' baseline characteristics were similar in the two groups . Hospital stay was significantly lower in the EFG ( 4.0 [ ±3.7 ] versus 7.6 [ ±8.1 ] days ; p = 0.000 ) . Diet tolerance and progression were similar between groups . Time to first flatus after surgery was significantly lower in the EFG ( 1.5 [ ±0.5 ] versus 2.0 [ ±0.7 ] days ; p = 0.019 ) . Complication and readmission rates were similar in both groups . Conclusions Early oral nutrition associated with a simplified perioperative rehabilitation program reduces postoperative length of hospital stay and ileus time after elective colonic resection without increasing rates of complications or readmissions ",
"BACKGROUND / AIMS Early enteral nutrition ( EEN ) has benefits in reducing infectious complication , length of stay ( LOS ) and preserving liver function . There are few data about the effect of EEN in the patients who had total gastrectomy . The aim of this r and omized and prospect i ve study was to evaluate the effect of EEN after total gastrectomy on nutritional status , liver function , complications and LOS , compared to total parenteral nutrition ( TPN ) in patients with gastric cancer . METHODS Among 56 patients with gastric cancer , 36 and 20 were r and omly assigned to EEN and TPN groups , and finally 17 and 16 completed EEN and TPN schedules , respectively . The nutritional parameters , liver function , LOS and abdominal symptoms were compared between 2 groups on pre-operative day and post-operative 7th day . RESULTS There was no significant difference in the nutritional parameters , liver function between EEN and TPN groups . Vomiting and abdominal distention were more frequent in EEN than TPN group ( 2 vs. 0 cases , p=0.485 ; 1 vs. 0 case , p=1.000 , respectively ) , while increased AST , ALT and total bilirubin were more common in TPN than EEN group ( 4 vs. 2 cases , p=0.398 ; 1 vs. 0 case , p=0.485 , respectively without statistical significance ) . LOS was shorter in EEN than TPN group without statistical significance ( 12 vs. 13 days , p=0.289 ) . CONCLUSIONS No significant differences were found in the nutritional status parameters , liver function , complications and LOS between EEN and TPN groups on 7th day after total gastrectomy . Further large scale studies on the advantages and disadvantages of EEN after total gastrectomy are warranted",
"OBJECTIVE To investigate the feasibility of no nasogastric intubation and early oral feeding at will after thoracolaparoscopic esophagectomy for patients with esophageal cancer . METHODS Between January 2013 and January 2014 , the feasibility of no nasogastric intubation and early oral feeding at postoperative day(POD ) 1 after thoracolaparoscopic esophagectomy was prospect ively investigated in 156 patients ( trial group ) with esophageal cancer in the Henan Cancer Hospital . One hundred and sixty patients previously managed in the same unit who were treated routinely after thoracolaparoscopic esophagectomy were served as control group . RESULTS Of 156 patients of trial group , 6(3.8 % ) patients could not take food early as planned because of postoperative complications . The overall complication rate in trial group was 19.2%(30/156 ) , which was 25.0%(30/160 ) in control group ( P=0.217 ) . The anastomotic leakage in trial group and control group was 2.6%(4/156 ) and 4.3%(7/160 ) respectively ( P=0.380 ) . Compared with control group , time to first flatus [ ( 2.1±0.9 ) d vs. ( 3.3±1.1 ) d , P ] , bowel movement [ ( 4.4±1.3 ) d vs. ( 6.6±1.0 ) d , P and postoperative hospital stay [ ( 8.3±3.2 ) d vs. ( 10.4±3.6 ) d , P early oral feeding postoperatively in patients with thoracolaparoscopic esophagectomy is feasible and safe . This management can shorten postoperative hospital stay and fasten postoperative bowel function recovery",
"OBJECTIVE Prolonged preoperative fasting increases postoperative hospital length of stay and current evidence recommends patients drink a carbohydrate-based liquid drink 2 h before surgery . The aim of this study was to investigate whether the addition of hydrolyzed protein to a carbohydrate-based drink would reduce both the inflammatory response and hospital length of stay . METHODS We evaluated 22 patients of both sexes , undergoing gastrointestinal resection due to cancer . Patients were r and omized into two groups : control group ( n = 12 ; 6 - 8 h fast ) and the intervention group ( n = 10 ; fasted to solids for 6 h ; and given a beverage containing 11 % pea protein hydrolysate and 89 % carbohydrates ( 79 % maltodextrin and 21 % sucrose ) , 400 mL the night before and 200 mL 3 h before surgery . Blood sample s were collected the morning before surgery and on postoperative day 2 . RESULTS Overall mortality was 4.5 % ( one case , control group ) . The duration of postoperative hospital stay was twofold longer in the control group ( P = 0.04 ) . A significant increase of serum C-reactive protein/albumin ratio was observed in controls compared with the intervention group ( P = 0.04 ) . CONCLUSION The abbreviation of preoperative fasting time to 3 h using a solution containing carbohydrates and hydrolyzed pea proteins reduces the acute-phase inflammatory response and decreases the postoperative length of stay in patients undergoing major surgery for a malignancy",
"OBJECTIVE To determine the effects of total parenteral nutrition ( TPN ) and enteral nutrition ( EN ) on biochemical and clinical outcomes in pancreatic cancer patients who underwent pancreaticoduodenectomy . METHODS From the year 2006 to 2008 , 60 patients who underwent pancreaticoduodenectomy in Tianjin Third Central Hospital were enrolled in this study . They were r and omly divided into the EN group and the TPN group . The biochemical and clinical parameters were recorded and analyzed between the two groups . RESULTS There was no significant difference in the nutritional status , liver and kidney function , and blood glucose levels between the TPN and EN groups on the preoperative day , the 1st and 3 rd postoperative days . However , on the 7th postoperative day , there was significant difference between the two groups in 24 h urinary nitrogen , serum levels of , total protein ( TP ) , transferrin ( TF ) , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , alkaline phosphatase ( ALP ) , and γ-glutamyl transpeptadase ( GGT ) , blood urea nitrogen ( BUN ) and creatinine ( Cr ) . On the 14th postoperative day , there was a significant difference between the two groups in terms of urinary levels of 24 h nitrogen , TP , TF , retinol binding protein , ALT , AST , ALP , GGT , total bilirubin , direct bilirubin , BUN , Cr , and glucose . The incidence of delayed gastric emptying in the EN and TPN groups was 0 % and 20 % , respectively . Moreover , the incidence of pancreatic fistulas and hemorrhages in the EN group were 3.6 % and 3.6 % , versus 26.7 % and 30 % in the TPN group , respectively . CONCLUSIONS EN is better than TPN for pancreatic cancer patients who received pancreaticoduodenectomy",
"Objectives Despite increasing trends toward the early initiation of oral feeding after gastrointestinal ( GI ) surgeries , current evidence has not been convincing . The present r and omized clinical trial aim ed to compare the clinical outcomes of early oral feeding ( EOF ) with late oral feeding ( LOF ) following surgery for upper GI tumors . Methods One hundred and nine consecutive patients with esophageal or gastric tumors undergoing surgical resection in two hospitals in Tehran , Iran , were enrolled in this prospect i ve r and omized controlled trial , and were r and omly assigned to a group starting EOF on the first postoperative day and another group that remained nil by mouth until the return of bowel sounds ( LOF group ) . The clinical and surgical outcomes were compared between the two groups . Results The clinical outcomes were significantly better in the patients in the EOF group ( p Repeated nil per os ( 14.8 vs. 30.9 % ) and re-hospitalization ( 1.8 vs. 7.3 % ) were more common in LOF group ( p gas passage , nasogastric tube ( NGT ) discharge , a decrease in intravenous serum to less than 1000 ml per day , the time to start a soft diet and hospital discharge following surgery occurred significantly earlier in the EOF group than in the LOF group ( p Early oral feeding after the surgical resection of esophageal and gastric tumors is safe , and is associated with favorable early in-hospital outcomes and a sooner return to physiological GI function and hospital discharge",
"BACKGROUND & AIMS Fast track protocol s have been successfully used in abdominal surgery but there are no r and omized trials on fast track after appendectomy . The aim of this study was to evaluate the safety and feasibility of fast track perioperative care protocol including early feeding with opioid-sparing analgesia after open appendectomy . METHODS We r and omly allocated 62 consecutive patients who underwent appendectomy to an early feeding with opioid-sparing analgesia and traditional care group . The study was not blinded regarding the mode of postoperative rehabilitation . Clinical primary endpoint was length of postoperative hospital stay . Secondary endpoints were morbidity rate , time to bowel sounds and passage of flatus or stools , tolerance of solid diet and facial visual pain score . RESULTS The mean length of primary hospital stay was significantly shorter in the early feeding with opioid-sparing analgesia than in traditional care group ( 2.2 versus 4.0 days , P demographics , degree of pathological changes in the appendix , and in the secondary endpoints such as morbidity , frequency of vomiting , visual facial pain score , time to first flatus or stools , resumption of bowel sounds and toleration of solid diet . CONCLUSIONS This study indicates that early feeding and opioid-sparing analgesia after open appendectomy is safe and reduces length of hospital stay without deterioration of pain control",
"Background : The preoperative period ( prehabilitation ) may represent a more appropriate time than the postoperative period to implement an intervention . The impact of prehabilitation on recovery of function al exercise capacity was thus studied in patients undergoing colorectal resection for cancer . Methods : A parallel-arm single-blind superiority r and omized controlled trial was conducted . Seventy-seven patients were r and omized to receive either prehabilitation ( n = 38 ) or rehabilitation ( n = 39 ) . Both groups received a home-based intervention of moderate aerobic and resistance exercises , nutritional counseling with protein supplementation , and relaxation exercises initiated either 4 weeks before surgery ( prehabilitation ) or immediately after surgery ( rehabilitation ) , and continued for 8 weeks after surgery . Patients were managed with an enhanced recovery pathway . Primary outcome was functional exercise capacity measured using the vali date d 6-min walk test . Results : Median duration of prehabilitation was 24.5 days . While awaiting surgery , functional walking capacity increased ( ≥20 m ) in a higher proportion of the prehabilitation group compared with the rehabilitation group ( 53 vs. 15 % , adjusted P = 0.006 ) . Complication rates and duration of hospital stay were similar . The difference between baseline and 8-week 6-min walking test was significantly higher in the prehabilitation compared with the rehabilitation group ( + 23.7 m [ SD , 54.8 ] vs. −21.8 m [ SD , 80.7 ] ; mean difference 45.4 m [ 95 % CI , 13.9 to 77.0 ] ) . A higher proportion of the prehabilitation group were also recovered to or above baseline exercise capacity at 8 weeks compared with the rehabilitation group ( 84 vs. 62 % , adjusted P = 0.049 ) . Conclusion : Meaningful changes in postoperative functional exercise capacity can be achieved with a prehabilitation program ",
"A carbohydrate‐rich drink ( CHO ) has been shown to reduce preoperative discomfort . It was hypothesized that it may also reduce postoperative nausea and vomiting ( PONV ) ",
"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",
"Background : Esophagectomy represents an exemplar of controlled major trauma , with marked metabolic , immunologic , and physiologic changes as well as an associated high incidence of complications . Eicosapentaenoic acid ( EPA ) enriched enteral nutrition ( EN ) modulates immune function and limits catabolism in patients with advanced cancer , but its impact in the peri-operative period is unclear . Objectives : To examine the effects of perioperative EPA enriched EN on the metabolic , nutritional , and immuno-inflammatory response to esophagectomy , and on postoperative complications . Methods : In a double-blind design , patients were r and omized to a st and ard EN formula or a formula enriched with 2.2 g EPA/d for 5 days preoperatively ( orally ) and 21 days postoperatively ( jejunostomy ) . Segmental bioelectrical impedance analysis was performed preoperatively and on POD 21 . Postoperative complications were monitored , as well as the acute phase response , coagulation markers , and serum cytokines . Results : Fifty-three patients ( 28 EPA , 25 st and ard ) completed the study , and both groups were well matched . Serum and peripheral blood mononuclear cell ( P BMC ) membrane EPA levels were significantly increased in the EPA group . There was no difference in the incidence of major complications . The EPA group maintained all aspects of body composition postoperatively , whereas patients in the st and ard EN group lost significant amounts of fat-free mass ( 1.9 kg , P = 0.030 ) compared with the EPA group [ leg ( 0.3 kg , P = 0.05 ) , arm ( 0.17 kg , P = 0.01 ) , and trunk ( 1.44 kg , P = 0.03 ) ] . The EPA group had a significantly ( P attenuated stress response for TNFα , IL-10 , and IL-8 compared with the st and ard group . Conclusions : EPA supplemented early EN is associated with preservation of lean body mass post esophagectomy compared with a st and ard EN . These properties may merit longer-term study to address its impact on recovery of function and quality of life in models of complex surgery or multimodal cancer treatment regimens",
"In the attempt to reduce postoperative complications and costs and improve outcomes , the concept of fast track surgery has been proposed . Improvements in anesthesia techniques and a better underst and ing of the pathophysiologic events occurring during and after surgery have made it possible . A group of patients undergoing colorectal resections with a fast track approach were investigated ; specifically , the effects on postoperative morbidity , resumption of intestinal function , and duration of hospitalization . Fifty patients were managed according to a protocol , which included epidural analgesia , early ambulation , and oral feeding ( fast track group ) ; they were compared with 50 patients managed with a different protocol : no epidural analgesia , early ambulation , and early oral diet ( control group ) . Primary outcome end-points reported include morbidity , time to passage of flatus and stool , and length of hospital stay . Fourteen complications occurred in the fast track group and 13 in the control group ( P = not significant ( NS ) ) . Resumption of intestinal function occurred after 3 days , and length of hospital stay was 5 days in the fast track group compared with 4 and 7 days respectively in control patients ( P = NS , P Patients undergoing elective colorectal resections can be managed safely with fast track protocol s reducing hospital stay",
"PURPOSE : Although laparoscopic surgery may permit earlier recovery compared with open surgery , no published r and omized controlled trial has investigated the benefit of a multimodal rehabilitation program after laparoscopic colonic resection . This study aim ed to evaluate the efficacy of a rehabilitation program after laparoscopic colon surgery in the context of a r and omized controlled trial . METHODS : Between September 2007 and October 2009 , 100 patients who had received laparoscopic colon surgery were selected for the study and r and omly assigned on a 1:1 basis to a rehabilitation program group with early mobilization and diet ( n = 46 ) or conventional care group ( n = 54 ) . The rehabilitation program group received early oral feeding , early ambulation , and regular laxative . The primary outcome was recovery time , measured with criteria of tolerable diet for 24 hours , safe ambulation , analgesic-free , and afebrile status without major complications . Secondary outcomes were postoperative hospital stay , complications , quality of life by Short Form 36 , pain by visual analog scale , and readmission . This study was registered ( ID number NCT00606944 , http://register . clinical trials.gov ) . RESULTS : Recovery time was shorter in the rehabilitation program group than in the conventional care group ( median ( interquartile range ) , 4 ( 3–5 ) d vs 6 ( 5–7 ) d , respectively ; P in postoperative hospital stay between the 2 groups ( rehabilitation program group , 7 ( 6–8 ) d vs conventional care group , 8 ( 7–9 ) d ; P = .065 ) . There was no difference in complication rates between the rehabilitation program group and conventional care group ( 10.9 % vs 20.4 % , respectively ; P = .136 ) . Quality of life and pain were similar in both groups . There were no readmissions or mortality . CONCLUSIONS : A rehabilitation program with early mobilization and diet after laparoscopic colon surgery results in reduced recovery time without increased complications . These results suggest that a multimodal rehabilitation program may increase the short-term benefits after laparoscopic colon surgery",
"Preoperative 12.6 % oral carbohydrate loading is an element of the Enhanced Recovery After Surgery ( ERAS ) protocol aim ed at alleviating postoperative insulin resistance ; however , in Japan , beverages with 18 % carbohydrate content are generally used for preoperative carbohydrate loading . We investigated the effect of 18 % carbohydrate loading on alleviating insulin resistance . Six healthy volunteers participated in this crossover-r and omized study and were segregated into 2 groups : volunteers in the carbohydrate-loading group ( group A ) who fasted from after 9 pm and ingested 375 mL of a beverage containing 18 % carbohydrate ( ArginaidWaterTM ; Nestle , Tokyo , Japan ) between 9 pm and 12 pm , and 250 mL of the same liquid at 6:30 am . Volunteers in control group ( group B ) drank only water . At 8:30 am , a hyperinsulinemic normoglycemic clamp was initiated . Glucose infusion rate ( GIR ) and levels of ketone bodies and cytokines ( IL-1β , IL-6 , and TNF-α ) before clamping were evaluated . p statistically significant . Levels of blood glucose , insulin , and cytokines at the start of the clamp were similar in both the groups . The GIR in group A was significantly higher than that in group B ( 11.5±2.4 vs 6.2±2.2 mg/kg/min , p=0.005 ) , while blood ketone body levels were significantly lower in group A ( 22±4 vs 124±119 μmol/L , p=0.04 ) . Preoperative 18 % carbohydrate loading could prevent the decrease in insulin sensitivity and suppress catabolism in healthy volunteers . Thus , carbohydrate loading with a beverage with 18 % carbohydrate content might contribute to improvements in perioperative management",
"OBJECTIVES Investigate both the utility and feasibility of perioperative nutritional supplementation with an arginine-enriched immunonutrition formula to high-risk head and neck cancer surgical patients and examine its effects on acute post-operative clinical outcomes . MATERIAL S & METHODS This prospect i ve , non-r and omized , interventional cohort study compared high-risk head and neck cancer surgical patients who consumed a pre- and post-operative arginine-based nutritional supplement to those that did not . Outcome measures included post-operative complications , length of hospitalization , readmission rates and measurement of nutritional biomarkers . RESULTS 195 high-risk head and neck cancer surgical patients were enrolled . 59 % of the patients used the nutritional supplement , 41 % did not . Of the 80 patients who did not receive the immunonutrition formula , 38 ( 47.5 % ) experienced post-operative complications of all types as compared to 29 of the 115 ( 25.2 % ) patients who did consume the product ( p=0.0021 ) . Pharyngeal leaks or fistulas were the most common post-operative complications in both groups and more common in patients who did not receive supplementation ( p=0.007 ) . Length of stay was on average 2.8 days longer in patients who did not have enhanced nutrition ( p=0.02 ) , while readmission rates between the two groups were similar ( p=0.91 ) . Measurements of nutritional biomarkers were not reported secondary to low collection rates . CONCLUSION Enhanced perioperative nutrition may result in significant reductions of post-operative fistula formations and decreased length of stay in a high-risk head and neck cancer population , even in the setting of poor compliance . The potential quality improvement in both patient care and healthcare cost is both real and significant",
"Major surgery is associated with postoperative insulin resistance which is attenuated by preoperative carbohydrate ( CHO ) treatment . The effect of this treatment on clinical outcome after major abdominal surgery has not been assessed in a double‐blind r and omized trial",
"Objective : The aim of this trial was to investigate whether a routine of allowing normal food at will increases morbidity after major upper gastrointestinal ( GI ) surgery . Summary Background Data : Nil-by-mouth with enteral tube feeding is widely practice d for several days after major upper GI surgery . After other abdominal operations , normal food at will has been shown to be safe and to improve gut function . Methods : Patients were r and omly assigned to a routine of nil-by-mouth and enteral tube feeding by needle-catheter jejunostomy ( ETF group ) or normal food at will from the first day after major upper GI surgery . Primary end point was rate of major complications and death . Secondary outcomes were minor complications and adverse events , bowel function , and length of stay . All patients were invited to a follow-up at 8 weeks after discharge from the hospital . Results : Four hundred fifty-three patients who underwent major open upper GI surgery in 5 centers were enrolled between 2001 and 2006 . Four hundred forty-seven patients were correctly r and omized . Of 227 patients 76 ( 33.5 % ) had major complications in the ETF group compared with 62 ( 28.2 % ) of 220 patients allowed normal food at will ( P = 0.26 , 95 % CI for the difference in rate from −3.3 to 13.9 ) . In the ETF group , 36 ( 15.9 % ) patients were reoperated compared with 29 ( 13.2 % ) in the group allowed normal food at will ( P = 0.50 ) and 30-day mortality was 10 ( 4.4 % ) of 227 and 11 ( 5.0 % ) of 220 patients , respectively ( P = 0.83 ) . Time to resumed bowel function was significantly in favor of allowing normal food at will ( P = 0.01 ) , as were the total number of major complications , length of stay , and rate of postdischarge complications . Conclusions : Allowing patients to eat normal food at will from the first day after major upper GI surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding",
"Postoperative convalescence is mainly determined by the extent and duration of postoperative ileus . This r and omized clinical trial evaluated the effects of early oral feeding on functional gastrointestinal recovery and quality of life",
" Background : Surgery is succeeded by long‐lasting state of relative peripheral insulin resistance , which is reduced by giving glucose infusion or oral carbohydrate‐rich drinks immediate before operating instead of fasting . The aim of the present study was to investigate whether oral carbohydrate or carbohydrate with peptide drinks preoperatively instead of fasting would improve postoperative voluntary muscle strength , nutritional intake and ambulation , decrease postoperative fatigue , anxiety and discomfort , and reduce the endocrine response to surgery",
"AIM To evaluate published trials examining oral post-operative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results . METHODS Data base search es ( MEDLINE , BIOSIS , EMBASE , Cochrane Trials , Cinahl , and CAB ) , search es of reference lists of relevant papers , and expert referral were used to identify prospect i ve r and omized controlled clinical trials . The following terms were used to locate articles : \" oral ' ' or \" enteral ' ' and \" postoperative care ' ' or \" post-surgical ' ' and \" proteins ' ' or \" milk proteins ' ' or \" dietary proteins ' ' or \" dietary supplements ' ' or \" nutritional supplements ' ' . In data bases that allowed added limitations , results were limited to clinical trials that studied humans , and publications between 1990 and 2014 . Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted . RESULTS Search es identified 629 papers of which , following review , 7 were deemed eligible for qualitative evaluation . Protein supplementation does not appear to affect mortality but does reduce weight loss , and improve nutritional status . Reduction in grip strength deterioration was observed in a majority of studies , and approximately half of the studies described reduced complication rates . No changes in duration of hospital stay or plasma protein levels were reported . There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population . However , despite comprehensive search es , clinical trials that varied only the amount of protein provided via oral nutritional supplements ( discrete from other nutritional components ) were not found . At present , there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage . CONCLUSION The optimal level of protein supplementation required to maximise recovery in gastrointestinal surgery patients is effectively unknown , and may warrant further study",
"Background and Aim : Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery . The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients . Material and Methods : Between June 1 , 2001 , and December 31 , 2005 , a group of 214 well-nourished patients was initially assessed ( 150 men , 64 women , mean age 61.2 years ) to participate in the study . Nine patients were subsequently excluded and the remaining 205 subjects were r and omly assigned in a 2 × 2 factorial design into 4 study groups , ie , st and ard enteral nutrition ( n = 53 ) , immunomodulating enteral nutrition ( n = 52 ) , st and ard parenteral nutrition ( n = 49 ) , and immunomodulating enteral nutrition ( n = 51 ) . The study was design ed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery ; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates , and hospital stay . The study was registered in the Clinical Trials Data base – number NCT 00558155 . Results : The overall morbidity rate was 33 % and the incidence of individual complications was comparable between all groups . Infectious complications occurred in 26 of 102 patients given st and ard diets and in 22 of 103 patients receiving immunomodulatory formulas ( odds ratio 0.81 ; 95 % CI , 0.43–1.50 ) . There were no significant differences between infectious complications in patients using parenteral nutrition ( 22 of 100 patients ) and parenteral formulas ( 26 of 105 , odds ratio 1.14 ; 95 % CI , 0.61–2.14 ) . Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures , including overall morbidity and mortality rates , and hospital stay . Conclusions : Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery . Both enteral and parenteral treatment options showed similar efficacy , tolerance , and effects on protein synthesis . Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition . However , because of its cost-efficiency , enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy",
"BACKGROUND SMOFlipid 20 % is intravenous lipid emulsion ( ILE ) containing long-chain triglycerides ( LCT ) , medium-chain triglycerides ( MCT ) , olive oil , and fish oil as a mixed emulsion containing α-tocopherol . The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT . METHODS In this prospect i ve study , 40 patients were r and omized to SMOFlipid 20 % or MCT/LCT ( Lipovenoes 20 % ) group . Clinical and biochemistry data were collected . Inflammatory markers ( CRP , IL-6 , IL-10 , TNF-α , TGF-β1 ) and oxidative stress ( ROS and superoxide ) were measured . RESULTS Thirty-five patients ( 17 males and 18 females ) with a mean age of 57 years completed the study . The patients ' demographic characteristics ( age , gender , height , body weight , and BMI ) were similar without significant differences between groups . The increment of triglyceride on day 6 from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group . Inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups . CONCLUSIONS Despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-6:n-3 ratio , and high vitamin E content , SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery",
"BACKGROUND Weight loss is frequent in patients with gastrointestinal ( GI ) cancer . Nutritional status deteriorates throughout anti-cancer treatment , mostly after major surgery , increasing complications , reducing tolerance and worsening the final prognosis . Enteral nutrition is safe and effective in malnourished patients undergoing major GI surgery . R and omised trials aim ed at investigating the effects of home enteral nutrition ( HEN ) in post-surgical patients with GI cancer are lacking . This study compares HEN and counselling in limiting weight loss during oncologic treatment . PATIENTS AND METHODS Patients with upper GI cancer and c and i date to major surgery were included in the protocol when the nutritional risk screening ( NRS 2002 ) score was ≥3 . All patients were supported with enteral nutrition through a jejunostomy after surgery and r and omly assigned to continue enteral nutrition or receiving nutritional counselling after discharge . Nutritional and performance status , quality of life ( QoL ) and tolerance to cancer treatment have been evaluated at 2 and 6 months after discharge . RESULTS Seventy-nine patients were r and omised ; 38 continued enteral nutrition at home and 41 patients received nutritional counselling only . After 2 months , patients on HEN maintained their mean body weight , while patients in the nutritional counselling group showed a weight loss of 3.6 kg . Patients supported on HEN had a higher chance to complete chemotherapy as planned ( 48 % versus 34 % ) . QoL was not worsened by HEN . No complications were reported . CONCLUSIONS HEN is a simple and feasible treatment to support malnourished patients with upper GI cancer after major surgery and during chemotherapy in order to limit further weight loss "
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OBJECTIVES It is known that psychotropic medications have an impact on the readings found in Electroencephalogram ( EEG ) . In the field of psychiatry , there are several psychotropics utilized by clinicians . This review seeks to investigate all the available data for psychotropic drugs and their impact on EEG changes . METHODS A systematic review of all the published and ongoing literature was conducted via PubMed . The Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) method was used for each search . Key words for search es include ' EEG and Psychotropics ' , ' EEG and Mood Stabilizers ' , ' EEG and Clozapine ' , ' EEG and Bupropion ' , ' EEG and SSRI ' , ' EEG and Lamotrigine ' , ' EEG and Carbamazepine ' , ' EEG and Lithium ' and ' EEG and Valproate ' , ' EEG and Haloperidol ' , ' EEG and Aripiprazole ' , ' EEG and Methylpheni date ' , ' EEG and Topiramate ' , ' EEG and Gabapentin ' and ' EEG and Oxcarbamazepine ' . After applying the inclusion criteria , 201 articles were eligible and review ed . RESULTS Following an extensive review of selected studies from the 201 articles , the studies indicate that each of the psychotropic medications review ed impact alpha , beta , delta and theta waves independently and differently from each other . Additionally , certain medications , particularly haloperidol and valproic acid , have dissimilar results exemplified in all waveforms . CONCLUSIONS This PRISMA systematic review illustrates that while there is available data on psychotropic medications and their proposed effect on EEG activity , further research is needed to confirm these findings to help allow clinical correlations to be made between the patient 's response and the psychotropic agent | [
"OBJECTIVE To investigate the role of frontal EEG as predictor of clinical response to SSRIs or venlafaxine in major depressive disorder ( MDD ) . METHOD 82 subjects ( age 35.9+/-13.0 ; 47.6 % female ) meeting DSM-IV criteria for MDD entered an 8-week prospect i ve treatment with SSRIs or venlafaxine . At baseline and week 1 we recorded serial , 4-channel EEGs ( F7-Fpz , F8-Fpz , A1-Fpz , A2-Fpz ) . We evaluated prospect ively the relative theta power as predictor of treatment outcome . We also developed an Antidepressant Treatment Response ( ATR ) index using EEG parameters assessed at baseline and week 1 . RESULTS 45 subjects ( 54.9 % ) responded to treatment ( HAM-D-17 reduction > or=50 % ) . At baseline , frontal relative theta power ( i.e. , 4 - 8 Hz power/2 - 20 Hz power ) was significantly ( p=0.017 ) lower ( 21 % ) in treatment responders than in non-responders ( 24 % ) . Baseline relative theta power predicted treatment response with 63 % accuracy [ 64 % sensitivity , 62 % specificity , 66 % area under the receiver operator curve ( AUROC ) ( p=0.014 ) ] . Relative theta power at week 1 predicted treatment response with 60 % accuracy [ 62 % sensitivity , 57 % specificity , 61 % AUROC ( p=0.089 ) ] . ATR predicted response with 70 % accuracy [ 82 % sensitivity , 54 % specificity , 72 % AUROC ( p=0.001 ) ] . CONCLUSION Using automated analysis of frontal EEG collected during the first week of antidepressant treatment it may be possible to facilitate prediction of SSRI or venlafaxine efficacy in MDD",
"Background The present study examined absolute alpha power using quantitative electroencephalogram ( qEEG ) in bilateral temporal and parietal cortices in novice soldiers under the influence of methylpheni date ( MPH ) during the preparatory aim ing period in a practical pistol-shooting task . We anticipated higher bi-hemispheric cortical activation in the preparatory period relative to pre-shot baseline in the methylpheni date group when compared with the control group because methylpheni date has been shown to enhance task-related cognitive functions . Methods Twenty healthy , novice soldiers were equally distributed in control ( CG ; n = 10 ) and MPH groups 10 mg ( MG ; n = 10 ) using a r and omized , double blind design . Subjects performed a pistol-shooting task while electroencephalographic activity was acquired . Results We found main effects for group and practice blocks on behavioral measures , and interactions between group and phases on electroencephalographic measures for the electrodes T3 , T4 , P3 and P4 . Regarding the behavioral measures , the MPH group demonstrated significantly poorer in shooting performance when compared with the control and , in addition , significant increases in the scores over practice blocks were found on both groups . In addition , regarding the electroencephalographic data , we observed a significant increase in alpha power over practice blocks , but alpha power was significantly lower for the MPH group when compared with the placebo group . Moreover , we observed a significant decrease in alpha power in electrodes T4 and P4 during PTM . Conclusion Although we found no correlation between behavioral and EEG data , our findings show that MPH did not prevent the learning of the task in healthy subjects . However , during the practice blocks ( PBs ) it also did not favor the performance when compared with control group performance . It seems that the CNS effects of MPH dem and ed an initial readjustment period of integrated operations relative to the sensorimotor system . In other words , MPH seems to provoke a period of initial instability due to a possible modulation in neural activity , which can be explained by lower levels of alpha power ( i.e. , higher cortical activity ) . However , after the end of the PB1 a new stabilization was established in neural circuits , due to repetition of the task , result ing higher cortical activity during the task . In conclusion , MPH group performance was not initially superior to that of the control group , but eventually exceeded it , albeit without achieving statistical significance",
"UNLABELLED Quantitative EEG ( QEEG ) effects of therapeutic doses of carbamazepine ( CBZ ) , oxcarbazepine ( OXC ) , valproate ( VA ) and lamotrigine ( LA ) monotherapy were investigated in patients with beginning epilepsy . Baseline waking EEG ( EEG1 ) was recorded in the untreated state , the second EEG ( EEG2 ) was done after 8 weeks of reaching the therapeutic dose . Left occipital data were used for analysis . QEEG target parameters were absolute b and -power ( delta : AD , theta : AT , alpha : AA , beta : AB ) , and alpha mean frequency ( AMF ) . Group effects ( untreated versus treated condition in the CBZ , VA , OXC , LA groups ) were computed for each target parameter . One group with benign rol and ic epilepsy remained untreated for clinical reasons and served to estimate the QEEG test-retest differences . In addition , the individual QEEG response to each drug was calculated as ( EEG2-EEG1 ) . RESULTS statistically significant ( p AT increase and AMF decrease . OXC caused AMF decrease . VA and LA did not decrease AMF ( LA even increased it ) , but reduced broad-b and power . Individual power and AMF changes showed considerable variability in each group . > 0.5 Hz AMF decrease ( that was reported to predict cognitive impairment in prior studies ) occurred in 10/41 patients in the CBZ group but never in the OXC , VA , LA groups . The results may be utilized in planning further studies addressing the relationship between antiepileptic drugs and their CNS effects . In addition , the relationship of AED-related cognitive impairment and AMF changes was discussed",
"Rationale Both psychotropic drugs and mental disorders have typical signatures in quantitative electroencephalography ( EEG ) . Previous studies found that some psychotropic drugs had EEG effects opposite to the EEG effects of the mental disorders treated with these drugs ( key – lock principle ) . Objectives We performed a placebo-controlled pharmaco-EEG study on two conventional antipsychotics ( chlorpromazine and haloperidol ) and four atypical antipsychotics ( olanzapine , perospirone , quetiapine , and risperidone ) in healthy volunteers . We investigated differences between conventional and atypical drug effects and whether the drug effects were compatible with the key – lock principle . Methods Fourteen subjects underwent seven EEG recording sessions , one for each drug ( dosage equivalent of 1 mg haloperidol ) . In a time-domain analysis , we quantified the EEG by identifying clusters of transiently stable EEG topographies ( microstates ) . Frequency-domain analysis used absolute power across electrodes and the location of the center of gravity ( centroid ) of the spatial distribution of power in different frequency b and s. Results Perospirone increased duration of a microstate class typically shortened in schizophrenics . Haloperidol increased mean microstate duration of all classes , increased alpha 1 and beta 1 power , and tended to shift the beta 1 centroid posterior . Quetiapine decreased alpha 1 power and shifted the centroid anterior in both alpha b and s. Olanzapine shifted the centroid anterior in alpha 2 and beta 1 . Conclusions The increased microstate duration under perospirone and haloperidol was opposite to effects previously reported in schizophrenic patients , suggesting a key – lock mechanism . The opposite centroid changes induced by olanzapine and quetiapine compared to haloperidol might characterize the difference between conventional and atypical antipsychotics",
"The risk of dose-dependent seizures is a safety issue with bupropion hydrochloride . To evaluate the presence of specific electroencephalographic ( EEG ) waveforms , 210 adult subjects taking stable doses of bupropion hydrochloride were recruited to undergo 2 EEGs in a prospect i ve , single-center cohort study . The occurrence of spike waves , sharp waves , and focal slowing was recorded and assessed with a continuation ratio logit model for polytomous responses . This model showed that there was a relationship between sex and the incidence of these waveforms , such that the odds of female subjects having sharp waves was increased by a factor of 2.53 ( P = 0.05 ) when compared with male subjects and controlled for both age and dose . Similarly , female subjects were 2.45 ( P = 0.09 ) times more likely than males to have focal slowing on EEG . Overall , 19.8 % ( 39/197 ) of this representative population was found to have abnormal , asymptomatic EEG findings . The presence of these waveforms in individuals taking a medication known to lower the seizure threshold may be a risk factor for developing seizures",
"Information on the effects of newer antiepileptic drug ( AEDs ) on the electroencephalogram ( EEG ) is sparse and contradictory . Quantitative EEG ( qEEG ) provides a method of estimating the effects of drugs on the central nervous system . Twenty-three adult patients with difficult-to-control complex partial seizures , with or without secondary generalization , participated in an add-on study with one of three newer AEDs : vigabatrin ( n = 10 ) , lamotrigine ( n = 6 ) , and topiramate ( n = 7 ) . Frequency analysis and topographic mapping of awake EEGs before and during treatment with the drug were compared . Statistical analysis was performed using 2-way analysis of variance ( ANOVA ) with repeated measures . Vigabatrin administration was followed by a diffuse decrease in the absolute alpha ( p ) and beta ( p activities and a decrease in the absolute theta in the frontal and parieto-occipital regions ( p Lamotrigine caused a significant diffuse increase in the faster frequencies ( relative alpha p slower activities ( relative theta in the posterior head regions p Topiramate increased the absolute beta ( p and theta ( p ) activities diffusely and decreased the relative alpha activity over the left hemisphere ( p electrical brain activity may reflect their different mechanisms of action",
"OBJECTIVE To investigate the quantitative EEG effects of lamotrigine ( LTG ) monotherapy . HYPOTHESIS LTG was predicted to decrease thalamo-cortical neuronal synchronization in idiopathic generalized epilepsy ( IGE ) . METHODS Waking EEG background activity of 19 IGE patients was investigated before treatment and in the course of LTG monotherapy . Raw absolute power ( RAP ) , raw percent power ( RRP ) , and raw mean frequency ( RMF ) were computed for 19 electrodes and four frequency b and s ( delta=1.5 - 3.5Hz , theta=3.5 - 7.5Hz , alpha=7.5 - 12.5Hz , and beta=12.5 - 25.0Hz ) . Inter- and intrahemispheric coherence was computed for eight electrode pairs and the four frequency b and s. In addition , scalp-averages were calculated for each variable . Group differences were computed by means of nonparametric statistics including correction for multiple comparisons . RESULTS Main results were decreased delta and theta RAP ( p baseline neuronal synchronization , the marked the dampening effect of LTG on it . The remaining findings were decreased theta RRP , theta RMF , and increased alpha RMF ( p pathological thalamo-cortical synchronization in use-dependent manner . 2 . LTG did not cause quantitative EEG alterations suggesting worsening of the physiological brain functions . Instead , its profile suggested a mild psychostimulant effect . SIGNIFICANCE The results contribute to the underst and ing of the effect of LTG at the network level",
"Summary 15 normal volunteers were treated over three weeks with haloperidol ( HAL ) and in the third week additionally with biperidene ( BIP ) . The order of the EEG spectra at different topographical locations and in different frequency b and s during a movement task was analyzed using uncertainty analysis ( UA ) , a multivariate analysis technique based on informationtheoretical methods . Different patterns of drug-induced changes were found . HAL decreases the theta and alpha b and order at the fronto- central lateral areas but increases it at the fronto- central midline in the theta b and and at the parietal areas in the alpha b and . With the exception of the fronto- central midline locations , BIP more or less counterbalances the effect of HAL . Volunteers felt unwell and had motor disturbances during HAL and felt well again during HAL + BIP . Reaction time values were increased during HAL and normalized during HAL + BIP",
"OBJECTIVE To investigate whether applying advanced machine learning ( ML ) method ologies to pre-treatment electroencephalography ( EEG ) data can predict the response to clozapine therapy in adult subjects suffering from chronic schizophrenia . METHODS Pre-treatment EEG data are collected in 23 + 14 schizophrenic adults . Treatment outcome , after at least one year follow-up , is determined using clinical ratings by a trained clinician blind to EEG results . First , a feature selection scheme is employed to select a reduced subset of features extracted from the subjects ' EEG that is most statistically relevant to our treatment-response prediction . These features are then entered into a classifier , which is realized in the form of a kernel partial least squares regression method that performs response prediction . Various scales , including the positive and negative syndrome scale ( PANSS ) are used as treatment-response indicators . RESULTS We determined that a set of discriminating EEG features do exist . A low-dimensional representation of the feature space showed significant clustering into clozapine responder and non-responder groups . The minimum level of performance of the proposed prediction methodology , tested over a range of conditions using the leave-one-out cross-validation method using the original 23 subjects , with further testing in an independent sample of 14 subjects , was 85 % . CONCLUSIONS These findings indicate that analysis of pre-treatment EEG data can predict the clinical response to clozapine in treatment resistant schizophrenia . SIGNIFICANCE If replicated in a larger population , this novel approach to EEG analysis may assist the clinician in determining treatment-efficacy",
"Introduction The psychomotor stimulant methylpheni date ( MPH ) has been shown to improve attentional processes , reflected in behavioural measures such as vigilance , reaction time and visual attention tasks . The neural mechanisms of MPH action on sensory information processing , however , remain poorly understood . To the authors ’ knowledge , this present study is the first to investigate whether a single dose of MPH affects neural substrates of passive attention in healthy adults studied with simultaneous whole-head magnetoencephalography ( MEG ) and electroencephalography ( EEG ) . Methods Monaural left-ear auditory stimuli were presented in an oddball paradigm with infrequent deviant tones differing in frequency and duration . Neuronal activity was recorded with simultaneous whole-head MEG and EEG in 13 healthy subjects ( five females ; aged 27 ± 5 years ) after oral administration of 40 mg MPH or placebo in a r and omised , double-blind , cross-over design . We analysed both electric and magnetic N100 , P200 and mismatch negativity ( MMN ) components . Results MPH increased arousal levels in visual analogue scales . MPH had no effect on the dipole strength of MMN or MMNm in either frequency or duration deviations . MPH did , however , reduce P200 amplitudes in EEG . Conclusions The lack of effect of MPH on either MMN or MMNm suggests no association between catecholaminergic activities and MMN generation . However , our findings imply that MPH may change the neural bases of auditory information processing such as the early stimulus evaluation reflected in the P200 component . Dopamine and noradrenaline neurotransmitter systems could be responsible for the modulation of these processes . The exclusive effect of MPH on the P200 component could have a clinical application",
"Rationale Though sertraline , a selective serotonin reuptake inhibitor ( SSRI ) , causes autonomic and cognitive adverse events such as dry mouth and somnolence , there is a paucity of appropriately design ed studies on the cognitive and autonomic effects of the drug in the literature . Objective To compare the effects of sertraline on cognitive and autonomic functions with those of placebo in healthy humans . Method A r and omized , double blind , cross over study of 12 healthy male volunteers aged 24 ( 21– 32 ; median ; range ) years . Subjects orally received 50 mg sertraline and placebo once daily for periods of 14 days each with at least 14 days in between . Heart rate variability ( HRV ) , skin conductance level ( SCL ) and skin conductance response ( SCR ) following sudden deep respiration were employed as parameters for autonomic function . Quantitative EEG ( qEEG ) and psychometric tests served as parameters for cognitive function . Measurements were performed repeatedly before the start of drug administration and on the last treatment day . Results Sertraline caused a significant reduction of heart rate and SCL ( P HRV and SCR were not changed . Cognitive functions such as flicker fusion frequency , memory , choice reaction time and psychomotor performance were not influenced by sertraline but slow and fast beta power density in the qEEG was increased . Conclusion Cognitive and psychomotor performance are not altered in healthy humans receiving multiple dosing with sertraline . The observed decreases in heart rate and SCL may be due to a sympatho-inhibitory effect of sertraline",
"The relationship between prior antidepressant treatment and prefrontal brain functional response to subsequent treatment with antidepressant medication or placebo is unknown . Eighty-nine adults with Major Depressive Disorder ( MDD ) , characterized as antidepressant-experienced or antidepressant-naive , received one week of single-blind placebo treatment prior to eight weeks of r and omized treatment with medication ( fluoxetine or venlafaxine ; n = 47 ) or placebo ( n = 42 ) in one of three similar placebo-controlled trials . Brain function was assessed at baseline , end of placebo lead-in , and during r and omized treatment using quantitative electroencephalography ( qEEG ) . The authors assessed change in prefrontal theta-b and cordance ( PFC ) in antidepressant-experienced vs. antidepressant-naive subjects . Treatment history groups differed significantly on PFC change during the placebo lead-in even when controlling for clinical and demographic variables ( F(1,62 ) = 4.27 , p = .04 ) . As assessed in linear mixed models that examined treatment history ( antidepressant-experienced or antidepressant-naive ) , treatment assignment ( medication or placebo ) , and their interaction as predictors , treatment history also predicted PFC change during the r and omized phase of treatment even when controlling for pretreatment clinical and demographic and symptom improvement during treatment ( F(1,5o ) = 5.20 , p = .03 ) . The interaction was not significant . Post hoc analyses showed that antidepressant-experienced subjects treated with placebo showed PFC changes that did not differ from PFC changes seen in the medication group . Results suggest that prefrontal brain functional changes during treatment for MDD may differ depending upon prior treatment with antidepressant medication ",
"Central Nervous System ( CNS ) effects of talnetant , an NK-3 antagonist in development for schizophrenia , were compared to those of haloperidol and placebo . The study was r and omised , double-blind , three-way crossover of talnetant 200 mg , haloperidol 3 mg or placebo . Twelve healthy males participated and EEG , saccadic and smooth pursuit eye movements , adaptive tracking , body sway , finger tapping , hormones , visual analogue scales ( VAS ) for alertness , mood and calmness and psychedelic effects , left/right distraction task , Tower of London and Visual and Verbal Learning Task were assessed . Haloperidol showed ( difference to placebo ; 95 % CI ; p-value ) decreases in EEG α power ( −0.87μV ; −1.51/−0.22 ; p = 0.0110 ) , saccadic inaccuracy ( 2.0 % ; 0.5/3.6 ; p = 0.0133 ) , smooth pursuit eye movements ( −7.5 % ; −12.0/−3.0 ; p = 0.0026 ) , adaptive tracking ( −3.5 % ; −5.4/−1.7 ; p = 0.0009 ) , alertness ( −6.8 mm ; −11.1/−2.4 ; p = 0.0039 ) , negative mood ( −4.6 mm ; −8.6/−0.6 ; p = 0.0266 ) , the ability to control thoughts ( 1.2 mm ; 0.2/2.3 ; p = 0.0214 ) , and an increase of serum prolactin ( ratio 4.1 ; 3.0/5.6 ; p ) . Talnetant showed decreased alpha power ( −0.69 μV ; −1.34/−0.04 ; p = 0.0390 ) , improved adaptive tracking ( 1.9 % ; 0.1/3.7 ; p = 0.0370 ) and reduced calmness on VAS Bond and Lader ( −4.5 mm ; −8.0/−1.0 ; p = 0.0151 ) . Haloperidol effects were predominantly CNS-depressant , while those of talnetant were slightly stimulatory . The results suggest that talnetant penetrates the brain , but it remains to be established whether this dose is sufficient and whether the observed effect profile is class-specific for NK3-antagonists",
"A prospect i ve study comparing the immediate changes in occipital electroencephalographic ( EEG ) frequency following institution of carbamazepine therapy to long-term alterations of neuropsychological performance is reported . The patient group consisted of 16 previously untreated children in the 5 - 14-year age range who had recent onset partial seizures and were managed for at least 1 year with carbamazepine monotherapy . EEG changes following initiation of carbamazepine therapy , as compared to baseline , were determined by a computer-based quantitative method . Neuropsychological factors were assessed at baseline and after 1 year of therapy . While the alpha frequency decreased following institution of carbamazepine in most subjects , a greater decline ( typically > 0.5 Hz ) was observed in the subset who subsequently demonstrated decreased neuropsychological performance at 1 year . The major effects could be attributed to the Arithmetic and Picture Completion subtests of the Wechsler Intelligence Scale for Children-Revised ( WISC-R ) . The findings suggest that quantitative EEG analysis may be useful for identifying individuals at increased risk for developing anticonvulsant-related long-term cognitive changes",
"PURPOSE Antiepileptic drugs ( AEDs ) can be associated with adverse neurologic effects including cognitive dysfunction . Objective methods for recognizing AED effects on the brain could be valuable for long-term management . We compared quantitative EEG measures and cognitive tests in a group of patients beginning or ending AED therapy . METHODS Subjects included 20 patients beginning AED therapy ( AEDon ) , 12 patients stopping AED therapy ( AEDoff ) , 33 patient controls receiving stable AED therapy ( AEDco ) , and 73 healthy controls ( Nco ) . All subjects underwent structured EEG recording and a cognitive test battery before change in AED dose and again 12 - 16 weeks later , > or=4 weeks after the last dose change . Four occipital EEG measures ( peak frequency , median frequency , relative theta and delta power ) were analyzed . Cognitive test changes were scored by using test-retest regression equations based on the Nco subjects . Wilcoxon tests were used for two-group comparisons . RESULTS AEDons had a significant decrease , and AEDoffs , a significant increase in the peak frequency of the EEG rhythm , as compared with controls . Results for median frequency and theta power were similar . Change in the EEG peak frequency correlated with an aggregate cognitive change measure ( r2= 0.71 ; p individual cognitive measures , and subjective complaints . Of the combined AEDon/AEDoff patients , 58 % exceeded the 95 % confidence interval for test-retest change in EEG peak frequency . CONCLUSIONS Quantitative measures derived from the occipital EEG are sensitive to AEDs and correlate with AED-related cognitive effects and subjective complaints . Although this correlation does not indicate a direct relation , quantified EEG may be a practical measure of AED impact on the brain",
"1 . Twelve healthy male volunteers participated in four experimental occasions during each of which they were dosed with one of the following anti-psychotic drugs : chlorpromazine ( 50 mg ) , haloperidol ( 3 mg ) , sulpiride ( 400 mg ) and placebo . Drugs were allocated to subjects in a double-blind , crossover fashion . 2 . The subject 's mood state , psychometric performance and electroencephalogram ( EEG ) were assessed pre-dose , and at 2 , 4 , 6 , 8 , 24 and 48 h post-dose . Mood states were assessed using 16 visual analogue scales and psychomotor performance was measured using the following tests : elapsed time estimation , tapping rate , choice reaction times , a rapid information processing task , flash fusion threshold , a manipulative motor task , digit span , body sway and tremor . 3 . Chlorpromazine and haloperidol significantly reduced subjective ratings of ' alertness ' and ' contentedness ' , and haloperidol significantly reduced feelings of ' calmness ' . Sulpiride did not significantly affect any of the visual analogue scales . 4 . All three anti-psychotic drugs had similar EEG effects with peak effect 2 to 4 h postdose . The profile was characterised by an increase in the proportion of slow wave activity ( delta and theta ) as well as decreased alpha ( 8 - 14 Hz ) and faster ( beta ) wave activity . 5 . Chlorpromazine reduced tapping rate and increased choice reaction movement times . Haloperidol reduced the flash fusion threshold frequency at 6 h post-dose . Sulpiride prolonged the duration of the manipulative motor task , particularly at 48 h post-dose . 6 . All three anti-psychotic drugs impaired performance on the rapid information processing task . Chlorpromazine significantly reduced the number of correct letter pair identification s at 2 , 4 and 6 h post-dose , haloperidol at 4 , 6 , 8 , 24 and 48 h post-dose , and sulpiride at 24 h post-dose . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The aim of the study was to determine the possible differences in quantitative EEG parameters of schizophrenic patients before and during therapy with neuroleptics . First EEG recordings were obtained from schizophrenic patients ( n = 50 ) who had not been taking any medicaments during the preceding 2 months . Second EEG recordings were obtained during the administration of neuroleptic therapy . Amplitude values of particular spectral segment , i.e. delta , theta , alpha 1 , alpha 2 , beta 1 and beta 2 ( after fast Fourier transformation ) were analyzed . The F3 , F4 , C3 , C4 , T3 , T4 , P3 , P4 , O1 and O2 regions were observed . The effect of pharmacotherapy manifested as a decrease in delta and beta 2 activities . The alterations of the delta spectrum were recorded in each patient subgroup ( regardless of the neuroleptic used ) . The changes in beta 2 activity were registered in patients on haloperidol and fluphenazine",
"PURPOSE Antiepileptic drug ( AED ) therapy can be associated with neurotoxic side effects including cognitive dysfunction . Objective methods for detection of neurotoxicity in individual patients would be useful . We studied the effects of gabapentin ( GBP ) and carbamazepine ( CBZ ) on neurophysiologic and cognitive/behavioral measures in healthy volunteers . METHODS In a 12-week , r and omized , double-blind , parallel-group study of CBZ and GBP in healthy volunteers , 23 subjects completed the protocol . All achieved the target dose of 1,200 mg CBZ or 3,600 mg GBP . A structured EEG for quantitative analysis and a cognitive test battery were administered before AED therapy and again after 12 weeks of therapy . Test-retest differences were compared with those of 72 untreated control subjects . RESULTS Both CBZ and GBP significantly decreased the peak frequency of the posterior ( alpha ) rhythm , with CBZ exerting a greater effect . Ten CBZ and six GBP subjects exceeded the 95 % confidence interval ( CI ) for an individual . Cognitive tests revealed AED vs. control group effects for two of seven measures ( Digit Symbol , Stroop ) and all subjective measures . However , few subjects exceeded the 95 % CI for any objective test . Differences between CBZ and GBP were not significant . Greater EEG slowing was associated with greater subjective neurotoxicity and poorer test-retest performance on a cognitive test summary measure . CONCLUSIONS Prolonged CBZ and GBP therapy induced EEG slowing that correlated with cognitive complaints and often exceeded the confidence interval for individual subjects . Quantitative EEG measures may be useful in the objective determination of AED-related neurotoxicity",
"BACKGROUND The adverse effects of the antiepileptic drugs ( AEDs ) originally developed are well known , while those of the newer AEDs remain unclear . OBJECTIVE To investigate clinical , cognitive , and neurophysiologic effects of carbamazepine , oxcarbazepine , and levetiracetam in healthy volunteers . METHODS A double-blind crossover study was conducted in 10 volunteers . Eight-day treatment with carbamazepine , oxcarbazepine , levetiracetam , or placebo was administered in r and om order . Drug doses were titrated gradually to the daily target doses on day 7 : carbamazepine 800 mg , oxcarbazepine 1200 mg , and levetiracetam 1500 mg . At baseline and at the end of each treatment period , participants underwent cognitive and neurophysiologic assessment . A washout period of 14 days between treatment periods was conducted . RESULTS More adverse events were self-reported with carbamazepine ( 63 % ) than the other treatments ( oxcarbazepine 12 % , levetiracetam 20 % , placebo 5 % ; p Carbamazepine induced the greatest motor slowing ( p = 0.002 ) , followed by oxcarbazepine ( p = 0.01 ) . Levetiracetam left baseline motor speed unchanged . All AEDs increased attention span from baseline values as shown on the Stroop test . Quantitative electroencephalogram ( EEG ) analysis showed that carbamazepine significantly increased the delta – theta power and reduced the frequency of alpha rhythm ; oxcarbazepine induced smaller changes than carbamazepine . Levetiracetam did not change any EEG measurements . On color visually evoked potential ( VEP ) tests , carbamazepine induced a constant slowing of P1 latency , while oxcarbazepine induced changes only after the blue – black pattern . All color VEP measures for volunteers receiving levetiracetam were almost unchanged . CONCLUSIONS After short-term treatment in healthy volunteers , carbamazepine induced major clinical and neurophysiologic changes . Oxcarbazepine was better tolerated than carbamazepine . Levetiracetam interfered least with clinical and neurophysiologic test results",
"In a double-blind , placebo-controlled study the encephalotropic and psychotropic properties of gabapentin - a new gaba-analogue with anticonvulsant and antispastic properties penetrating the blood brain barrier easily - were studied in 10 normal subjects by means of quantitative pharmaco-EEG and psychometric analyses . They received r and omized and in weekly intervals single oral doses of 50 mg , 100 mg , 200 mg and 400 mg gabapentin as well as placebo . EEG recordings and evaluation of pulse , blood pressure and side effects were carried out after 0 , 1 , 2 , 4 , 6 and 8 hours ; psychometric tests were done at the same times except for the first hour . Computer-assisted spectral analysis of the EEG showed moderate though significant central effects of gabapentine in doses of 200 - 400 mg as compared with placebo , which were maximally pronounced in the 2nd hour post drug . These alterations were generally characterized by an attenuation of total power , augmentation of delta and theta activity and a decrease of alpha activity indicating CNS-inhibitory properties . Only at the late hours did the type of changes shift towards a vigilance-promoting one . Beta activity showed alternating changes . Psychometric and psychophysiological evaluations demonstrated subtle psychotropic effects as compared with placebo characterized mostly by an improvement in concentration , numerical memory , complex reaction and performance in the alphabetical reaction test while performance variability increased as well . Subjectively experienced well-being changed dose-dependently . CFF decreased after 100 mg as did pupil size after 50 - 200 mg . Evaluation of pulse , blood pressure and side effects demonstrated good tolerability of the drug",
"An array of variables have been assessed as potential early predictors of antidepressant response in depressed patients . This exploratory study examined the relationship of clinical outcome , following pharmacotherapeutic treatment , with quantitative electroencephalographic ( EEG ) features assessed prior to treatment onset . In 70 major affective disorder patients , pre-treatment spectrum-analysed topographic EEG indices ( absolute power , relative power , mean frequency , inter-hemispheric power asymmetry and coherence for 4 frequency b and s ) were assessed in relation to baseline HAM-D ratings and HAM-D rating changes following 6 weeks of open-label paroxetine treatment . EEG slow wave ( theta ) activities were positively correlated with depression ratings prior to treatment . Of the patients ( n = 51 ) completing treatment , 80 % evidence d a > 50 % reduction in HAM-D ratings . Improved rating changes in general were found to be negatively related to slow ( delta and theta ) wave activity and positively related to fast ( beta ) activity at frontal recording sites . Findings are discussed in relation to the neurochemistry and neurobiology of depressive disorders",
"PURPOSE Anatomical localization of the cortical effect of lamotrigine ( LTG ) in patients with idiopathic generalized epilepsy ( IGE ) . METHODS 19 patients with untreated IGE were investigated . EEG was recorded in the untreated condition and 3 months later when LTG treatment abolished the seizures . 19-channel EEG was recorded , and a total of 2min artifact-free , waking EEG was processed to low-resolution electromagnetic tomography ( LORETA ) analysis . Activity ( that is , current source density , A/m(2 ) ) was computed in four frequency b and s ( delta , theta , alpha , and beta ) , for 2394 voxels that represented the cortical gray matter and the hippocampi . Group differences between the untreated and treated conditions were computed for the four b and s and all voxels by multiple t-tests for interdependent data sets . The results were presented in terms of anatomical distribution and statistical significance . RESULTS p ( decrease of activity ) emerged in the theta and the alpha b and s. Theta activity decreased in a large cluster of voxels including parts of the temporal , parietal , occipital cortex bilaterally , and in the transverse temporal gyri , insula , hippocampus , and uncus on the right side . Alpha activity decreased in a relatively smaller cortical area involving the right temporo-parietal junction and surrounding parts of the cortex , and part of the insula on the right side . CONCLUSIONS LTG decreased theta activity in several cortical areas where abnormally increased theta activity had been found in a prior study in another cohort of untreated IGE patients [ Clemens , B. , Bessenyei , M. , Piros , P. , Tóth , M. , Seress , L. , Kondákor , I. , 2007b . Characteristic distribution of interictal brain electrical activity in idiopathic generalized epilepsy . Epilepsia 48 , 941 - 949 ] . These LTG-related changes might be related to the decrease of seizure propensity in IGE"
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BACKGROUND Hemostatic agents have been used clinical ly in dentistry for many years to control bleeding . The authors review ed scientific publications in which research ers investigated the effects of hemostatic agents on dentin and enamel surfaces and on bonding of adhesive systems and resin cements . TYPES OF STUDIES REVIEW ED The authors screened PubMed and Scopus data bases for studies in English published from 1980 to 2013 . They read the titles and abstract s to identify literature that fulfilled the inclusion criteria . The authors included studies in which research ers evaluated the hemostatic action on the dentin and enamel surfaces or its influence on the bond strength of adhesive systems or resin cements . They used cross-referencing to identify more articles . RESULTS Twenty in vitro studies met the inclusion criteria . Investigators in 12 of these studies evaluated the bond strength to contaminated dentin . Investigators in 10 of these studies reported a significant decrease in bond strength . Those in two studies evaluated the influence of a hemostatic agent on the dental enamel and reported decreases in bond strength . Research ers also reported significant increases in microleakage of self-etching adhesives on contaminated dentin . Scanning electron microscopy revealed partial removal of the smear layer or an etching effect of dentin as a result of the application of hemostatic agents on dentin . PRACTICAL IMPLICATION S Adhesive procedures may be affected adversely when performed on dentin and enamel contaminated by hemostatic agents . Hemostatic agents may induce changes in the dentin surface morphology . The results of this review indicate that the bond strength of self-etching adhesive systems is affected more negatively than is that of etch- and -rinse systems . The authors found that a 60-second application of ethylenediaminetetraacetic acid followed by a water spray restored the bond strength of a self-etching adhesive to dentin ; use of phosphoric acid for 15 seconds followed by a water spray also was an effective cleaning method . Direct comparison of selected studies was not possible , however , mainly because of method ological differences hampering definitive conclusions | [
"PURPOSE The effects of 2 chemical retraction agents on gingival blood flow and systemic blood pressure in subjects with healthy gingiva were investigated . MATERIAL S AND METHODS Thirty volunteer dental students were selected for the study and r and omly divided into 2 groups . Aluminium chloride-impregnated cord ( right side ) and nonimpregnated cord ( left side ) were placed in the gingival sulcus of group 1 . Epinephrine-impregnated cord ( right side ) and nonimpregnated cord ( left side ) were placed in group 2 . Blood flow in the retracted marginal gingiva was measured by laser Doppler flowmetry , and the systemic blood pressures of subjects were recorded before and after the retraction procedure . RESULTS A statistically significant decrease in blood flow was observed in group 2 , but there was no significant change in gingival blood flow in group 1 . A decrease in diastolic blood pressure of the subjects in group 2 was also observed . However , there was no significant change in blood pressure of the subjects in group 1 . CONCLUSION Gingival retraction affects gingival blood flow temporarily . Epinephrine-impregnated cords can be used safely in patients who have healthy gingiva , if patient stress and gingival trauma are avoided during cord placement",
"Aim : The aim of this in vitro study was to evaluate the microleakage of two different generation bonding agents in the presence of various surface contaminants . Material s and Methods : Class V cavities were prepared on 150 extracted human permanent molars . The sample s were r and omly divided into two main groups of 75 teeth each . Group I : Fifth generation bonding system ( Single Bond , 3 M ) . Group II : Seventh generation bonding system ( iBond , Kulzer ) . Subgroups were formed according to exposure to different surface contaminants ( saliva , blood , caries disclosing agent and haemostatic agent ) . Cavities were restored with hybrid composite ( Z-100 , 3 M ) and evaluated for microleakage . The scores were subjected to ‘ t ’ test and analysis of variance ( ANOVA ) test . Results : Single Bond and iBond did not provide complete resistance to microleakage when there was no contamination . Microleakage was minimum in the no contamination subgroup and maximum with the haemostatic agent subgroup for both the groups . Conclusion : Single bond showed lesser micro leakage in contaminated conditions",
"Objective : This in vitro study evaluated the effect of Ankaferd Blood Stopper ( ABS ) contamination on the microleakage of one-step and two-step self-etching adhesives . Study design : Class V cavities were prepared at the cemento-enamel junction on both buccal and lingual surfaces of 60 freshly extracted human molars . Teeth were r and omly assigned into three groups according to contamination material applied ( Group I , no contamination ; Group II , blood contamination ; Group III , ABS contamination ) . In contaminated groups , one drop of blood and ABS solution was applied directly to the dentin surface and air-dried . Each group was further divided into two subgroups according to bonding agent used [ Group A , Clearfil SE Bond ( two-step self-etching adhesive ) ; Group B , Adper Easy One ( one-step self-etching adhesive ) ] . Adhesive material s were applied according to the manufacturers ’ recommendations . The specimens were restored using a universal microhybrid composite ( Arabesk ) . After thermocycling ( 5000x , 5 ° C – 55 ° C ) and immersion in a 0.5 % basic fuchsin , dye penetration was evaluated under a stereomicroscope . Statistical analysis was performed with Kruskal-Wallis and Mann-Whitney U tests at p higher microleakage scores were observed when one-step self-etching adhesive was applied to blood- and ABS-contaminated dentin . However , when a two-step self etching adhesive was used , microleakage was observed only following blood contamination , not following ABS contamination . Conclusions : Although , blood contamination before adhesive application result ed in increased microleakage with both one-step and two-step self-etching adhesive systems , ABS contamination did not affect microleakage when a two-step self-ething adhesive system was used . Key words : Ankaferd Blood Stopper , blood , microleakage , self-etching adhesive ",
"Objectives : Since hemostatic agents can induce changes on enamel and dentin surfaces and influence composite resin adhesion , the aim of the present study was to evaluate the effect of the aluminum chloride hemostatic agent on the gingival margin microleakage of class V ( Cl V ) composite resin restorations bonded with all-in-one adhesive . Study design : Cl V cavities were prepared on the buccal surfaces of 60 sound bovine permanent incisors . Gingival margins of the cavities were placed 1.5 mm apical to the cemento-enamel junction ( CEJ ) . The teeth were r and omly divided into two groups of 30 . In group 1 , the cavities were restored without the application of a hemostatic agent ; in group 2 , the cavities were restored after the application of the hemostatic agent . In both groups all-in-one adhesive and Z250 composite resin were used to restore the cavities with the incremental technique . After finishing and polishing , the sample s underwent a thermocycling procedure , followed by immersion in 2 % basic fuschin solution for 24 hours . The sample s were sectioned and gingival microleakage was evaluated under a stereomicroscope . The non-parametric Mann-Whitney U test was used to compare microleakage between the two groups . Statistical significance was defined at P microleakage between the two groups ( P aluminum chloride hemostatic agent significantly increases restoration gingival margin microleakage . Key words : All-in-one adhesive resin , composite resin restoration , hemostatic agent , microleakage",
"Objective : The purpose of this study was to evaluate the effects of blood contamination and haemostatic agents such as Ankaferd Blood Stopper ( ABS ) and hydrogen peroxide ( H2O2 ) on the microtensile bond strength between dual cured resin cement-dentin interface . Material and Methods : Twelve pressed lithium disilicate glass ceramics were luted to flat occlusal dentin surfaces with Panavia F under the following conditions : Control Group : no contamination , Group Blood : blood contamination , Group ABS : ABS contamination Group H2O2 : H2O2 contamination . The specimens were sectioned to the beams and microtensile testing was carried out . Failure modes were classified under stereomicroscope . Two specimens were r and omly selected from each group , and SEM analyses were performed . Results : There were significant differences in microtensile bond strengths ( µTBS ) between the control and blood-contaminated groups ( p0.05 ) . Conclusions : Contamination by blood of dentin surface prior to bonding reduced the bond strength between resin cement and the dentin . Ankaferd Blood Stoper and H2O2 could be used safely as blood stopping agents during cementation of all-ceramics to dentin to prevent bond failure due to blood contamination",
"STATEMENT OF PROBLEM The presence of irrigation solution prior to the application of dentin bonding agents may be one source of contamination and may adversely affect bond strength . PURPOSE The purpose of this in vitro investigation was to evaluate the effect of irrigation solutions of different purity levels on the shear bond strength of a hybrid composite to dentin . MATERIAL AND METHODS Forty extracted , intact human molars were h and -scaled . All soft tissue was removed , and the teeth were stored in room-temperature tap water for 1 week . Subsequently , each tooth was embedded in autopolymerizing acrylic resin with the coronal portion exposed . After complete polymerization of the resin , the dentin surfaces were exposed , and the crown was cut longitudinally on all 4 sides to produce flat dentin surfaces for bonding . The prepared specimens were assigned to 4 groups of irrigation solutions : tap water ( control ) , sterile water , 0.9 % NaCl irrigation solution , and filtered water . Within each irrigation group were 4 dentin bonding agent subgroups : Prime & Bond NT , One-Step , Single Bond Adhesive , and OptiBond Solo . The dentin surfaces ( n = 10 per irrigation/bonding agent pair ) were etched with 37 % phosphoric acid , rinsed with the assigned irrigation solution for 15 seconds , and then dried . Plastic cylinders ( 3 mm long x 3 mm inner diameter ) were filled with a hybrid composite ( Herculite XRV ) and bonded to the dentin . Specimens were loaded in a universal testing machine , and shear force was applied to the base of the composite cylinders , parallel to the dentin surfaces , at a crosshead speed of 0.05 in/min until fracture . Failure loads were recorded . Bond strength data were compared with analysis of variance ( P Tap water irrigation ( control ) produced no significant difference in bond strengths for all dentin bonding agents tested . When other irrigation solutions were used , One-Step consistently produced significantly lower bond strengths than other dentin bonding agents ( P bond strengths ( P<.05 ) . CONCLUSION Within the limitations of this study , the bond strength to dentin of a hybrid composite irrigated with different solutions was dependent on the dentin bonding agent used",
"Aim : This study investigated the effect of one hemostatic agent on the shear bond strength of self-etch and etch- and -rinse adhesive systems . Material s and Methods : Sixty extracted third molars were selected . After preparing a flat surface of superficial dentin , they were r and omly divided into six groups . Adhesives were Tetric N-Bond , AdheSE , and AdheSE One F. Before applying adhesives , surfaces were contaminated with ViscoStat for 60 s in three groups and rinsed . Then composite were attached to surfaces and light cured . After thermocycling , the bond strength was calculated and failure modes were determined by stereomicroscope . The data were analyzed by t-test and one-way ANOVA with P shear bond strength of AdheSE ( P Modes of failures in all groups were mainly adhesive . Conclusion : Contamination had an adverse effect on the shear bond strength of AdheSE and reduced it",
"OBJECTIVE To determine the effect of Ankaferd Blood Stopper ( ABS ) on the shear bond strength ( SBS ) of orthodontic attachments . MATERIAL S AND METHODS The study material consisted of 60 freshly extracted bovine permanent m and ibular incisor teeth . All teeth were cleaned and r and omly divided into three groups of 20 specimens and etched with 37 % phosphoric acid for 15 seconds , washed , and air-dried . Teeth in groups 1 and 2 were contaminated with ABS and blood , respectively . Teeth in group 3 were only air-dried . Roth Generous maxillary central incisor brackets were bonded with Transbond XT to all teeth . SBS was applied using a universal test machine . The one-way analysis of variance ( ANOVA ) test was used to determine significant differences in SBS between the three groups , and Tukey honestly significant post hoc test was used to compare subgroups . RESULTS The mean bond strengths and st and ard deviations of groups 1 , 2 , and 3 were 9.58 + /- 0.95 , 4.04 + /- 0.69 , and 19.56 + /- 1.84 MPa , respectively . CONCLUSIONS Specimens contaminated with blood showed a statistically significant lower in vitro SBS than those contaminated with ABS . ABS may be used clinical ly for obtaining a blood-free tooth surface during application of the brackets on surgically exposed , impacted teeth",
"This study evaluated in vitro the influence of a temporary filling { zinc oxide-eugenol ( ZOE ) } and two pulpotomy agents { formocresol ( FC ) and ferric sulfate ( FS ) } on shear bond strength ( SBS ) of two dentin adhesives to the dentin of primary molars . A total of 80 dentin surfaces were prepared and r and omly allocated into 10 groups of 8 specimens each . Groups were subjected to different treatments , which included covering with a paste of ZOE mixed at different powder : liquid ( P : L ) ratios , placement on a gauze soaked in FC or FS , or they received no pretreatment and served as a control . XRV Herculite composite cylinders were bonded to dentin surfaces using Prime and Bond NT adhesive resin or Opti Bond Solo Plus adhesive resin . SBSs were determined using the lnstron testing machine running at a crosshead speed of 0.5 mm/min . The use of ZOE mixed at the lower P : L ratio of 10g:2 g significantly decreased the values of SBS of the two adhesives . The use of two pulpotomy agents ( FC and FS ) significantly decreased the SBS of the two adhesives . The bond strength to dentin of primary teeth was influenced by the pulpotomy agents used and the ZOE P : L ratio but not by the adhesive system used",
"This study investigated the effect of Ankaferd Blood Stopper ( ABS ) contamination on bond strength of total- and self-etching systems . Seventy m and ibular third molars sectioned in a mesio-distal direction were mounted in acrylic resin , and flat dentin surfaces were exposed . The specimens were r and omly assigned to seven groups ( n=20 ) , according to the surface treatment : Group I , ABS contamination+37 % phosphoric acid+Solobond M ; Group II , ABS contamination+Clearfil SE Bond ; Group III , ABS contamination+All Bond SE ; Group VI , 37 % phosphoric acid+ABS contamination+Solobond M ; Group V , Solobond M ; Group VI , Clearfil SE Bond ; and Group VII , All Bond SE . Next , a resin composite ( Gr and io ) was built up using a plastic apparatus and polymerized . The specimens were tested in shear mode at a crosshead speed of 1 mm/min . There were significant differences in bond strengths between the control and ABS-contaminated sample s. These findings suggest that ABS contamination reduced bond strength of total- and self-etching adhesives",
"This study evaluated the effect of tooth-preparation cleansing protocol s on the bond strength of a self-adhesive resin cement to dentin contaminated with two different types of hemostatic agents . The occlusal surface of extracted third molars was flattened to expose the dentin surface and prepared for a full crown . Acrylic temporary crowns were fabricated and placed using temporary cement . The specimens were stored at 100 % relative humidity for seven days . Following removal of the temporary crowns , the specimens were surface debrided using aluminum oxide abrasion with a particle size of 27 μm at 40 psi . The specimens were r and omly assigned to three groups , according to the hemostatic agents : Group I – an agent containing aluminum chloride was applied to the tooth surface ; Group II – an agent containing ferric sulfate was applied to the tooth surface and Group III – uncontaminated ( control ) . The contaminated specimens were then further subdivided into three subgroups ( A – C ; n=12 ) : Group A – tooth surface cleansing with water spray ; Group B – tooth surface cleansing with phosphoric acid etch and Group C – tooth surface cleansing with aluminum oxide abrasion with a particle size of 27 μm at 40 psi . Ceramic blocks were treated with a 9.5 % hydrofluoric acid-etch and silanized prior to being cemented with self-adhesive resin luting agent ( RelyX Unicem ) to the prepared dentin . The shear bond strength was determined at a crosshead speed of 0.5 mm/minute . The data were analyzed with two-way ANOVA , followed by the Duncan multiple range test , to determine any significant differences between the testing groups . The microstructure morphology of the tooth surface was evaluated using SEM analysis . The results revealed that there was a significant difference between the bond strength of the control and the contaminated testing groups ( p tooth preparation cleansing protocol using particle abrasion with low-pressure aluminum oxide particles provided a significant improvement in bond strength to contaminated dentin , while rinsing with water spray result ed in the lowest mean bond strength of the self-adhesive resin cement to dentin ( p<0.05 )",
"This study evaluated the bond strength of a total-etch and a self-etch adhesive to dentin contaminated with a hemostatic agent containing aluminum chloride ( AlCl3 ) . Eighteen occlusal dentin discs were prepared from human molars . Each disc was ground and sectioned into two halves , one for normal dentin and the other for contaminated dentin . The specimens of both normal and contaminated dentin were r and omly divided into three groups and treated with the following material s : ( 1 ) Excite ( EX ) ; ( 2 ) Clearfil SE Bond with 20-second primer application time ( CB 20 ) and ( 3 ) Clearfil SE Bond with 40-second primer application time ( CB 40 ) . The microshear bond strength specimens were prepared using the resin composite Clearfil APX . The bond strengths were evaluated on a universal testing machine . Statistical analysis was performed at alpha = 0.05 . The surface micromorphology and aluminum content of the different dentin conditions were also examined . In EX , no significant difference was found between the bond strengths of normal dentin and contaminated dentin . The bond strength of CB20 to contaminated dentin was significantly lower than that to normal dentin . The extension of primer application time from 20 to 40 seconds significantly increased the bond strength of CB to contaminated dentin ",
"PURPOSE To examine the effects of the hemostatic agents ViscoStat and ViscoStat Plus on the shear bond strength ( SBS ) of composite resin ( CR ) to dentin in the presence and absence of blood . MATERIAL S AND METHODS Sixty permanent teeth mounted in acrylic were r and omly divided into 5 groups ( n = 12 ) : ( 1 ) control , C ; ( 2 ) ViscoStat , VS ; ( 3 ) ViscoStat Plus , VS+ ; ( 4 ) ViscoStat and blood , VS/B ; ( 5 ) ViscoStat Plus and blood , VS+/B. Groups 2 and 3 were exposed to VS and VS+ , respectively . Freshly drawn human blood was placed on groups 4 and 5 immediately followed by VS and VS+ , respectively . Specimens remained undisturbed for 1 min and were rinsed with tap water for 1 min . All groups were etched with 35 % phosphoric acid and were bonded utilizing the Ultradent bonding clamp , Optibond Solo Plus , and Z-250 composite resin . Following water storage for 48 hrs at 37 degrees C , specimens were debonded in an Instron test frame at a crosshead speed of 0.5 mm/min . Statistical analysis was done with one-way analysis of variance . RESULTS The mean SBS+/-SD in MPa were C : 44.2+/-4.8 , VS : 42.3+/-8.7 , VS+ : 46.2+/-7.8 , VS/B : 43.0+/-6.4 , VS+/B : 44.0+/-8.1 . ANOVA revealed no significant difference ( p > 0.05 ) between SBS of VS or VS+ and the control with or without blood present . ostatic CONCLUSION This controlled laboratory study concluded that the use of ViscoStat or ViscoStat Plus as a hem agent does not have a significant effect on the shear bond strength of composite resin to dentin when using Optibond Solo Plus",
"This study evaluated the effect of saliva contamination and decontamination methods on the dentin bond strength of one-step self-etching adhesive systems . Three commercially available \" all-in-one \" adhesives ( One Up Bond F , Xeno III and Adper Prompt ) and one resin composite ( Filtek Z-250 ) were used . Third molars stored in distilled water with 0.5 % thymol at 4 degrees C were ground with # 600 SiC paper under running water to produce a st and ardized smear layer . The specimens were r and omly divided into groups according to contamination methods : no contamination , which was the control ( C ) ; contamination of the adhesive surface with fresh saliva before light curing ( A ) and contamination of the adhesive surface with fresh saliva after light curing ( B ) . Each contamination group was further subdivided into three subgroups according to the decontamination method : A1-Saliva was removed by a gentle air blast and the adhesive was light-cured ; A2-Saliva was rinsed for 10 seconds , gently air-dried and the was adhesive light-cured ; A3-Saliva was rinsed and dried as in A2 , then the adhesive was re-applied to the dentin surface and light-cured ; B1-Saliva was removed with a gentle air blast ; B2-Saliva was rinsed and dried ; B3-Saliva was rinsed , dried and the adhesive was re-applied and light cured . Tygon tubes filled with resin composite were placed on each surface and light cured . All specimens were stored in distilled water at 37 degrees C for 24 hours . Microshear bond strength was measured using a universal testing machine ( EZ test ) , and data were analyzed by one-way ANOVA followed by the Duncan test to make comparisons among the groups ( p modes of fracture . The A2 subgroup result ed in the lowest bond strength . For One Up Bond F and Adper Prompt , there was no significant difference between subgroup A1 and the control , and subgroup A3 and the control ( p>0.05 ) . Bond strengths of all B groups were significantly lower compared to the controls ( p greatest decrease in bond strength as compared to the control ( p resistance to salivary contamination after adhesive curing . There was no statistically significant difference among the control groups ( p>0.05 )"
] | 41166802-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND AND PURPOSE Only a few r and omized controlled trials in acute stroke have shown a treatment-related benefit . Inadequate trial design , especially low sample size , may partly explain this failure . We investigated sample size calculations ( SSCs ) in a systematic review of acute stroke trials . METHODS Full reports of nonconfounded r and omized controlled trials that recruited patients within 1 week of stroke onset and were published before the end of 2001 were identified from the Cochrane Library and other bibliographic data bases . Information on the SSC and outcome event rates was collected for each trial . RESULTS Of 189 identified trial reports , 57 ( 30 % ) reported > or = 1 components of the SSC , phase II 14/129 ( 11 % ) versus phase III 43/60 ( 72 % ) ( P case fatality 21.8 % ( 11.8 % , 23.5 % , n=4 ) and combined death or disability/dependency 55.5 % ( 44.5 % , 66.3 % , n=20 ) ; 25 studies used other outcomes and 8 studies gave insufficient information . Four of the 22 trials achieved a control rate within 5 % of their prediction . 49 ( 86 % ) reports gave the anticipated treatment effect ; case fatality : anticipated 9.5 % ( 1.1 % , 12.5 % , n=6 ) , achieved -0.3 % ( -4.1 % , + 2.4 % ) ; combined death or disability/dependency : anticipated 13.0 % ( 10.0 % , 16.0 % , n=25 ) , achieved 1.8 % ( -0.5 % , + 5.4 % ) . The median calculated sample size was 600 ( 198 , 995 , n=54 ) . CONCLUSIONS Too few trial publications report the assumptions underlying their SSC . Most trials were underpowered , ie , power < 0.90 , used inappropriate assumptions for event rates , and were grossly overoptimistic in their expectation of treatment effect . These deficiencies will together have result ed in trials being far too small and reduced their chance of being able to detect real treatment effects | [
"BACKGROUND AND PURPOSE The efficacy and safety of the neuroprotective drug clomethiazole was tested in a double blind placebo controlled trial in patients with a clinical diagnosis of acute hemispheric stroke . METHODS Patients with symptom onset of Clomethiazole ( 75 mg/kg ) or placebo was given as an intravenous infusion over a 24-hour period . Patients were followed up for 90 days . The primary efficacy variable was the proportion of patients reaching relative functional independence ( > /=60 points on the Barthel Index ) at 90 days . RESULTS A total of 1360 patients were included . In the main efficacy analysis ( n=1353 ) , 56.1 % of patients taking clomethiazole and 54.8 % of placebo patients reached relative functional independence . The difference was not statistically significant . An analysis of the effect of time since onset of symptoms showed no difference between the treatment groups . Clomethiazole was generally well tolerated and appeared safe in the population studied . Sedation was the most common adverse event , leading to treatment withdrawal that occurred in 15.6 % of clomethiazole-treated patients compared with 4.2 % of placebo-treated patients . In a subgroup classified before r and omization as having total anterior circulation syndrome ( TACS ) ( n=545 , or 40 % of all r and omized patients ) , the percentage of those reaching relative functional independence was 40.8 % on clomethiazole and 29.8 % on placebo , a difference of approximately 11 percentage units . TACS patients have clinical symptoms suggesting a \" large \" stroke . CONCLUSIONS Clomethiazole had no adverse or beneficial effect on long-term outcome for all patients but produced sedation . The hypothesis that clomethiazole is effective in patients with large strokes will be tested in a further study",
"Background and Purpose The Early Stroke Trial ( EST ) is a r and omized , double-blind , placebo-controlled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke . Methods Sixteen clinical centers recruited 805 patients , of whom 792 were confirmed to be eligible . Treatment , consisting of a first dose of either 200 mg GM-1 or placebo , was initiated within 5 hours of the onset of stroke ; a second dose of either 100 mg GM-1 or placebo was administered 12 hours later . Thereafter , patients received a daily injection of 100 mg GM-1 or placebo intravenously from day 2 through 10 and intramuscularly from day 11 through 21 . Patients were followed up for a total of 4 months . Results Survival was similar in the two treatment groups . Improvement in neurological status , as measured by the change in Canadian Neurological Scale score between baseline and 4-month assessment s , was greater in the group receiving GM-1 ; the observed difference between treatment groups was 0.22 ( P=.06 ) . A post hoc analysis in the subgroup of patients treated within 4 hours showed a statistically significant difference , with Canadian Neurological Scale mean improvement of 0.41 ( P=.016 ) . GM-1 use was not associated with differences in frequency , nature , or severity of adverse experiences . Conclusions These findings suggest that GM-1 is safe in the dose and treatment schedule used and that its efficacy in ischemic stroke is greater when given soon after onset of stroke",
"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 AND PURPOSE It is not yet known which end points are the most suitable for evaluation of the effects of acute stroke intervention . The European Cooperative Acute Stroke Study ( ECASS ) I study used 2 primary end points . The study was powered to detect a 15 % improvement of the median of each primary end point . The study failed to show this effect and was negative in the intention-to-treat analysis . The National Institute of Neurological Disorders and Stroke ( NINDS ) study used 4 dichotomized end points and applied a global end-point analysis . This study was positive and led to FDA approval of thrombolytic therapy for acute ischemic stroke . This study was undertaken to answer the question of whether a different statistical design may have shown a positive results of the ECASS I trial . METHODS We performed a retrospective analysis of the ECASS I intention-to-treat data set ( 615 r and omized and treated patients , rtPA treatment versus placebo ) and post hoc application of the NINDS trial statistical methodology ( global end-point analysis ) . The scores of the modified Rankin Scale ( mRS ) , Barthel Index ( BI ) , and the National Institutes of Health Stroke Scale ( NIHSS ) were dichotomized according to the criteria used in the NINDS trial . Favorable outcome was defined as a score of 0 or 1 on mRS , a score of 95 or 100 on BI , and a score of 0 or 1 on NIHSS . RESULTS The number of patients reaching favorable outcome were higher in all 3 end points in the rtPA-treated group . The effect sizes were 8 % for mRS , 6 % for BI , and 14 % for NIHSS , respectively . The differences are statistically significant for the mRS ( P=0.044 ; odds ratio [ OR ] , 1 . 4 ; 95 % confidence interval [ CI ] , 1.0 to 2.0 ) and the NIHSS ( P=0.001 ; OR , 1.9 ; 95 % CI , 1.4 to 2.8 ) , while for the BI significance was missed ( P=0.102 ; OR , 1.3 ; 95 % CI , 0.9 to 1.8 ) . The global end-point statistics , however , shows a significant increase ( P=0.008 ; OR , 1.5 ; 95 % CI , 1.1 to 2.0 ) of favorable outcome in the rtPA-treated patient group . CONCLUSIONS Using the global end-point analysis , ECASS is positive in the intention-to-treat analysis . This may indicate that the time window for thrombolysis may be as long as 6 hours . Looking at the 3 dichotomized end points , the effect sizes for 2 end points , mRS and BI , are smaller in the ECASS 6-hour intention-to-treat population compared with the NINDS trial , whereas the effect size for the NIHSS is larger . While in the NINDS trial all 3 end points reveal statistically significant results , in ECASS only 2 of the 3 corresponding end points , mRS and NIHSS , were statistically significant . This finding underlines an important difference of a global end-point approach : it may show a positive overall result although one of the end points is not positive",
"The efficacy and safety of pentoxifylline were assessed in 297 adult patients with ischemic stroke in a multicenter , double-blind , r and omized and placebo-controlled trial . Treatment was started within 12 hours after the stroke onset . Study medication was administered intravenously continuously ( 16 mg/kg/day , maximum 1,200 mg/day ) for 3 days and per os ( 400 mg t.i.d . ) for the remainder of 28 days . Demographic data were comparable , and functional impairment and mortality ( pentoxifylline 12 % , placebo 10 % ) were not different between the two groups . Neurologic deficit scores improved from baseline admission scores during the 4-week study in both groups but did not differ between groups at admission or throughout the study except during the first few days when the consciousness level ( Days 1 and 2 ) , motor function ( Days 1 and 2 ) , cranial nerve function ( Days 1 - 4 ) , and total neurologic deficit scores ( Days 1 and 2 ) were better in the pentoxifylline group than in the placebo group , especially in a subset of patients with severe deficits at admission . Laboratory values and side effects were also comparable between groups . Our study indicates that pentoxifylline can be given safely in patients with acute ischemic stroke . Although pharmacologic effects were present during the first few days , the clinical benefits were small and not sustained",
"BACKGROUND Despite doubts about their efficacy and concern about their safety , antithrombotic agents are often used to treat acute ischemic stroke . Recent experience in patients with other thromboembolic disorders suggests that low-molecular-weight heparin , which requires only subcutaneous administration once or twice daily , may be more effective and safer than st and ard ( unfractionated ) heparin . METHODS We conducted a r and omized , double-blind , placebo-controlled trial comparing two dosages of low-molecular-weight heparin with placebo in the treatment of ischemic stroke . Patients were r and omly assigned within 48 hours of the onset of symptoms to receive high-dose nadroparin ( 4100 anti-factor Xa IU twice daily ) , low-dose nadroparin ( 4100 IU once daily ) , or placebo subcutaneously for 10 days . The primary measure of outcome was death or dependency regarding activities of daily living six months after r and omization . Secondary outcomes were death , hemorrhagic transformation of the infa rct ion , and other complications at 10 days , and death or dependency at 3 months . RESULTS A total of 2750 patients were screened for the study . Among 312 patients r and omized , 306 had outcomes that were analyzed at six months . Forty-five patients ( 45 percent ) in the high-dose group , 53 patients ( 52 percent ) in the low-dose group , and 68 patients ( 65 percent ) in the placebo group died or became dependent . There was a significant dose-dependent effect among the three study groups in favor of low-molecular-weight heparin ( P = 0.005 by the chi-square test for trend ) . No significant differences among the groups in the occurrence of secondary outcomes were observed at 10 days . CONCLUSIONS For patients with ischemic stroke treated within 48 hours of the onset of symptoms , low-molecular-weight heparin was effective in improving outcomes at six months",
"BACKGROUND Early treatment may improve acute ischaemic stroke outcome . Gavestinel is a selective antagonist at the glycine site of the N-methyl-D-aspartate ( NMDA ) receptor , and is neuroprotective in animal models of ischaemic stroke . METHODS We did a r and omised , double-blind , placebo-controlled trial to test whether gavestinel could improve functional outcome after acute stroke in human beings . Conscious patients with stroke involving limb weakness received either gavestinel at an intravenous loading dose of 800 mg followed by 200 mg every 12 h for five doses , or matching placebo , within 6 h of stroke onset . Stratification variables were age and stroke severity . A computed tomography brain scan within 18 h of stroke onset identified the primary efficacy population with ischaemic stroke . Outcome was assessed by an independent observer with the Barthel index at 3 months . Three outcome categories were applied : good ( Barthel index 95 - 100 ) , moderate ( 60 - 90 ) , and poor ( 0 - 55 or dead ) . Analysis was by intention to treat . FINDINGS Of 1804 patients r and omised , 16 received no treatment , and 333 had primary intracranial haemorrhage . 891 patients received gavestinel and 897 received placebo . Outcome in 721 patients who received gavestinel and were analysed for the primary endpoint at 3 months was good in 246 ( 34.1 % ) , moderate in 136 ( 18.8 % ) , and poor in 339 ( 47.0 % ) , compared with 256 ( 34.9 % ) , 133 ( 18.1 % ) , and 345 ( 47.0 % ) , respectively , of 734 patients who received placebo ( p=0.8 ) . Mortality at 3 months was 147 ( 20.4 % ) in the gavestinel group and 138 ( 18.8 % ) in the placebo group . Outcomes within preplanned subgroup and secondary analyses were also neutral . There were no significant differences in serious side-effects between the groups . INTERPRETATION Treatment with gavestinel within 6 h of acute ischaemic stroke did not improve outcome",
"Backgound and Purpose — The Very Early Nimodipine Use in Stroke ( VENUS ) trial was design ed to test the hypothesis that early treatment with nimodipine has a positive effect on survival and functional outcome after stroke . This was suggested in a previous meta- analysis on the use of nimodipine in stroke . However , in a recent Cochrane review we were unable to reproduce these positive results . This led to the early termination of VENUS after an interim analysis . Methods — In this r and omized , double-blind , placebo-controlled trial , treatment was started by general practitioners or neurologists within 6 hours after stroke onset ( oral nimodipine 30 mg QID or identical placebo , for 10 days ) . Main analyses included comparisons of the primary end point ( poor outcome , defined as death or dependency after 3 months ) and secondary end points ( neurological status and blood pressure 24 hours after inclusion , mortality after 10 days , and adverse events ) between treatment groups . Subgroup analyses ( on final diagnosis and based on the per- protocol data set ) were performed . Results — At trial termination , after inclusion of 454 patients ( 225 nimodipine , 229 placebo ) , no effect of nimodipine was found . After 3 months of follow-up , 32 % ( n=71 ) of patients in the nimodipine group had a poor outcome compared with 27 % ( n=62 ) in the placebo group ( relative risk , 1.2 ; 95 % CI , 0.9 to 1.6 ) . A treatment effect was not found for secondary outcomes and in the subgroup analyses . Conclusions — The results of VENUS do not support the hypothesis of a beneficial effect of early nimodipine in stroke patients",
"CONTEXT Elucidation of the ischemic cascade has helped stimulate development of neuroprotective drugs aim ed at limiting brain injury in the hours following an ischemic stroke . To date , none of these drugs has shown clinical efficacy . OBJECTIVE To examine the efficacy of gavestinel ( GV150526 ) , an antagonist of the glycine site of the N-methyl-D-aspartate receptor , as a neuroprotective therapy for acute ischemic stroke when administered within 6 hours of symptom onset . DESIGN The Glycine Antagonist in Neuroprotection ( GAIN ) Americas trial , a r and omized , double-blind placebo-controlled trial with enrollment from April 1998 to October 1999 . SETTING One hundred thirty-two hospital centers across the United States and Canada . PATIENTS The primary efficacy population consisted of 1367 ischemic stroke patients with a predefined level of limb weakness and functional independence prior to stroke , stratified at r and omization by age ( 75 years ) and initial stroke severity ( National Institutes of Health [ NIH ] Stroke Scale scores of 2 - 5 , 6 - 13 , or > /=14 ) . INTERVENTION Patients were r and omly assigned to receive an intravenous loading dose ( 800 mg ) plus 5 maintenance doses ( 200 mg every 12 hours ) of gavestinel ( n = 701 ) or placebo ( n = 666 ) for 3 days . MAIN OUTCOME MEASURE Functional capability at 3 months , measured by the Barthel Index ( BI ) , with scores trichotomized as dead/0 - 55 , 60 - 90 , and 95 - 100 , compared between the gavestinel and placebo groups . RESULTS Treatment groups were well matched for baseline characteristics . For each group , median NIH Stroke Scale was 12 , median age was 72 years , and median time to treatment was 5.2 hours . No statistically significant improvement on the 3-month BI trichotomy was demonstrated for gavestinel ( P = .79 ) . The proportion who were functionally independent ( BI score = 95 - 100 ) was 39 % in the gavestinel group and 37 % in the placebo group . No statistically significant difference in 3-month survival was observed using Kaplan-Meier curves ( P = .11 ) . No other secondary end point suggested an advantage for gavestinel . Among the 333 patients ( 24 % ) who received recombinant tissue-type plasminogen activator , there was also no benefit for gavestinel ( P = .53 ) . There were no serious safety issues . CONCLUSION In this study , gavestinel administered up to 6 hours after an acute ischemic stroke did not improve functional outcome at 3 months",
"BACKGROUND Aspirin is effective in the treatment of acute myocardial infa rct ion and in the long-term prevention of serious vascular events in survivors of stroke and myocardial infa rct ion . There is , however , no reliable evidence on the effectiveness of early aspirin use in acute ischaemic stroke . METHODS The Chinese Acute Stroke Trial ( CAST ) was a large r and omised , placebo-controlled trial of the effects in hospital of aspirin treatment ( 160 mg/day ) started within 48 h of the onset of suspected acute ischaemic stroke and continued in hospital for up to 4 weeks . The primary endpoints were death from any cause during the 4-week treatment period and death or dependence at discharge , and the analyses were by intention to treat . 21,106 patients with acute ischaemic stroke were enrolled in 413 Chinese hospitals at a mean of 25 h after the onset of symptoms ( 10,554 aspirin , 10,552 placebo ) . 87 % had a CT scan before r and omisation . It was prospect ively planned that the results would be analysed in parallel with those of the concurrent . International Stroke Trial ( IST ) of 20,000 patients with acute stroke from other countries . FINDINGS There was a significant 14 % ( SD 7 ) proportional reduction in mortality during the scheduled treatment period ( 343 [ 3.3 % ] deaths among aspirin-allocated patients vs 398 [ 3.9 % ] deaths among placebo-allocated patients ; 2p = 0.04 ) . There were significantly fewer recurrent ischaemic strokes in the aspirin-allocated than in the placebo-allocated group ( 167 [ 1.6 % ] vs 215 [ 2.1 % ] ; 2p = 0.01 ) but slightly more haemorrhagic strokes ( 115 [ 1.1 % ] vs 93 [ 0.9 % ] ; 2p > 0.1 ) . For the combined in-hospital endpoint of death or non-fatal stroke at 4 weeks , there was a 12 % ( 6 ) proportional risk reduction with aspirin ( 545 [ 5.3 % ] vs 614 [ 5.9 % ] ; 2p = 0.03 ) , an absolute difference of 6.8 ( 3.2 ) fewer cases per 1000 . At discharge , 3153 ( 30.5 % ) aspirin-allocated patients and 3266 ( 31.6 % ) placebo-allocated patients were dead or dependent , corresponding to 11.4 ( 6.4 ) fewer per 1000 in favour of aspirin ( 2p = 0.08 ) . INTERPRETATION There are two major trials of aspirin in acute ischaemic stroke . Taken together , CAST and the similarly large IST show reliably that aspirin started early in hospital produces a small but definite net benefit , with about 9 ( SD 3 ) fewer deaths or non-fatal strokes per 1000 in the first few weeks ( 2p = 0.001 ) , and with 13 ( 5 ) fewer dead or dependent per 1000 after some weeks or months of follow-up ( 2p < 0.01 )",
"Background and Purpose A r and omized , double‐blind , placebo‐controlled multicenter trial was conducted to test the hypothesis that nimodipine would improve the functional outcome in acute ischemic hemispheric stroke . Methods A total of 350 patients were r and omized to nimodipine 120 mg/d PO or matching placebo for 21 days . R and omization was stratified by onset of therapy , age , and stroke severity . Treatment was begun within 48 hours of onset . The patients had neurological evaluation on admission , on days 1 , 7 , and 21 , and at 3 and 12 months . The primary end points were Rankin grade , neurological score , and mobility at 12 months . Results We did not find any differences in the functional outcome between the treatment groups or between the stratified subgroups . We were also unable in post hoc analyses to find any groups of patients who benefited from nimodipine . During the first month and at 3 months the case‐fatality rate was higher in the nimodipine‐treated patients than in those on placebo ( P=.004 and P=.030 , respectively ) , but at the 1‐year follow‐up this difference had lost statistical significance . During the first week nimodipine had a statistically significant lowering effect on both systolic ( P=.005 ) and diastolic ( P=.013 ) blood pressure . Conclusions Nimodipine did not improve the functional outcome of acute ischemic hemispheric stroke . The early case‐fatality rate was higher in the nimodipine group , possibly due to the blood pressure‐lowering effect of nimodipine . ( Stroke . 1994;25:1348‐1353 .",
"In a double-blind , placebo-controlled trial , 225 patients with acute partial stable thrombotic stroke were r and omly assigned to receive continuous intravenous heparin therapy or placebo for 7 days for the prevention of stroke progression or death . No statistically significant difference between the two groups was found in degree of neurologic change ; incidence of stroke progression after 7 days ; or functional activity level of survivors at 7 days , 3 months and at 1 year after treatment . Compared with controls , a statistically significant greater number of patients in the group receiving heparin died in the year after the stroke . These deaths occurred 3 to 12 months after the initial stroke and probably were not related to treatment . Results of this study do not support the use of intravenous heparin to treat patients who have had acute partial stroke",
"High blood pressure in acute stroke is common and appears to be associated with a poor outcome . Lowering blood pressure might therefore improve outcome , provided that cerebral perfusion is not compromised . We assessed the effects of glyceryl trinitrate ( GTN ) on cerebral and systemic hemodynamic measures in acute stroke . Ninety patients with acute ischemic or hemorrhagic stroke were r and omized within 72 hours of ictus to transdermal GTN given daily for 10 days ( either 5 mg , 5 mg for 4 days then 10 mg , or 10 mg ) or control . Twenty-four hour blood pressure monitoring , middle cerebral artery blood velocity , cardiac output , augmentation index , and plasma nitric oxide levels were each measured at baseline and then on days 1 , 4 , 5 , and 10 . The primary outcome was blood pressure on day 1 . We found that GTN lowered mean peripheral arterial blood pressure on day 1 by 5.3 % to 6.7 % in a dose dependent manner as compared with control ( mean , SD ) : control , 108.8 ( 15.1 ) mmHg ; 5 mg , 102.5 ( 13.9 ) mmHg ; 5/10 mg , 103.4 ( 14.9 ) mmHg ; 10 mg , 101.5 ( 12.6 ) mmHg ; ( P = .005 ) . Increasing the dose from 5 to 10 mg on day 5 result ed in an overall reduction in blood pressure of 11.4 % as compared with leaving the dose at 5 mg ( P = .006 ) . GTN reduced peripheral pulse pressure , central aortic blood pressure , pulse pressure , and augmentation index on day 1 . Middle cerebral artery blood velocity and pulsatility index in the affected hemisphere , cardiac output , systemic peripheral resistance , and plasma nitric oxide levels were not altered by GTN . Treatment with GTN was associated with headache : control 0 ( 0 % ) , GTN 9 ( 15 % ) ( P = .027 ) ; no negative effect on end-of-treatment death or deterioration , or 3 month death or dependency was discernable . GTN reduced peripheral blood pressure in a dose-dependent fashion in patients with acute stroke at day 1 and also reduced central blood pressure and augmentation index . In contrast , GTN did not alter middle cerebral artery blood velocity or pulsatility index in the affected hemispheres , suggesting that cerebral blood flow did not change . A trial assessing the effect of lowering blood pressure with GTN on safety and functional outcome in patients with acute stroke is now warranted",
"The value of oral nimodipine 120 mg per day for acute stroke was assessed in a r and omised , double-blind , placebo-controlled multicentre study of 1215 patients . The primary end-point was independence after 6 months , defined as a score of 60 or more on an activities of daily living ( ADL ) scale , the Barthel index . Patients were entered into the trial if they were aged over 40 , became hemiparetic in the previous 48 h , were conscious , were able to swallow , and had been living independently before the stroke . At 6 months , 55 % of the nimodipine group and 58 % of the placebo group were independent , the odds ratio for independence on nimodipine being 0.88 ( 95 % confidence limits 0.70 - 1.10 ) . For mortality the odds ratio with nimodipine was 1.22 ( 95 % confidence limits 0.95 - 1.57 ) . ADL and neurological scores also suggested delayed recovery in the nimodipine group at 3 weeks . The results do not support the case for oral nimodipine therapy 120 mg per day starting within 48 h of the stroke , for patients with acute stroke",
"A multicenter double-blind placebo-controlled study of cytidine 5'-diphosphocholine ( CDP-choline ) was conducted to evaluate possible clinical benefits of the drug in patients with acute , moderate to severe cerebral infa rct ion . The patients included also suffered from moderate to mild disturbances of consciousness , and all were admitted within 14 days of the ictus . Patients were allocated r and omly to treatment with either CDP-choline ( 1,000 mg/day i.v . once daily for 14 days ) or with placebo ( physiological saline ) . One hundred thirty-three patients received CDP-choline treatment , and 139 received placebo . The group treated with CDP-choline showed significant improvements in level of consciousness compared with the placebo-treated group , and CDP-choline was an entirely safe treatment",
"A blind controlled trial of dextran 40 in ischaemic stroke is reported . In the treated group mortality in the acute stage in patients with severe strokes was significantly reduced but survivors were severely disabled and six months later no significant benefit could be detected . In less severe strokes no effect of treatment was found . It is concluded that the action of dextran 40 in reducing acute mortality probably lay in preventing or reversing cerebral swelling but no evidence of the expected action in reducing the area of infa rct ion following improved blood flow was found . The importance of extending assessment beyond the two weeks customary in therapeutic trials in stroke is emphasized",
"BACKGROUND AND PURPOSE Several studies have shown that the quality of reporting of trials throughout medicine is variable and often poor . We report on the quality of the final reports of r and omized controlled trials ( RCTs ) of drug therapies assessed in acute stroke . METHODS English- language reports published up to the end of 1996 relating to completed RCTs in acute stroke were identified from electronic search es of the Cochrane Stroke Review Group data base of stroke trials and the Cochrane Controlled Trials Register ( CD-ROM issue 1 , 1997 , of the Cochrane Library ) . Report quality was assessed with the 33 criteria of the CONSORT statement and 53 additional factors relevant to acute stroke or trials in general . Trial quality was also assessed with a 7-point scale . RESULTS Up to 1996 , 114 RCTs were published which involved 20 536 patients ( median , 80 ; range , 16 to 1267 per trial ) ; 39 ( 35.5 % ) of these were published in Stroke . The median total report quality was 40/86 ( range , 15 to 61 ) for all criteria and 19/33 ( range , 9 to 29 ) for the CONSORT criteria alone . Although adequate information was given in the introduction and discussion sections of most reports , insufficient details were given on methods , assignment of patients to treatment groups , statistical analyses , the prevalence of risk factors , and assessment of outcomes . Report quality has improved between 1956 and 1996 ( Spearman correlation coefficient [ rs ] , 0.575 ; 95 % confidence interval [ CI ] , 0 . 439 to 0.685 ) and was superior in large trials ( rs=0.434 ; 95 % CI , 0 . 274 to 0.571 ) . Although report quality was related to trial quality ( rs=0.675 ; 95 % CI , 0.563 to 0.763 ) , it was not related to journal impact factor ( rs=0.170 ; 95 % CI , -0.015 to 0.344 ) . Trials with a positive outcome tended to be less well reported than those with a neutral or negative outcome ( rs=-0.192 ; 95 % CI , -0.351 to -0.011 ) . CONCLUSIONS The overall quality of study reports for parallel group RCTs in acute stroke is poor but appears to be improving with time and in parallel with an increase in trial size . Reports often lack detailed information on the methods of r and omization , concealment of allocation , and statistical analysis , all factors which can , if undertaken poorly , affect trial results and validity . It is vital that future trials are adequately reported ; we believe that authors should follow the CONSORT guidelines and that referees and editors should ensure this happens",
"BACKGROUND AND PURPOSE Based on neuroprotective efficacy in animal models , we evaluated the N-methyl D-aspartate antagonist Selfotel in patients with ischemic stroke , after doses up to 1.5 mg/kg were shown to be safe in phase 1 and phase 2a studies . METHODS Two pivotal phase 3 ischemic stroke trials tested the hypothesis , by double-blind , r and omized , placebo-controlled parallel design , that a single intravenous 1.5 mg/kg dose of Selfotel , administered within 6 hours of stroke onset , would improve functional outcome at 90 days , defined as the proportion of patients achieving a Barthel Index score of > /=60 . The trials were performed in patients aged 40 to 85 years with acute ischemic hemispheric stroke and a motor deficit . RESULTS The 2 trials were suspended on advice of the independent Data Safety Monitoring Board because of an imbalance in mortality after a total enrollment of 567 patients . The groups were well matched for initial stroke severity and time from stroke onset to therapy . There was no difference in the 90-day mortality rate , with 62 deaths ( 22 % ) in the Selfotel group and 49 ( 17 % ) in the placebo-treated group ( RR=1.3 ; 95 % CI 0.92 to 1.83 ; P=0.15 ) . However , early mortality was higher in the Selfotel-treated patients ( day 30 : 54 of 280 versus 37 of 286 ; P=0.05 ) . In patients with severe stroke , mortality imbalance was significant throughout the trial ( P=0.05 ) . CONCLUSIONS Selfotel was not an effective treatment for acute ischemic stroke . Furthermore , a trend toward increased mortality , particularly within the first 30 days and in patients with severe stroke , suggests that the drug might have a neurotoxic effect in brain ischemia",
"Steroid treatment is widely used in acute cerebral infa rct ion yet its value is controversial . High dose dexamethasone ( 480 mg over 12 days ) was given in a double blind , r and omised controlled trial to 113 consecutive eligible patients with acute cerebral infa rct ion admitted to an acute stroke unit . Those with stroke for more than 48 hours , known embolic sources , diabetes , and infection were excluded . Death and quality of survival were recorded over 21 days . The active drug group ( 54 patients ) matched the placebo group ( 59 patients ) for age , initial stroke score , delay in beginning treatment , and other relevant variables . The two groups did not differ significantly in death rate or quality of survivorship . The small difference in mortality between the two groups may have represented a marginal therapeutic effect , which might reach significance in a larger sample . The widespread use of steroids in response to such a marginal therapeutic gain would expose large numbers of patients with stroke to more serious hazards of steroid treatment and convert patients who would otherwise have died into neurovegetative survivors . High dose steroid treatment was ineffective in ischaemic stroke , and the data suggest that further evaluation by a larger multicentre trial is not justified",
"Background : There has been recent interest in the possible role of reperfusion-induced inflammation with neuronal injury after stroke . Enlimomab , a murine intercellular adhesion molecule-1 ( ICAM-1 ) antibody , reduces leukocyte adhesion and infa rct size in experimental stroke studies . The purpose of the current clinical trial was to evaluate the use of enlimomab after ischemic stroke . Methods : A total of 625 patients with ischemic stroke were r and omized to receive either enlimomab ( n = 317 ) or placebo ( n = 308 ) within 6 hours of stroke onset . Treatment was given over 5 days . Patients were evaluated at baseline and on days 5 and 90 after initiation of treatment ; long-term assessment s were carried out after 6 and 12 months . The primary efficacy endpoint was the response to therapy at 90 days on the Modified Rankin Scale ; other endpoints included Barthel Index ( BI ) and NIH Stroke Scale and survival . Results : At day 90 , the Modified Rankin Scale score was worse in patients treated with enlimomab than with placebo ( p = 0.004 ) . Fewer patients had symptom-free recovery on enlimomab than placebo ( p = 0.004 ) , and more died ( 22.2 versus 16.2 % ) . The negative effect of enlimomab was apparent on days 5 , 30 , and 90 of treatment ( p = 0.005 ) . There were significantly more adverse events with enlimomab treatment than placebo , primarily infections and fever . Patients experiencing fever were more likely to have a poor outcome or die . Conclusions : The authors conclude that anti-ICAM therapy with enlimomab is not an effective treatment for ischemic stroke in the model studied and , indeed , may significantly worsen stroke outcome",
"Assessment of the results of medical intervention in acute stroke presents particular difficulties . Firstly the condition is extremely variable both in its clinical presentation and in its underlying pathology . Secondly , extreme care must be taken over the methods used to assess outcome . A reduction in mortality is no indication of success if there is a consequent increase in the number of survivors with extreme disability . Nor is it valid to compare functional or neurological outcome in survivors , since differences in mortality between treatment groups may upset the balancing effect of initial r and omisation . Furthermore , overall ' neurological scores ' are of dubious validity when the progress of patients with different patterns of disability has to be compared . Despite these difficulties a pragmatic approach can be used in which the design and conduct of a stroke trial closely resemble the normal clinical situation . This requires a knowledge of the range and natural history of stroke cases seen , best obtained from a stroke register . A pilot trial is then needed to assess the extent of variation in outcome and thus to estimate the numbers needed for the main study . The latter should then be conducted in two stages . Initially ' neurological benefit ' should be assessed by counting the number of individual neurological signs which show improvement or deterioration in patients in each treatment group . Finally , a simple functional end-point should be compared in large numbers of patients with death being treated as equivalent to the worst possible non-fatal outcome . These principles are now being applied in a large , double-blind , placebo-controlled trial of low-dose beta-blockers in conscious stroke victims",
"The beta blocker stroke ( \" BEST \" ) trial was design ed to see if the apparent protective effect of propranolol on cerebral function in patients with subarachnoid haemorrhage applied also to patients suffering from acute stroke . Three hundred and two conscious patients with clinical ly diagnosed hemispheric strokes sustained within the past 48 hours were r and omly assigned to receive atenolol , propranolol , or matching placebo capsules for three weeks . More early deaths occurred among the patients allocated to receive beta blockers , but this was largely explained by differences in the initial characteristics of the patients among the different treatment groups . By contrast , the outcome in a further 60 patients , who had been taking beta blockers at the time of their stroke but were otherwise similar to the patients in the trial , was considerably better , suggesting that prior treatment with beta blockers might be protective . The search for an effective medical treatment for acute stroke must continue . The approach used here , in which neurological outcome was assessed in a modest number of patients with a view to proceeding subsequently to a full scale trial of functional outcome , allows practical benefits of a treatment to be evaluated under realistic conditions and an ineffective treatment to be eliminated without undue cost",
"BACKGROUND AND PURPOSE Tirilazad mesylate , a nonglucocorticoid 21-aminosteroid lipid peroxidation inhibitor , has shown promise as a neuroprotectant in experimental models of focal cerebral ischemia . METHODS To test whether early treatment with tirilazad , 6 mg/kg per day for 3 days , would improve functional outcome after acute human stroke , 27 North American centers conducted a prospect i ve , r and omized , double-blinded , vehicle-controlled trial in patients with acute stroke treated within 6 hours of onset . The primary outcome measures were disability as measured by the Glasgow Outcome Scale and activities of daily living by the Barthel Index determined 3 months after stroke . RESULTS From May 1993 through December 1994 , 660 patients were r and omized . The trial was prematurely terminated on the advice of an independent monitoring committee after review of outcome data at a preplanned interim analysis . In 556 fully eligible patients ( 276 tirilazad , 280 vehicle ) , the odds ratio of a favorable outcome in favor of tirilazad was 0.87 ( 95 % confidence interval [ CI ] , 0.60 to 1.25 ) for the Glasgow Outcome Scale and 0.87 ( 95 % CI , 0.60 to 1.25 ) for the Barthel Index , after adjustment for imbalances between the groups in preexisting disability , prior stroke , and diabetes . CONCLUSIONS These observations suggest that tirilazad , 6 mg/kg per day for 3 days administered beginning at a median of 4.3 hours after stroke , does not improve overall functional outcome",
"BACKGROUND AND PURPOSE A r and omized , double-blind , multicenter clinical trial of placebo versus nimodipine was conducted to test the hypothesis that nimodipine would reduce the frequency of death and of worsening by 30 % compared with placebo . METHODS Nimodipine was used in doses of 60 mg , 120 mg , and 240 mg daily in 1,064 patients treated for 21 days . Treatment was begun within 48 hours of stroke due to infa rct ion as inferred by initial computed tomographic scan findings . The Toronto and motor scales were analyzed by analysis of covariance , using covariance-adjusted means , the last-value-carried-forward , to compare the baseline value with the 3 assessment days ( days 4 , 10 , and 21 ) . RESULTS No difference in mortality or neurological outcome was found with any of the rating scales for the overall cohort . Planned but post hoc subgroup analysis showed a reduction in worsening frequency of 30 % compared with placebo and significantly better outcome scores with 120 mg nimodipine daily started within 18 hours of stroke as measured by the Toronto scale ( p less than 0.005 ) and when the pretreatment computed tomographic scan was negative ( p less than 0.003 ) . CONCLUSIONS Nimodipine had no overall effect when treatment was begun within 48 hours . Confirmation of the benefits suggested by post hoc analyses for the subgroup treated with 120 mg nimodipine within 18 hours , and who had negative computed tomographic scans , would require a separate trial",
"BACKGROUND AND PURPOSE Abciximab is a potent parenterally administered platelet glycoprotein IIb/IIIa antagonist . Because this agent has been shown to improve outcomes in coronary artery disease , there is interest to evaluate whether it could improve cerebral perfusion and outcomes after ischemic stroke . This study was design ed to evaluate the safety of abciximab in acute ischemic stroke and to obtain pilot efficacy data . METHODS We conducted a r and omized , double-blind , placebo-controlled , dose-escalation trial . Seventy-four eligible and consenting patients presenting within 24 hours after ischemic stroke onset at 38 study sites were r and omly allocated to receive either an escalating dose of abciximab ( 54 patients ) or placebo ( 20 patients ) in a ratio of 3:1 . We studied 4 escalating doses of abciximab . Patients underwent a scheduled follow-up head CT scan 24 to 36 hours after the completion of study agent administration to monitor for bleeding complications and were evaluated through 3 months . RESULTS There were no cases of major intracranial hemorrhage . Asymptomatic parenchymal hemorrhages were detected on post- study agent CT in 4 of 54 abciximab patients ( 7 % ) and in 1 of 20 placebo patients ( 5 % ) . Six additional abciximab patients had asymptomatic hemorrhagic lesions detected by unscheduled brain imaging during their follow-up period . Nine of 11 patients with asymptomatic hemorrhage had a baseline National Institutes of Health Stroke Scale score > 14 . At 3 months , there was a trend toward a higher rate of minimal residual disability ( Barthel Index > or = 95 or modified Rankin scale abciximab patients compared with those who received placebo . CONCLUSIONS Abciximab appears to be safe when administered up to 24 hours after stroke onset , and it might improve functional outcome",
"Hemodilution by the combination of venesection and dextran 40 administration has previously been reported to enhance neurologic recovery in the acute phase of ischemic stroke . To study this therapeutic principle in its \" natural habitat , \" a stratified and r and omized multicenter trial involving 15 large and small hospitals was performed . Patients with acute ischemic stroke of less than 48 hours ' duration and with hematocrits of 38 - 50 % on admission were r and omized to a hemodilution ( 183 patients , mean age 72.0 years ) or a control group ( 190 patients , mean age 71.6 years ) . The two groups did not differ in sex distribution or medical history . Hematocrit , blood pressure , and neurologic score were closely similar at entry . By grade d venesection ( 250 - 1000 ml ) during the first 2 days and dextran 40 infusions ( 500 ml daily ) during 5 days , the mean hematocrit was reduced from 44.2 to 37.1 % . Three-month survival expressed as life table product was 0.84 in hemodilution and 0.88 in control patients . In survivors , neurologic score and activities of daily living performance during 3 months of follow-up were not improved by hemodilution . Length of stay in an acute-care hospital and the need for long-term institutional care was not reduced among patients in the hemodilution group . Major cardiovascular events occurred somewhat more often and there was an apparent increase in mortality during the first few days of hemodilution therapy . However , the differences were not significant . We conclude that the present st and ardized treatment with moderate hemodilution has no overall beneficial effects in general patients with acute ischemic stroke",
"Introduction ‐ An international , multicenter trial was conducted in 331 patients to determine the effect of a large dose of flunarizine ( a calcium entry blocker ) in the treatment of acute ischemic stroke in the territory of the Middle cerebral artery . Methods ‐ The administration of the trial medication should start within 24 h after the initial symptoms of stroke . According to a r and om schedule , the patients were assigned to a 4‐weeks double‐blind treatment with either flunarizine ( n= 166 ) or placebo ( n= 165 ) : one week intravenous administration ( 50 mg daily ) , followed by 3 weeks oral treatment ( week 2 , 21 mg daily ; week 3–4 , 7 mg daily ) . All patients had to be investigated by computerized tomography ( CT ) within 7 days after stroke onset ; 36 patients were secundarily excluded because the CT showed another pathology . During the treatment period , other “ stroke therapies ” were not allowed . Patients were followed up for 24 weeks . Results ‐ After the 24 weeks trial period , the percentage of patients who were dead or pendent ( modified Rankin score 3–5 ) was similar in both treatment groups ( flunarizine 67 % , placebo 65 % ) . During the trial , the scores for h and icap severity ( modified Rankin scale ) , neurological status ( Orgogozo ) and activities of daily living ( modified Barthel index ) strongly improved in both treatment groups , but no differences were found between the treatment groups . In this trial , the administration of trial treatment started relatively late after stroke onset ( flunarizine group : mean time interval 13.5 h ; placebo 12.3 h ) . A subgroup of patients received trial medication within 6 h after stroke onset ( flunarizine n= 31 ; placebo n= 29 ) . Also in this subgroup , no differences were found between the flunarizine and placebo group . Conclusion ‐ Flunarizine did not improve neurologic and functional outcome in patients with acute ischemic stroke",
"BACKGROUND In patients with acute ischemic stroke , early treatment with thrombolytic agents is thought to permit reperfusion of ischemic neurons and to promote recovery of function . The Multicenter Acute Stroke Trial-Europe ( MAST-E ) was design ed to assess the efficacy and safety of streptokinase in patients with acute ischemic stroke . METHODS Patients with moderate-to-severe ischemia in the territory of the middle cerebral artery were r and omly assigned to receive streptokinase ( 1.5 million units over a period of one hour ) or placebo within six hours after the onset of stroke . The primary efficacy outcome was a binary criterion combining mortality and severe disability at six months , with severe disability defined as a score of 3 or higher on the Rankin scale . The primary safety outcomes were mortality at 10 days and cerebral hemorrhage . RESULTS All r and omized patients ( 156 in the streptokinase group and 154 in the placebo group ) were evaluated at six months . The incidence of the primary efficacy outcome was similar in the two groups ( 124 patients in the streptokinase group and 126 in the placebo group died or had a Rankin score > or = 3 ) . However , the mortality rate at 10 days was significantly higher in the streptokinase group than in the placebo group ( 34.0 percent vs. 18.2 percent , P = 0.002 ) . The higher rate in the streptokinase group was mainly due to the hemorrhagic transformation of ischemic cerebral infa rcts . At six months , more deaths had occurred in the streptokinase group than in the placebo group ( 73 vs. 59 , P = 0.06 ) . CONCLUSIONS In patients with acute ischemic stroke , treatment with streptokinase result ed in an increase in mortality . The routine use of streptokinase can not be recommended in acute ischemic stroke",
" In a multicentre clinical trial 1267 patients with hemispheric stroke of duration 12 h or less and haematocrit of 35 % or more were prospect ively r and omised to either haemodilution ( by venesection and replacement of the same volume of dextran 40 in saline solution ) or control treatment groups . In the haemodiluted group mean haematocrit declined from 43 % to 37 % at 48 h and this fall was maintained for seven days . A plain computed tomographic scan was obtained in all but 37 patients . 87 % of the strokes were infa rcts and 13 % were haemorrhages . After six months the numbers of dead or severely disabled patients were equally distributed in the two treatment groups , and this was true also within the ischaemic and haemorrhagic subgroups . Furthermore , haemodilution did not improve outcome either in the group with very recent ischaemic stroke ( less than 6 h ) or in the subgroup with highest haematocrit ( greater than 45 % ) . Thus , moderate haemodilution does not improve the outcome in acute stroke patients",
"BACKGROUND AND PURPOSE The goals of the present study were to assess the efficacy and safety of nalmefene ( Cervene ) in patients with acute ( and to investigate the safety of combined recombinant tissue plasminogen activator and nalmefene in a separate subset of patients . Nalmefene , an opioid antagonist with relative kappa receptor selectivity , has shown neuroprotective effects in multiple experimental central nervous system injury and ischemic models . Results from an earlier phase II study in patients with acute ischemic stroke suggested that nalmefene was safe and tolerable and may be effective for patients METHODS This investigation was a phase III , placebo-controlled , double-blind , r and omized study of a 24-hour infusion of nalmefene . Patients with acute ischemic stroke who had an onset of symptoms within 6 hours and a baseline score of > or = 4 on the NIH Stroke Scale were r and omized to receive either 60 mg nalmefene administered as a 10-mg bolus over 15 minutes and then a 50-mg infusion over 23.75 hours or placebo . The primary efficacy outcome was the proportion of patients achieving a score of > or = 60 on the Barthel Index and a rating of \" moderate disability \" or better on the Glasgow Outcome Scale at 12 weeks . Assessment s were performed at baseline ( predose ) , hours 12 and 24 , days 2 and 7 , and week 12 . RESULTS A total of 368 patients were r and omized at 42 centers , including 32 patients treated with recombinant tissue plasminogen activator and study drug . Nalmefene was well tolerated . Overall , there was no significant difference in 3-month functional outcome for nalmefene treatment compared with placebo on any of the planned analyses . A prospect i ve secondary analysis also failed to find a treatment effect in patients . CONCLUSIONS Although nalmefene appears to be safe and well tolerated , this study failed to find any treatment benefit in stroke patients treated within 6 hours",
"Wound-care journals contain abundant reports of trials , but not all report a satisfactory methodology . Systematic review s of wound-care trials have highlighted many areas for improvement , and the National Institute for Clinical Excellence ( NICE ) guidelines recommend that primary research in the field of pressure ulcer prevention should adhere more closely to current method ological st and ards in terms of conduct and reporting . The CONSORT tool was developed to help achieve these improvements in the design and reporting of r and omised controlled trials ( RCTs )",
"CONTEXT Recombinant tissue-type plasminogen activator ( rt-PA ) improves outcomes for patients with acute ischemic stroke , but current approved use is limited to within 3 hours of symptom onset . This restricts the number of patients who can be treated , since most stroke patients present more than 3 hours after symptom onset . OBJECTIVE To test the efficacy and safety of rt-PA in patients with acute ischemic stroke when administered between 3 and 5 hours after symptom onset . DESIGN The Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke ( ATLANTIS ) study is a phase 3 , placebo-controlled , double-blind r and omized study conducted between December 1993 and July 1998 , with up to 90 days of follow-up . SETTING One hundred forty university and community hospitals in North America . PATIENTS An intent-to-treat population of 613 acute ischemic stroke patients was enrolled , with 547 of these treated as assigned within 3 to 5 hours of symptom onset . A total of 39 others were treated within 3 hours of symptom onset , 24 were treated more than 5 hours after symptom onset , and 3 never received any study drug . INTERVENTION Administration of 0.9 mg/kg of rt-PA ( n = 272 ) or placebo ( n = 275 ) intravenously over 1 hour . MAIN OUTCOME MEASURES Primary efficacy was an excellent neurologic recovery at day 90 ( National Institutes of Health Stroke Scale [ NIHSS ] score of excellent recovery on functional outcome measures ( Barthel index , modified Rankin scale , and Glasgow Outcome Scale ) at days 30 and 90 . Serious adverse events were also assessed . RESULTS In the target population , 32 % of the placebo and 34 % of rt-PA patients had an excellent recovery at 90 days ( P = .65 ) . There were no differences on any of the secondary functional outcome measures . In the first 10 days treatment with rt-PA significantly increased the rate of symptomatic intracerebral hemorrhage ( ICH ) ( 1.1 % vs 7.0 % [ P symptomatic ICH ( 4.7 % vs 11.4 % [ P = .004 ] ) , and fatal ICH ( 0.3 % vs 3.0 % [ P Mortality at 90 days was 6.9 % with placebo and 11.0 % with rt-PA ( P = .09 ) . Results in the intent-to-treat population were similar . CONCLUSIONS This study found no significant rt-PA benefit on the 90-day efficacy end points in patients treated between 3 and 5 hours . The risk of symptomatic ICH increased with rt-PA treatment . These results do not support the use of intravenous rt-PA for stroke treatment beyond 3 hours",
"In a r and omized , single-blind study , 30 patients with acute ischemic stroke were treated with either low-molecular weight dextran and mannitol alone ( group A , mean age , 63.3 + /- 11.8 years , n = 15 ) or in combination with the viper venom enzyme ancrod ( group B , mean age , 67.9 + /- 7.6 years , n = 15 ) . Lowering of plasma fibrinogen levels to 100 - 130 mg/dL with ancrod result ed in a significant reduction of the apparent blood viscosity , ie , of 37 % at a shear rate of 0.03 s-1 , compared with only 7 % in group A. Fibrin degradation products increased considerably from 3.1 + /- 0.4 to 154.3 + /- 31.6 mg/L on day 3 , while plasminogen decreased from 98.2 % + /- 2.0 % to 79.8 % + /- 2.9 % in group B. Global coagulation and platelet function tests were not influenced by either treatment . Neurological score improved by 1.1 arbitrary units ( AU ) in group A and by 2.6 AU in group B. Five patients in group A and two in group B died during the first two weeks . This preliminary study indicated a slightly better outcome in the ancrod treated patients . The beneficial effect may be due to the anticoagulative and fibrinolytic activity of ancrod rather than its effect on blood viscosity",
"Eleven of 31 clinical centers participating in the Italian Acute Stroke Study --Hemodilution carried out a preliminary study on the effectiveness of ganglioside GM1 in acute stroke ; 502 patients were r and omized to GM1 ( GM1 , n = 121 ) , GM1 plus hemodilution ( GM1 + H , n = 128 ) , placebo ( P , n = 130 ) , or placebo plus hemodilution ( P + H , n = 123 ) groups less than or equal to 12 hours after onset of a hemispheric cerebral infa rct . The patients were treated for 15 days and were evaluated on Days 21 and 120 after the onset of stroke . Intention-to-treat analysis failed to show any differences in neurologic deficit , mortality , or neurologic disability among the groups . Efficacy analysis showed a significantly higher degree of neurologic improvement in GM1 group patients compared with patients in the P group during the first 15 days . GM1-treated patients ( GM1 and GM1 + H groups ) showed a significantly higher degree of neurologic improvement during the first 10 days compared with the placebo-treated patients ( P and P + H groups ) . These differences were no longer statistically significant at Day 120 . Our results provide a rationale for the planning of a larger , multicenter trial of GM1 ganglioside in acute stroke",
"In a double‐blind trial intravenous aminophylline was compared with placebo in 79 patients with acute cerebral infa rct ion . Immediate improvement in the neurological evaluation score was significantly more frequent in patients receiving aminophylline ( 38 per cent ) than in those on placebo ( 15 per cent ) ; only patients with mild or moderately severe strokes responded to the injection . After 3 weeks , however , the treated patients did not fare significantly better than the controls in terms of neurological score and residual disability . Survival rate , length of stay in hospital , and social readaptation were similar in the two groups . It is concluded that intravenous aminophylline in patients with ischaemic strokes can bring about an immediate symptomatic relief , but without appreciably influencing the ultimate recovery",
"Background and Purpose : Hypertension is a common medical complication in acute stroke and is associated with a poor outcome . However , no large trials have assessed the effect of lowering blood pressure ( BP ) on outcome , and it remains unclear how BP should be managed in acute stroke . We assessed , in a double-blind r and omised controlled trial , whether the nitric oxide ( NO ) donor glyceryl trinitrate ( GTN , a known systemic and cerebral vasodilator ) , would lower BP and alter platelet function . Methods : Thirty-seven patients with recent ( and omised by minimisation to 12 days of daily treatment with transdermal GTN or matching placebo patches . Twenty-four-hour ambulatory BP was measured before and during GTN treatment at days 0 , 1 and 8 . Platelet aggregation and expression of adhesion molecules were assessed at the same time points . Functional outcome ( Rankin scale ) and case fatality were assessed at 3 months . Analysis was by intention-to-treat . Results : GTN significantly lowered BP by 13.0/5.2 mm Hg at day 1 and 9.3/5.0 mm Hg at day 8 . The lesser reduction at day 8 than day 1 suggests that tolerance to GTN was developing . Non-significant falls of 0.9/0.6 and 3.8/0.0 mm Hg occurred at days 1 and 8 , respectively , in the placebo group . GTN had no effect on heart rate , or platelet aggregation or expression of platelet adhesion molecules , including glycoproteins Ia , Ib , IIIa and P-selectin . Additionally , GTN did not alter case fatality or dependency , although the study was not powered for these outcomes . Conclusions : Transdermal GTN , an NO donor , lowered BP by 5–8 % , a clinical ly significant and relevant , but not excessive , degree in patients with acute stroke . However , GTN had no effect on platelet aggregation or expression of adhesion molecules . Since NO donors increase cerebral blood flow in patients with acute ischaemic stroke , GTN may be an appropriate drug for testing the effect of lowering BP on functional outcome",
"Background and Purpose : Lubeluzole is a benzothiazole derivative that has shown neuroprotective properties in different experimental models . This multicentre , double-blind , placebo-controlled trial was conducted to assess the safety and efficacy of lubeluzole in patients with an acute ischaemic stroke . Methods : Patients who presented with clinical signs and symptoms of acute cerebral hemispheric ischaemic stroke were r and omised to intravenous therapy with placebo ( n = 360 ) or lubeluzole 7.5 mg over 1 h followed by 10 mg/day for up to 5 days ( n = 365 ) . Treatment was initiated within 6 h of symptom onset . Mortality at 12 weeks was the primary end point . Secondary end points included neurological status ( European Stroke Scale ) , functional outcome ( Barthel Index ) , and disability level ( Rankin Scale ) . The primary and secondary end points were all analysed using the protocol -defined Cochran-Mantel-Haenszel ’s general association test . An additional analysis , the logistic regression approach , that included risk factors of age , baseline stroke severity and their interactions with treatment , was used to analyze outcome measures at 3 months . Results : In the total ischaemic stroke population , the overall mortality rate at 3 months was similar for lubeluzole ( 21.0 % ) and placebo ( 21.4 % ) . The logistic regression model confirmed the effect of age on mortality risk , but showed that this was independent of treatment . Treatment benefit was related to stroke severity , as determined by the Clinical Global Impression rating , that is a pronounced clinical ly significant reduction in mortality was noted in the lubeluzole-treated patients for whom stroke severity was mild to moderate , but not in those for whom it was severe . This was found on the basis of a post hoc analysis not specified in the hypothesis . Lubeluzole did not increase morbidity among stroke survivors , as measured by the European Stroke Scale , Barthel Index and Rankin Scale . No safety concerns were seen with lubeluzole treatment . Conclusions : In the overall study population , treatment with intravenous lubeluzole within 6 h of the onset of ischaemic stroke did not affect mortality or clinical outcome . Among patients with mild to moderate ischaemic stroke , lubeluzole decreased mortality without increasing morbidity"
] | 4116683e-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To systematic ally review the evidence examining the use of incentive spirometry ( IS ) for the prevention of postoperative pulmonary complications ( PPCs ) . METHODS We search ed MEDLINE , CINAHL , HealthSTAR , and Current Contents data bases from their inception until June 2000 . Key terms included " incentive spirometry , " " breathing exercises , " " chest physical therapy , " and " pulmonary complications . " Articles were limited to human studies in English . A secondary search of the reference lists of all identified articles also was conducted . A critical appraisal form was developed to extract and assess information . Each study was review ed independently by one of three pairs of group members . The pair then met to reach consensus before presenting the report to the entire review group for final agreement . RESULTS The search yielded 85 articles . Studies dealing with the use of IS for preventing PPCs ( n = 46 ) were accepted for systematic review . In 35 of these studies , we were unable to accept the stated conclusions due to flaws in methodology . Critical appraisal of the 11 remaining studies indicated 10 studies in which there was no positive short-term effect or treatment effect of IS following cardiac or abdominal surgery . The only supportive study reported that IS , deep breathing , and intermittent positive-pressure breathing were equally more effective than no treatment in preventing PPCs following abdominal surgery . CONCLUSIONS Presently , the evidence does not support the use of IS for decreasing the incidence of PPCs following cardiac or upper abdominal surgery | [
"Abstract Background : Chest physiotherapy is a common practice after open reflux and obesity surgery . It is now possible to perform fundoplication and vertical b and ed gastroplasty ( VBG ) by the laparoscopic technique . The aim of this study was to evaluate in a prospect i ve , r and omized , controlled trial whether chest physiotherapy affects the postoperative course . Method : A series of 40 patients underwent laparoscopic fundoplication ; another 40 underwent laparoscopic VBG . Twenty patients in each series received prophylactic chest physiotherapy ; the other 20 served as control patients and were not given any information or training . Results : Postoperatively , all patients had a significant reduction in respiratory function , measured as oxygen saturation , forced vital capacity , and peak expiratory flow , but the differences between the groups within each series were not significant . Postoperatively , one patient in the VBG treatment group had hypoxemia ( SaO2 postoperative pneumonia . Conclusions : This study indicates that routine chest physiotherapy is not necessary in patients undergoing laparoscopic upper gastrointestinal surgery , such as fundoplication and VBG",
" Forty-nine adults who had undergone cardiopulmonary bypass surgery were r and omly assigned to one of three exercise programs to determine if either maximal inspiratory breathing exercises or incentive spirometry offered a therapeutic advantage over early mobilization alone . After extubation , the patients started their assigned exercise programs . A physical examination and pulmonary function tests were performed preoperatively , at the start of the exercise program , and 24 and 48 hours after the start of the program . The results showed a significant decrease ( approximately 50 % ) in lung volumes but no airflow obstruction in patients who had coronary artery bypass graft . In those patients who had valve replacement , lung volumes fell , and in addition , mild airflow obstruction occurred . A majority of patients had postoperative pulmonary complications . There were no significant differences among the exercise programs in improving lung volumes and airflow or in preventing postoperative complications . We conclude that maximal inspiratory breathing exercises or incentive spirometry , when used in addition to early mobilization , offers no therapeutic advantage over early mobilization alone after cardiopulmonary bypass surgery",
"Postoperative pulmonary complications , alveolar-arteriolar oxygen difference ( [A-a]O2-diff ) , peak expiratory flow ( PEF ) and forced vital capacity ( FVC ) were compared in patients using continuous positive airway pressure ( CPAP ) and positive expiratory pressure ( PEP ) administered by face mask against those of a control group using a deep-breathing device ( Triflo ) . Forty-three consecutive , r and omized patients undergoing elective upper abdominal surgery were included . CPAP , PEP and Triflo were administered for 30 consecutive breaths in every waking hour for three days postoperatively . The (A-a)O2-difference increased equally and significantly in the three groups after surgery , reaching a maximum on the first postoperative day . After this day , however , (A-a)O2-diff decreased in the CPAP and PEP groups , being significantly lower in the PEP group compared to the control group , two days postoperatively ( p less than 0.05 ) and significantly lower in both the PEP and CPAP groups three days postoperatively ( p less than 0.001 and p less than 0.05 , respectively . ) PEF did not differ significantly between the groups before or after surgery , while FVC was significantly higher in the PEP and CPAP groups , compared to control , on the third postoperative day ( p less than 0.05 ) . Atelectatic consolidation was observed in six of 15 patients in the control group three days postoperatively , the incidence being significantly lower in both the PEP group ( 0 of 15 , p less than 0.001 ) and the CPAP group ( one of 13 , p less than 0.05 ) . We concluded that periodic face mask administration of CPAP and PEP are superior to deep breathing exercises with respect to gas exchange , preservation of lung volumes and development of atelectasis after upper abdominal surgery . We also conclude that the simple and commercially available PEP mask is as effective as the more complicated CPAP system",
"One hundred and ten men undergoing coronary artery bypass grafting took part in a prospect i ve r and omised study comparing three physiotherapy protocol s. All patients were taught self supported huffing and coughing by a physiotherapist and encouraged to move about . This comprised the sole treatment for the 37 control patients ( group 3 ) . Additional physiotherapy included breathing exercises for the 35 patients in group 1 and use of an incentive spirometer for the 38 patients in group 2 . Functional residual capacity ( FRC ) was measured daily at the bedside until the fifth postoperative day and arterial blood gas tensions were measured on the second and fourth postoperative days . After surgery patients developed a severe restrictive ventilatory defect and profound arterial hypoxaemia . There were no differences between the three groups . Mean FRC on day 2 was 1.90 litres ( 61 % of the preoperative value ) , increasing to 2.32 1 by day 5 ( 76 % of the preoperative value ) . The mean arterial oxygen tension was 7.37 kPa on day 2 and 8.58 kPa on day 4 . Four patients in group 1 , two in group 2 , and five in group 3 developed a chest infection . It is concluded that the addition of breathing exercises or incentive spirometry to a regimen of early mobilisation and huffing and coughing confers no extra benefit after uncomplicated coronary artery bypass grafting",
"A national survey of hospitals was conducted to evaluate the usage of lung expansion maneuvers in the prevention and management of postoperative atelectasis associated with abdominal and thoracic surgery . Equal numbers of hospitals were r and omly selected from the nine American Hospital Association regions and from bed-size groups of 50 to 200 beds , 201 to 400 beds , and greater than 400 beds . Preoperative and postoperative prophylactic therapy was found to be similar in all groups except for a lower usage of intermittent positive-pressure breathing ( IPPB ) in the western third of the United States compared with the central third . In the treatment of postoperative atelectasis there are significant differences in the use of chest physical therapy , IPPB , and intermittent continuous positive airway pressure based on hospital size . Objective measurements of tidal volume or inspiratory capacity as a guide to therapeutic decisions are performed more frequently in the western regions . Surgical statistics relative to the number of abdominal and surgical procedures done and the incidence of postoperative atelectasis are also presented",
"BACKGROUND AND PURPOSE The purpose of this study was to determine whether the addition of incentive spirometry ( IS ) to postoperative pulmonary physical therapy is more effective than physical therapy alone in reducing postoperative pulmonary complications in high-risk patients after coronary artery bypass grafting ( CABG ) . Patients were given the spirometer and instructed in its use , as often occurs in clinical setting s. SUBJECTS Patients with chronic airflow limitation following CABG ( N = 185 ) participated . METHODS Subjects were r and omly assigned to receive either postoperative pulmonary physical therapy ( breathing exercises , secretion removal , mobility ) or physical therapy combined with IS . RESULTS No difference was found between the two groups in atelectasis , spirometry , oxygen saturation , pulmonary infection , or hospital stay . CONCLUSION AND DISCUSSION Incentive spirometry combined with physical therapy is no more effective than postoperative physical therapy alone in reducing atelectasis for this population . Use of the spirometer , however , was not monitored , and although the study mimicked practice as it often occurs , the effectiveness of the spirometer can not be fully evaluated",
"To determine the potential benefit of incentive spirometry , which has been advocated to prevent pulmonary complications after upper-abdominal surgery , we compared a group of patients receiving incentive spirometry to another group receiving no specialized postoperative respiratory care . Forty patients in the American Society of Anesthesiologists ' class 1 and 2 who were undergoing cholecystectomy ( through right subcostal incision ) were included in the study and were r and omly allocated to one of the two groups . Patients receiving incentive spirometry were encouraged by a specialized respiratory physiotherapist to breathe deeply for five minutes hourly , 12 times daily , for three postoperative days . No statistically significant difference between the two groups was found in the radiologic evidence of postoperative pulmonary complications , arterial oxygen pressure , spirometric measurement , and clinical evaluation at the second or fourth postoperative day ( or both ) . In particular , deterioration on the chest x-ray film at the fourth postoperative day was observed in eight of 20 patients in the group receiving incentive spirometry and in six of 20 in the control group . Our study confirms the postoperative deterioration of respiratory function after upper-abdominal surgery and demonstrates the lack of therapeutic values of incentive spirometry in these patients at low risk for pulmonary complications",
"Sustained maximal inspiration ( incentive spirometry ) is used for the prevention and management of atelectasis in major abdominal and thoracic surgery . Patients with head and neck surgery are predisposed to postoperative disturbances in lung function after extensive surgical resection , immobilization , or significant chest wall deformity from various reconstructive procedures . The patient often requires tracheostomy or permanent laryngeal stoma . A prospect i ve clinical study on patients with major head and neck surgery was conducted to evaluate the use of incentive spirometry to improve postoperative lung function . An adaptor was first design ed to allow patients with tracheostomy tubes to use the spirometers . Parameters studied include vital signs , arterial blood gases ( A-a gradient ) , and pulmonary function test . Significant improvement of lung function and lack of complication warrant the use of incentive spirometry in postoperative head and neck surgery patients",
"Objective : To investigate the additional effect of incentive spirometry to chest physiotherapy to prevent postoperative pulmonary complications after thoracic surgery for lung and esophageal resections . Design : R and omized controlled trial . Setting : University hospital , intensive care unit , and surgical department . Patients : Sixty‐seven patients ( age , 59 ± 13 yrs ; forced expiratory volume in 1 sec , 93 % ± 22 % predicted ) undergoing elective thoracic surgery for lung ( n = 40 ) or esophagus ( n = 27 ) resection . Interventions : Physiotherapy ( breathing exercises , huffing , and coughing ) ( PT ) plus incentive spirometry ( IS ) was compared with PT alone . Measurements and Main Results : Lung function , body temperature , chest radiograph , white blood cell count , and number of hospital and intensive care unit days were all measured . Pulmonary function was significantly reduced after surgery ( 55 % of the initial value ) and improved significantly in the postoperative period in both groups . However , no differences were observed in the recovery of pulmonary function between the groups . The overall score of the chest radiograph , based on the presence of atelectasis , was similar in both treatment groups . Eight patients ( 12 % ) ( three patients with lobectomy and five with esophagus resection ) developed a pulmonary complication ( abnormal chest radiograph , elevated body temperature and white blood cell count ) , four in each treatment group . Adding IS to regular PT did not reduce hospital or intensive care unit stay . Conclusions : Pulmonary complications after lung and esophagus surgery were relatively low . The addition of IS to PT did not further reduce pulmonary complications or hospital stay . Although we can not rule out beneficial effects in a subgroup of high‐risk patients , routine use of IS after thoracic surgery seems to be ineffective",
"Controversy exists regarding the routine use of aids to lung expansion in the prevention of pulmonary complications after abdominal surgery . We prospect ively r and omized 172 patients into 1 of 4 groups : the control group ( 44 patients ) received no respiratory treatment , the IPPB group ( 45 patients ) received intermittent positive pressure breathing therapy for 15 min 4 times daily , the IS group ( 42 patients ) was treated with incentive spirometry 4 times daily , and the DBE group ( 41 patients ) carried out deep breathing exercises under supervision for 15 min 4 times daily . Roentgenographic changes , observed 24 h after surgery , were comparable in the 4 groups ( 20.5 to 36.6 % ) . Pulmonary complications were defined as the development of 3 or more of 6 new findings : cough , phlegm , dyspnea , chest pain , temperature greater than 38 degrees C , pulse rate more than 100 beats/min . The frequency of development of pulmonary complications was 48 % in the control group , 22 % in the IPPB group ( p less than 0.05 ) , 21 % in the IS group ( p less than 0.05 ) , and 22 % in the DBE group ( p less than 0.05 ) . Side effects of respiratory treatment were observed only in the IPPB group ( 18 % ; p less than 0.05 ) . Hospital stay in patients undergoing upper abdominal surgery was significantly shorter in the IS group ( mean + /- SD , 8.6 + /- 3 days ) than in the control group ( 13 + /- 5 days ) . This difference was not observed for the other 2 treatment groups . ( ABSTRACT TRUNCATED AT 250 WORDS",
"We undertook this study to characterize the postthoracotomy compartmental displacement and respiratory mechanical changes occurring during and after the performance of the incentive spirometry maneuver . We also evaluated the effect of recumbency angle on compartmental recruitment . Sixteen patients were r and omized to perform incentive spirometry either at 30 degrees or 60 degrees recumbency angle . They were studied using respiratory inductance plethysmography to measure tidal volume , respiratory frequency , inspiratory time , rib cage motion/tidal volume ratio , inspiratory duty cycle , and inspiratory flow . Patients were studied before surgery and on postoperative days 1 and 3 . Statistical analysis was accomplished using multiple measures ANOVA with post-hoc Student 's t-tests when appropriate . Preoperative incentive spirometry augmented VT by increasing both VT/TI and TI . Postoperatively , the incentive recruitment of VT was reduced , a result of a decrease in TI and TI/TTOT ; VT/TI was unchanged . There was postoperative decrease of AB and AB/VT during incentive spirometry , greatest in the 60 degrees group . Our results characterize the nature of the respiratory recruitment afforded by incentive spirometry , before and after thoracotomy . We also found evidence of postthoracotomy diaphragmatic derecruitment during incentive spirometry exacerbated by a high recumbency angle",
"A r and om comparison of early mobilization and chest physiotherapy ( mainly breathing exercises ) with or without bronchodilatating inhalations for prophylaxis against pulmonary complications in patients undergoing elective gall-bladder surgery is presented . The operation was performed with a subcostal incision and peroperatively , intercostal nerve block was administered . Preoperative pulmonary status ( dynamic volume spirometry , peak expiratory flow rate , arterial blood gas analysis ) showed no differences between the groups , and postoperative blood gas analysis and pulmonary X-ray or evident clinical findings did also not show any differences between the groups . Thus early mobilization was as effective in our study as the other prophylactic treatments . In patients without pulmonary disease perhaps early mobilization and efficient analgesia after surgery is as effective as more re source dem and ing physiotherapy for prophylaxis against postoperative pulmonary complications",
"Although the objective of incentive spirometry is to achieve and hold high lung volumes , many patients with pain or weakness are unable to sustain the effort needed to perform effective exercises . We question ed whether using a one-way valve to prevent exhalation would allow rest between inspiratory efforts and cause volume to cumulate during successive tidal efforts , improving both the depth and duration of the inspiratory maneuver . We studied 26 cooperative but naive patients recovering from surgery , trauma , or critical illness whose pain or weakness impaired ability to achieve and sustain deep inspiration . All subjects breathed via mouthpiece from a spirometer prefilled with 100 % oxygen . Three different maneuvers were performed in r and om order by all subjects : ( 1 ) st and ard inspiratory capacity without valve or inspiratory hold , ( 2 ) inspiratory capacity ( IC ) with breathholding aided by a one-way valve , and ( 3 ) uncoached breath-stacking , during which successive tidal breaths were cumulated by one-way valving . A fourth maneuver was added in the last 13 subjects studied : an initial coached IC effort with subsequent valved stacking of tidal efforts . When compared with IC , \" breath stacking \" ( valved ) maneuvers increased inspired volume by an average of 15 to 20 % ( p less than 0.05 ) . More importantly , there was a severalfold increase in the time over which high lung volume was sustained ( p less than 0.001 ) . Our results indicate that one-way valving helps to achieve and sustain deep inspiration , even in uncoached patients",
"Prospect ively studied were 520 patients undergoing elective thoracic , upper abdominal and lower abdominal surgeries to analyze risk factors for postoperative pneumonias . Over-all , pneumonias developed in 91 of the 520 patients studied ( 17.5 percent ) . The acquisition of pneumonia was highly associated with preoperative markers of the severity of underlying diseases such as low serum albumin concentrations on admission ( P less than 0.005 ) and high American Society of Anesthesiologists pre-anesthesia physical status classification ( P less than 0.0001 ) . History of smoking ( P less than 0.001 ) , longer preoperative stays ( P less than 0.0001 ) , longer operative procedures ( P less than 0.0001 ) and thoracic or upper abdominal sites of surgery ( P less than 0.0001 ) were also significant risk factors for postoperative pneumonias . Although massive obesity , old age and male sex were also associated with increased incidences of pneumonia , statistical significance was lost when these variables were controlled for site or duration of surgery . We were able to identify risk factors for pneumonia and to define a sub population of patients in which the risk of pneumonia was negligible . The acquisition of pneumonia by a low-risk patient should alert the physician to the possibility of a potentially preventable nosocomial infection",
"Of 38 patients undergoing median sternotomy for cardiac operations all developed profound restrictive defects in pulmonary function during the first 72 h after tracheal extubation . Although decreased lung volumes were refractory to correction by vigorous , aggressive pulmonary therapy during this period , frequent and supervised treatment may prevent further deterioration in pulmonary function . The overall incidence of pneumonia was only 3 % ( 1/38 ) . Continuous positive airway pressure delivered by mask proved to be a nearly effortless form of postoperative respiratory therapy that was less painful than incentive spirometry or coughing and deep breathing , and therefore may be preferable"
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BACKGROUND Bariatric ( weight loss ) surgery for obesity is considered when other treatments have failed . The effects of the available bariatric procedures compared with medical management and with each other are uncertain . This is an up date of a Cochrane review first published in 2003 and most recently up date d in 2009 . OBJECTIVES To assess the effects of bariatric surgery for overweight and obesity , including the control of comorbidities . SEARCH METHODS Studies were obtained from search es of numerous data bases , supplemented with search es of reference lists and consultation with experts in obesity research . Date of last search was November 2013 . SELECTION CRITERIA R and omised controlled trials ( RCTs ) comparing surgical interventions with non-surgical management of obesity or overweight or comparing different surgical procedures . DATA COLLECTION AND ANALYSIS Data were extracted by one review author and checked by a second review author . Two review authors independently assessed risk of bias and evaluated overall study quality utilising the GRADE instrument . MAIN RESULTS Twenty-two trials with 1798 participants were included ; sample sizes ranged from 15 to 250 . Most studies followed participants for 12 , 24 or 36 months ; the longest follow-up was 10 years . The risk of bias across all domains of most trials was uncertain ; just one was judged to have adequate allocation concealment . All seven RCTs comparing surgery with non-surgical interventions found benefits of surgery on measures of weight change at one to two years follow-up . Improvements for some aspects of health-related quality of life ( QoL ) ( two RCTs ) and diabetes ( five RCTs ) were also found . The overall quality of the evidence was moderate . Five studies reported data on mortality , no deaths occurred . Serious adverse events ( SAEs ) were reported in four studies and ranged from 0 % to 37 % in the surgery groups and 0 % to 25 % in the no surgery groups . Between 2 % and 13 % of participants required reoperations in the five studies that reported these data .Three RCTs found that laparoscopic Roux-en-Y gastric bypass (L)(RYGB ) achieved significantly greater weight loss and body mass index ( BMI ) reduction up to five years after surgery compared with laparoscopic adjustable gastric b and ing ( LAGB ) . Mean end-of- study BMI was lower following LRYGB compared with LAGB : mean difference ( MD ) -5.2 kg/m² ( 95 % confidence interval ( CI ) -6.4 to -4.0 ; P 265 participants ; 3 trials ; moderate quality evidence ) . Evidence for QoL and comorbidities was very low quality . The LRGYB procedure result ed in greater duration of hospitalisation in two RCTs ( 4/3.1 versus 2/1.5 days ) and a greater number of late major complications ( 26.1 % versus 11.6 % ) in one RCT . In one RCT the LAGB required high rates of reoperation for b and removal ( 9 patients , 40.9%).Open RYGB , LRYGB and laparoscopic sleeve gastrectomy ( LSG ) led to losses of weight and /or BMI but there was no consistent picture as to which procedure was better or worse in the seven included trials . MD was -0.2 kg/m² ( 95 % CI -1.8 to 1.3 ) ; 353 participants ; 6 trials ; low quality evidence ) in favour of LRYGB . No statistically significant differences in QoL were found ( one RCT ) . Six RCTs reported mortality ; one death occurred following LRYGB . SAEs were reported by one RCT and were higher in the LRYGB group ( 4.5 % ) than the LSG group ( 0.9 % ) . Reoperations ranged from 6.7 % to 24 % in the LRYGB group and 3.3 % to 34 % in the LSG group . Effects on comorbidities , complications and additional surgical procedures were neutral , except gastro-oesophageal reflux disease improved following LRYGB ( one RCT ) . One RCT of people with a BMI 25 to 35 and type 2 diabetes found laparoscopic mini-gastric bypass result ed in greater weight loss and improvement of diabetes compared with LSG , and had similar levels of complications . Two RCTs found that biliopancreatic diversion with duodenal switch ( BDDS ) result ed in greater weight loss than RYGB in morbidly obese patients . End-of- study mean BMI loss was greater following BDDS : MD -7.3 kg/m² ( 95 % CI -9.3 to -5.4 ) ; P ; 107 participants ; 2 trials ; moderate quality evidence ) . QoL was similar on most domains . In one study between 82 % to 100 % of participants with diabetes had a HbA1c of less than 5 % three years after surgery . Reoperations were higher in the BDDS group ( 16.1 % to 27.6 % ) than the LRYGB group ( 4.3 % to 8.3 % ) . One death occurred in the BDDS group . One RCT comparing laparoscopic duodenojejunal bypass with sleeve gastrectomy versus LRYGB found BMI , excess weight loss , and rates of remission of diabetes and hypertension were similar at 12 months follow-up ( very low quality evidence ) . QoL , SAEs and reoperation rates were not reported . No deaths occurred in either group . One RCT comparing laparoscopic isolated sleeve gastrectomy ( LISG ) versus LAGB found greater improvement in weight-loss outcomes following LISG at three years follow-up ( very low quality evidence ) . QoL , mortality and SAEs were not reported . Reoperations occurred in 20 % of the LAGB group and in 10 % of the LISG group . One RCT ( unpublished ) comparing laparoscopic gastric imbrication with LSG found no statistically significant difference in weight loss between groups ( very low quality evidence ) . QoL and comorbidities were not reported . No deaths occurred . Two participants in the gastric imbrication group required reoperation . AUTHORS ' CONCLUSIONS Surgery results in greater improvement in weight loss outcomes and weight associated comorbidities compared with non-surgical interventions , regardless of the type of procedures used . When compared with each other , certain procedures result ed in greater weight loss and improvements in comorbidities than others . Outcomes were similar between RYGB and sleeve gastrectomy , and both of these procedures had better outcomes than adjustable gastric b and ing . For people with very high BMI , biliopancreatic diversion with duodenal switch result ed in greater weight loss than RYGB . Duodenojejunal bypass with sleeve gastrectomy and laparoscopic RYGB had similar outcomes , however this is based on one small trial . Isolated sleeve gastrectomy led to better weight-loss outcomes than adjustable gastric b and ing after three years follow-up . This was based on one trial only . Weight-related outcomes were similar between laparoscopic gastric imbrication and laparoscopic sleeve gastrectomy in one trial . Across all studies adverse event rates and reoperation rates were generally poorly reported . Most trials followed participants for only one or two years , therefore the long-term effects of surgery remain unclear | [
"OBJECTIVE To determine the within-trial cost-efficacy of surgical therapy relative to conventional therapy for achieving remission of recently diagnosed type 2 diabetes in class I and II obese patients . RESEARCH DESIGN AND METHODS Efficacy results were derived from a 2-year r and omized controlled trial . A health sector perspective was adopted , and within-trial intervention costs included gastric b and ing surgery , mitigation of complications , outpatient medical consultations , medical investigations , pathology , weight loss therapies , and medication . Re source use was measured based on data drawn from a trial data base and patient medical records and valued based on private hospital costs and government schedules in 2006 Australian dollars ( AUD ) . An incremental cost-effectiveness analysis was undertaken . RESULTS Mean 2-year intervention costs per patient were 13,400 AUD for surgical therapy and 3,400 AUD for conventional therapy , with laparoscopic adjustable gastric b and ( LAGB ) surgery accounting for 85 % of the difference . Outpatient medical consultation costs were three times higher for surgical patients , whereas medication costs were 1.5 times higher for conventional patients . The cost differences were primarily in the first 6 months of the trial . Relative to conventional therapy , the incremental cost-effectiveness ratio for surgical therapy was 16,600 AUD per case of diabetes remitted ( currency exchange : 1 AUD = 0.74 USD ) . CONCLUSIONS Surgical therapy appears to be a cost-effective option for managing type 2 diabetes in class I and II obese patients",
"Laparoscopic adjustable gastric b and ing ( LAGB ) and vertical-b and ed gastroplasty ( VBG ) are surgical treatment modalities for morbid obesity . This prospect i ve study describes the long-term results of LAGB and VBG . One hundred patients were included in the study . Fifty patients underwent LAGB and 50 patients , open VBG . Study parameters were weight loss , changes in obesity-related comorbidities , long-term complications , re-operations including conversions to other bariatric procedures and laboratory parameters including vitamin status . From 91 patients ( 91 % ) , data were obtained with a mean follow-up duration of 84 months ( 7 years ) . Weight loss [ percent excess weight loss ( EWL ) ] was significantly more after VBG compared with LAGB , 66 % versus 54 % , respectively . All comorbidities significantly decreased in both groups . Long-term complications after VBG were mainly staple line disruption ( 54 % ) and incisional hernia ( 27 % ) . After LAGB , the most frequent complications were pouch dilatation ( 21 % ) and anterior slippage ( 17 % ) . Major re-operations after VBG were performed in 60 % of patients . All re-operations following were conversions to Roux-en-Y gastric bypass ( RYGB ) . In the LAGB group , 33 % of patients had a refixation or replacement of the b and , and 11 % underwent conversion to another bariatric procedure . There were no significant differences in weight loss between patients with or without re- interventions . No vitamin deficiencies were present after 7 years , although supplement usage was inconsistent . This long-term follow-up study confirms the high occurrence of late complications after restrictive bariatric surgery . The failure rate of 65 % after VBG is too high , and this procedure is not performed anymore in our institution . The re-operation rate after LAGB is decreasing as a result of new techniques and material s. Results of the re-operations are good with sustained weight loss and reduction in comorbidities . However , in order to achieve these results , a durable and complete follow-up after restrictive procedures is imperative",
"BACKGROUND Duodenal switch provides greater weight loss than gastric bypass in severely obese patients ; however , comparative data on the changes in gastrointestinal symptoms , bowel function , eating behavior , dietary intake , and psychosocial functioning are limited . METHODS The setting for the present study was 2 university hospitals in Norway and Sweden . Participants with a body mass index of 50 - 60 kg/m(2 ) were r and omly assigned to gastric bypass ( n = 31 ) or duodenal switch ( n = 29 ) and followed up for 2 years . Of the 60 patients , 97 % completed the study . Their mean weight decreased by 31.2 % after gastric bypass and 44.8 % after duodenal switch . At inclusion and 1 and 2 years of follow-up , the participants completed the Gastrointestinal Symptom Rating Scale , a bowel function question naire , the Three-Factor Eating Question naire-R21 , a 4-day food record , and the Obesity-related Problems scale . RESULTS Compared with the gastric bypass group , the duodenal switch group reported more symptoms of diarrhea ( P = .0002 ) , a greater mean number of daytime defecations ( P = .007 ) , and more anal leakage of stool ( 50 % versus 18 % of participants , respectively ; P = .015 ) after 2 years . The scores for uncontrolled and emotional eating were significantly and similarly reduced after both operations . The mean total caloric intake and intake of fat and carbohydrates were significantly reduced in both groups . Protein intake was significantly reduced only after gastric bypass ( P = .008 , between-group comparison ) . Psychosocial function was significantly improved after both operations ( P = .23 , between the 2 groups ) . CONCLUSION Gastrointestinal side effects and anal leakage of stool were more pronounced after duodenal switch than after gastric bypass . Both procedures led to reduced uncontrolled and emotional eating , reduced caloric intake , and improved psychosocial functioning",
"BACKGROUND There are few studies of long-term outcomes for either laparoscopic adjustable gastric b and ing ( LAGB ) or laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . The objective of this study was to compare outcomes of patients r and omly assigned to undergo LAGB or LRYGB at 10 years . METHODS LAGB , using the pars flaccida technique , and st and ard LRYGB were performed . From January 2000 to November 2000 , 51 patients ( mean age 34.0 ± 8.9 years ; range 20 - 49 ) were r and omly allocated to undergo either LAGB ( n = 27 , 5 men and 22 women ; mean age 33.3 years ; mean weight 120 kg ; mean body mass index [ BMI ] 43.4 kg/m(2 ) ) or LRYGB ( n = 24 , 4 men and 20 women ; mean age 34.7 ; mean weight 120 kg ; mean BMI 43.8 kg/m(2 ) ) . Data on complications , reoperations , weight , BMI , percentage of excess weight loss , and co-morbidities were collected yearly . The data were analyzed using Student 's t test and Fisher 's exact test , with P died . Conversion to laparotomy was performed in 1 ( 4.2 % ) of 24 LRYGB patients . Reoperations were required in 9 ( 40.9 % ) of 22 LAGB patients and in 6 ( 28.6 % ) of the 21 LRYGB patients . At 10-year follow-up , the LRYGB patients had a greater percentage of mean excess weight loss than did the LAGB patients ( 69±29 % versus 46±27 % ; P = .03 ) . CONCLUSION LRYGB was superior to LAGB in term of excess weight loss results ( 76.2 % versus 46.2 % ) at 10 years . However , LRYGB exposes patients to higher early complication rates than LAGB ( 8.3 % versus 0 % ) and potentially lethal long-term surgical complications ( internal hernia and bowel obstruction rate : 4.7 % )",
"Background Currently , there is a debate whether the laparoscopic gastric imbrication ( LGI ) offers similar weight loss when compared to the laparoscopic sleeve gastrectomy ( LSG ) . On the surface , they seem to offer similar-sized stomachs after the procedures are performed . We chose to perform a r and omized double-blinded trial to see if similar-sized pouches result in similar types of weight loss . Our belief was that sleeve gastrectomy would offer at least a 10 % better weight loss over a 3-year period . Methods Thirty patients were r and omized to one of two arms . The patients and the third party administrator following the patients were blinded as to which procedure was chosen . The surgeon had full knowledge of the patients ’ surgery throughout the treatment . The decision of which arm to place them was made by a single employee of the third party administrator and not shared with the employees following the patients . Patients were then followed for 3 years . Results There were no differences in weight , age , or BMI preoperatively . There were no differences between the two groups at any follow-up time point from 6 months to 3 years . Follow-up was 100 % . Conclusion Due to the large st and ard deviations present in both groups , there was no statistical difference between either of the groups in terms of weight loss",
"CONTEXT Obstructive sleep apnea ( OSA ) is strongly related to obesity . Weight loss is recommended as part of the overall management plan for obese patients diagnosed with OSA . OBJECTIVE To determine whether surgically induced weight loss is more effective than conventional weight loss therapy in the management of OSA . DESIGN , SETTING , AND PATIENTS A r and omized controlled trial of 60 obese patients ( body mass index : > 35 and These patients had been prescribed continuous positive airway pressure ( CPAP ) therapy to manage OSA and were identified via accredited community sleep clinics . The trial was conducted between September 2006 and March 2009 by university- and teaching hospital-based clinical research ers in Melbourne , Australia . Patients with obesity hypoventilation syndrome , previous bariatric surgery , contraindications to bariatric surgery , or significant cardiopulmonary , neurological , vascular , gastrointestinal , or neoplastic disease were excluded . INTERVENTIONS Patients were r and omized to a conventional weight loss program that included regular consultations with a dietitian and physician , and the use of very low-calorie diets as necessary ( n = 30 ) or to bariatric surgery ( laparoscopic adjustable gastric b and ing ; n = 30 ) . MAIN OUTCOME MEASURES The primary outcome was baseline to 2-year change in AHI on diagnostic polysomnography scored by staff blinded to r and omization . Secondary outcomes were changes in weight , CPAP adherence , and functional status . RESULTS Patients lost a mean of 5.1 kg ( 95 % CI , 0.8 to 9.3 kg ) in the conventional weight loss program compared with 27.8 kg ( 95 % CI , 20.9 to 34.7 kg ) in the bariatric surgery group ( P AHI decreased by 14.0 events/hour ( 95 % CI , 3.3 to 24.6 events/hour ) in the conventional weight loss group and by 25.5 events/hour ( 95 % CI , 14.2 to 36.7 events/hour ) in the bariatric surgery group . The between-group difference was -11.5 events/hour ( 95 % CI , -28.3 to 5.3 events/hour ; P = .18 ) . CPAP adherence did not differ between the groups . The bariatric surgery group had greater improvement in the Short Form 36 physical component summary score ( mean , 9.3 [ 95 % CI , 0.5 to 18.0 ] ; P = .04 ) . CONCLUSION Among a group of obese patients with OSA , the use of bariatric surgery compared with conventional weight loss therapy did not result in a statistically greater reduction in AHI despite major differences in weight loss . TRIAL REGISTRATION anzctr.org Identifier : 12605000161628",
"CONTEXT Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes . OBJECTIVE To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control . DESIGN , SETTING , AND PARTICIPANTS Unblinded r and omized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia , with general community recruitment to established treatment programs . Participants were 60 obese patients ( BMI > 30 and INTERVENTIONS Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric b and ing with conventional diabetes care . MAIN OUTCOME MEASURES Remission of type 2 diabetes ( fasting glucose level glycated hemoglobin [ HbA1c ] value weight and components of the metabolic syndrome . Analysis was by intention-to-treat . RESULTS Of the 60 patients enrolled , 55 ( 92 % ) completed the 2-year follow-up . Remission of type 2 diabetes was achieved by 22 ( 73 % ) in the surgical group and 4 ( 13 % ) in the conventional-therapy group . Relative risk of remission for the surgical group was 5.5 ( 95 % confidence interval , 2.2 - 14.0 ) . Surgical and conventional-therapy groups lost a mean ( SD ) of 20.7 % ( 8.6 % ) and 1.7 % ( 5.2 % ) of weight , respectively , at 2 years ( P Remission of type 2 diabetes was related to weight loss ( R2 = 0.46 , P lower baseline HbA1c levels ( combined R2 = 0.52 , P no serious complications in either group . CONCLUSIONS Participants r and omized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss . These results need to be confirmed in a larger , more diverse population and have long-term efficacy assessed . TRIAL REGISTRATION actr.org Identifier : ACTRN012605000159651",
"IMPORTANCE Controlling glycemia , blood pressure , and cholesterol is important for patients with diabetes . How best to achieve this goal is unknown . OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 2-group unblinded r and omized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c ( HbA1c ) level of 8.0 % or higher , body mass index ( BMI ) between 30.0 and 39.9 , C peptide level of more than 1.0 ng/mL , and type 2 diabetes for at least 6 months . The study began in April 2008 . INTERVENTIONS Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery . Medications for hyperglycemia , hypertension , and dyslipidemia were prescribed according to protocol and surgical techniques that were st and ardized . MAIN OUTCOMES AND MEASURES Composite goal of HbA1c less than 7.0 % , low-density lipoprotein cholesterol less than 100 mg/dL , and systolic blood pressure less than 130 mm Hg . RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were r and omly assigned to undergo Roux-en-Y gastric bypass . After 12-months , 28 participants ( 49 % ; 95 % CI , 36%-63 % ) in the gastric bypass group and 11 ( 19 % ; 95 % CI , 10%-32 % ) in the lifestyle-medical management group achieved the primary end points ( odds ratio [ OR ] , 4.8 ; 95 % CI , 1.9 - 11.7 ) . Participants in the gastric bypass group required 3.0 fewer medications ( mean , 1.7 vs 4.8 ; 95 % CI for the difference , 2.3 - 3.6 ) and lost 26.1 % vs 7.9 % of their initial body weigh compared with the lifestyle-medical management group ( difference , 17.5 % ; 95 % CI , 14.2%-20.7 % ) . Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss . There were 22 serious adverse events in the gastric bypass group , including 1 cardiovascular event , and 15 in the lifestyle-medical management group . There were 4 perioperative complications and 6 late postoperative complications . The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group . CONCLUSIONS AND RELEVANCE In mild to moderately obese patients with type 2 diabetes , adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal . Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00641251",
"BACKGROUND Few weight loss surgery trials have evaluated the changes in health-related quality of life ( HRQOL ) relative to obese individuals not participating in weight loss interventions . In a prospect i ve study at a bariatric surgery practice , we evaluated the 2-year changes in HRQOL in gastric bypass patients compared with 2 severely obese groups who did not undergo surgical weight loss . METHODS A total of 308 gastric bypass patients were compared with 253 individuals who sought but did not undergo gastric bypass and 272 population -based obese individuals using the weight-related ( Impact of Weight on Quality of Life-Lite ) and general ( Medical Outcomes Study 36-item Short-Form Health Survey ) HRQOL question naires at baseline and 2 years of follow-up . RESULTS The percentage of weight loss was 34.2 % for the gastric bypass and 1.4 % for the no gastric bypass groups , with a .5 % gain for population -based obese group . Both measures of HRQOL showed greater improvements for the gastric bypass group , even after controlling for baseline differences . Effect sizes for changes in physical and weight-related HRQOL were very large for gastric bypass , but small to medium for the 2 comparison groups . Effect sizes for changes in the psychosocial aspects of HRQOL were moderate to very large for gastric bypass , but small for the 2 comparison groups . Of the gastric bypass patients , 97 % had meaningful improvements in the Impact of Weight on Quality of Life-Lite total score compared with 43 % of the no gastric bypass group and 30 % of the population -based obese group . CONCLUSION Dramatic improvements had occurred in weight-related and physical HRQOL for gastric bypass patients at 2 years after surgery compared with 2 severely obese groups who had not undergone surgery . These results support the effectiveness of gastric bypass surgery in improving patients ' HRQOL",
"BACKGROUND To perform a prospect i ve , r and omized comparison of laparoscopic adjustable gastric b and ing ( LAGB ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . METHODS LAGB , using the pars flaccida technique , and st and ard LRYGB were performed . From January 2000 to November 2000 , 51 patients ( mean age 34.0 + /- 8.9 years , range 20 - 49 ) were r and omly allocated to undergo either LAGB ( n = 27 , 5 men and 22 women , mean age 33.3 years , mean weight 120 kg , mean body mass index [ BMI ] 43.4 kg/m(2 ) ; percentage of excess weight loss 83.8 % ) or LRYGB ( n = 24 , 4 men and 20 women , mean age 34.7 , mean weight 120 kg , mean BMI 43.8 kg/m(2 ) , percentage of excess weight loss 83.3 ) . Data on the operative time , complications , reoperations with hospital stay , weight , BMI , percentage of excess weight loss , and co-morbidities were collected yearly . Failure was considered a BMI of > 35 at 5 years postoperatively . The data were analyzed using Student 's t test and Fisher 's exact test , with P mean operative time was 60 + /- 20 minutes for the LAGB group and 220 + /- 100 minutes for the LRYGB group ( P died . Conversion to laparotomy was performed in 1 ( 4.2 % ) of 24 LRYGB patients because of a posterior leak of the gastrojejunal anastomosis . Reoperations were required in 4 ( 15.2 % ) of 26 LAGB patients , 2 because of gastric pouch dilation and 2 because of unsatisfactory weight loss . One of these patients required conversion to biliopancreatic diversion ; the remaining 3 patients were on the waiting list for LRYGB . Reoperations were required in 3 ( 12.5 % ) of the 24 LRYGB patients , and each was because of a potentially lethal complication . No LAGB patient required reoperation because of an early complication . Of the 27 LAGB patients , 3 had hypertension and 1 had sleep apnea . Of the 24 LRYGB patients , 2 had hyperlipemia , 1 had hypertension , and 1 had type 2 diabetes . Five years after surgery , the diabetes , sleep apnea , and hyperlipemia had resolved . At the 5-year ( range 60 - 66 months ) follow-up visit , the LRYGB patients had significantly lower weight and BMI and a greater percentage of excess weight loss than did the LAGB patients . Weight loss failure ( BMI > 35 kg/m(2 ) at 5 yr ) was observed in 9 ( 34.6 % ) of 26 LAGB patients and in 1 ( 4.2 % ) of 24 LRYGB patients ( P LAGB group and 24 in the LRYGB group , 3 ( 11.5 % ) and 15 ( 62.5 % ) had a BMI of weight loss and a reduced number of failures compared with LAGB , despite the significantly longer operative time and life-threatening complications",
"BACKGROUND In an attempt to potentiate the effect of laparoscopic gastric b and ing ( LGB ) on weight reduction and to reduce the risk of weight regain , we added laparoscopic truncal vagotomy ( TV ) to adjustable LGB . We report on our early interim results of a prospect i ve 5-year r and omized clinical trial comparing patients who underwent LGB plus TV ( LGBTV ) with a control group who underwent LGB alone . METHODS From December 2005 to November 2006 , patients were r and omly allocated to LGBTV or LGB alone . In the LGBTV group , the anterior and posterior vagus trunks were isolated and resected after preparing and encircling the esophagus at the diaphragmatic crus . In both groups , an 11-cm Lap-B and System was positioned by way of the pars flaccida . RESULTS A total of 50 patients were entered into the study . No mortality result ed , and no conversion to laparotomy was needed . Neither group had any intra- or postoperative complications . The mean weight , body mass index , and percentage of excess weight loss were not significantly different statistically between the 2 groups at 12 or 18 months after surgery ( P = NS ) . At 6 months of follow-up , b and adjustment was not required in 10 ( 50 % ) of 20 patients with LGBTV compared with 5 ( 20 % ) of 25 patients with LGB alone ( P = .034 ) . At 12 months , 7 ( 35 % ) of 20 LGBTV patients and 2 ( 8 % ) of 25 LGB patients still did not require b and adjustment ( P = .024 ) . CONCLUSION The results of our study have shown that adding TV to LGB does not cause specific morbidity or mortality compared with LGB alone . During the first postoperative year , the addition of TV to LGB decreased the number of patients requiring b and adjustments",
"BACKGROUND Gastric bypass and duodenal switch are currently performed bariatric surgical procedures . Uncontrolled studies suggest that duodenal switch induces greater weight loss than gastric bypass . OBJECTIVE To determine whether duodenal switch leads to greater weight loss and more favorable improvements in cardiovascular risk factors and quality of life than gastric bypass . DESIGN R and omized , parallel-group trial . ( Clinical Trials.gov registration number : NCT00327912 ) SETTING 2 academic medical centers ( 1 in Norway and 1 in Sweden ) . PATIENTS 60 participants with a body mass index ( BMI ) between 50 and 60 kg/m(2 ) . INTERVENTION Gastric bypass ( n = 31 ) or duodenal switch ( n = 29 ) . MEASUREMENTS The primary outcome was the change in BMI after 2 years . Secondary outcomes included anthropometric measures ; concentrations of blood lipids , glucose , insulin , C-reactive protein , and vitamins ; and health-related quality of life and adverse events . RESULTS Fifty-eight of 60 participants ( 97 % ) completed the study . The mean reductions in BMI were 17.3 kg/m(2 ) ( 95 % CI , 15.7 to 19.0 kg/m(2 ) ) after gastric bypass and 24.8 kg/m(2 ) ( CI , 23.0 to 26.5 kg/m(2 ) ) after duodenal switch ( mean between-group difference , 7.44 kg/m(2 ) [ CI , 5.24 to 9.64 kg/m(2 ) ] ; P Total cholesterol concentration decreased by 0.24 mmol/L ( CI , -0.03 to 0.50 mmol/L ) ( 9.27 mg/dL [ CI , -1.16 to 19.3 mg/dL ] ) after gastric bypass and 1.07 mmol/L ( CI , 0.79 to 1.35 mmol/L ) ( 41.3 mg/dL [ CI , 30.5 to 52.1 mg/dL ] ) after duodenal switch ( mean between-group difference , 0.83 mmol/L [ CI , 0.48 to 1.18 mmol/L ] ; 32.0 mg/dL [ CI , 18.5 to 45.6 mg/dL ] ; P ≤ 0.001 ) . Reductions in low-density lipoprotein cholesterol concentration , anthropometric measures , fat mass , and fat-free mass were also greater after duodenal switch ( P ≤ 0.010 for each between-group comparison ) . Both groups had reductions in blood pressure and mean concentrations of glucose , insulin , and C-reactive protein , with no between-group differences . The duodenal switch group , but not the gastric bypass group , had reductions in concentrations of vitamin A and 25-hydroxyvitamin D. Most Short Form-36 Health Survey dimensional scores improved in both groups , with greater improvement in 1 of 8 domains ( bodily pain ) after gastric bypass . From surgery until 2 years , 10 participants ( 32 % ) had adverse events after gastric bypass and 18 ( 62 % ) after duodenal switch ( P = 0.021 ) . Adverse events related to malnutrition occurred only after duodenal switch . LIMITATION Clinical experience was greater with gastric bypass than with duodenal switch at the study centers . CONCLUSION Duodenal switch surgery was associated with greater weight loss , greater reductions of total and low-density lipoprotein cholesterol concentrations , and more adverse events . Improvements in other cardiovascular risk factors and quality of life were similar after both procedures . PRIMARY FUNDING SOURCE South-Eastern Norway Regional Health Authority",
"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 Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) is currently the gold st and ard bariatric procedure for the treatment of morbid obesity . Laparoscopic sleeve gastrectomy ( LSG ) is a relatively innovative procedure which has been increasingly applied lately as a sole bariatric procedure . A r and omized trial was conducted in a Greek population to evaluate perioperative safety and 3-years results . Methods Sixty patients with body mass index ( BMI ) ≤ 50 Kg/m2 were r and omized to LRYGB or LSG . Patients were monitored for 3 years postoperatively and throughout the study period weight loss , in terms of percent excess weight loss ( % EWL ) , early and late complications , improvement of obesity related comorbidities and nutritional deficiencies were compared between groups . Results There was no death in either group and there was no significant difference in early ( 10 % after LRYGB and 13 % after LSG , P > 0.05 ) and late morbidity ( 10 % in each group ) . Weight loss was significantly better after LSG in the first years of the study and at 3 years % EWL reached 62 % after LRYGB and 68 % after LSG ( p = 0.13 ) . There was no significant difference in the overall improvement of comorbidities . Nutritional deficiencies occurred at the same rate in the two groups except to vitamin B12 deficiency which was more common after LRYGB ( P = 0.05 ) . Conclusion LSG and LRYGB are equally safe and effective in the amelioration of comorbidities , while LSG is associated with fewer postoperative metabolic deficiencies , without the need of supplementation . Furthermore , LSG is a promising bariatric procedure , equally effective to LRYGB at 3 years follow up on weight reduction",
"Aims /hypothesisBariatric surgery is gaining acceptance as a ‘ metabolic surgical intervention ’ for patients with type 2 diabetes . The optimal form of surgery and the mechanism of action of these procedures are much debated . We compared two bariatric procedures for obese patients with type 2 diabetes and evaluated their effects on HbA1c and glucose tolerance . Methods We performed a parallel un-blinded r and omised trial of Roux-en-Y gastric bypass ( RYGB ) vs sleeve gastrectomy ( SG ) in 41 obese patients with type 2 diabetes , who were bariatric surgery c and i date s attending the obesity clinic . HbA1c , body composition and glucose tolerance were evaluated at baseline , and at 3 and 12 months . Results Of the 41 patients , 37 completed the follow-up ( 19 RYGB , 18 SG ) . Both groups had similar baseline anthropometric and biochemical measures , and showed comparable weight loss and fat : fat-free mass ratio changes at 12 months . A similar normalisation of HbA1c levels was observed as early as 3 months post-surgery ( 6.37 ± 0.71 % vs 6.23 ± 0.69 % for RYGB vs SG respectively , p HbA1c levels or weight loss during 12 months of follow-up . Trial registration Clinical Trials.gov NCT00667706 Funding This work was supported by grant no. 3 - 000 - 8480 from the Israel Ministry of Health Chief Scientist , the Stephen Morse Diabetes Research Foundation and by Johnson & Johnson",
"Background The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment . Laparoscopic adjustable gastric b and and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed . Design This open parallel-group r and omised controlled trial will compare the effectiveness , cost-effectiveness and acceptability of gastric b and ( B and ) versus gastric bypass ( Bypass ) in adults with severe and complex obesity . It has an internal pilot phase ( in two centres ) with integrated qualitative research to establish effective and optimal methods for recruitment . Adults with a body mass index ( BMI ) of 40 kg/m2 or more , or a BMI of 35 kg/m2 or more and other co-morbidities will be recruited . At the end of the internal pilot the study will exp and into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and r and omised are met and if the expected rates of retention and adherence to treatment allocation are achieved . The trial will test the joint hypotheses that Bypass is non-inferior to B and with respect to more than 50 % excess weight loss and that Bypass is superior to B and with respect to health related quality of life ( HRQOL , EQ-5D ) at three years . Secondary outcomes include other weight loss measures , waist circumference and remission/resolution of co-morbidities ; generic and symptom-specific HRQOL ; nutritional blood test results ; re source use ; eating behaviours and adverse events . A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design . Discussion By-B and is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity . The design will enable and empower surgeons to learn to recruit and participate in a r and omised study . Early evidence shows that timely recruitment is possible . Trial registration Current Controlled Trials IS RCT N00786323",
"Background : Bariatric surgery is currently the most effective treatment in morbidly obese patients , leading to durable weight loss . Objective : In this prospect i ve double blind study , we aim to evaluate and compare the effects of laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) with laparoscopic sleeve gastrectomy ( LSG ) on body weight , appetite , fasting , and postpr and ial ghrelin and peptide-YY ( PYY ) levels . Methods : After r and omization , 16 patients were assigned to LRYGBP and 16 patients to LSG . Patients were reevaluated on the 1st , 3rd , 6th , and 12th postoperative month . Blood sample s were collected after an overnight fast and in 6 patients in each group after a st and ard 420 kcal mixed meal . Results : Body weight and body mass index ( BMI ) decreased markedly ( P Excess weight loss was greater after LSG at 6 months ( 55.5 % ± 7.6 % vs. 50.2 % ± 6.5 % , P = 0.04 ) and 12 months ( 69.7 % ± 14.6 % vs. 60.5 % ± 10.7 % , [ P = 0.05 ] ) . After LRYGBP fasting ghrelin levels did not change significantly compared with baseline ( P = 0.19 ) and did not decrease significantly after the test meal . On the other h and , LSG was followed by a marked reduction in fasting ghrelin levels ( P . Fasting PYY levels increased after either surgical procedure ( P ≤ 0.001 ) . Appetite decreased in both groups but to a greater extend after LSG . Conclusion : PYY levels increased similarly after either procedure . The markedly reduced ghrelin levels in addition to increased PYY levels after LSG , are associated with greater appetite suppression and excess weight loss compared with LRYGBP",
"Context Observational studies have shown sustained weight loss after surgery for extreme obesity . No r and omized trial of contemporary surgical methods has been performed . Contribution The authors r and omly assigned 80 mildly to moderately obese ( body mass index , 30 to 35 kg/m2 ) adults to laparoscopic placement of an adjustable gastric b and or to an intensive nonsurgical weight loss program . After 2 years , the surgical group had lost 21.6 % of initial weight , and the nonsurgical group had lost 5.5 % of initial weight . Four patients required laparoscopic revision of the gastric b and . Caution s The study was not design ed to detect uncommon adverse events . Implication s Laparoscopic gastric b and ing is effective treatment for mild to moderate obesity . The Editors The development of a safe and effective treatment for obesity is a leading challenge in health care today . Obesity is an increasing health problem across the world with a prevalence of more than 20 % among the adult population in Western countries and more than 30 % in the United States ( 1 , 2 ) . The increasing prevalence is associated with a parallel increase of several obesity-related diseases , in particular , the diseases of the metabolic syndrome ( 3 , 4 ) , which include type 2 diabetes , hypertension , and dyslipidemia , and are linked to nonalcoholic steatohepatitis , obstructive sleep apnea , and the polycystic ovary syndrome . For obese individuals , the options are limited . Behavioral therapies of reduced energy intake , improved eating practice s , and increased exercise and activity , supplemented by pharmacotherapy , generally achieve only modest and often transient effects ( 5 , 6 ) . Observational studies have shown that bariatric surgical therapies involving gastric restriction by various forms of stapling with or without diversion of the gut to generate malabsorption of food are effective in achieving major weight loss and clinical ly significant improvements in health and quality of life ( 7 - 11 ) . Strong direct evidence from r and omized , controlled trials of the relative benefits of nonsurgical and surgical therapies is lacking . We are aware of only a single study , performed in the 1980s , in which 60 morbidly obese patients were r and omly assigned , without informed consent , to diet plus an early form of gastric stapling or to diet alone ( 12 ) . The maximum weight losses did not differ between the groups . However , the weight regain was greater in the diet-only group . The advent of the laparoscopic adjustable gastric b and has provided a new bariatric surgical option , which has proved to be safe , minimally invasive in its application , gentle in its use through its adjustability and easy reversibility , and similarly effective to the other bariatric procedures ( 10 , 13 , 14 ) . Figure 1 shows the LAP-B AND System ( INAMED Health , Santa Barbara , California ) and demonstrates the key feature of adjustability of the area within the b and through which it induces satiety ( 15 ) . Patients require no more than an overnight hospital stay , and the procedure has been shown to be markedly safer than gastric bypass surgery ( 13 ) . Figure 1 . The laparoscopic adjustable gastric b and ( LAP-B AND System , INAMED Health , Santa Barbara , California ) with no added fluid ( top ) and with 2 mL of fluid added ( bottom ) . We hypothesized that surgical therapy would induce more weight loss , health benefit , and improvement in quality of life than nonsurgical therapy and have conducted a r and omized , controlled trial comparing the effectiveness of current nonsurgical therapy with laparoscopic adjustable gastric b and ing in a group of mildly to moderately obese adults ( body mass index , 30 kg/m2 to 35 kg/m2 ) . We did not study patients with a body mass index greater than 35 kg/m2 because current observational data suggest that outcomes after nonsurgical treatment were unlikely to be equal to those after surgical care for these patients . The principal outcome measures were weight change , health , quality of life , and complications of therapy . Methods Patient Recruitment We recruited patients for the study through a newspaper advertisement . All patient assessment s and outpatient treatments were conducted at a community clinic dedicated to obesity management or in the clinics of a university department of surgery . Surgical procedures were conducted at a private community hospital experienced in the care of bariatric surgical patients . Patients in both groups did not pay any medical costs generated by the study . The human ethics committees of The Alfred Hospital and The Avenue Hospital approved the study in accordance with the guidelines of the National Health and Medical Research Council ( www.nhmrc.gov.au/publications/synopses/e35syn.htm ) and with the Helsinki Declaration of 1975 , as revised in 2000 ( www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf ) . Inclusion Criteria We considered patients to be eligible if they were between 20 and 50 years of age ; had a body mass index of 30 kg/m2 to 35 kg/m2 ; had identifiable problems , including an obesity-related comorbid condition ( such as hypertension , dyslipidemia , diabetes , obstructive sleep apnea , or gastroesophageal reflux disease ) , severe physical limitations , or clinical ly significant psychosocial problems associated with their obesity ; had attempted to reduce weight over at least the previous 5 years ; could underst and the options offered and the r and omization process ; and were willing to comply with the requirements of each program . Exclusion Criteria We excluded c and i date s with a history of bariatric surgery or medical problems that contraindicated treatment in either study group , such as impaired mental status , drug or alcohol addiction , or portal hypertension . In addition , we excluded participants if they had undergone an intensive , physician-supervised program that used very-low-calorie diets or pharmacotherapy or if they did not attend the 2 initial patient information visits . Assessment We provided detailed information about the problems of obesity and about the 2 study groups through at least 2 discussion periods and a patient information booklet . Initial assessment included anthropometric measures ; identification of medical , physical , or psychosocial problems ( both weight-related and other ) ; and a discussion of previous weight loss efforts . The assessment included a detailed dietary history by the trial dietitian and a review by a specialist physician to determine the presence and severity of associated medical conditions . Initial investigations included measurements of fasting blood glucose level ; serum insulin level ; and a lipid profile , including HDL cholesterol and LDL cholesterol levels . After initial assessment , we instituted a program of advice on appropriate eating patterns and exercise and followed each patient on a monthly basis for 3 months . During this time , we assessed the patients ' fulfillment of tasks , such as completion of a food diary , and overall adherence to appointments . R and omization Process We r and omly allocated eligible patients to receive a conventional , intensive , nonsurgical program or laparoscopic adjustable gastric b and ing . A computer-derived r and om allocation sequence , without blocking or stratification , performed the r and omization . This was prepared at the trial office . The trial coordinator enrolled participants and informed them of the trial allocation . After assessment had confirmed a participant 's suitability for r and omization , the coordinator contacted the trial office by telephone for allocation . The study was not blinded . Description of Nonsurgical and Surgical Interventions Common Program We instructed and encouraged all patients to follow appropriate lifestyle behavior of good eating practice s and increased exercise and activity . We also encouraged them to exercise for at least 200 minutes per week . Nonsurgical Program This program centered on the use of behavioral modification , very-low-calorie diet , and pharmacotherapy with education and professional support on appropriate eating and exercise behavior . During the 2-year period , 3 trained physicians developed a program using all the available modalities for each individual on the basis of guidelines prepared and continually review ed by a panel of experienced bariatric physicians . The program began with an intensive 6-month period of very-low-calorie diet ( 500 to 550 kcal/d ) using 1 to 3 packets of Optifast ( Novartis , Fremont , Michigan ) daily for 12 weeks , followed by a transition phase over 4 weeks combining some very-low-calorie meals with 120 mg of orlistat before nonvery-low-calorie diet meals , and then 120 mg of orlistat before all meals until the completion of the intensive phase . This intensive 6-month program was followed by further courses of very-low-calorie diets or orlistat as tolerated , as well as continual behavioral , dietary , and exercise advice to assist the participant in maintaining weight loss over a prolonged period . Sibutramine was not approved for use in Australia during the first 12 months of the study and , therefore , was not incorporated into the medical program . The management program for each individual was design ed to reflect good clinical practice . A physician saw each patient every 2 weeks during the very-low-calorie diet program and every 4 to 6 weeks during the rest of the study . All patients were seen at least every 6 weeks . Surgical Program Two experienced surgeons performed the laparoscopic adjustable gastric b and ( LAP-B AND System ) procedure , by a st and ardized method ( 14 ) , within 1 month of r and omization . The b and was placed along the perigastric pathway in all cases ( 16 ) . The treating surgeon review ed patient progress every 4 to 6 weeks during the study period and made adjustments to the volume of saline within the b and in the office by using st and ard clinical criteria ( 17 ) . Adverse Events All patients in the study were question ed about the occurrence of adverse events at each consultation , and physicians recorded the",
"The present study was design ed to evaluate the 3 year effects of a lifestyle intervention on weight loss and maintenance , dietary , and physical activity habits and eating behavior of patients following vertical b and ed gastroplasty ( VBG ) . Thirty severely obese female volunteers were included in the study and they were r and omly assigned to one of two intervention groups : usual care ( UC ) or lifestyle intervention ( LS ) group . Patients were followed for 3 years postoperatively . Outcome measures included weight loss , dietary habits , physical activity level ( PAL ) , and eating behavior changes . Weight was significantly lower in the LS group after 12 months ( 84.4 + /- 3.9 kg vs. 98.4 + /- 4.4 kg , P PAL and TV viewing . With regard to eating behavior , the LS group scored significantly better in total Dutch Eating Behavior Question naire ( DEBQ ) , Restraint Eating and External Eating scales at all postoperative time points . Similarly , significant differences were found between the two groups in dietary intake . These findings outline the importance of lifestyle intervention on weight loss and maintenance following bariatric surgery . The favorable effects of lifestyle intervention may be through adoption of healthier eating behaviors and increased physical activity",
"BACKGROUND Nocturnal hypertension , increased night-to-day systolic blood pressure ( BP ) ratio and nondipper status ( night-to-day systolic BP ratio > 0.9 ) are associated with an increased risk of cardiovascular disease . Our aim was to compare the 1-year effect of Roux-en-Y gastric bypass ( RYGB ) versus a program of intensive lifestyle intervention ( ILI ) only on nocturnal hypertension and circadian BP rhythm . METHODS The study participants were part of a 1-year , controlled clinical trial comparing the effect of RYGB or ILI on obesity-related comorbidities . Ninety participants ( 49 in the RYGB group ) successfully completed 24-hour ambulatory BP monitoring at baseline and follow-up and were eligible subsequently for analysis . RESULTS A total of 71 subjects ( 79 % ) had nocturnal hypertension at baseline . The number of subjects with nocturnal hypertension decreased from 42 to 14 in the RYGB group ( P ≤ .001 ) and from 29 to 27 ( P = .791 ) in the ILI group . Subjects in the RYGB group had a lesser adjusted odds ratio ( OR ) of nocturnal hypertension at follow-up ( OR 0.15 ; 95 % confidence interval , 0.05 - 0.42 ; P ≤ .001 ) ; however , after further adjustment for weight loss , there was no additional beneficial effect of RYGB ( P = .674 ) . No differences between groups regarding improvement in the night-to-day systolic BP ratio were found after adjustment for 24-hour systolic pressure ( P = .107 ) . Both interventions showed a decrease in the proportion of subjects classified as nondippers , namely , 44 % ( P ≤ .001 ) and 28 % ( P = .002 ) in the RYGB and ILI groups , respectively . CONCLUSION Only RYGB was associated with a decrease in the prevalence of nocturnal hypertension . Both interventions showed an improvement in dipper status , although RYGB was more effective",
"Objective The effects of various weight loss strategies on pancreatic beta cell function remain unclear . We aim ed to compare the effect of intensive lifestyle intervention ( ILI ) and Roux-en-Y gastric bypass surgery ( RYGB ) on beta cell function . Design One year controlled clinical trial ( Clinical Trials.gov identifier NCT00273104 ) . Methods One hundred and nineteen morbidly obese participants without known diabetes from the MOBIL study ( mean ( s.d . ) age 43.6 ( 10.8 ) years , body mass index ( BMI ) 45.5 ( 5.6 ) kg/m2 , 84 women ) were allocated to RYGB ( n=64 ) or ILI ( n=55 ) . The patients underwent repeated oral glucose tolerance tests ( OGTTs ) and were categorised as having either normal ( NGT ) or abnormal glucose tolerance ( AGT ) . Twenty-nine normal-weight subjects with NGT ( age 42.6 ( 8.7 ) years , BMI 22.6 ( 1.5 ) kg/m2 , 19 women ) served as controls . OGTT-based indices of beta cell function were calculated . Results One year weight reduction was 30 % ( 8) after RYGB and 9 % ( 10 ) after ILI ( P Disposition index ( DI ) increased in all treatment groups ( all P Stimulated proinsulin-to-insulin ( PI/I ) ratio decreased in both surgery groups ( both P higher DI and lower stimulated PI/I ratio than controls ( both P beta cell function to a significantly greater extent than ILI . Supra-physiological insulin secretion and proinsulin processing may indicate excessive beta cell function after gastric bypass surgery",
"Objective : As large weight losses are rarely achieved through any method except bariatric surgery , there have been no studies comparing individuals who initially lost large amounts of weight through bariatric surgery or non-surgical means . The National Weight Control Registry ( NWCR ) provides a re source for making such unique comparisons . This study compared the amount of weight regain , behaviors and psychological characteristics in NWCR participants who were equally successful in losing and maintaining large amounts of weight through either bariatric surgery or non-surgical methods . Design : Surgical participants ( n=105 ) were matched with two non-surgical participants ( n=210 ) on gender , entry weight , maximum weight loss and weight-maintenance duration , and compared prospect ively over 1 year . Results : Participants in the surgical and non-surgical groups reported having lost approximately 56 kg and keeping ⩾13.6 kg off for 5.5±7.1 years . Both groups gained small but significant amounts of weight from registry entry to 1 year ( P=0.034 ) , but did not significantly differ in magnitude of weight regain ( 1.8±7.5 and 1.7±7.0 kg for surgical and non-surgical groups , respectively ; P=0.369 ) . Surgical participants reported less physical activity , more fast food and fat consumption , less dietary restraint , and higher depression and stress at entry and 1 year . Higher levels of disinhibition at entry and increased disinhibition over 1 year were related to weight regain in both groups . Conclusions : Despite marked behavioral differences between the groups , significant differences in weight regain were not observed . The findings suggest that weight-loss maintenance comparable with that after bariatric surgery can be accomplished through non-surgical methods with more intensive behavioral efforts . Increased susceptibility to cues that trigger overeating may increase risk of weight regain regardless of initial weight-loss method",
"Objective Weight reduction improves several obesity-related health conditions . We aim ed to compare the effect of bariatric surgery and comprehensive lifestyle intervention on type 2 diabetes and obesity-related cardiovascular risk factors . Design One-year controlled clinical trial ( Clinical Trials.gov identifier NCT00273104 ) . Methods Morbidly obese subjects ( 19–66 years , mean ( s.d . ) body mass index 45.1 kg/m2 ( 5.6 ) , 103 women ) were treated with either Roux-en-Y gastric bypass surgery ( n=80 ) or intensive lifestyle intervention at a rehabilitation centre ( n=66 ) . The dropout rate within both groups was 5 % . Results Among the 76 completers in the surgery group and the 63 completers in the lifestyle group , mean ( s.d . ) 1-year weight loss was 30 % ( 8) and 8 % ( 9 ) respectively . Beneficial effects on glucose metabolism , blood pressure , lipids and low- grade inflammation were observed in both groups . Remission rates of type 2 diabetes and hypertension were significantly higher in the surgery group than the lifestyle intervention group ; 70 vs 33 % , P=0.027 , and 49 vs 23 % , P=0.016 . The improvements in glycaemic control and blood pressure were mediated by weight reduction . The surgery group experienced a significantly greater reduction in the prevalence of metabolic syndrome , albuminuria and electrocardiographic left ventricular hypertrophy than the lifestyle group . Gastrointestinal symptoms and symptomatic postpr and ial hypoglycaemia developed more frequently after gastric bypass surgery than after lifestyle intervention . There were no deaths . Conclusions Type 2 diabetes and obesity-related cardiovascular risk factors were improved after both treatment strategies . However , the improvements were greatest in those patients treated with gastric bypass surgery",
"Introduction Roux-en-Y gastric bypass ( RYGB ) is considered the gold st and ard bariatric procedure with documented safety and effectiveness . Laparoscopic sleeve gastrectomy ( LSG ) is a newer procedure being done with increasing frequency . R and omized comparisons of LSG and other bariatric procedures are limited . We present the results of the first prospect i ve r and omized trial comparing LSG and RYGB in the Polish population . Aim To assess the efficacy and safety of LSG versus RYGB in the treatment of morbid obesity and obesity-related comorbidities . Material and methods Seventy-two morbidly obese patients were r and omized to RYGB ( 36 patients ) or LSG ( 36 patients ) . Both groups were comparable regarding age , gender , body mass index ( BMI ) and comorbidities . The follow-up period was at least 12 months . Baseline and 6 and 12 month outcomes were analyzed including assessment of percent excess weight lost ( % EWL ) , reduction in BMI , morbidity ( minor , major , early and late complications ) , mortality , reoperations , comorbidities and nutritional deficiencies . Results There was no 30-day mortality and no significant difference in major complication rate ( 0 % after RYGB and 8.3 % after LSG , p > 0.05 ) or minor complication rate ( 16.6 % after RYGB and 10.1 % after LSG , p > 0.05 ) . There were no early reoperations after RYGB and 2 after LSG ( 5.5 % ) ( p > 0.05 ) . Weight loss was significant after RYGB and LSG but there was no difference between both groups at 6 and 12 months of follow-up . At 12 months % EWL in RYGB and LSG groups reached 64.2 % and 67.6 % respectively ( p > 0.05 ) . There was no significant difference in the overall prevalence of comorbidities and nutritional deficiencies . Conclusions Both LSG and RYGB produce significant weight loss at 6 and 12 months after surgery . The procedures are equally effective with regard to % EWL , reduction in BMI and amelioration of comorbidities at 6 and 12 months of follow-up . Laparoscopic sleeve gastrectomy and RYGB are comparably safe techniques with no significant differences in minor and major complication rates at 6 and 12 months",
"Objective : Laparoscopic sleeve gastrectomy ( LSG ) has been proposed as an effective alternative to the current st and ard procedure , laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . Prospect i ve data comparing both procedures are rare . Therefore , we performed a r and omized clinical trial assessing the effectiveness and safety of these 2 operative techniques . Methods : Two hundred seventeen patients were r and omized at 4 bariatric centers in Switzerl and . One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line , and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb . The mean body mass index of all patients was 44 ± 11.1 kg/m2 , the mean age was 43 ± 5.3 years , and 72 % were female . Results : The 2 groups were similar in terms of body mass index , age , sex , comorbidities , and eating behavior . The mean operative time was less for LSG than for LRYGB ( 87 ± 52.3 minutes vs 108 ± 42.3 minutes ; P = 0.003 ) . The conversion rate was 0.9 % in both groups . Complications ( the difference in severe complications did not reach statistical significance ( 4.5 % for LRYGB vs 1 % for LSG ; P = 0.21 ) . Excessive body mass index loss 1 year after the operation was similar between the 2 groups ( 72.3 % ± 22 % for LSG and 76.6 % ± 21 % for LRYGB ; P = 0.2 ) . Except for gastroesophageal reflux disease , which showed a higher resolution rate after LRYGB , the comorbidities and quality of life were significantly improved after both procedures . Conclusions : LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB . Both procedures were almost equally efficient regarding weight loss , improvement of comorbidities , and quality of life 1 year after surgery . Long-term follow-up data are needed to confirm these facts",
"OBJECTIVES To determine the efficacies of 2 weight-reducing operations on diabetic control and the role of duodenum exclusion . DESIGN Double-blind r and omized controlled trial . SETTING Department of Surgery of the Min-Sheng General Hospital , National Taiwan University . PATIENTS We studied 60 moderately obese patients ( body mass index > 25 and 30 to 7.5 % ) after conventional treatment ( > 6 months ) from September 1 , 2007 , through June 30 , 2008 . Patients and observers were masked during the follow-up , which ended in 2009 , 1 year after final enrollment . INTERVENTIONS Gastric bypass with duodenum exclusion ( n = 30 ) vs sleeve gastrectomy without duodenum exclusion ( n = 30 ) . MAIN OUTCOME MEASURES The primary outcome was remission of T2DM ( fasting glucose without glycemic therapy ) . Secondary measures included weight and metabolic syndrome . Analysis was by intention to treat . RESULTS Of the 60 patients enrolled , all completed the 12-month follow-up . Remission of T2DM was achieved by 28 ( 93 % ) in the gastric bypass group and 14 ( 47 % ) in the sleeve gastrectomy group ( P = .02 ) . Participants assigned to gastric bypass had lost more weight , achieved a lower waist circumference , and had lower glucose , HbA(1c ) , and blood lipid levels than the sleeve gastrectomy group . No serious complications occurred in either group . CONCLUSIONS Participants r and omized to gastric bypass were more likely to achieve remission of T2DM . Duodenum exclusion plays a role in T2DM treatment and should be assessed . Trial Registration clinical trials.gov Identifier : NCT00540462 ( http://www . clinical trials.gov )",
"BACKGROUND The surgical treatment of diabetes had witnessed progressive development and success since the first case of pancreatic transplantation . Although this was a great step , wide clinical application was limited by several factors . Bariatric surgery such as gastric bypass is emerging as a promising option in obese patients with type 2 diabetes . The aim of this article is to explore the current application of gastric bypass in patients with type 2 diabetes and the theoretical bases of gastric bypass as a treatment option for type 1 diabetes . METHODS We performed a MEDLINE search for articles published from August 1955 to December 2008 using the words \" surgical treatment of diabetes , \" \" etiology of diabetes \" and \" gastric bypass . \" RESULTS We identified 3215 studies and selected 72 relevant papers for review . Surgical treatment of diabetes is evolving from complex pancreatic and islets transplantation surgery for type 1 diabetes with critical postoperative outcome and follow-up to a metabolic surgery , including gastric bypass . Gastric bypass ( no immune suppression or graft rejection ) has proven to be highly effective treatment for obese patients and nonobese animals with type 2 diabetes . There are certain shared criteria between types 1 and 2 diabetes , making a selected spectrum of the disease a potential target for metabolic surgery to improve or cure diabetes . CONCLUSION Roux-en-Y gastric bypass is a promising option for lifelong treatment of type 2 diabetes . It has the potential to improve or cure a selected spectrum of type 1 diabetes when performed early in the disease . Further animal model studies or r and omized controlled trials are needed to support our conclusion",
"Objectives : This prospect i ve , r and omized trial compared the safety and effectiveness of laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) and laparoscopic mini-gastric bypass ( LMGBP ) in the treatment of morbid obesity . Summary Background Data : LRYGBP has been the gold st and ard for the treatment of morbid obesity . While LMGBP has been reported to be a simple and effective treatment , data from a r and omized trial are lacking . Methods : Eighty patients who met the NIH criteria were recruited and r and omized to receive either LRYGBP ( n = 40 ) or LMGBP ( n = 40 ) . The minimum postoperative follow-up was 2 years ( mean , 31.3 months ) . Perioperative data were assessed . Late complication , excess weight loss , BMI , quality of life , and comorbidities were determined . Changes in quality of life were assessed using the Gastro-Intestinal Quality of Life Index ( GIQLI ) . Results : There was one conversion ( 2.5 % ) in the LRYGBP group . Operation time was shorter in LMGBP group ( 205 versus 148 , P no mortality in each group . The operative morbidity rate was higher in the LRYGBP group ( 20 % versus 7.5 % , P late complications rate was the same in the 2 groups ( 7.5 % ) with no reoperation . The percentage of excess weight loss was 58.7 % and 60.0 % at 1 and 2 years , respectively , in the LPYGBP group , and 64.9 % and 64.4 % in the LMGBP group . The residual excess weight LMGBP group ( P obesity-related clinical parameters and complete resolution of metabolic syndrome in both groups were noted . Both gastrointestinal quality of life increased significantly without any significant difference between the groups . Conclusion : Both LRYGBP and LMGBP are effective for morbid obesity with similar results for resolution of metabolic syndrome and improvement of quality of life . LMGBP is a simpler and safer procedure that has no disadvantage compared with LRYGBP at 2 years of follow-up",
"Background Proven short-term effectiveness of obesity therapy should be re-evaluated in the long-term . The objective of this paper is to determine the long-term ( 10 years ) outcome for patients from a r and omised controlled trial ( RCT ) . Methods A RCT in 2002 compared laparoscopic adjustable gastric b and ( LAGB ) for obesity with non-surgical therapy . Follow-up has been conducted at 10 years . Eighty patients ( BMI 30–35 ) were r and omised to a non-surgical or a surgical program . Outcome data are available on 37 ( 92.5 % ) of the surgical patients and 27 ( 62.5 % ) of the non-surgical patients at 10 years . Results Weight change , the metabolic syndrome , quality of life , adverse events and direct costs of the surgical cohort were the main results of the study . A durable weight loss is present in the surgical group with a mean ( SD ) 10-year weight loss of 14.1 ( 7.7 ) kg ( 63.4 % EWL ) , better than the non-surgical group ( mean ( SD ) = 0.4 ( 10.5 ) kg ; p ) . The metabolic syndrome was reduced from 14 to 4 of the 37 patients who completed 10 years within the LAGB groups . Proximal gastric enlargements occurred in 17 ( 30 % ) of the 57 who had LAGB and removal of the b and occurred in 7 ( 12 % ) . The annual maintenance costs including additional surgery was AUD $ 765 per patient per year . Conclusions Bariatric surgery with the LAGB can achieve long-term weight reduction which is better than a program of non-surgical therapy . There is also a sustained reduction of the metabolic syndrome . There is a significant maintenance requirement after LAGB",
"BACKGROUND Bariatric surgery is widely performed to induce weight loss . OBJECTIVE The objective was to examine changes in vitamin status after 2 bariatric surgical techniques . DESIGN A r and omized controlled trial was conducted in 2 Sc and inavian hospitals . The subjects were 60 superobese patients [ body mass index ( BMI ; in kg/m(2 ) ) : 50 - 60 ] . The surgical interventions were either laparoscopic Roux-en-Y gastric bypass or laparoscopic biliopancreatic diversion with duodenal switch . All patients received multivitamins , iron , calcium , and vitamin D supplements . Gastric bypass patients also received a vitamin B-12 substitute . The patients were examined before surgery and 6 wk , 6 mo , and 1 y after surgery . RESULTS Of 60 surgically treated patients , 59 completed the follow-up . After surgery , duodenal switch patients had lower mean vitamin A and 25-hydroxyvitamin D concentrations and a steeper decline in thiamine concentrations than did the gastric bypass patients . Other vitamins ( riboflavin , vitamin B-6 , vitamin C , and vitamin E adjusted for serum lipids ) did not change differently in the surgical groups , and concentrations were either stable or increased . Furthermore , duodenal switch patients had lower hemoglobin and total cholesterol concentrations and a lower BMI ( mean reduction : 41 % compared with 30 % ) than did gastric bypass patients 1 y after surgery . Additional dietary supplement use was more frequent among duodenal switch patients ( 55 % ) than among gastric bypass patients ( 26 % ) . CONCLUSIONS Compared with gastric bypass , duodenal switch may be associated with a greater risk of vitamin A and D deficiencies in the first year after surgery and of thiamine deficiency in the initial months after surgery . Patients who undergo these 2 surgical interventions may require different monitoring and supplementation regimens in the first year after surgery . This trial was registered at Clinical Trials.gov as NCT00327912",
"AIMS The aim of this study was to evaluate the effect of laparoscopic Roux-en-Y gastric bypass ( RYGB ) surgery compared with usual care with and without Exenatide therapy in obese people with type 2 diabetes mellitus ( T2DM ) and hypertension . METHODS 108 obese T2DM with hypertension were enrolled and r and omly allocated to usual care ( group A ) , usual care plus Exenatide ( group B ) , and RYGB surgery ( group C ) . Demographic characteristics , metabolic parameters and cardiac structure/function along with inflammatory cytokines were measured and compared before and after 12 months . RESULTS At 12 months , diabetes remission had occurred in no patients in groups A and B versus 90 % in group C , and there was a significant decrease in requirement of antihypertensive drugs in group C compared with groups A and B ( P ( body mass index , hemoglobin A1c , homeostasis model assessment of insulin resistance , lipids ) , inflammation index ( high sensitivity C-reactive protein , tumor necrosis factor-α , high molecular weight adiponectin ) and cardiac structure ( left ventricular mass index ) were significantly improved in groups B and C , but patients in group C had the greatest degree of improvement ( P CONCLUSION RYGB surgery improves a number of parameters including cardiovascular function in obese hypertensive people with T2DM . This is likely to be due to , at least in part , an improvement in the abnormal metabolic panel and to reduced inflammation",
"Background : Laparoscopic adjustable gastric b and ing ( GB ) is the most popular restrictive procedure for obesity in Europe . Isolated sleeve gastrectomy ( SG ) , is less common , but more invasive and with a higher learning curve . The aim of this prospect i ve r and omized study was to compare the results of GB and SG after 1 and 3 years of surgery . Methods : 80 patient c and i date s for laparoscopic restrictive surgery were operated consecutively and r and omly , between January and December 31 , 2002 , by GB ( 7 M , 33F ) or by SG ( 9 M , 31F ) ( NS ) . Median age was 36 ( 20 - 61 ) for GB versus 40 ( 22 - 65 ) for SG ( NS ) . Median BMI was 37 ( 30 - 47 ) for GB versus 39 ( 30 - 53 ) for SG ( NS ) . After 1 and 3 years : weight loss , feeling of hunger , sweet eating , gastroesophageal reflux disease ( GERD ) , complications and re-operations were recorded in both groups . Results : Median weight loss after 1 year was 14 kg ( −5 to + 38 ) for GB and 26 kg ( 0 to 46 ) for SG ( P P after 1 year was 15.5 kg/m 2 ( 5 to 39 ) after GB and 25 kg/m2 ( 0 to 45 ) after SG ( P ( P=0.0004 ) . Median % EWL at 1 year was 41.4 % ( −11.8 to + 130.5 ) after GB and 57.7 % ( 0 to 125.5 ) after SG ( P=0.0004 ) ; and at 3 years was 48 % ( 0 to 124.8 ) after GB and 66 % ( −3.1 to + 152.4 ) after SG ( P=0.0025 ) . Loss of feeling of hunger after 1 year was registered in 42.5 % of patients with GB and in 75 % of patients with SG ( P=0.003 ) ; and after 3 years in 2.9 % of patients with GB and 46.7 % of patients with SG ( P Loss of craving for sweets after 1 year was achieved in 35 % of patients with GB and 50 % of patients with SG ( NS ) ; and after 3 years in 2.9 % of patients with GB and 23 % of patients with SG ( NS ) . GERD appeared de novo after 1 year in 8.8 % of patients with GB and 21.8 % of patients with SG ( NS ) ; and after 3 years in 20.5 % of patients with GB and 3.1 % of patients with SG ( NS ) . Postoperative complications requiring re-operation were necessary for 2 patients after SG . Late complications requiring re-operation after GB included 3 pouch dilations treated by b and removal in 2 and 1 laparoscopic conversion to Roux-en-Y gastric bypass ( RYGBP ) , 1 gastric erosion treated by conversion to RYGBP , and 3 disconnections of the system treated by reconnection . Inefficacy affected 2 patients after GB , treated by conversion into RYGBP and 2 patients after SG treated by conversion to duodenal switch . Conclusion : Weight loss and loss of feeling of hunger after 1 year and 3 years are better after SG than GB . GERD is more frequent at 1 year after SG and at 3 years after GB . The number of re-operations is important in both groups , but the severity of complications appears higher in SG",
"Background : Gastric bypass and adjustable gastric b and ing are the 2 most commonly performed bariatric procedures for the treatment of morbid obesity . The aim of this study was to compare the outcomes , quality of life , and costs of laparoscopic gastric bypass versus laparoscopic gastric b and ing . Study Design : Between 2002 and 2007 , 250 patients with a body mass index of 35 to 60 kg/m2 were r and omly assigned to gastric bypass or gastric b and ing . After exclusion , 111 patients underwent gastric bypass and 86 patients underwent gastric b and ing . Outcome measures included demographic data , operative time , blood loss , length of hospital stay , morbidity , mortality , early and late reoperation rate , weight loss , changes in quality of life , and cost . Treatment failure was defined as losing less than 20 % of excess weight or conversion to another bariatric operation for failure of weight loss . Results : There were no deaths at 90 days in either group . The mean body mass index was higher in the gastric bypass group ( 47.5 vs. 45.5 kg/m2 , respectively , P gastric b and ing , operative blood loss was higher and the mean operative time and length of stay were longer in the gastric bypass group . The 30-day complication rate was higher after gastric bypass ( 21.6 % vs. 7.0 % for gastric b and ) ; however , there were no life-threatening complications such as leaks or sepsis . The most frequent late complication in the gastric bypass group was stricture ( 14.3 % ) . The 1-year mortality was 0.9 % for the gastric bypass group and 0 % for the gastric b and group . The percent of excess weight loss at 4 years was higher in the gastric bypass group ( 68 ± 19 % vs. 45 ± 28 % , respectively , P Treatment failure occurred in 16.7 % of the patients who underwent gastric b and ing and in 0 % of those who underwent gastric bypass , with male gender being a predictive factor for poor weight loss after gastric b and ing . At 1-year postsurgery , quality of life improved in both groups to that of US norms . The total cost was higher for gastric bypass as compared with gastric b and ing procedure ( $ 12,310 vs. $ 10,766 , respectively , P and gastric b and ing are both safe and effective approaches for the treatment of morbid obesity . Gastric bypass result ed in better weight loss at medium- and long-term follow-up but was associated with more perioperative and late complications and a higher 30-day readmission rate . There was a wide variation in weight loss after gastric b and ing with a small proportion of patients considered as treatment failure , and male gender was a predictive factor for poor weight loss",
"OBJECTIVE To assess changes in body composition with weight loss in obese subjects r and omized to a laparoscopic adjustable gastric b and surgical program or a medical program using a very-low-energy diet and orlistat . RESEARCH METHODS AND PROCEDURES Using body composition measurements by DXA , neutron activation for total body nitrogen , and whole body gamma counting for total body potassium , we studied changes in fat mass , fat distribution , fat-free mass , total bone mineral content , total body protein , and body cell mass at 6 ( n = 61 paired ) and 24 months ( n = 53 paired ) after r and omization . RESULTS At 24 months , the surgical group had lost significantly more weight ( surgical , 20.3 + /- 6.5 kg ; medical , 5.9 + /- 8.0 kg ) . There was favorable fat-free mass to fat mass loss ratios for both groups ( surgical , 1:5.5 ; medical , 1:5.9 ) . Changes in total body nitrogen or potassium were favorable in each group . A small reduction in mean bone mineral content occurred throughout the study but was not associated with extent of weight loss or treatment group . At 6 months , weight loss for both groups was similar ( surgical , 14.1 + /- 4.5 kg ; medical , 13.3 + /- 7.3 kg ) . The medical program subjects lost less fat-free mass and skeletal muscle and had increased total body protein . The proportion of body fat to limb fat remained remarkably constant throughout the study . DISCUSSION Weight loss programs used in this study induced fat loss without significant deleterious effects on the components of fat-free mass",
"Background : The endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been design ed to achieve weight loss in morbidly obese patients . We report on the first European experience with this device . Methods : A multicenter , r and omized clinical trial was performed . Forty-one patients were included and 30 underwent sleeve implantation . Eleven patients served as a diet control group . All patients followed the same low-calorie diet during the study period . The purpose of the study was to determine the safety and efficacy of the device . Results : Twenty-six devices were successfully implanted . In 4 patients , implantation could not be achieved . Four devices were explanted prior to the initial protocol end point because of migration ( 1 ) , dislocation of the anchor ( 1 ) , sleeve obstruction ( 1 ) , and continuous epigastric pain ( 1 ) . The remaining patients all completed the study . Mean procedure time was 35 minutes ( range : 12–102 minutes ) for a successful implantation and 17 minutes ( range : 5–99 minutes ) for explantation . There were no procedure related adverse events . During the study period the 26 duodenal-jejunal bypass sleeve patients ( 100 % ) had at least one adverse event , mainly abdominal pain and nausea during the first week after implantation . Initial mean body mass index ( BMI , kg/m2 ) was 48.9 and 47.4 kg/m2 for the device and control patients , respectively . Mean excess weight loss after 3 months was 19.0 % for device patients versus 6.9 % for control patients ( P in BMI at 3 months was 5.5 and 1.9 kg/m2 , respectively . Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period ( lower glucose levels , HbA1c , and medication requirements ) . Conclusion : The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results . The device also has a significant positive effect on type 2 diabetes mellitus . Long-term r and omized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity . This study was registered at www . clinical trials.gov ( registration number : NCT00830440 )",
"BACKGROUND Laparoscopic gastric plication ( LGP ) is emerging as a safe and effective bariatric procedure . However , there are no reports on the comparison between the efficacy and complications of LGP and laparoscopic mini-gastric bypass ( LMGB ) , which is still an investigational bariatric procedure . The objective of this study was to compare safety and efficacy of LGP and LMGB in the treatment of morbid obesity in a one-year follow-up study . METHODS Forty patients met the National Institutes of Health criteria and were r and omly assigned to receive either LGP ( n = 20 ) or LMGB ( n = 20 ) by a block r and omization method . Early and late complications , body mass index ( BMI ) , excess weight loss , and obesity-related co-morbidities were determined at the 1-year follow-up . RESULTS Operative time and mean length of hospitalization were shorter in the LGP group ( 71.0 minutes versus 125.0 minutes , P mean percentage of excess weight loss ( % EWL ) at 12 months follow-up was 66.9 % in the LMGB group and 60.8 % in the LGP group ( P = .34 ) . Improvement was observed in all co-morbidities in both groups , with the exception of hyperlipidemia , which remained unresolved in 4 patients . Lower incidence of iron deficiency occurred in the LGP group ( P = .035 ) . Rehospitalization and reoperation were not required in any cases . Considering the cost of instruments used in the LMGB procedure and operative time , LGP saved approximately $ 2,500 per case compared with LMGB . CONCLUSION Both LGP and LMGB are effective weight loss procedures . LGP proved to be a simpler and less costly procedure compared with LMGB with a lower risk of iron deficiency during a 1-year follow-up study",
"Objective To explore efficacy and safety of laparoscopic sleeve gastrectomy for the treatment of obesity . Methods Forty patients underwent laparoscopic sleeve gastrectomy as a treatment option for weight reduction between December 2006 and February 2010.Mean preoperative body weight (BW),body mass index ( BMI ) and exceed body weight ( EBW ) were(104.2 ±3.3 ) kg,(36.9 ± 1.0 ) kg/m2 and ( 37.8 ±3.0 ) kg , respectively . Outcome data were collected and assessed prospect ively . Results Laparoscopic procedures were completed in all patients , with no conversion to open surgery . The operation time averaged ( 80 ± 18 ) min , and there were no severe postoperative complications . The median postoperative hospital stay was ( 5.5 ± 1.5 ) days . BMI loss was ( 4.3 ± 1.7 ) kg/m2 , ( 7.0 ± 1.9 ) kg/m2,(9.3 ±3.1 ) kg/m2 and ( 10.1 ±3.8 ) kg/m2,respectively , and percentage of EBW loss was 35.0％ ± 13.5％,57.1％ ± 17.7％,74.2％ ±27.2％ , and 81.8％ ±29.4％,respectively , at 1,3,6 , and 12 months following the procedure . Conclusion Laparoscopic sleeve gastrectomy is an effective and safe surgical option for the treatment of obesity with lower BMI .Additional long-term studies are still needed to accurately compare laparoscopic sleeve gastrectomy with other procedures of weight reduction . Key words : Obesity , morbid ; Laparoscopy ;",
"BACKGROUND Obesity is a rising threat to public health . The relative increase in the incidence of morbid obesity is most pronounced in the most severely obese . Roux-en-Y gastric bypass ( RYGB ) results in inferior weight loss in this group . Therefore , we have offered biliopancreatic diversion with duodenal switch ( BPD/DS ) as an alternative for this patient category . Our objective was to compare BPD/DS and RYGB in the surgical treatment of morbid obesity in patients with a body mass index ( BMI ) > 48 kg/m(2 ) . The setting was a university hospital in Sweden . METHODS In a controlled trial ( registration number IS RCT N10940791 ) , 47 patients ( 25 men , BMI 54.5 ± 6.1 kg/m(2 ) ) were r and omized to RYGB ( n = 23 ) or BPD/DS ( n = 24 ) . Biochemical data were collected preoperatively and 1 and 3 years postoperatively . A question naire addressing weight , general satisfaction , and gastrointestinal symptoms was distributed a median of 4 years postoperatively . RESULTS Both procedures were safe . The duration of surgery and postoperative morphine consumption were greater after BPD/DS than after RYGB ( 157 versus 117 min and 140 versus 93 mg , respectively ) . BPD/DS result ed in greater weight loss than RYGB ( -23.2 ± 4.9 versus -16.2 ± 6.9 BMI units or 80 % ± 15 % versus 51 % ± 23 % excess BMI loss , P ) . BPD/DS yielded lower glucose and glycated hemoglobin levels at 3 years . More patients listed troublesome diarrhea and malodorous flatus in the question naire after BPD/DS , but no significant difference was seen ( P = .078 and P = .073 , respectively ) . CONCLUSIONS BPD/DS produced superior weight results and lower glycated hemoglobin levels compared with RYGB in patients with a BMI > 48 kg/m(2 ) . Both operations yield high satisfaction rates . However , diarrhea tended to be more common after BPD/DS ",
"Background This study presents late results of a previously published 2-year prospect i ve comparison between Roux-en-Y gastric bypass ( RYGBP ) versus biliopancreatic diversion with Roux-en-Y gastric bypass ( BPD-RYGBP ) in an exclusively non-superobese population . Methods From a cohort of 130 patients with a BMI of 35–50 kg/m2 , 65 were r and omly selected to undergo RYGBP and 65 to BPD-RYGBP . All underwent follow-up evaluation at 1 , 3 , 6 , and 12 months postoperatively and every year thereafter . Results Follow-up at the eighth year was achieved in 60 % of the BPD-RYGBP and in 58 % of the RYGBP group ( p = 1.00 ) . Mean excess weight loss ( EWL% ) , was significantly higher following BPD-RYGBP ( 76.89 ± 1.53 ) as compared to RYGBP ( 67.17 ± 1.43 ) ( p = 0.0004 ) . The mean success rate ( percentage of patients with EWL% ≥50 % ) was significantly higher after BPD-RYGBP ( 95.85 ± 1.01 ) than RYGBP ( 75.91 ± 3.58 ) ( p = 0.0001 ) . No significant differences were observed for late non-metabolic complications . The incidence of anemia , iron deficiency , B12 deficiency , and low-ferritin levels was relatively high in both groups with not always significant differences . Severe protein malnutrition occurred in four patients ( three BPD-RYGBP and one RYGBP ) ( p = 0.37 ) . In only one BPD-RYGBP patient ( 1.54 % ) was revision surgery to RYGBP necessary , due to recurrent episodes of hypoproteinemia . The remaining patients were treated successfully with total parenteral nutrition and nutritional counseling . Conclusions Late results presented in this paper agree with the previously published 2-year results of the same patient cohort . Although both procedures are safe and effective , BPD-RYGBP seems to prevail in terms of successful weight loss without a significantly higher incidence of metabolic and non-metabolic complications",
"Obesity adversely affects myocardial metabolism , efficiency , and diastolic function . Our objective was to determine whether weight loss can ameliorate obesity-related myocardial metabolism and efficiency derangements and that these improvements directly relate to improved diastolic function in humans . We studied 30 obese ( BMI > 30 kg/m2 ) subjects with positron emission tomography ( PET ) ( myocardial metabolism , blood flow ) and echocardiography ( structure , function ) before and after marked weight loss from gastric bypass surgery ( N = 10 ) or moderate weight loss from diet ( N = 20 ) . Baseline BMI , insulin resistance , hemodynamics , left ventricular ( LV ) mass , systolic function , myocardial oxygen consumption ( MVO2 ) , and fatty acid ( FA ) metabolism were similar between the groups . MVO2/g decreased after diet-induced weight loss ( P = 0.009 ) . Total MVO2 decreased after dietary ( P = 0.02 ) and surgical weight loss ( P = 0.0006 ) and was related to decreased BMI ( P = 0.006 ) . Total myocardial FA utilization decreased ( P = 0.03 ) , and FA oxidation trended lower ( P = 0.06 ) only after surgery . FA esterification and LV efficiency were unchanged . After surgical weight loss , LV mass decreased by 23 % ( Doppler-derived ) E/E ' by 33 % , and relaxation increased ( improved ) by 28 % . Improved LV relaxation related significantly to decreased BMI , insulin resistance , total MVO2 , and LV mass but not FA utilization . Decreased total MVO(2 ) predicted LV relaxation improvement independent of BMI change ( P = 0.02 ) . Weight loss can ameliorate the obesity-related derangements in myocardial metabolism and LV structure and diastolic function . Decreased total MVO2 independently predicted improved LV relaxation , suggesting that myocardial oxygen metabolism may be mechanistically important in determining cardiac relaxation",
"Morbid obesity is associated with excessive daytime sleepiness and reduced health-related quality of life . We prospect ively evaluated the pre- and postoperative responses of bariatric surgery recipients with the Epworth Sleepiness Scale ( ESS ) and the Short Form-12 . Participants ( n = 223 ; 79 % women ) with a mean body mass index ( BMI ) and ESS of 44.8 ± 7.9 kg/m2 and 7.9 ± 4.5 , respectively , received a vertical gastrectomy ( 76 % ) or Roux-en-Y gastric bypass ( 12 % ) . Preoperatively , 30 % of patients complained of excessive daytime sleepiness ( ESS > 10 ) . Patients with preoperative excessive daytime sleepiness were more obese ( p = 0.002 ) , had higher fasting glucose levels ( p = 0.02 ) , more likely to have a diagnosis of sleep-disordered breathing ( p report snoring ( p lower health-related quality of life measures particularly physical function ( p ) , depression ( p = 0.006 ) , and sexual satisfaction ( p = 0.04 ) than non-sleepy patients . At 12-months postoperatively , most patients experienced a significant reduction in BMI ( 28.6 ± 5.5 kg/m2 , p ) and excessive daytime sleepiness ( mean ESS 5.3 ± 3.3 , p the ESS at 12-months post-operatively had greater improvements in physical function ( p = 0.009 ) and snoring ( p = 0.010 ) and were more likely still using positive airway pressure therapy ( p = 0.032 ) than patients without a clinical ly relevant improvement . Statistically and clinical ly significant improvements in all health-related quality of life measures were noted at 24 months . Bariatric surgery is associated with dramatic weight loss and improvements in physical functioning and daytime sleepiness ",
"The goal of this study was to underst and the mechanisms of greater weight loss by gastric bypass ( GBP ) compared to gastric b and ing ( GB ) surgery . Obese weight- and age-matched subjects were studied before ( T0 ) , after a 12 kg weight loss ( T1 ) by GBP ( n = 11 ) or GB ( n = 9 ) , and at 1 year after surgery ( T2 ) . peptide YY(3 - 36 ) ( PYY(3 - 36 ) ) , ghrelin , glucagon-like peptide-1 ( GLP-1 ) , leptin , and amylin were measured after an oral glucose challenge . At T1 , glucose-stimulated GLP-1 and PYY levels increased significantly after GBP but not GB . Ghrelin levels did not change significantly after either surgery . In spite of equivalent weight loss , leptin and amylin decreased after GBP , but not after GB . At T2 , weight loss was greater after GBP than GB ( P = 0.003 ) . GLP-1 , PYY , and amylin levels did not significantly change from T1 to T2 ; leptin levels continued to decrease after GBP , but not after GB at T2 . Surprisingly , ghrelin area under the curve ( AUC ) increased 1 year after GBP ( P = 0.03 ) . These data show that , at equivalent weight loss , favorable GLP-1 and PYY changes occur after GBP , but not GB , and could explain the difference in weight loss at 1 year . Mechanisms other than weight loss may explain changes of leptin and amylin after GBP",
"Background Laparoscopic adjustable silicone gastric b and ing ( LASGB ) and laparoscopic vertical b and ed gastroplasty ( LVBG ) are the most frequently performed restrictive operations for morbid obesity . The question of whether bariatric restrictive procedures increase or reduce gastroesophageal reflux disease ( GERD ) remains open . This study aim ed to compare the long-term results of LASGB with those of LVBG in terms of postoperative GERD and esophageal motility function . Methods From February 1999 to December 2000 , 175 patients underwent bariatric surgery . After 75 of these patients were excluded from the study , the remaining 100 patients were r and omly assigned to one of two treatment groups : LASGB or LVBG . The end points of the study were evaluation of clinical and instrumental GERD and esophageal function . The follow-up protocol included clinical assessment using the Gastroesophageal Reflux Health-Related Quality -of-Life ( GERD-HRQOL ) scale at 3 , 12 , and 96 months . Esophageal manometry , 24-h pH monitoring , and endoscopy were performed at 12 and 96 months . Results At 12 months , GERD had developed in 13 ( 26 % ) LASGB and 11 ( 21.6 % ) LVBG patients . In the majority of cases , GERD result ed from pouch dilation or poor compliance and required either reoperation ( ten after LASGB and three after LVBG ) or endoscopic dilation of the neopylorus ( four after LVBG ) . In all , 71 patients completed the 96-month follow-up protocol . The findings showed that three ( 11.5 % ) of 26 LASGB patients and four ( 9 % ) of 45 LVBG patients were receiving proton pump inhibitor ( PPI ) therapy for GERD . Postoperative lower esophageal sphincter ( LES ) pressure and esophageal motility did not differ from preoperative data except for the presence of aperistaltic waves in one LASGB and two LVBG symptomatic GERD patients . Conclusions No significant association between gastric restrictive procedures and GERD or esophageal function was found during long-term follow-up assessment . The increased occurrence of GERD in the early follow-up period often is due to a technical defect or poor patient compliance",
"Background Glycemic control of type 2 diabetes mellitus ( T2DM ) remains a dilemma to physicians . Although gastric bypass surgery undertaken for morbid obesity has been shown to resolve this disease well , data on the effectiveness of duodenojejunal bypass in improving or resolving T2DM and the metabolic syndrome ( MS ) , especially in nonobese patients are scarce . This study was intended to evaluate the clinical effects of laparoscopic duodenojejunal bypass ( LDJB ) in patients with T2DM and a body mass index of Methods We conducted a 12-month prospect i ve study on the changes in glucose homeostasis and the MS in seven T2DM subjects undergoing LDJB with similar DM duration , type of DM treatment , and glycemic control . Laboratory values including glycosylated hemoglobin A ( HbA1c ) , fasting blood glucose , cholesterol , triglyceride , and C-peptide were followed throughout the 12 months . Serum levels of gastric inhibitory peptide and ghrelin were followed for 1 month . Serum levels of gastrin and glucagon-like peptide were followed for 3 months . Results At 12 months after surgery , all subjects consistently felt relief from fatigue , pain and /or numbness in the extremities , polyuria , and polydypsia . Clinical resolution was obtained for one patient , and the preoperative diabetic medication requirements decreased for most of the other patients . The subjects demonstrated an overall improved HbA1c ( from 9.4 % to 8.5 % ) and fasting blood glucose level ( from 209 to 154 mg/dl ) . Although the change in fasting blood glucose approached statistical significance , these measures of glucose homeostasis did not achieve significance . Cholesterol and triglycerides increased slightly , and C-peptide decreased slightly over 1 year . These changes were not statistically significant . Conclusions Although this is a small series , our data show that at 12 months after surgery , clinical improvement was obvious in all of our seven patients , but LDJB may not be effective at inducing remission of T2DM and the MS in certain patients undergoing this operation . This suggests that larger patient studies should be conducted , before concluding that surgery may offer clinical and biochemical resolution to a disease once treated only medically . Longer follow-up is required for better evaluation",
"Background Deficiencies in micronutrients after bariatric operations are frequent , despite routine supplementation . Main outcome measures were pre- and postoperative frequency of nutrient deficiencies and success rate of their treatment . Methods Between 5/2004 and 12/2006 , 136 patients ( m : f = 0:4 ) with an average body mass index of 45 ( 35–58 ) kg/m2 and age of 53 ( 21–66 ) years were prospect ively analysed . Laparoscopic Roux-Y-gastric bypass ( LRYGB ) was performed in 86 patients and laparoscopic sleeve gastrectomy ( LSG ) was performed in 50 patients . The patients were examined before surgery as well as 3 , 6 , 12 , 24 , 30 , and 36 months postoperatively using a st and ard protocol including laboratory tests . The mean follow-up time was 24.4 ( 12–40 ) months ; the follow-up rate was 100 % . Results Prior to surgery , 57 % of the patients had at least one deficiency , 23 % of whom had vitamin D3 deficiency . Frequent postoperative deficiencies after LSG were zinc , vitamin D3 , folic acid , iron , and vitamin B12 ; after LRYGB , vitamin B12 , vitamin D3 , zinc , and secondary hyperparathyroidism . No vitamin B1 or B6 deficiencies were found . Calcium levels were normal in all patients . Treatment of the deficiencies was mostly successful . Conclusion Preoperatively , 57 % of morbidly obese patients already had a deficiency . Postoperatively , significantly more vitamin B12 and vitamin D deficiencies and hyperparathyroidism were found in patients who had undergone LRYGB . After LSG , folate deficiency was more frequent ( but not significantly so ) . Calcium levels were normal in all patients ; therefore , parathyroid hormone and vitamin D3 levels are more sensitive markers for early detection of disorders of calcium metabolism . Iron deficiency anaemia is most efficiently treated by IV therapy",
"Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) is the most common bariatric technique . Laparoscopic sleeve gastrectomy ( LSG ) is a restrictive procedure ; the metabolic and endocrine effects of which remain unknown . We compared the effects of both procedures on glucose metabolism and fasting and meal-stimulated gut hormone levels . Methods Seven patients were r and omised to LRYGB and eight to LSG . All patients were evaluated before and at 3 and 12 months postoperatively . Plasma levels of glucose , insulin , ghrelin , leptin , peptide YY ( PYY ) , GLP-1 and pancreatic polypeptide were measured before and after 10 and 60 min of a st and ard test meal ingestion . Results Age , body mass index and preoperative hormone levels were similar in both groups . A significant reduction of plasma glucose and insulin levels was observed after surgery . Moreover , a normalisation of homeostatic model assessment for insulin resistance value was also seen after both procedures . The fasting and postpr and ial leptin levels were significantly lower in the LRYGB group . LSG was followed by a significant reduction in fasting ghrelin levels . In the LRYGB group , GLP-1 levels increased significantly after the test meal . Conclusions LRYGB and LSG markedly improved glucose homeostasis . Only LSG decreased fasting and postpr and ial ghrelin levels , whereas GLP-1 and PYY levels increased similarly after both procedures",
"Background Aim of the study is to present long-term results of a prospect i ve r and omized single-institution clinical trial comparing laparoscopic adjustable silicone gastric b and ing ( LASGB ) with laparoscopic vertical b and ed gastroplasty ( LVBG ) in morbid obesity . Methods A total of 100 morbidly obese patients ( body mass index 40 to 50 kg/m2 ) were r and omized to LASGB ( n = 49 ) or LVBG ( n = 51 ) and followed up for a minimum of 7 years . Results Mean operative time was 65.4 min in LASGBs and 94.2 min in LVBGs ( p mean hospital stay was 3.7 and 6.6 days , respectively ( p Late complication rates were 36.7 % in LASGBs vs 15.7 % in LVBGs at 3 years ( p Late reoperation rates were 28.6 % in LASGBs and 2.0 % in LVBGs at 3 years ( p Excess weight loss in LASGBs was 41.8 % at 3 years , 33.2 % at 5 years , and 29.9 % at 7 years ; excess weight loss in LVBGs was 60.9 % , 57 % , and 53.1 % , respectively ( p LVBG is significantly more effective than LASGB in terms of late complications , late reoperations , and long-term results on weight loss",
"AIM To evaluate the cost-effectiveness of laparoscopic adjustable gastric b and ing ( LAGB ) versus st and ard medical management ( SMM ) in obese patients with type 2 diabetes from a UK healthcare payer perspective . METHODS A vali date d computer model of diabetes was used to project outcomes reported from a r and omized clinical trial of LAGB versus SMM in obese patients with type 2 diabetes . Two-year follow-up data from the trial were projected over a 40-year time horizon and cost-effectiveness was assessed from the perspective of the National Health Service . Future costs and clinical outcomes were discounted at 3.5 % annually and all costs were reported in 2010 pounds sterling . A series of sensitivity analyses were performed . RESULTS LAGB was associated with benefits in HbA1c , systolic blood pressure , body mass index and serum lipid concentrations , which led to significant increases in discounted life expectancy ( an increase of 0.64 years ) and quality -adjusted life expectancy ( an increase of 0.92 quality -adjusted life years , QALYs ) and reduced incidence of diabetes complications relative to SMM . Treatment costs in the LAGB arm increased by 4552 Great British Pounds ( GBP ) , but this was partially offset by cost savings result ing from a reduction in the incidence of all modelled diabetes complications . The incremental cost-effectiveness ratio of GBP 3602 per QALY in the base case fell well below commonly quoted willingness-to-pay thresholds in the UK setting . CONCLUSIONS On the basis of data from a recent r and omized controlled trial , LAGB is likely to be considered cost-effective from the healthcare payer perspective when compared with SMM of obesity in patients with type 2 diabetes in the UK setting",
"CONTEXT Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone . Bariatric surgery is being evaluated as a possible treatment option . Laparoscopic adjustable gastric b and ing ( gastric b and ing ) has the potential to provide a safe and effective treatment . OBJECTIVE To compare the outcomes of gastric b and ing with an optimal lifestyle program on adolescent obesity . DESIGN , SETTING , AND PATIENTS A prospect i ve , r and omized controlled trial of 50 adolescents between 14 and 18 years with a body mass index ( BMI ) higher than 35 , recruited from the Melbourne , Australia , community , assigned either to a supervised lifestyle intervention or to undergo gastric b and ing , and followed up for 2 years . The study was performed between May 2005 and September 2008 . MAIN OUTCOME MEASURES Weight loss . Secondary outcomes included change in metabolic syndrome , insulin resistance , quality of life , and adverse outcomes . RESULTS Twenty-four of 25 patients in the gastric b and ing group and 18 of 25 in lifestyle group completed the study . Twenty-one ( 84 % ) in the gastric b and ing and 3 ( 12 % ) in the lifestyle groups lost more than 50 % of excess weight , corrected for age . Overall , the mean changes in the gastric b and ing group were a weight loss of 34.6 kg ( 95 % CI , 30.2 - 39.0 ) , representing an excess weight loss of 78.8 % ( 95 % CI , 66.6%-91.0 % ) , 12.7 BMI units ( 95 % CI , 11.3 - 14.2 ) , and a BMI z score change from 2.39 ( 95 % CI , 2.05 - 2.73 ) to 1.32 ( 95 % CI , 0.98 - 1.66 ) . The mean losses in the lifestyle group were 3.0 kg ( 95 % CI , 2.1 - 8.1 ) , representing excess weight loss of 13.2 % ( 95 % CI , 2.6%-21.0 % ) , 1.3 BMI units ( 95 % CI , 0.4 - 2.9 ) , and a BMI z score change from 2.41 ( 95 % CI , 2.21 - 2.66 ) to 2.26 ( 95 % CI , 1.91 - 2.43 ) . At entry , 9 participants ( 36 % ) in the gastric b and ing group and 10 ( 40 % ) in the lifestyle group had the metabolic syndrome . At 24 months , none of the gastric b and ing group had the metabolic syndrome ( P = .008 ; McNemar chi(2 ) ) compared with 4 of the 18 completers ( 22 % ) in the lifestyle group ( P = .13 ) . The gastric b and ing group experienced improved quality of life with no perioperative adverse events . However , 8 operations ( 33 % ) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up . CONCLUSIONS Among obese adolescent participants , use of gastric b and ing compared with lifestyle intervention result ed in a greater percentage achieving a loss of 50 % of excess weight , corrected for age . There were associated benefits to health and quality of life . TRIAL REGISTRATION ANZCTR Identifier : 12605000160639",
"The long‐term results of Roux‐en‐$\\hbox{Y}$ gastric bypass ( gastric bypass ) and vertical b and ed gastroplasty ( VBG ) from r and omized studies have not been described in detail",
"Laparoscopic Roux‐en‐$\\font\\ss = cmss10 scaled 1000 \\hbox{Y}$ gastric bypass ( LRYGB ) and laparoscopic biliopancreatic diversion with duodenal switch ( LDS ) are surgical options for superobesity . A r and omized trial was conducted to evaluate perioperative ( 30‐day ) safety and 1‐year results ",
"BACKGROUND Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) leads to significant weight loss and correction of co-morbidities in most patients . B and ed LRYGB was design ed to enhance weight loss and avoid weight regain . METHODS A r and omized controlled pilot trial was design ed to comparatively analyze the results and complications of b and ed ( 6.5 cm ) and unb and ed LRYGB . The present study was an interim analysis focused on morbidity , mortality , and maximal weight loss . RESULTS The 60 patients were divided into 2 groups . Group 1 underwent unb and ed LRYGB ( n = 30 ) and group 2 underwent b and ed LRYGB ( n = 30 ) . No differences were found between the 2 groups in terms of age , gender , body mass index , or operative time . No significant differences were found in the percentage of excess weight loss and body mass index at 6 , 12 , and 24 months between the 2 groups . The frequency of complications was similar in both groups ; 1 patient required b and removal because of stenosis at the level of the mesh . CONCLUSION The weight loss pattern in both groups was similar at 1 and 2 years postoperatively . Proper assessment of weight maintenance and late weight regain will require longer follow-up",
"BACKGROUND Roux-en-Y gastric bypass and biliopancreatic diversion can markedly ameliorate diabetes in morbidly obese patients , often result ing in disease remission . Prospect i ve , r and omized trials comparing these procedures with medical therapy for the treatment of diabetes are needed . METHODS In this single-center , nonblinded , r and omized , controlled trial , 60 patients between the ages of 30 and 60 years with a body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) of 35 or more , a history of at least 5 years of diabetes , and a glycated hemoglobin level of 7.0 % or more were r and omly assigned to receive conventional medical therapy or undergo either gastric bypass or biliopancreatic diversion . The primary end point was the rate of diabetes remission at 2 years ( defined as a fasting glucose level of glycated hemoglobin level of diabetes remission had occurred in no patients in the medical-therapy group versus 75 % in the gastric-bypass group and 95 % in the biliopancreatic-diversion group ( P Age , sex , baseline BMI , duration of diabetes , and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months . At 2 years , the average baseline glycated hemoglobin level ( 8.65±1.45 % ) had decreased in all groups , but patients in the two surgical groups had the greatest degree of improvement ( average glycated hemoglobin levels , 7.69±0.57 % in the medical-therapy group , 6.35±1.42 % in the gastric-bypass group , and 4.95±0.49 % in the biliopancreatic-diversion group ) . CONCLUSIONS In severely obese patients with type 2 diabetes , bariatric surgery result ed in better glucose control than did medical therapy . Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures . ( Funded by Catholic University of Rome ; Clinical Trials.gov number , NCT00888836 . )",
"BACKGROUND Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery . METHODS In this r and omized , nonblinded , single-center trial , we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes . The mean ( ±SD ) age of the patients was 49±8 years , and 66 % were women . The average glycated hemoglobin level was 9.2±1.5 % . The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0 % or less 12 months after treatment . RESULTS Of the 150 patients , 93 % completed 12 months of follow-up . The proportion of patients with the primary end point was 12 % ( 5 of 41 patients ) in the medical-therapy group versus 42 % ( 21 of 50 patients ) in the gastric-bypass group ( P=0.002 ) and 37 % ( 18 of 49 patients ) in the sleeve-gastrectomy group ( P=0.008 ) . Glycemic control improved in all three groups , with a mean glycated hemoglobin level of 7.5±1.8 % in the medical-therapy group , 6.4±0.9 % in the gastric-bypass group ( P ( P=0.003 ) . Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group ( -29.4±9.0 kg and -25.1±8.5 kg , respectively ) than in the medical-therapy group ( -5.4±8.0 kg ) ( P comparisons ) . The use of drugs to lower glucose , lipid , and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only . The index for homeostasis model assessment of insulin resistance ( HOMA-IR ) improved significantly after bariatric surgery . Four patients underwent reoperation . There were no deaths or life-threatening complications . CONCLUSIONS In obese patients with uncontrolled type 2 diabetes , 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone . Further study will be necessary to assess the durability of these results . ( Funded by Ethicon Endo-Surgery and others ; Clinical Trials.gov number , NCT00432809 . )",
"BACKGROUND Obesity is a risk factor for cancer . Intentional weight loss in the obese might protect against malignancy , but evidence is limited . To our knowledge , the Swedish Obese Subjects ( SOS ) study is the first intervention trial in the obese population to provide prospect i ve , controlled cancer-incidence data . METHODS The SOS study started in 1987 and involved 2010 obese patients ( body-mass index [ BMI ] > or=34 kg/m(2 ) in men , and > or=38 kg/m(2 ) in women ) who underwent bariatric surgery and 2037 contemporaneously matched obese controls , who received conventional treatment . While the main endpoint of SOS was overall mortality , the main outcome of this exploratory report was cancer incidence until Dec 31 , 2005 . Cancer follow-up rate was 99.9 % and the median follow-up time was 10.9 years ( range 0 - 18.1 years ) . FINDINGS Bariatric surgery result ed in a sustained mean weight reduction of 19.9 kg ( SD 15.6 kg ) over 10 years , whereas the mean weight change in controls was a gain of 1.3 kg ( SD 13.7 kg ) . The number of first-time cancers after inclusion was lower in the surgery group ( n=117 ) than in the control group ( n=169 ; HR 0.67 , 95 % CI 0.53 - 0.85 , p=0.0009 ) . The sex-treatment interaction p value was 0.054 . In women , the number of first-time cancers after inclusion was lower in the surgery group ( n=79 ) than in the control group ( n=130 ; HR 0.58 , 0.44 - 0.77 ; p=0.0001 ) , whereas there was no effect of surgery in men ( 38 in the surgery group vs 39 in the control group ; HR 0.97 , 0.62 - 1.52 ; p=0.90 ) . Similar results were obtained after exclusion of all cancer cases during the first 3 years of the intervention . INTERPRETATION Bariatric surgery was associated with reduced cancer incidence in obese women but not in obese men . FUNDING Swedish Research Council , Swedish Foundation for Strategic Research , Swedish Federal Government under the LUA/ALF agreement , Hoffmann La Roche , Cederoths , AstraZeneca , Sanofi-Aventis , Ethicon Endosurgery",
"Background The incidence of obesity and related metabolic disorders in India and that of stomach carcinoma is one of the highest in the world . Hence , one requires a procedure that allows postoperative surveillance of the stomach with the best outcomes in terms of weight control and resolution of co-morbidities . Here , we compare one such procedure , duodenojejunal bypass with sleeve against the st and ard Roux-en Y gastric bypass . Methods Fifty-seven patients who were selected for a bypass procedure were r and omized into two groups of laparoscopic duodenojejunal bypass with sleeve ( DJB ) and laparoscopic Roux en Y gastric bypass . The limb lengths were similar in both the groups , and the sleeve was done over a 36F bougie . Results The mean body mass index and percent excess weight loss at the end of 3 , 6 , and 12 months between the groups were not statistically significant . The operating times were higher in the DJB group . The rate of resolution of diabetes , hypertension , and dyslipidemias were also similar with no statistical significance . There was 100 % resolution of dyslipidemias in both groups . There was one patient in the DJB group who presented with internal herniation 1 month post-op and was managed surgically . There was no mortality in both the groups . Conclusion Laparoscopic duodenojejunal with sleeve gastrectomy , a procedure which combines the principles and advantages of sleeve gastrectomy and foregut hypothesis , is a safe and effective alternative to gastric bypass in weight reduction and resolution of co-morbidities especially for Asian countries . But , long-term follow-up is required"
] | 41166924-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Necrotizing enterocolitis ( NEC ) is a costly gastrointestinal disorder that mainly affects preterm and low-birth-weight infants and can lead to considerable morbidity and mortality . Mother 's own milk is protective against NEC but is not always available . In such cases , donor human milk has also been shown to be protective ( although to a lesser extent ) compared with formula milk , but it is more expensive . This systematic review aim ed at evaluating the cost of donor milk , the cost of treating NEC , and the cost-effectiveness of exclusive donor milk versus formula milk feeding to reduce the short-term health and treatment costs of NEC . MATERIAL S AND METHODS We systematic ally search ed five relevant data bases to find studies with verifiable costs or charges of donor milk and /or treatment of NEC and any economic evaluations comparing exclusive donor milk with exclusive formula milk feeding . All search results were double screened . RESULTS Seven studies with verifiable donor milk costs and 17 with verifiable NEC treatment costs were included . The types of cost or charge included varied considerably across studies , so quantitative synthesis was not attempted . Estimates of the incremental length of stay associated with NEC were ∼18 days for medical NEC and 50 days for surgical NEC . Two studies cl aim ed to report economic evaluations but did not do so in practice . CONCLUSIONS It is likely that donor milk provides short-term cost savings by reducing the incidence of NEC . Future studies should provide more details on cost components included and a full economic evaluation , including long-term outcomes , should be undertaken | [
"OBJECTIVE To compare the duration of parenteral nutrition , growth , and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula ( BOV ) or donor human milk and human milk-based human milk fortifier ( HUM ) , in a r and omized trial of formula vs human milk . STUDY DESIGN Multicenter r and omized controlled trial . The authors studied extremely preterm infants whose mothers did not provide their milk . Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM . The major outcome was duration of parenteral nutrition . Secondary outcomes were growth , respiratory support , and necrotizing enterocolitis ( NEC ) . RESULTS Birth weight ( 983 vs 996 g ) and gestational age ( 27.5 vs 27.7 wk ) , in BOV and HUM , respectively , were similar . There was a significant difference in median parenteral nutrition days : 36 vs 27 , in BOV vs HUM , respectively ( P = .04 ) . The incidence of NEC in BOV was 21 % ( 5 cases ) vs 3 % in HUM ( 1 case ) , P = .08 ; surgical NEC was significantly higher in BOV ( 4 cases ) than HUM ( 0 cases ) , P = .04 . CONCLUSIONS In extremely preterm infants given exclusive diets of preterm formula vs human milk , there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula . This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit",
"OBJECTIVES Human milk ( HM ) feeding is associated with lower incidence and severity of costly prematurity-specific morbidities compared to formula feeding in very low birth weight ( VLBW ; . However , the costs of providing HM are not routinely reimbursed by payers and can be a significant barrier for mothers . This study determined the initial maternal cost of providing 100 mL of HM for VLBW infants during the early neonatal intensive care unit ( NICU ) stay . METHODS This secondary analysis examined data from 111 mothers who provided HM for their VLBW infants during the early NICU stay . These data were collected during a multisite , r and omized clinical trial where milk output and time spent pumping were recorded for every pumping session ( n = 13,273 ) . The cost analysis examined the cost of the breast pump rental , pump kit , and maternal opportunity cost ( an estimate of the cost of maternal time ) . RESULTS Mean daily milk output and time spent pumping were 558.2 mL ( SD = 320.7 ; range = 0 - 2,024 ) and 98.7 minutes ( SD = 38.6 ; range = 0 - 295 ) , respectively . The mean cost of providing 100 mL of HM varied from $ 2.60 to $ 6.18 when maternal opportunity cost was included and from $ 0.95 to $ 1.55 when it was excluded . The cost per 100 mL of HM declined with every additional day of pumping and was most sensitive to the costs of the breast pump rental and pump kit . CONCLUSIONS These findings indicate that HM is reasonably inexpensive to provide and that the maternal cost of providing milk is mitigated by increasing milk output over the early NICU stay",
"OBJECTIVE This study evaluated the cost-effectiveness of a 100 % human milk-based diet composed of mother 's milk fortified with a donor human milk-based human milk fortifier ( HMF ) versus mother 's milk fortified with bovine milk-based HMF to initiate enteral nutrition among extremely premature infants in the neonatal intensive care unit ( NICU ) . METHODS A net expected costs calculator was developed to compare the total NICU costs among extremely premature infants who were fed either a bovine milk-based HMF-fortified diet or a 100 % human milk-based diet , based on the previously observed risks of overall necrotizing enterocolitis ( NEC ) and surgical NEC in a r and omized controlled study that compared outcomes of these two feeding strategies among 207 very low birth weight infants . The average NICU costs for an extremely premature infant without NEC and the incremental costs due to medical and surgical NEC were derived from a separate analysis of hospital discharges in the state of California in 2007 . The sensitivity of cost-effectiveness results to the risks and costs of NEC and to prices of milk supplements was studied . RESULTS The adjusted incremental costs of medical NEC and surgical NEC over and above the average costs incurred for extremely premature infants without NEC , in 2011 US$ , were $ 74,004 ( 95 % confidence interval , $ 47,051-$100,957 ) and $ 198,040 ( 95 % confidence interval , $ 159,261-$236,819 ) per infant , respectively . Extremely premature infants fed with 100 % human-milk based products had lower expected NICU length of stay and total expected costs of hospitalization , result ing in net direct savings of 3.9 NICU days and $ 8,167.17 ( 95 % confidence interval , $ 4,405-$11,930 ) per extremely premature infant ( p Costs savings from the donor HMF strategy were sensitive to price and quantity of donor HMF , percentage reduction in risk of overall NEC and surgical NEC achieved , and incremental costs of surgical NEC . CONCLUSIONS Compared with feeding extremely premature infants with mother 's milk fortified with bovine milk-based supplements , a 100 % human milk-based diet that includes mother 's milk fortified with donor human milk-based HMF may result in potential net savings on medical care re sources by preventing NEC",
"The aim of this study was to determine the effect of human milk feeding during NICU hospitalization on neurodevelopment at 24 months of corrected age in very low birth weight infants . A cohort of 316 very low birth weight newborns ( weight ≤ 1500 g ) was prospect ively enrolled in a follow-up program on admission to the Neonatal Intensive Care Unit of S. Orsola Hospital , Bologna , Italy , from January 2005 to June 2011 . Neurodevelopment was evaluated at 24 months corrected age using the Griffiths Mental Development Scale . The effect of human milk nutrition on neurodevelopment was first investigated using a multiple linear regression model , to adjust for the effects of gestational age , small for gestational age , complications at birth and during hospitalization , growth restriction at discharge and socio-economic status . Path analysis was then used to refine the multiple regression model , taking into account the relationships among predictors and their temporal sequence . Human milk feeding during NICU hospitalization and higher socio-economic status were associated with better neurodevelopment at 24 months in both models . In the path analysis model intraventricular hemorrhage — periventricular leukomalacia and growth restriction at discharge proved to be directly and independently associated with poorer neurodevelopment . Gestational age and growth restriction at birth had indirect significant effects on neurodevelopment , which were mediated by complications that occurred at birth and during hospitalization , growth restriction at discharge and type of feeding . In conclusion , our findings suggest that mother ’s human milk feeding during hospitalization can be encouraged because it may improve neurodevelopment at 24 months corrected age",
"Objective . Compared with preterm formula ( PF ) , mother 's milk ( MM ) is associated with lower rates of late-onset sepsis ( LOS ) and necrotizing enterocolitis ( NEC ) among premature infants . Because not all mothers of premature infants produce sufficient milk to supply their infants throughout hospitalization , we reasoned that pasteurized donor human milk ( DM ) would be a suitable alternative . Methods . Extremely premature infants ( were assigned r and omly to receive either pasteurized DM or PF if the supply of their own MM became insufficient during the study ( birth to 90 days of age or hospital discharge ) . Infection-related events ( LOS , NEC , meningitis , presumed sepsis , or urinary tract infection ) that occurred after the attainment of a milk intake of 50 mL/kg , dietary intake , growth , skin-to-skin contact , and duration of hospital stay were compared . The primary analysis compared groups DM and PF on an intent-to-treat basis . If no differences were noted , then these groups were combined and compared with the reference group , group MM . If differences were noted , then the subsequent analyses compared each group with group MM . Results . Of 243 infants , 70 ( 29 % ) received only MM ; group DM included 81 infants and group PF included 92 infants . Because of poor weight gain , 17 infants ( 21 % ) , all in group DM , were switched to PF . There were no differences in birth weight , gestational age , multiple births , and age at attainment of feeding of 50 mL/kg among groups . There were no differences between group DM and group PF in LOS and /or NEC , other infection-related events , hospital stay , or number of deaths . Group DM received a greater intake of milk and more nutritional supplements but had a slower rate of weight gain , compared with group PF . Compared with groups DM and PF , group MM had fewer episodes of LOS and /or NEC and total infection-related events and a shorter duration of hospital stay . Group MM also had fewer Gram-negative organisms isolated from blood cultures than did the other groups . Conclusions . In this r and omized , blinded trial of feeding of extremely premature infants , we found that , as a substitute for MM , DM offered little observed short-term advantage over PF for feeding extremely premature infants . Advantages to an exclusive diet of MM were observed in terms of fewer infection-related events and shorter hospital stays",
"In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die",
"Background : Necrotizing enterocolitis ( NEC ) is a costly morbidity in very low birth weight ( VLBW ; that increases hospital length of stay and requires expensive treatments . Objectives : To evaluate the cost of NEC as a function of dose and exposure period of human milk ( HM ) feedings received by VLBW infants during the neonatal intensive care unit ( NICU ) hospitalization and determine the drivers of differences in NICU hospitalization costs for infants with and without NEC . Methods : This study included 291 VLBW infants enrolled in an NIH-funded prospect i ve observational cohort study between February 2008 and July 2012 . We examined the incidence of NEC , NICU hospitalization cost , and cost of individual re sources used during the NICU hospitalization . Results : Twenty-nine ( 10.0 % ) infants developed NEC . The average total NICU hospitalization cost ( in 2012 USD ) was USD 180,163 for infants with NEC and USD 134,494 for infants without NEC ( p = 0.024 ) . NEC was associated with a marginal increase in costs of USD 43,818 , after controlling for demographic characteristics , risk of NEC , and average daily dose of HM during days 1 - 14 ( p of HM during days 1 - 14 decreased non-NEC-related NICU costs by USD 534 ( p exclusive HM feedings during the first 14 days of life is an effective strategy to reduce the risk of NEC and result ing NICU costs in VLBW infants . Hospitals investing in initiatives to feed exclusive HM during the first 14 days of life could substantially reduce NEC-related NICU hospitalization costs"
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Type 2 diabetes mellitus ( T2DM ) is one of the most important public health issues . Vitamin K supplementation might have favorable effect on risk factors of T2DM . The aim of this study was to perform a systematic review and meta- analysis of interventional studies to examine the effect of vitamin K supplementation on glycemic indices . A systematic search was performed in electronic data bases including PubMed , Science Direct , ProQuest , Institute of Scientific Information Web of Science , and Google scholar up to July 2017 . We used a r and om effects model to estimate pooled effect size of fasting blood sugar ( FBS ) , 2-h oral glucose tolerance test ( 2-h OGTT ) , fasting insulin ( FINS ) , and homeostasis model assessment -estimated insulin resistance ( HOMA-IR ) . Five clinical trials ( 533 participants ) fulfilled the eligibility criteria of the present meta- analysis . Overall , meta- analysis could not show any beneficial effect of vitamin K supplementation on FBS ( -0.91 mg/dl , 95 % CI : -2.57 , 0.76 , p=0.28 ) , FINS ( -0.35 μIU/ml , 95 % CI : -1.70 , 1.00 , p=0.61 ) , HOMA-IR ( -0.06 , 95 % CI : -0.32 , -0.19 , p=0.63 ) , and 2-h OGTT ( -4.00 mg/dl , 95 % CI : -20.00 , 11.99 , p=0.62 ) . Sensitivity analysis showed that overall estimates were not affected by elimination of any study . We did not observe any evidence regarding publication bias . In conclusion , vitamin K supplementation had no significant effect on glycemic control in healthy subjects . However , further studies should be performed on diabetic and pre-diabetic patients to determine the effect of vitamin K supplementation on impaired glycemic control | [
"BACKGROUND Vitamin K modulates cytokines involved in bone turnover , including interleukin-6 ( IL-6 ) and osteoprotegerin in vitro . OBJECTIVE The objective of this study was to assess 1 ) associations between measures of vitamin K status [ plasma phylloquinone and serum percentage of undercarboxylated osteocalcin ( % ucOC ) ] and IL-6 , osteoprotegerin , and C-reactive protein ( CRP ) concentrations and 2 ) the effect of daily 500 mug phylloquinone supplementation for 3 y on cytokine concentrations . DESIGN Concentrations of IL-6 , osteoprotegerin , and CRP and bone mineral density ( BMD ) were measured at baseline and after 3 y of follow-up in 379 healthy men and women ( 60 - 81 y ; 58.5 % women ) participating in a r and omized trial that studied the effect of vitamin K supplementation on bone loss . RESULTS Cross-sectionally , plasma phylloquinone was inversely associated with IL-6 and CRP , whereas serum % ucOC was inversely associated with IL-6 . Osteoprotegerin was associated positively with plasma phylloquinone and inversely with % ucOC . No differences were observed in the 3-y change in IL-6 , osteoprotegerin , and CRP concentrations between participants who received phylloquinone supplementation and those who did not . Overall , no association was observed between the 3-y changes in circulating cytokines and BMD . CONCLUSIONS Poor vitamin K status was associated with high concentrations of cytokines involved in bone turnover , but vitamin K supplementation did not confer a decrease in cytokine concentrations . The healthy status of this cohort may explain a lack of effect of vitamin K supplementation on cytokine concentrations . This trial was registered with www . clinical trials.gov as NCT00183001",
"OBJECTIVE Compelling biological pathways suggest that selenium ( Se ) may lower onset of type 2 diabetes mellitus ( T2DM ) , but very few studies have evaluated this relationship , with mixed results . We examined the association between toenail Se and incidence of T2DM . RESEARCH DESIGN AND METHODS We performed prospect i ve analyses in two separate U.S. cohorts , including 3,630 women and 3,535 men , who were free of prevalent T2DM and heart disease at baseline in 1982–1983 and 1986–1987 , respectively . Toenail Se concentration was quantified using neutron activation analysis , and diabetes cases were identified by biennial question naires and confirmed by a detailed supplementary question naire . Hazard ratios of incident T2DM according to Se levels were calculated using Cox proportional hazards . RESULTS During 142,550 person-years of follow-up through 2008 , 780 cases of incident T2DM occurred . After multivariable adjustment , the risk of T2DM was lower across increasing quintiles of Se , with pooled relative risks across the two cohorts of 1.0 ( reference ) , 0.91 ( 95 % CI 0.73–1.14 ) , 0.78 ( 0.62–0.99 ) , 0.72 ( 0.57–0.91 ) , and 0.76 ( 0.60–0.97 ) , respectively ( P for trend = 0.01 ) . Results were similar excluding the few individuals ( 4 % ) who used Se supplements . In semiparametric analyses , the inverse relationship between Se levels and T2DM risk appeared to be linear . CONCLUSIONS At dietary levels of intake , individuals with higher toenail Se levels are at lower risk for T2DM . Further research is required to determine whether varying results in this study versus prior trials relate to differences in dose , source , statistical power , residual confounding factors , or underlying population risk",
"OBJECTIVE —Vitamin K has a potentially beneficial role in insulin resistance , but evidence is limited in humans . We tested the hypothesis that vitamin K supplementation for 36 months will improve insulin resistance in older men and women . RESEARCH DESIGN AND METHODS —This was an ancillary study of a 36-month , r and omized , double-blind , controlled trial design ed to assess the impact of supplementation with 500 μg/day phylloquinone on bone loss . Study participants were older nondiabetic men and women ( n = 355 ; aged 60–80 years ; 60 % women ) . The primary outcome of this study was insulin resistance as measured by homeostasis model assessment ( HOMA-IR ) at 36 months . Fasting plasma insulin and glucose were examined as the secondary outcomes . RESULTS —The effect of 36-month vitamin K supplementation on HOMA-IR differed by sex ( sex × treatment interaction P = 0.02 ) . HOMA-IR was statistically significantly lower at the 36-month visit among men in the supplement group versus the men in the control group ( P = 0.01 ) after adjustment for baseline HOMA-IR , BMI , and body weight change . There were no statistically significant differences in outcome measures between intervention groups in women . CONCLUSIONS —Vitamin K supplementation for 36 months at doses attainable in the diet may reduce progression of insulin resistance in older men",
"Consumption of sugar-sweetened beverages has been shown , largely in American population s , to increase type 2 diabetes incidence . We aim ed to evaluate the association of consumption of sweet beverages ( juices and nectars , sugar-sweetened soft drinks and artificially sweetened soft drinks ) with type 2 diabetes incidence in European adults . We established a case – cohort study including 12,403 incident type 2 diabetes cases and a stratified subcohort of 16,154 participants selected from eight European cohorts participating in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) study . After exclusions , the final sample size included 11,684 incident cases and a subcohort of 15,374 participants . Cox proportional hazards regression models ( modified for the case – cohort design ) and r and om-effects meta-analyses were used to estimate the association between sweet beverage consumption ( obtained from vali date d dietary question naires ) and type 2 diabetes incidence . In adjusted models , one 336 g ( 12 oz ) daily increment in sugar-sweetened and artificially sweetened soft drink consumption was associated with HRs for type 2 diabetes of 1.22 ( 95 % CI 1.09 , 1.38 ) and 1.52 ( 95 % CI 1.26 , 1.83 ) , respectively . After further adjustment for energy intake and BMI , the association of sugar-sweetened soft drinks with type 2 diabetes persisted ( HR 1.18 , 95 % CI 1.06 , 1.32 ) , but the association of artificially sweetened soft drinks became statistically not significant ( HR 1.11 , 95 % CI 0.95 , 1.31 ) . Juice and nectar consumption was not associated with type 2 diabetes incidence . This study corroborates the association between increased incidence of type 2 diabetes and high consumption of sugar-sweetened soft drinks in European adults",
"OBJECTIVE To investigate whether dietary phylloquinone and menaquinones intakes are related to risk of type 2 diabetes . RESEARCH DESIGN AND METHODS We used data from a prospect i ve cohort study in 38,094 Dutch men and women , aged 20–70 years . Dietary phylloquinone and menaquinones intakes were assessed using a vali date d food frequency question naire . Diabetes case patients were ascertained mainly via self-report and verified against medical records . RESULTS During 10.3 years of follow-up , 918 incident cases of diabetes were documented . In a multivariate model adjusting for diabetes risk factors and dietary factors , phylloquinone intake tended to be associated ( P = 0.08 ) with a reduced risk of type 2 diabetes with a hazard ratio ( HR ) of 0.81 ( 95 % CI 0.66–0.99 ) for the highest versus the lowest quartile . For menaquinones intake , a linear , inverse association ( P = 0.038 ) with risk of type 2 diabetes was observed with an HR of 0.93 ( 0.87–1.00 ) for each 10-μg increment in the multivariate model . CONCLUSIONS This study shows that both phylloquinone and menaquinones intakes may be associated with a reduced risk of type 2 diabetes",
"Background Vitamin K , as a cofactor in the gamma carboxylation of certain glutamic acid ( Gla ) residues , has been related to glucose metabolism and insulin sensitivity . Osteocalcin , also known as bone γ-carboxyglutamic acid , increases β-cell proliferation as well as insulin and adiponectin secretion , which improve glucose tolerance and insulin sensitivity . Thus , the purpose of the present study was to examine the possible role of adiponectin as a mediator of glucose homeostasis following phylloquinone supplementation in premonopause women with prediabetes . Methods Eighty two women were r and omized to consume vitamin k1 supplement ( n = 39 ) or placebo ( n = 43 ) for four weeks . Participants in vitamin K1 treatment group received one pearl softgel capsule containing 1000 micrograms phylloquinone while the placebo group received one placebo capsules daily for four weeks . The Blood sample s were collected at baseline and after a four-week intervention to quantify osteocalcin , adiponectin , leptin and relevant variables . Results Phylloquinone supplementation significantly increased serum adiponectin concentration ( 1.24 ± 1.90 compared with −0.27 ± 1.08 μg/ml ) , and did not alter total osteocalcin ( 0.50 ± 4.11 compared with 0.13 ± 1.85 ng/ml ) and leptin ( −0.29 ± 8.23 compared with −1.15 ± 5.25 ng/ml ) compared with placebo . Adjustments for total osteocalcin and adiponectin using analysis of covariance ( ANCOVA ) did not affect the association of glycemic status with related variables . Conclusions In conclusion our study demonstrated that phylloquinone supplementation improved glycemic status in premonopausal prediabetic women independent of adiponectin . Trial registration This trial was registered in Iranian Registry of Clinical Trials with ID number of I RCT 2013120915724N1",
"The purpose of the present study was to examine the effect of vitamin K2 on cancellous and cortical bone mass in rats with streptozotocin (STZ)-induced type 1 diabetes . Twenty-seven male Sprague-Dawley rats aged 12 weeks were r and omized by the weight-stratified method into the following three groups : age-matched control group , STZ + vehicle group , and STZ + vitamin K2 group . STZ ( 40 + 50 mg/kg ) was administered intravenously twice during the initial 1-week period . Vitamin K2 ( menatetrenone , 30 mg/kg ) was administered orally 5 days a week . After 12 weeks of treatment , the serum glucose concentration and femoral length and weight were measured and histomorphometric analysis was performed on the cancellous and cortical bone of the distal femoral metaphysis and femoral diaphysis , respectively . STZ administration induced hyperglycemia and a decrease in femoral weight . The STZ + vehicle group also showed cancellous osteopenia due to a decrease in the number of osteoblasts/bone surface ( N.Ob/BS ) and the osteoblast surface (ObS)/BS without any significant changes in bone-resorption parameters , but it did not have a significant decrease in cortical bone mass . Administration of vitamin K2 to STZ-treated rats prevented the development of hyperglycemia and a decrease in femoral weight . Vitamin K2 also prevented cancellous osteopenia by inhibiting the decrease in N.Ob/BS and ObS/BS without significantly affecting bone-resorption parameters , but it did not significantly increase cortical bone mass . These results suggest that vitamin K2 has beneficial effects on glucose concentration and cancellous bone mass in rats with STZ-induced type 1 diabetes"
] | 4116699c-06ff-11f0-808a-c43d1ab1c353 |
Background This systematic review and meta- analysis aims at assessing the composition and performance of care management models evaluated in the last decade and their impact on patient important outcomes . Methods A comprehensive literature search of electronic bibliographic data bases was performed to identify care management trials in type 2 diabetes . R and om effects meta- analysis was used when feasible to pool outcome measures . Results Fifty-two studies were eligible . Most commonly reported were surrogate outcomes ( such as HbA1c and LDL ) , followed by process measures ( clinic visit or testing frequency ) . Less frequently reported were quality of life , patient satisfaction , self-care , and healthcare utilization . Most care management modalities were carved out from primary care . Meta- analysis demonstrated a statistically significant but trivial reduction of HbA1c ( weighted difference in means -0.21 % , 95 % confidence interval -0.40 to -0.03 , p LDL-cholesterol ( weighted difference in means -3.38 mg/dL , 95 % confidence interval -6.27 to -0.49 , p care management programs for patients with type 2 diabetes are ' carved-out ' , accomplish limited effects on metabolic outcomes , and have unknown effects on patient important outcomes . Comparative effectiveness research of different models of care management is needed to inform the design of medical homes for patients with chronic conditions | [
"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",
"OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P HDL cholesterol rose and triglycerides fell in the web-based group ( P Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes",
"OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 ( 64 % ) at the comparison sites participated ; 83 of 103 ( 81 % ) of the intervention-site subjects returned for follow-up at year 2 . Performance of the six recommended assessment s improved in intervention-site subjects at year 2 compared with year 1 ( 5.8 vs. 4.3 , P = 0.0001 ) and compared with comparison-site subjects at year 2 ( 4.2 , P = 0.014 ) . No significant changes were noted in intermediate outcomes . CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes . Additional interventions are needed to improve intermediate outcomes ",
"BACKGROUND In the Medicare Modernization Act of 2003 , Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program . METHODS The Medicare Health Support Pilot Program was a large , r and omized study of eight commercial programs for disease management that used nurse-based call centers . We r and omly assigned patients with heart failure , diabetes , or both to the intervention or to usual care ( control ) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care , acute care utilization , and Medicare expenditures for Medicare fee-for-service beneficiaries . RESULTS The study included 242,417 patients ( 163,107 in the intervention group and 79,310 in the control group ) . The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits , as compared with usual care . We observed only 14 significant improvements in process-of-care measures out of 40 comparisons . These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ( $ 400 million ) , with no demonstrable savings in Medicare expenditures . CONCLUSIONS In this large study , commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality -of-care measures , with no demonstrable reduction in the utilization of acute care or the costs of care",
"Purpose This study developed and tested a culturally appropriate , church-based intervention to improve diabetes self-management . Research Design and Methods This was a r and omized trial conducted at 24 African American churches in central North Carolina . Churches were r and omized to receive the special intervention ( SI ; 13 churches , 117 participants ) or the minimal intervention ( MI ; 11 churches , 84 participants ) . The SI included an 8-month intensive phase , consisting of 1 individual counseling visit , 12 group sessions , monthly phone contacts , and 3 encouragement postcards , followed by a 4-month reinforcement phase including monthly phone contacts . The MI received st and ard educational pamphlets by mail . Outcomes were assessed at 8 and 12 months ; the primary outcome was comparison of 8-month A1C levels . Results At baseline , the mean age was 59 years , A1C 7.8 % , and body mass index 35.0 kg/m2 ; 64 % of participants were female . For the 174 ( 87 % ) participants returning for 8-month measures , mean A1C ( adjusted for baseline and group r and omization ) was 7.4 % for SI and 7.8 % for MI , with a difference of 0.4 % ( 95 % confidence interval [ CI ] , 0.1 - 0.6 , P = .009 ) . In a larger model adjusting for additional variables , the difference was 0.5 % ( 95 % CI , 0.2 - 0.7 , P Diabetes knowledge and diabetes-related quality of life significantly improved in the SI group compared with the MI group . Among SI participants completing an acceptability question naire , intervention components and material s were rated as highly acceptable . Conclusions The church-based intervention was well received by participants and improved short-term metabolic control",
"Poor adjustment to diabetes in older African American women may result from uncertainty , stemming from a lack of information about self-care activities , a complexity of self-care activities , comorbid conditions , and a lack of re sources . This study evaluated a telephone intervention to reduce uncertainty ( through problem-solving strategies , information , cognitive reframing , and improved patient — provider communication)—namely , to measure its effects on diabetes self-care and psychosocial adjustment . Sixty-eight older African American women were r and omly assigned to an experimental group and a control group . The experimental group received the intervention for 4 weeks , and the control group received usual care . Psychosocial adjustment and self-care were measured in all participants at baseline and 6 weeks postbaseline . The experimental group reported increased participation in exercise ( self-care component ; p improvement in psychosocial adjustment ( p < .001 ) . Thus , reducing the uncertainty related to diabetes self-care improves self-care exercise , as well as psychosocial adjustment",
"OBJECTIVE The objective of this study was to assess the impact of active versus usual monitoring of algorithmic insulin titration and point-of-care ( POC ) versus laboratory HbA1c ( A1C ) measurement on glycemic control in primary care . RESEARCH DESIGN AND METHODS The Glycemic Optimization with Algorithms and Labs at Point of Care ( GOAL A1C ) study was a 24-week , r and omized , parallel-group , four-arm , open-label study of 7,893 adults with type 2 diabetes uncontrolled by oral antidiabetic agents and requiring insulin . Patients were r and omly assigned by investigators from 2,164 sites in the U.S. to insulin glargine with either 1 ) usual ( no unsolicited contact between visits ) insulin titration using a simple algorithm with laboratory A1C testing , 2 ) usual titration with POC A1C testing , 3 ) active ( weekly monitored ) titration with laboratory A1C testing , or 4 ) active titration with POC A1C testing . Outcome measures included a change in A1C and fasting self-monitoring of blood glucose ( SMBG ) levels , percentage of patients achieving A1C RESULTS Significant A1C and SMBG reductions were observed in all arms ( P A1C reduction ( 1.5 vs. 1.3 % ; P SMBG reduction ( 88 vs. 79 mg/dl ; P achieving A1C an A1C Hypoglycemia rates were low ( usual vs. active groups : 3.7 vs. 6.0 all confirmed episodes/patient-year [ P glycemic control in patients with type 2 diabetes in all four study arms . Active titration result ed in significant incremental improvements in glycemic control , and , among patients receiving active titration , POC A1C testing result ed in a greater portion achieving A1C < 7.0 %",
"BACKGROUND Patient education is a cornerstone of treatment in diabetes mellitus , but there is not unanimity of opinion as to how it should be delivered . OBJECTIVE To determine whether a single , intensive group educational program would improve glycosylated hemoglobin ( HbA(1c ) ) levels when compared with passive education . METHODS A total of 106 patients with HbA(1c ) levels greater than 8.5 % were r and omized to either an intensive ( n = 50 ) or a passive education ( n = 56 ) group . The intensive education group received 3.5 days of a structured curriculum involving a physician , nurse , nutritionist , pharmacist , exercise physiologist , and a social worker . The passive education group received material sent by mail every 3 months providing basic information on topics related to diabetes management . Patients continued care with their diabetes care provider during the study period . Levels of HbA(1c ) were measured at baseline and 3 , 6 , and 12 months after r and omization . A matched control group of individuals who declined participation also had HbA(1c ) levels measured at baseline and 12 months . RESULTS Mean + /- SD HbA(1c ) levels fell significantly ( P HbA(1c ) levels than a matched control group ( -1.2 % ) with similar baseline HbA(1c ) levels that did not receive education . CONCLUSIONS Patients with elevated HbA(1c ) levels who were receptive to education had substantial improvement in HbA(1c ) levels after receiving an educational intervention . In this population , intensive or passive methods of delivering patient education seemed to have similar effect on improving glycemic control",
"Background Regular physical activity is an important goal for elders with chronic health conditions . Context This report describes Physical Activity for a Lifetime of Success ( PALS ) , an attempt to translate a motivational support program for physical activity , Active Choices , for use by a group of diverse , low-income , community-dwelling elders with diabetes . Methods PALS linked physical activity assessment and brief counseling by primary care providers with a structured referral to a community-based motivational telephone support program delivered by older adult volunteers . People with diabetes aged 65 years or older who were receiving care at two community clinics were r and omized to receive either immediate or delayed intervention . The main intended outcome measure was physical activity level ; the secondary outcome measure was mean hemoglobin A1c . Consequences One-third of those offered referral to the PALS program in the clinic setting declined . Another 44 % subsequently declined enrollment or were unreachable by the support center . Only 14 ( 21 % ) of those offered referral enrolled in the program . Among these 14 , the percentage who were sufficiently active was higher at follow-up than at enrollment , though not significantly so . Using an intent-to-treat analysis , which included all r and omized clinic patients , we found no significant change in mean hemoglobin A1c for the intervention group compared with controls . Interpretation A community-based referral and support program to increase physical activity among elderly , ethnically diverse , low-income people with diabetes , many of whom are not English-speaking , may be thwarted by unforeseen barriers . Those who enroll and participate in the PALS program appear to increase their level of physical activity",
"OBJECTIVE To assess two physician learning interventions design ed to improve safety and quality of diabetes care delivered by primary care physicians ( PCPs ) . RESEARCH DESIGN AND METHODS This group r and omized clinical trial included 57 consenting PCPs and their 2,020 eligible adult patients with diabetes . Physicians were r and omized to no intervention ( group A ) , a simulated case-based physician learning intervention ( group B ) , or the same simulated case-based learning intervention with physician opinion leader feedback ( group C ) . Dependent variables included A1C values , LDL cholesterol values , pharmacotherapy intensification rates in patients not at clinical goals , and risky prescribing events . RESULTS Groups B and C had substantial reductions in risky prescribing of metformin in patients with renal impairment ( P = 0.03 ) . Compared with groups A and C , physicians in group B achieved slightly better glycemic control ( P = 0.04 ) , but physician intensification of oral glucose-lowering medications was not affected by interventions ( P = 0.41 ) . Lipid management improved over time ( P case-based learning intervention for physicians significantly reduced risky prescribing events and marginally improved glycemic control in actual patients . The addition of opinion leader feedback did not improve the learning intervention . Refinement and further development of this approach is warranted",
"OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P reduced waist circumference ( P reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the case management group lowered their use of medications , primarily diabetes medications , by 0.8 medications per day more than participants treated with usual care ( P = 0.03 ) . In seven of nine quality -of-life domains , the case management group improved compared with usual care ( P health indicators among obese patients with type 2 diabetes",
"OBJECTIVE To compare the effectiveness of a telephonic and a print intervention over 1 year to improve diabetes control in low-income urban adults . RESEARCH DESIGN AND METHODS A r and omized trial in Spanish and English comparing a telephonic intervention implemented by health educators with a print intervention . Participants ( N = 526 ) had an A1C ≥7.5 % and were prescribed one or more oral agents . All were members of a union/employer jointly sponsored health benefit plan . Health coverage included medications . Primary outcomes were A1C and pharmacy cl aims data ; secondary outcomes included self-report of two medication adherence measures and other self-care behaviors . RESULTS Participants were 62 % black and 23 % Hispanic ; 77 % were foreign born , and 42 % had annual family incomes . Baseline median A1C was 8.6 % ( interquartile range 8.0–10.0 ) . Insulin was also prescribed for 24 % of participants . The telephone group had mean ± SE decline in A1C of 0.23 ± 0.11 % over 1 year compared with a rise of 0.13 ± 0.13 % for the print group ( P = 0.04 ) . After adjusting for baseline A1C , sex , age , and insulin use , the difference in A1C was 0.40 % ( 95 % CI 0.10–0.70 , P = 0.009 ) . Change in medication adherence measured by cl aims data , but not by self-report measures , was significantly associated with change in A1C ( P = 0.01 ) . Improvement in medication adherence was associated ( P = 0.005 ) with the telephonic intervention , but only among those not taking insulin . No diabetes self-care activities were significantly correlated with the change in A1C . CONCLUSIONS A 1-year tailored telephonic intervention implemented by health educators was successful in significantly , albeit modestly , improving diabetes control compared with a print intervention in a low-income , insured , minority population",
"Objectives .The objective of this work was to evaluate the reach , effectiveness , adoption , and implementation of a brief behavioral dietary intervention and 2 supplemental components of diabetes self-management support : telephone follow-up calls and community re sources enhancement . Design and Subjects . This was a 2 × 2 r and omized , controlled trial investigating the incremental effects of telephone follow-up and community re sources enhancement with 320 adult type 2 diabetes out patients . Methods .Key outcomes included behavioral ( dietary patterns , fat intake ) , physiologic ( HbA1C , lipids ) , and quality -of-life/patient satisfaction measures and were collected at baseline and 3- and 6-month follow-up . Results .Despite high reach ( 76 % patient participation ) , excellent adoption ( all 12 primary care practice s approached participated ) , and good implementation , there were few outcome differences among treatment conditions . There was significant improvement across conditions in most outcomes in each category at both follow-ups . Conclusions .A brief , computer-assisted , dietary goal – setting intervention basic treatment condition was moderately successful in producing dietary improvements but less so in producing biologic or quality -of-life outcomes . Additions of follow-up phone calls or a community re sources enhancement component did not produce incremental improvements over this basic intervention",
"PURPOSE To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control , intermediate cardiovascular outcomes , satisfaction with care , and re source utilization . METHODS We conducted a r and omized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C ) ( HbA(1C ) ) levels > or=7.5 % . Two nurse practitioner case managers worked with patients and their primary care providers , monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts , collaborative goal setting , and treatment algorithms . Control patients received educational material s and usual care from their primary care providers . RESULTS At the conclusion of the study , both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C ) level ( 9.3 % vs. 9.2 % ; difference = 0.1 % ; 95 % confidence interval : -0.4 % to 0.7 % ; P = 0.65 ) . There was also no evidence that the intervention result ed in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy . However , intervention patients were substantially more satisfied with their diabetes care , with 82 % rating their providers as better than average compared with 64 % of patients in the control group ( P = 0.04 ) . CONCLUSION An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes . The type of patients targeted for intervention , organizational factors , and program structure are likely critical determinants of the effectiveness of case management . Health systems must underst and the potential limitations before expending substantial re sources on case management , as the expected improvements in outcomes and downstream cost savings may not always be realized",
"OBJECTIVE Management of diabetes is frequently suboptimal in primary care setting s , where providers often fail to intensify therapy when glucose levels are high , a problem known as clinical inertia . We asked whether interventions targeting clinical inertia can improve outcomes . RESEARCH DESIGN AND METHODS A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center . We studied all patients ( 4,138 ) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were r and omized to be control subjects or to receive one of three interventions . Instead of consultative advice , the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient 's visit , individual face-to-face feedback on performance for 5 min every 2 weeks , or both . RESULTS Over an average patient follow-up of 15 months within the intervention site , improvements in and final HbA1c ( A1C ) with feedback + reminders ( deltaA1C 0.6 % , final A1C 7.46 % ) were significantly better than control ( deltaA1C 0.2 % , final A1C 7.84 % , P systolic blood pressure ( sBP ) and LDL cholesterol . Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP . Over a 2-year period , overall glycemic control improved in the intervention site but did not change in other primary care sites ( final A1C 7.5 vs. 8.2 % , P internal medicine resident primary care providers improves glycemic control . Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care setting",
"OBJECTIVE To assess the impact of a quality improvement ( QI ) intervention on the quality of diabetes care at primary care clinics . RESEARCH DESIGN AND METHODS Twelve primary care medical practice s were matched by size and location and r and omized to intervention or control conditions . Intervention clinic staff were trained in a seven-step QI change process to improve diabetes care . Surveys and medical record review s of 754 patients , surveys of 329 clinic staff , interviews with clinic leaders , and analysis of training session videotapes evaluated compliance with and impact of the intervention . Mixed-model nested analyses compared differences in the quality of diabetes care before and after intervention . RESULTS All intervention clinics completed at least six steps of the seven-step QI change process in an 18-month period and , compared with control clinics , had broader staff participation in QI activities ( P = 0.04 ) , used patient registries more often ( P = 0.03 ) , and had better test rates for HbA(1c ) ( A1C ) , LDL , and blood pressure ( P = 0.02 ) . Other processes of diabetes care were unchanged . The intervention did not improve A1C ( P = 0.54 ) , LDL ( P = 0.46 ) , or blood pressure ( P = 0.69 ) levels or a composite of these outcomes ( P = 0.35 ) . CONCLUSIONS This QI change process was successfully implemented but failed to improve A1C , LDL , or blood pressure levels . Data suggest that to be successful , such a QI change process should direct more attention to specific clinical actions , such as drug intensification and patient activation",
"OBJECTIVE Diabetic retinopathy affects > 60 % of people with type 2 diabetes during the first 2 decades of the disease and is ameliorated by good glycemic control . This study tested whether intensive diabetes case management could prevent or delay diabetic retinopathy in patients with established type 2 diabetes . RESEARCH DESIGN AND METHODS This study was part of a r and omized , controlled clinical trial of diabetes case management in type 2 diabetes in southern California counties serving low income ethnic minority population s. Subjects were r and omized to intervention ( diabetes case management ) or control ( traditional treatment ) groups . Subjects with at least two retinal photographs ( n = 149 ) were included in this analysis to assess the effect of intervention on development or progression of diabetic retinopathy . RESULTS Progression of retinopathy in the intervention group was not significantly less than in the control group ( P = 0.226 ) . However , those in the intervention group with no evidence of retinopathy at baseline were less likely to develop diabetic retinal changes ( 5/48 ) during a mean follow-up of 23.1 months than those in the control group ( 10/34 , chi(2 ) = 4.805 , P = 0.028 ) . This difference remained significant in a logistic regression model that controlled for potential confounders ( odds ratio 5.35 [ 95 % CI 1.14 - 25.12 ] ) . CONCLUSIONS This study shows that a relatively short duration of case management instituted before the onset of clinical ly identifiable retinopathy significantly diminished the risk of developing retinopathy in patients with type 2 diabetes . The findings also emphasized the retinal disease burden in this population , with development and progression of retinopathy occurring in < 2 years",
"OBJECTIVE To assess whether providing customized clinical information to patients and physicians improves safety or quality of diabetes care . RESEARCH DESIGN AND METHODS Study subjects included 123 primary care physicians and 3,703 eligible adult diabetic patients with elevated A1C or LDL cholesterol , who were r and omly assigned to receive customized feedback of clinical information as follows : 1 ) patient only , 2 ) physician only , 3 ) both the patient and physician , or 4 ) neither patient nor physician . In the intervention groups , patients received customized mailed information or physicians received printed , prioritized lists of patients with recommended clinical actions and performance feedback . Hierarchical models were used to accommo date group r and om assignment . RESULTS Study interventions did not improve A1C test ordering ( P = 0.35 ) and negatively affected LDL cholesterol test ordering ( P on LDL cholesterol values ( P = 0.64 ) , which improved in all groups over time . Interventions had a borderline unfavorable effect on A1C values among those with baseline A1C ≥7 % ( P = 0.10 ) and an unfavorable effect on A1C values among those with baseline A1C ≥8 % ( P reduce risky prescribing events or increase treatment intensification . Time to next visit was longer in all intervention groups compared with that for the control group ( P physicians and /or patients did not improve quality or safety of diabetes care and worsened A1C control in patients with baseline A1C ≥8 % . Future research ers should consider providing point-of-care decision support with re design of office systems and /or incentives to increase appropriate actions in response to decision-support information",
"Purpose An initial pilot program demonstrated promising results in improvements in glycosylated hemoglobin ( HbA1c ) , low-density lipoprotein cholesterol ( LDL-C ) , and systolic blood pressure ( SBP ) and prompted us to test these findings in a controlled trial . The purpose of the Diabetes-focused , Algorithm-directed care , Midlevel practitioner – administered , Electronically coached , Treatment ( DAMET-2 ) program clinical trial was to investigate the benefits of a novel program for disseminating guidance in the treatment of diabetes from a central specialist clinic to primary care centers with access to midlevel provider services . Data sources DAMET-2 included st and ardized treatment algorithms and education disseminated through computer-assisted and traditional methods associated with distance medicine . Two primary care practice s were selected and subjects with diagnosed type 2 diabetes ≥6 months , ≥18 years of age with one or more cardiovascular risk factors ( identified by chart review ) were eligible for inclusion . Midlevel practitioners for subjects in the experimental group ( N= 34 ) received training in American Diabetes Association treatment algorithms , had telephone consultations at 2- to 4-week intervals and bimonthly visits with diabetes specialists , and received treatment guidance within 24 h from remote diabetes specialists . Weekly diabetes clinics were made available to subjects in the experimental group . After 12 months , the last available subject data were extracted from the subjects ' charts and compared to 12-month chart data from a control group ( N= 101 ) that did not receive additional study services . Conclusions Mean HbA1c values decreased from baseline by 0.46 % in the active treatment group versus 0.06 % in the control group ; however , reductions in HbA1c did not achieve statistical significance potentially because of the small sample size of the experimental group . Mean SBP values were significantly reduced in both groups ; however , LDL-C was only significantly reduced in the control group , where more aggressive use of statins may have had an effect . Implication s for practice Despite the inconsistencies in risk factor reduction from the pilot program , the DAMET-2 program provided insights regarding the importance of electronic records and provider notifications , patient adherence , prioritization of provider re sources by risk factor level among patients , and access to self-management education",
"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",
"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",
"Introduction Detection and response to medically urgent situations in patients with diabetes mellitus can improve the process and outcomes of care and potentially decrease morbidity and mortality . We examined the detection and remediation of medically urgent situations among older patients receiving telemedicine case management for diabetes . Methods In the setting of a r and omized trial , 338 patients in the intervention group and living in upstate New York received a home telemedicine unit to transmit blood glucose and blood pressure values to a nurse case manager , videoconference with a nurse or dietitian every 4–6 weeks and access educational websites . The educators met with a supervising endocrinologist 4–5 times weekly and clinical recommendations were proposed to the primary care providers via mail , fax , or phone . Results Over a 36 month period , 67 medically urgent situations were identified and addressed ( 1.9 events/month ) . Some of these situations were potentially life-threatening , including major drug contraindications ( N = 24 ) , other medically urgent situations ( N = 19 ) , and medical urgent conditions ( ie , unstable angina ) ( N = 24 ) . Conclusion The interaction via telemedicine in rural upstate New York between patients with diabetes mellitus , a diabetes care team , and primary care providers can successfully identify and remediate medically urgent situations ",
"OBJECTIVE To determine if a patient-centered , computer-assisted diabetes care intervention increased perceived autonomy support , perceived competence ( from self-determination theory ) , and if these constructs mediated the effect of the intervention on ADA/NCQA recommended diabetes care outcomes . DESIGN A r and omized controlled trial of 866 adult type 2 diabetes patients in heterogeneous primary care setting s in Colorado . MAIN OUTCOME MEASURES Perceived autonomy support , perceived competence , patient satisfaction , glycemic control ( HbA1c ) , ratio of total to HDL cholesterol , diabetes distress , and depressive symptoms . RESULTS The computer-assisted intervention increased patient perception of autonomy support relative to a computer-based control condition ( p = .05 ) . Change in perceived competence partially mediated the effects of increased autonomy support on the change in lipids , diabetes distress , and depressive symptoms . The construct of autonomy support was found to be separate from that of patient satisfaction . CONCLUSIONS A patient-centered , computer-assisted intervention was effective in improving diabetes self-management outcomes , in part , because it increased patients ' perception that their autonomy was supported which changed perceived competence . These findings support the self-determination model for health behavior change and the chronic care model and support the further study of the use of these technologies to motivate patients to improve their health outcomes",
"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",
"OBJECTIVE To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus . STUDY DESIGN R and omized controlled trial in a university-affiliated primary care internal medicine clinic . METHODS We recruited 80 patients with poorly controlled type 2 diabetes mellitus . A clinical pharmacist provided evaluation and modification of pharmacotherapy , self-management diabetes education , and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up . The main clinical outcome was hemoglobin A1C ( HbA1C ) level ; process measures included HbA1C and low-density lipoprotein measurement , retinal examination , urine microalbumin testing ( or use of angiotensin-converting enzyme inhibitors ) , and monofilament screening for diabetic neuropathy . RESULTS Patients in the intervention and control groups were similar in age , sex , mean HbA1C levels ( 10.1 % and 10.2 % , respectively ; P = .65 ) , and current treatment regimens at baseline . Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group ( 2.1 % vs 0.9 % , P = .03 ) . Three of the 5 process measures were conducted more frequently in the intervention group than the control group , including low-density lipoprotein measurement ( 100.0 % vs 85.7 % , P = .02 ) , retinal examination ( 97.3 % vs 74.3 % ) , and monofilament foot screening ( 92.3 % vs 62.9 % ) . CONCLUSIONS Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures . This approach , integrated with and based in the primary care setting , was an effective and efficient approach to improving care , especially for those with poor glycemic control at baseline",
"BACKGROUND National data find glycemic control is within target ( A1c active interventions and usual care for glucose control in a r and omized clinical trial ( RCT ) among persons with diabetes cared for by primary care physicians ( PCPs ) over the course of 1 year . METHODS Physician practice s ( n=36 ) in 4 geographic areas are r and omly assigned to 1 of 4 study groups . The intervention is a diabetes communication system , using mobile phones and patient/physician portals to allow patient-specific treatment and communication . All physicians receive American Diabetes Association ( ADA ) Guidelines for diabetes care . Patients with poor diabetes control ( A1c > or = 7.5 % ) at baseline ( n=260 ) are enrolled in study groups based on PCP r and omization . All study patients receive blood glucose ( BG ) meters and a year 's supply of testing material s. Patients in three treatment groups select one of two mobile phone models , receive one-year unlimited mobile phone data and service plan , register on the web-based individual patient portal and receive study treatment phone software based on study assignment . Control group patients receive usual care from their PCP . The primary outcome is mean change in A1c over a 12-month intervention period . CONCLUSION Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes . Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians . This RCT is ongoing",
"We studied the impact of nurse case management ( NCM ) on blood pressure ( BP ) , hemoglobin A1C , lipids , and diabetes complication screening . A 1-year r and omized-controlled trial was conducted in two primary care clinics of the Penn State Hershey Medical Center . Diabetes patients were r and omized to control group ( CG ) ( n=182 ) who received usual care by their primary care provider and intervention group ( IG ) ( n=150 ) who received additional NCM care , including self-management education , and implementation of diabetes guidelines . Primary outcomes included BP , A1C , lipid , process measures , and secondary outcome was diabetes-related emotional distress as assessed by Problem Areas in Diabetes ( PAID ) . BP significantly decreased from 137/77 to 129/72 in IG as compared to an increase from 136/77 to 138/79 in CG after 1 year . PAID scores improved significantly in IG ( from 23 to 10 ) due to reduced emotional stress . A1C ( 7.4 ) and LDL ( 105 ) were unaffected . Complications screening significantly improved in IG compared to CG : opthalmologic exam 26 to 68 % , foot exam 47 to 64 % , and nephropathy screening 34 to 72 % . NCM improved BP , diabetes-related emotional distress , and process measures in primary care . Unchanged A1C and lipids might be due to a threshold effect . Intervention based upon initial risk assessment may prove more cost-effective ",
"PURPOSE The purpose of this study was to demonstrate the potential value of close collaboration at the office level of a nurse care manager with community-based primary care physicians in the care of adult patients with type 2 diabetes , particularly those physicians not affiliated with an integrated care system that some managed care organizations provide . METHODS Patients with type 2 diabetes were recruited from the general population of a large metropolitan area . Each received a comprehensive evaluation of his or her diabetes with results reported to patients and their physicians ( basic intervention ) . A r and om one-half of patients were additionally assigned to individual counseling , problem identification , care planning , and management recommendations by a nurse care manager ( individualized intervention ) . The patients receiving only the basic intervention served as the control group to those receiving the individualized intervention . Re-evaluation of all patients at 6 months after their entry into the study determined the effectiveness of the nurse-directed individualized intervention using A1C , blood pressure , and cholesterol as outcome measures . RESULTS Of 220 patients recruited , 197 had type 2 diabetes , r and omly assigned only the basic intervention ( 102 patients ) or individualized intervention ( 95 patients ) . Postintervention data were obtained on 164 patients ( 83 % ) . Significant improvement occurred in mean systolic blood pressure and A1C of all patients in the individualized but not the basic intervention only group . Patients with a systolic blood pressure > or=130 mm Hg at baseline showed improvement if they had more than 2 contacts with the study nurse but not if they had less than 2 contacts . CONCLUSIONS A nurse care manager collaborating at the office level with community-based primary care physicians can enhance the care provided to adult patients with type 2 diabetes . For those many physicians not affiliated with an integrated care system featured by some managed care organizations , this collaboration could underlie a team approach ( nurse/patient/physician ) for the ambulatory patient with diabetes that would be an essential element in a chronic disease model of care for diabetes at the community level",
"BACKGROUND : There is limited information from r and omized controlled studies about the influence of pharmacist interventions on diabetes control . OBJECTIVE : To evaluate the effect of a pharmacist intervention on improving diabetes control ; secondary endpoints were medication appropriateness and self-reported adherence . METHODS : A r and omized , controlled , multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics . Seventy-seven subjects , ⩾18 years old with a hemoglobin ( Hb ) A1c ⩾9 % at baseline and taking at least one oral diabetes medication , were r and omized to receive a pharmacist intervention ( n = 43 ) or usual care ( n = 34 ) for 6 months followed by a 6-month usual-care observation period for both groups . Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence . HbA1c , medication appropriateness , and self-reported adherence were assessed at baseline , 6 months , and 12 months . RESULTS : The mean HbA1c did not differ between groups over the 12-month period ( p = 0.61 ) . A reduction in HbA1c was noted for both groups over time compared with baseline ( p = 0.001 ) ; however , control subjects relied more heavily on provider visits . Medication appropriateness was not improved for diabetes medications ( p = 0.65 ) . Self-reported adherence was not significantly improved by the intervention . CONCLUSIONS : This pharmacist intervention did not significantly improve diabetes control , but did allow for similar HbA1c control with fewer physician visits . Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed",
"CONTEXT Though complementary and alternative medicine ( CAM ) treatments are popular , evidence to support their application to diabetes care is scarce . Previous CAM diabetes research has generally focused on single modalities , but CAM practitioners more commonly prescribe complex , multimodality interventions . OBJECTIVES The aims of this study were to determine the feasibility and clinical impact of a whole-system , Ayurvedic intervention for newly diagnosed people with type 2 diabetes . DESIGN Patients were r and omly assigned to either an experimental or control arm . SETTING Group model health maintenance organization . PARTICIPANTS We recruited 60 adult patients with baseline glycosylated hemoglobin ( HbA1c ) values between 6.0 and 8.0 . INTERVENTION Treatment for the experimental group included exercise , an Ayurvedic diet , meditation instruction , and an Ayurvedic herb supplement ( MA 471 ) . Control patients attended st and ard diabetes education classes with primary care clinician follow-up . MEASUREMENTS Clinical outcomes were assessed at 3 and 6 months and included HbA1c , fasting glucose , lipids , blood pressure , and weight . RESULTS Ninety-two percent of r and omized patients completed the study , and there were no significant adverse study -related events . Using analysis of co-variance ( ANCOVA ) , we found no significant differences for clinical outcomes at 6 months between on- study patient groups , though trends favored the Ayurvedic group . When we included a factor measuring how much baseline HbA1c exceeded the mean ( 6.5 % ) , however , we found statistically significant improvements in the Ayurvedic group for HbA1c ( P = .006 ) , fasting glucose ( P = .001 ) , total cholesterol ( P = .05 ) , low-density lipoprotein ( LDL ) cholesterol ( P = .04 ) , and weight ( P = .035 ) . CONCLUSIONS These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values , warranting further research",
"To evaluate group visits in the management of underinsured patients with uncontrolled type 2 diabetes , 120 eligible patients enrolled were r and omly assigned to receive care in groups or continue usual care . Feasibility , acceptability , and concordance with American Diabetes Association st and ards of care ( Diab Camre . 25[suppl 1]:533 - 549 ) were evaluated . Patients who received care in groups exhibited improvement in American Diabetes Association st and ards of care ( p improved sense of trust in physician ( p = .02 ) , and tended to report better coordination of care ( p = .07 ) , better community orientation ( p = .09 ) , and more culturally competent care ( p = .09 ) . Group visits offer a promising model for delivering health care to these patients",
"OBJECTIVE There is a well-documented gap between diabetes care guidelines and the services received by patients in most health care setting s. This report presents 12-month follow-up results from a computer-assisted , patient-centered intervention to improve the level of recommended services patients received from a variety of primary care setting s. RESEARCH DESIGN AND METHODS A total of 886 patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program . Physicians were stratified and r and omized to intervention or control conditions and evaluated on two primary outcomes : number of recommended laboratory screenings and recommended patient-centered care activities completed from the National Committee on Quality Assurance/American Diabetes Association Provider Recognition Program ( PRP ) . Secondary outcomes were evaluated using the Problem Areas in Diabetes 2 quality of life scale , lipid and HbA1c levels , and the Patient Health Question naire-9 depression scale . RESULTS The program was well implemented and significantly improved both the number of laboratory assays and patient-centered aspects of diabetes care patients received compared with those in the control condition . There was overall improvement on secondary outcomes of lipids , HbA1c , quality of life , and depression scores ; between-condition differences were not significant . CONCLUSIONS Staff in small , mixed-payer primary care offices can consistently implement a patient-centered intervention to improve PRP measures of quality of diabetes care . Alternative explanations for why these process improvements did not lead to improved outcomes , and suggested directions for future research are discussed",
"BACKGROUND Disease registries are powerful tools with the potential to transform the way chronic diseases are managed . To date , however , little work has been done to determine how to optimize the implementation of a chronic disease registry in practice . METHODS Twenty-nine physicians and their nurse teams in a large community internal medicine practice participated in this 6-month prospect i ve r and omized trial in 2000 . Teams were assigned to one of three implementation strategies using information from a diabetes registry . Process and outcome measures for diabetes management were analyzed . Process measures included the percentage of patients completing glycosylated hemoglobin ( Hgb ) testing within 6 months and low-density lipoprotein ( LDL ) testing within 12 months . Outcome measures included the percentage of patients with a glycosylated Hgb > 9.3 % ( equivalent to a HgbA1c > 8.0 % ) , the percentage of patients with an LDL cholesterol > 130 mg/dl , and the percentage of patients with controlled blood pressure , defined as Mean change in LDL and glycosylated Hgb values was also measured . RESULTS Teams r and omized to an intervention strategy that included direct letters to patients showed significant improvement across a number of measures . The improvement was most apparent among patients without recent testing or with poorly controlled disease . The two interventions that did not include direct patient letters result ed in limited improvement . DISCUSSION Disease registries can be used to improve outcomes in the management of diabetes and other chronic diseases . Better outcomes were seen in patients who received letters based on registry-generated data . This strategy should be included as part of a comprehensive chronic disease management plan . Further refinements in the use of registries should result in further incremental improvement",
"OBJECTIVE in an academic family practice clinic , we performed a controlled trial of a multifaceted intervention versus usual care for managing diabetes . Providers received didactic training and computerized compliance feedback to support staged diabetes management , an evidence d-based approach to diabetes care . RESEARCH DESIGN AND METHODS one firm of the clinic practice received the intervention , the other served as the control group during a 14-month baseline period and a 14-month study period . HbA1(c ) was the principal outcome measure . RESULTS there was a significant 0.71 % difference in change in HbA1(c ) values between the intervention and control firms ( P=0.02 ) . The subgroup with the greatest improvement in HbA1(c ) was those subjects who started the intervention with a HbA1(c ) above 8 % . The overall improvement in glycemic control could not be explained by differences in visit frequency or the aggressiveness of drug therapy . There were no changes in healthcare utilization or costs between the two firms . CONCLUSION in an academic family practice clinic , a multifaceted intervention in support of diabetes treatment guidelines modestly improved glycemic control without incurring additional costs . The improvement was mostly due to mitigation of the natural deterioration in control usually seen . Further efforts are required to involve all patients in co-managing their diabetes",
"OBJECTIVE To evaluate the effect of an educational intervention program on clinical outcomes and on compliance with medical therapy in patients with type 2 diabetes mellitus ( DM ) , hypertension , or both . STUDY DESIGN Six-month r and omized unblinded study . METHODS Three hundred fifty-two patients were screened , and 347 were r and omized to the intervention group ( education through the Know Your Health [ KYH ] program [ n = 174 ] ) or to the control group ( usual care [ n = 173 ] ) . Evaluation of the effectiveness of the KYH program was based on the cohort of patients who were not at goal at baseline ( 124 in the intervention group and 115 in the control group ) . The primary research interests were to assess patient acceptance of the KYH material s and to compare the clinical outcomes of the intervention group with those of the control group . RESULTS After 6 months , significantly more patients in the intervention group than in the control group were at goal ( 44.2 % vs 29.2 % , P = .046 ) . Among patients with hypertension , reductions in the mean diastolic blood pressure were significantly greater in the intervention group compared with the control group at month 6 ( -6.7 vs -3.6 mm Hg , P = .04 ) . The groups did not differ significantly on other primary end points ( percentage of patients with DM who were at goal , change from baseline glycosylated hemoglobin level , and change in Morisky score ) . CONCLUSIONS Participation in the KYH educational program during a 6-month period improved clinical outcomes in patients with type 2 DM or hypertension . The KYH material s were well received and were considered informative and easily comprehensible by patients who completed the program",
"OBJECTIVE The Veterans Affairs Cooperative Study in Diabetes Mellitus Type 2 Feasibility Trial ( VA CSDM ) studied st and ard and intensive glycemic treatment groups , achieving and maintaining for 27 months a difference in HbA1c of 2.1 % ( 9.2 % vs. 7.1 % , respectively ) . A sub study planned in advance examined health status as assessed by a health status question naire obtained at baseline and 24 months . DESIGN AND METHODS A r and omized , prospect i ve trial was carried out at five VA Medical Centers from 1990 to 1993 . The sample involved 153 male veterans 40 - 69 years of age and with diabetes duration of 8+/-4 years , who were suboptimally controlled with st and ard glucose lowering treatment . The participants were r and omized to intensive and st and ard treatment groups . In addition to a variety of indicators of glycemic control and complications , health-related qualify of life data were assessed using a 20- question version of the Medical Outcome Study instrument . Scores were evaluated at baseline and 24 months for changes between the treatment groups . RESULTS The two groups were similar at baseline with respect to age , duration of diabetes , complications , comorbidities , and reported physical activity . The intensive treatment group had more frequent , m and atory self-glucose monitoring ( vs. occasional measurement in the st and ard ) and received two or more daily insulin injections ( only one in the st and ard ) . This group had three times the number of clinic visits and 10-fold higher reported incidence of mild/moderate hypoglycemia . There were no significant changes in the health status over time in either the st and ard or intensive treatment groups , nor was there a difference between the two groups . CONCLUSIONS Intensive glucose control in advanced Type 2 diabetes mellitus ( DM ) has no effect on health status over 2 years . The successful lowering of glycemia does not improve health-related quality of life nor do the increased dem and s of an intensive therapy regimen worsen it",
"M eeting the complex needs of patients with chronic illness or impairment is the single greatest challenge facing organized medical practice . Usual care is not doing the job ; dozens of surveys and audits have revealed that sizable proportions of chronically ill patients are not receiving effective therapy , have poor disease con- trol , and are unhappy with their care ( 1 ) . Results of r and omized trials also show that effective disease management programs can achieve substantially better outcomes than usual care , the control intervention . These trials , along with the ideas and efforts for improvement discussed in this issue , show that we can improve care and outcomes . As the articles suggest , these improvements will not come easily . If we are to improve care for most patients with chronic illness , the evidence strongly suggests that we reshape our ambulatory care systems for this purpose . Pri- mary care practice was largely design ed to provide ready access and care to patients with acute , varied problems , with an emphasis on triage and patient flow ; short appointments ; diagnosis and treatment of symptoms and signs ; reliance on laborato- ry investigations and prescriptions ; brief , didactic patient education ; and patient- initiated follow-up . Patients and families struggling with chronic illness have differ- ent needs , and these needs are unlikely to be met by an acute care organization and culture . They require planned , regular interactions with their caregivers , with a focus on function and prevention of exacerbations and complications . This interac- tion includes systematic assessment s , attention to treatment guidelines , and behav- iorally sophisticated support for the patient 's role as self-manager . These interactions must be linked through time by clinical ly relevant information systems and continu- ing follow-up initiated by the medical practice . Comprehensive System",
"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",
"CONTEXT Diabetes care is challenging in rural areas . Research has shown that the utilization of electronic patient registries improves care ; however , improvements generally have been described in combination with other ongoing interventions . The level of basic registry utilization sufficient for positive change is unknown . PURPOSE The goal of the current study was to examine differential effects of basic registry utilization on diabetes care processes and clinical outcomes according to level of registry use in a rural setting . METHODS Patients with diabetes ( N = 661 ) from 6 Federally Qualified Health Centers in rural West Virginia were entered into an electronic patient registry . Data from pre- and post-registry were compared among 3 treatment and control groups that had different levels of registry utilization : low , medium , or high ( for example , variations in the use of registry-generated progress notes examined at the point-of-care and in the accuracy of registry-generated summary reports to track patients ' care ) . Data included care processes ( annual exams , screens to promote wellness , education , and self-management goal - setting ) and clinical outcomes ( HbA1c , LDL , HDL , cholesterol , triglycerides , blood pressure ) . FINDINGS The registry assisted in significantly improving 12 of 13 care processes and 3 of 6 clinical outcomes ( HbA1c , LDL , cholesterol ) for patients exposed to at least medium levels of registry utilization , but not for the controls . For example , the percent of patients who had received an annual eye exam at follow-up was 11 % , 34 % , and 38 % for the low , medium , and high utilization groups , respectively ; only the latter groups improved . CONCLUSIONS As an initial step to achieving control of diabetes , basic registry utilization may be sufficient to drive improvements in provider-patient care processes and in patient outcomes in rural clinics with few re sources",
"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",
"PURPOSE The outcomes of pharmacist-managed diabetes care services in a community health center were studied . METHODS Eligible patients were over age 18 years and had a diagnosis of type 2 diabetes mellitus . Patients were r and omly assigned by the clinical pharmacist and nurse to the intervention group ( n = 76 ) or control group ( n = 73 ) . Patients in the intervention group were enrolled in a pharmacist-managed diabetes care program . Patients in the control group received the st and ard diabetes care . The primary endpoint was reduction in glycosylated hemoglobin ( HbA(1c ) ) ; secondary outcome measures included weight loss , an improved body mass index , decreased blood pressure , and an improved lipid panel . Quality -of-life measures ( health level , satisfaction , impact , worry about disease , and worry about social and vocational issues ) were also assessed . RESULTS Demographic differences between groups were not remarkable . Mean HbA(1c ) levels fell significantly ( p HbA(1c ) levels ( 95 % confidence interval , 0.08 - 1.78 ; p Satisfaction level improved from 63.7 to 77.4 in the intervention group , which was significant when compared with the control group , whose satisfaction score improved from 57.0 to 63.4 ( p CONCLUSION Patients with type 2 diabetes mellitus who received pharmacist-managed diabetes care demonstrated improved HbA(1c ) , systolic blood pressure , and low-density-lipoprotein cholesterol levels and quality -of-life measures and met treatment goals more often than patients receiving st and ard care",
"Background Pharmacists in various setting s have been effective in initiating diabetes treatment . Patients with diabetes require ongoing disease management , and community pharmacists are in a strategic position to provide such extended care . Little is known , however , about the effects of community pharmacist – provided interventions beyond the initial treatment period . Objective To evaluate the effect of community pharmacist – provided extended diabetes care service on primary clinical outcomes , including hemoglobin A1c ( A1C ) , low-density lipoprotein cholesterol ( LDL-C ) , and blood pressure , and on patients ' reported self-care activities . Methods A r and omized controlled trial was conducted in patients with diabetes . Participants had already completed at least 2 diabetes education sessions at a local diabetes education center . Nine specially trained pharmacists administered interventions during up to 4 quarterly visits per patient . Interventions included discussing medications , clinical goals , and self-care activities with patients and recommending medication changes to physicians when appropriate . The main outcome measures were 12-month changes in A1C , LDL-C , blood pressure , and self-report of self-care activities . Results Seventy-eight patients participated in the study ( 36 intervention , 42 control ) ; 66 were included in the final analysis ( 31 intervention , 35 control ) . Compared with changes in the control group , patients who received interventions significantly increased the number of days per week that they engaged in a set of diet and diabetes self-care activities ( 1.25 and 0.73 more days/wk , respectively ) . The mean 12-month changes for A1C , LDL-C , and blood pressure were not significantly different between the 2 study groups . Conclusions Although pharmacist-provided interventions did not demonstrate statistically significant improvements in clinical outcomes over the study period , study results did show that pharmacists were effective at increasing the number of days that patients spent engaging in healthy diet and diabetes self-care activities . Addressing lifestyle and self-care behaviors can be a beneficial component of a pharmacist-provided extended diabetes care service",
"OBJECTIVE Disparities exist in the diabetes health status of ethnic minority and /or low-income population s relative to other groups . A primary objective of diabetes management is to improve glycemic control . The feasibility of implementing intensive diabetes case management in disparate population s remains largely untested . RESEARCH DESIGN AND METHODS Clinical sites in three southern California counties serving low-income , ethnic minority population s participated in our study . We r and omized 362 Medicaid ( called Medi-Cal in California ) recipients with type 2 diabetes for at least 1 year to intervention ( diabetes case management ) or control ( traditional primary care treatment ) groups . Fifty-five percent of participants were minorities . Participants with HbA(1c ) levels less than 7.5 % , serious diabetes-related complications , or other serious medical conditions were excluded . We assessed the effect of the intervention ( ongoing diabetes case management added to primary care ) on glycemic control using serial HbA(1c ) measurements over several years . RESULTS The mean duration of follow-up was 25.3 months . HbA(1c ) decreased substantially in both groups from an average of 9.54 - 7.66 % ( a reduction of 1.88 % ) in the intervention group and from an average of 9.66 - 8.53 % ( a reduction of 1.13 % ) in the control group . This improvement was sustained throughout the study . The reduction in HbA(1c ) was consistently greater in the intervention group at each time point ( P Diabetes case management , added to primary care , substantially improved glycemic control compared with the control group . Diabetes case management can help reduce disparities in diabetes health status among low-income ethnic population",
"PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control"
] | 411669d8-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To review the evidence for the effectiveness of exercise therapy and to estimate the additional effect of supervision on exercise therapy in patients with intermittent claudication . MATERIAL S AND METHODS A systematic review was performed of all r and omised controlled trials ( RCTs ) comparing supervised exercise therapy to unsupervised exercise regimens or observation in patients with intermittent claudication . Main endpoints were pain free walking distance ( PWD ) and absolute walking distance ( AWD ) . Quality assessment and data extraction were performed independently by two observers . RESULTS Fifteen manuscripts , published between 1990 and May 2006 , were eligible for analysis , evaluating 761 patients . In the studies comparing supervised exercise to st and ard care the weighted mean difference in pain free walking distance ( PWD ) and absolute walking distance ( AWD ) was 81.3meters ( 95 % CI ; 35.5 - 127.1 ) and 155.8meters ( 95 % CI ; 80.8 - 230.7 ) , respectively . In the studies comparing supervised to unsupervised exercise therapy , the weighted mean difference in PWD and AWD was 143.8meters ( 95 % CI ; 5.8 - 281.8 ) and 250.4meters ( 95 % CI ; 192.4 - 308.5 ) . CONCLUSION Exercise therapy increases the PWD and AWD in patients with intermittent claudication . Supervised exercise therapy increases the PWD and AWD more than st and ard care . However , the additional value of supervision over unsupervised exercise regimens needs further clarification | [
"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",
"Supervised , hospital-based exercise rehabilitation programs are effective for improving functional status for patients with claudication due to peripheral arterial occlusive disease . However , it has been suggested that unsupervised , home-based exercise programs , which have been relatively little evaluated , would be equally efficacious as compared with hospital-based programs . The authors tested the hypothesis that a hospital-based exercise rehabilitation program would improve treadmill exercise perfor mance more than a home-based program . Of 20 consecutively enrolled patients with claudication , 10 were r and omly placed into a supervised , hospital-based program and 10 into an unsupervised , home-based program for a three-month period . Exercise perfor mance was evaluated by treadmill testing using a grade d protocol . In addition , func tional status was evaluated by the Walking Impairment Question naire ( WIQ ) and the Medical Outcomes Study SF-20 question naire ( MOS ) . Patients in the hospital-based program were treated with treadmill walking three times a week for one hour/visit . Patients in the home-based program were instructed to walk at least three times a week and were contacted weekly to provide encouragement and to record compliance with ( continued on next page ) the program . Patients in the hospital-based group improved peak walking time by 137 % , pain-free walking time by 150 % , and peak oxygen consumption by 19 % ( all P walking distance and speed according to WIQ data ( both P MOS physical functioning score in the hospital-based group improved by 20 percentage points ( P exercise performance measured on the treadmill . Improvement in the ability to walk on the treadmill was greater in the hospital-based than the home- based program ( P ability to walk distances was the only question naire measure that improved in persons who received the home-based program ( P improving treadmill exercise performance than an unsupervised , home-based program",
"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",
"PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints . METHODS Patients with arterial claudication were r and omized to either a 12-week supervised exercise program ( SUPEX ) with weekly lectures relating to peripheral vascular disease or to a home exercise group ( HOMEX ) who attended an identical lecture program and received weekly exercise instruction . The study population included 29 men and 26 women , with a mean age of 69.1 + /- 8.1 years . Forty-seven patients completed the 12-week program , 46 were available for testing at completion , and 38 for 6-month testing . Claudication pain time ( CPT ) and maximum walking time ( MWT ) on a progressive treadmill exercise test were assessed at baseline , program completion , and 6 months . The Medical Outcomes Study Short Form-36 ( SF-36 ) was administered at these intervals to assess effects on quality of life . RESULTS Each group improved ( p CPT and MWT at the completion of the 12-week program , which was sustained at the 6-month follow-up . Increase in HOMEX CPT from baseline ( 3.6 + /- 2.73 minutes ) to 6-month follow-up ( 6.6 + /- 3.17 minutes ) was less than for the SUPEX group ( 3.8 + /- 2.74 to 11.2 + /- 4.02 minutes , respectively ) ; similar results were obtained for MWT . At both completion and 6 months , there was a significant intergroup difference for CPT and MWT ( p health perception based on the SF-36 demonstrated improvement ( p Physical Function Subscale , Bodily Pain Subscale , and Physical Composite Score . There were no between-group differences on the subsets of the SF-36 at the three assessment intervals . CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication , and both supervised and home based exercise therapy result in improved SF-36 functional measures . The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group . Although a supervised program results in optimal walking benefits , a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements",
"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",
"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",
"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",
"OBJECTIVES To identify a stable biochemical marker of disease severity in patients with intermittent claudication and to use these findings to assess the effect of therapeutic exercise training . DESIGN Case-control study : prospect i ve r and omised-controlled trial of exercise training . MATERIAL S AND METHODS Plasma fibrinogen , serum amyloid A protein ( SAA ) , C-reactive protein ( CRP ) and urinary albumin-creatinine ratio ( ACR ) were measured in 67 claudicants and 15 controls . Twenty-two patients were r and omised to supervised exercise training and 17 r and omised to observation . Subjects were review ed at 3 , 6 and 12 months . RESULTS The median ( interquartile range ) baseline fibrinogen was 3.7 g/l ( 3.3 - 4.25 ) in claudicants and 3.5 g/l ( 2.9 - 3.95 ) in controls ( p = 0.045 ) ; CRP was 4.7 mg/l ( 2.2 - 9.0 ) and 2.1 mg/l ( 1.0 - 2.8 ) , respectively ( p SAA was 72 mg/l ( 35 - 132 ) and 30 mg/l ( 20 - 89 ) ( p = 0.0009 ) . Claudicants showed an increased urinary ACR following treadmill exercise ( Wilcoxon , p Exercise training reduced SAA at 6 months , CRP at 3 months and progressively attenuated the post-exercise increase in ACR . No similar changes were found in controls . CONCLUSIONS Repetitive low- grade inflammatory events in claudicants lead to elevation of serum acute-phase proteins . Exercise training is associated with symptomatic improvement and reduction inflammatory markers . The concern that exercise has adverse systemic effects therefore seems to be unjustified",
"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",
"The efficacy of physical training alone or combined with antiplatelet thera py ( dipyridamole and aspirin ) was studied in 30 patients with stage II peripheral arterial occlusive disease ( PAOD ) . Patients were r and omly allocated to one of the following groups : Group A— dipyridamole 75 mg three times daily and aspirin 330 mg once daily : Group B— physical exercise ; Group C — physical exercise and dipyridamole 75 mg three time daily and aspirin 330 mg once daily . After six months ' treatment the pain-free walking time ( PFWT ) and the max imum walking time ( MWT ) improved significantly ( p PFWT lengthened by 35 % ( from 101.00 ± 34.56 to 137.32 ± 40.50 s ) and the MWT by 38 % ( from 150.34 ± 55.60 to 207.26 ± 60.67 s ) ; in group B the PFWT lengthened by 90 % ( from 90.65 ± 40.54 to 171.45 ± 55.60 s ) and the MWT by 86 % ( from 145.39 ± 60.50 to 270.63 ± 63.61 s ) . When physical exer cise was associated with drugs as in group C , the PFWT lengthened by 120 % ( from 89.51 ± 43.89 to 196.72 ±51.73 s ) and the MWT by 105 % ( from 160.43 ± 59.84 to 329.05 ± 63.96 s ) . No significant variations were observed at any stage of the study in the ankle/arm pressure ratio at rest and after st and ard treadmill exercise , in the plethysmographic rest and peak flows , or in the trans cutaneous oxygen pressure in basal conditions and in its half recovery time after an induced ischemia . The results confirm the benefits of regular exercise in stage II PAOD pa tients but suggest they may be enhanced by antiplatelet therapy ",
"PURPOSE To compare treadmill and shuttle walk tests for assessing functional capacity in patients with intermittent claudication , with respect to test-retest reliability , cardiovascular responses , and patient preferences . METHODS Patients with stable intermittent claudication ( N = 55 , ages 52 - 85 yr , median age 68 yr ) were recruited from the Sheffield Vascular Institute at the Northern General Hospital , Sheffield , UK . Each patient performed an incremental shuttle walk test , a constant-pace shuttle walk test , and a st and ardized treadmill test ( 3.2 km x h(-1 ) , 12 % gradient ) , each on three occasions . The incremental shuttle walk began at 3 km x h(-1 ) and increased by 0.5 km x h(-1 ) every minute , whereas the constant-pace shuttle walk was performed at the fixed pace of 4 km x h(-1 ) . Claudication distance ( CD ) , maximum walking distance ( MWD ) , heart rate ( HR ) , and blood pressure were assessed in each testing session . The patients also completed a test preference question naire . RESULTS CD and MWD for both shuttle walks were greater than the corresponding walking distances achieved in the treadmill test ( P Average coefficients of variation for repeated incremental shuttle walk , constant-pace shuttle walk , and treadmill tests were 15.9 % , 21.1 % , and 18.7 % , respectively , for MWD , corresponding to average intraclass correlation coefficients of 0.87 , 0.82 , and 0.87 . Treadmill walking evoked greater increases in HR and blood pressure ( P preference for it ( 24 vs 43 % for shuttle walking ) . CONCLUSION These findings indicated that shuttle walk testing exhibits similar test-retest reliability as treadmill testing , but that it evoked a lower level of cardiovascular stress and is preferred to treadmill testing by a large proportion of patients",
"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 . 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",
"The purpose of this study was to determine the impact of increased physical activity and cessation of smoking on the natural history of early peripheral arterial disease . We conducted a r and omised controlled trial in Perth , Western Australia , involving 882 men with early peripheral arterial disease identified via population -based screening using the Edinburgh Claudication Question naire and the ankle : brachial index . Members of the control group ( n = 441 ) received \" usual care \" from their general practitioner while members of the intervention group ( n = 441 ) were allocated to a \" stop smoking and keep walking \" regime - a combined community-based intervention of cessation of smoking ( where applicable ) and increased physical activity . Postal follow-up occurred at two and 12 months post-entry into the trial . The main outcome of interest was maximum walking distance . There were no statistically significant differences in the characteristics of the \" intervention \" and \" usual care \" groups at recruitment . Follow-up information at two and 12 months was available for 85 % and 84 % of participants , respectively . At 12 months , more men allocated to the intervention group had improved their maximum walking distance ( 23 % vs 15 % ; chi2 = 9.74 , df = 2 , p = 0.008 ) . In addition , more men in the intervention group reported walking more than three times per week for recreation ( 34 % vs 25 % , p = 0.01 ) . Although not statistically significant , more men in the intervention group who were smokers when enrolled in the trial had stopped smoking ( 12 % vs 8 % , p = 0.43 ) . It is concluded that referral of older patients with intermittent claudication to established physiotherapy programs in the community can increase levels of physical activity and reduce disability related to peripheral arterial disease . A combination of simple and safe interventions that are readily available in the community through physiotherapists and general practitioners has the potential to improve early peripheral arterial disease",
"BACKGROUND Peripheral arterial occlusive disease ( PAOD ) at II stage results in a moderate to severe impairment in walking ability . Aim of this study , controlled and r and omized , was to evaluate the efficacy of an intensive 4 weeks exercise training in PAOD followed by a six-month period and to analyse the risk factors for atherosclerosis and the site of the lesion for possible predictors of result outcome . METHODS Patients with PAOD were included in the study ( ankle/arm ratio claudication distance ( ICD ) absolute claudication distance ( ACD ) a supervised walking exercise ( mean ICD 121.8 m , ACD 289.7 m ) and 20 to a non exercising control group ( ICD 111.6 m , ACD 230.1 m ) . Both groups were tested at 4 weeks ( T1 ) and 6 months ( T2 ) . Training group was enrolled in a 4-week supervised training program . RESULTS In the training group 10 % of patients became asymptomatic ( > 1000 m ) . At T1 ICD increased 141 % ( p ACD was with low-pain-claudication > 1000 m in 50 % , at T2 ICD was 200 % ( p ICD and ACD . Control group has a no significant increase of ICD and ACD at T1 and T2 . Only arterial hypertension and intermittent claudication severity emerged as negative predictive factors for the results of training . CONCLUSIONS Vascular training produces a significant and lasting improvement in walking distance in PAOD"
] | 41166a14-06ff-11f0-808a-c43d1ab1c353 |
Risk stratification is essential for both clinical risk prediction and comparative audit . There are a variety of risk stratification tools available for use in major noncardiac surgery , but their discrimination and calibration have not previously been systematic ally review ed in heterogeneous patient cohorts . Embase , MEDLINE , and Web of Science were search ed for studies published between January 1 , 1980 and August 6 , 2011 in adult patients undergoing major noncardiac , nonneurological surgery . Twenty-seven studies evaluating 34 risk stratification tools were identified which met inclusion criteria . The Portsmouth-Physiology and Operative Severity Score for the enUmeration of Mortality and the Surgical Risk Scale were demonstrated to be the most consistently accurate tools that have been vali date d in multiple studies ; however , both have limitations . Future work should focus on further evaluation of these and other parsimonious risk predictors , including validation in international cohorts . There is also a need for studies examining the impact that the use of these tools has on clinical decision making and patient outcome | [
"Background : In established risk score models the collection and documentation of clinical data is time-consuming , causes labor-related costs , and is dependent on the examiner . Material and Methods : Based on low-cost laboratory parameters that are routinely measured at admission to the intensive care unit , a new score was developed ( n = 271 , study sample ) and vali date d in an independent group of patients ( n = 283 , validation sample ) . Parameters were selected by a stepwise logistic regression analysis . This new score was compared to established risk models ( APACHE II , SAPS II ) . Results : Mean age was 61.3 ± 1.2 years ( study sample ) and 63.1 ± 1.1 years ( validation sample ) , respectively . In-hospital mortality was 24.7 % ( 67/271 , study sample ) and 23.3 % ( 66/283 , validation sample ) . The following parameters were used to build the new score called Dense Laboratory Whole Blood Applied Risk Estimation ( DELAWARE ) : alanine aminotransferase , C-reactive protein , cholesterol , creatine kinase MB , leukocytes , potassium , thrombocytes , triglycerides , and age . The areas under the curves were 0.853/0.813 ( study sample /validation sample ) . In the study sample DELAWARE correlated with APACHE II ( r = 0.586 ) and SAPS II ( r = 0.614 ; p surgical intensive care patients solely based on quality controlled low-cost routine laboratory parameters is feasible",
"BACKGROUND Preoperative risk assessment is important yet inexact in older patients because physiologic reserves are difficult to measure . Frailty is thought to estimate physiologic reserves , although its use has not been evaluated in surgical patients . We design ed a study to determine if frailty predicts surgical complications and enhances current perioperative risk models . STUDY DESIGN We prospect ively measured frailty in 594 patients ( age 65 years or older ) presenting to a university hospital for elective surgery between July 2005 and July 2006 . Frailty was classified using a vali date d scale ( 0 to 5 ) that included weakness , weight loss , exhaustion , low physical activity , and slowed walking speed . Patients scoring 4 to 5 were classified as frail , 2 to 3 were intermediately frail , and 0 to 1 were nonfrail . Main outcomes measures were 30-day surgical complications , length of stay , and discharge disposition . Multiple logistic regression ( complications and discharge ) and negative binomial regression ( length of stay ) were done to analyze frailty and postoperative outcomes associations . RESULTS Preoperative frailty was associated with an increased risk for postoperative complications ( intermediately frail : odds ratio [ OR ] 2.06 ; 95 % CI 1.18 - 3.60 ; frail : OR 2.54 ; 95 % CI 1.12 - 5.77 ) , length of stay ( intermediately frail : incidence rate ratio 1.49 ; 95 % CI 1.24 - 1.80 ; frail : incidence rate ratio 1.69 ; 95 % CI 1.28 - 2.23 ) , and discharge to a skilled or assisted-living facility after previously living at home ( intermediately frail : OR 3.16 ; 95 % CI 1.0 - 9.99 ; frail : OR 20.48 ; 95 % CI 5.54 - 75.68 ) . Frailty improved predictive power ( p risk index ( ie , American Society of Anesthesiologists , Lee , and Eagle scores ) . CONCLUSIONS Frailty independently predicts postoperative complications , length of stay , and discharge to a skilled or assisted-living facility in older surgical patients and enhances conventional risk models . Assessing frailty using a st and ardized definition can help patients and physicians make more informed decisions",
"The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : \" 0 \" , 12 % ( 181 ) ; \" 1 - 2 \" , 26 % ( 225 ) ; \" 3 - 4 \" , 52 % ( 71 ) ; and \" greater than or equal to 5 \" , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : \" 0 \" , 8 % ( 588 ) ; \" 1 \" , 25 % ( 54 ) ; \" 2 \" , 48 % ( 25 ) ; \" greater than or equal to 3 \" , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small",
"BACKGROUND Cardiac complications are important causes of morbidity after noncardiac surgery . The purpose of this prospect i ve cohort study was to develop and vali date an index for risk of cardiac complications . METHODS AND RESULTS We studied 4315 patients aged > or = 50 years undergoing elective major noncardiac procedures in a tertiary-care teaching hospital . The main outcome measures were major cardiac complications . Major cardiac complications occurred in 56 ( 2 % ) of 2893 patients assigned to the derivation cohort . Six independent predictors of complications were identified and included in a Revised Cardiac Risk Index : high-risk type of surgery , history of ischemic heart disease , history of congestive heart failure , history of cerebrovascular disease , preoperative treatment with insulin , and preoperative serum creatinine > 2.0 mg/dL. Rates of major cardiac complication with 0 , 1 , 2 , or > or = 3 of these factors were 0.5 % , 1.3 % , 4 % , and 9 % , respectively , in the derivation cohort and 0.4 % , 0.9 % , 7 % , and 11 % , respectively , among 1422 patients in the validation cohort . Receiver operating characteristic curve analysis in the validation cohort indicated that the diagnostic performance of the Revised Cardiac Risk Index was superior to other published risk-prediction indexes . CONCLUSIONS In stable patients undergoing nonurgent major noncardiac surgery , this index can identify patients at higher risk for complications . This index may be useful for identification of c and i date s for further risk stratification with noninvasive technologies or other management strategies , as well as low-risk patients in whom additional evaluation is unlikely to be helpful",
"A 1‐year prospect i ve analysis was undertaken of all non‐day‐case general surgery in a district general hospital . Using the Physiological and Operative Severity Score for the en Umeration of Mortality and Morbidity ( POSSUM ) scoring system 3004 patients were assessed . From the predictions of mortality and morbidity so obtained , a quality measure , the ratio of observed to expected numbers of deaths and complications ( O : E ratio ) was determined for each surgeon , both overall and within specialty zones . The present study demonstrates the serious hazard in using ‘ raw ’ uncorrected mortality and morbidity statistics to compare surgeon performance . Mortality rates varied from 1·0 to 4·9 per cent whereas O : E ratios ranged from 0·83 to 1·06 ; morbidity rates varied from 5·3 to 12·6 per cent with O : E ratios 0·86‐1·02 . Great misunderst and ing may result from the publication of surgeon or hospital ‘ league tables ’ . The present study demonstrates a technique that might allow surgeon performance to be monitored adequately and accurately",
"BACKGROUND In adults , the appearance of nucleated red blood cells ( NRBC ) in the peripheral blood is associated with several severe diseases . When NRBC are detected in the blood , the prognosis is poor . The purpose of this study was to identify the impact of NRBC on the clinical outcomes of surgical intensive care patients under consideration of established risk models . METHODS In a prospect i ve study , the detection of NRBC in the peripheral blood of surgical intensive care patients was analyzed with regard to the in- hospital mortality . NRBC were daily measured with a Sysmex XE-2100 . The prognostic significance of NRBC in blood was analyzed under consideration of established risk scores for intensive care patients , i.e. , the Acute Physiology and Chronic Health Evaluation ( APACHE II ) and the Simplified Acute Physiology Score ( SAPS II ) . RESULTS Two hundred seventy-one surgical intensive care patients were included in this study . The mean age was 61.3 years + /- 1.2 years ( range , 18 - 98 years ) . The average APACHE II and SAPS II scores were 20.6 + /- 0.6 and 44.1 + /- 1.2 , respectively . The in-hospital mortality of NRBC-positive patients was 51.7 % ( 45 of 87 ) . This was significantly higher ( p mortality of NRBC-negative patients ( 12.0 % , 22 of 184 ) . The area under curve ( C-statistic ) was 0.77 . Mortality increased with the NRBC concentration . On average , in NRBC-positive patients who died , NRBC were detected for the first time 13.3 days + /- 3.1 days ( n = 45 , median = 6 days ) before death . Multiple logistic regression analysis under consideration of the APACHE II or the SAPS II revealed a significant association between NRBC and increased mortality , the mean odds ratio being 1.97 for each increase in the NRBC category ( 0/microL ; 1 - 40/microL ; 41 - 80/microL ; 81 - 240/microL , > 240/microL ) . In contrast , under consideration of the NRBC- data the mean odds ratios for the increase of one score point of the APACHE II and SAPS II were 1.10 and 1.05 , respectively . Therefore , each step-up in the NRBC category is equivalent to approximately 7 APACHE II-score points and 14 SAPS II-score points , respectively . CONCLUSIONS The daily screening for NRBC in blood of surgical intensive care patients is of prognostic power with regard to the patients ' in-hospital mortality . This prognostic significance of NRBC was independent of the scores APACHE II and SAPS II , respectively . Therefore , for prognostic purpose s an adjustment of these established risk models by including the NRBC- results is feasible",
"Objective : The purpose of this study was to determine the relationship between the American Society of Anesthesiologists ’ Physical Status ( ASA PS ) classifications and the other National Surgical Quality Improvement Program ( NSQIP ) preoperative risk factors . Background : The ASA PS has been shown to predict morbidity and mortality in surgical patients but is inconsistently applied and clinical ly imprecise . It is desirable to have a method for validating ASA PS classification levels . Methods : The NSQIP preoperative risk factors , including ASA PS , were recorded from a r and om sample of 5878 surgical patients on 6 services between October 1 , 2001 and September 30 , 2003 at the University of Kentucky Medical Center . Mortality , morbidity , costs , and length of stay were obtained and compared across ASA PS levels . The ability of 1 ) ASA PS alone , 2 ) the other NSQIP risk factors , and , 3 ) all factors combined to predict outcomes was analyzed . A model using the other NSQIP risk factors was developed to predict ASA PS . Results : ASA PS alone was a strong predictor of outcomes ( P ASA PS and the other NSQIP risk factors . Predictions of ASA PS using the other factors showed strong agreement with the anesthesiologists ’ assignments . Conclusions : The NSQIP risk factors other than ASA PS can and should be used to vali date ASA PS classifications",
"Background : Quality assessment in surgery is paramount for patients and health care providers . In our center , quality assessment is based on the recording of preoperative risk factors of each patient and a well-established grading system to track complications . Our prospect i ve quality data base is administrated by residents . However , the validity of such data collection is unknown . Methods : To evaluate the validity of the recorded data , a specially trained study nurse audited our prospect i ve quality data base over a 6-month period . In the first 3 months , the audit was done in an undisclosed manner . Then , the audit was disclosed to the residents who were again subjected to a teaching course . Thereafter , the audit was continued in a disclosed manner for another 3 months , and data were compared between the 2 periods . Furthermore , we inquired about the strategies to assess surgical quality in 108 European medical centers . Results : Surprisingly , residents failed to report most complications ; 80 % ( 164/206 ) and 79 % ( 275/347 ; P = 0.27 ) of the negative postoperative events were not recorded during the first and the second period , respectively . When captured , however , grading of complications was correct in 97 % of the cases . Moreover , comorbidities were incorrectly assessed in 20 % of the patients in the first period and in 14 % thereafter ( P = 0.07 ) . The survey disclosed that residents and junior staff are responsible of recording surgical outcome in 80 % of the participating European centers . Conclusions : Recording of outcome by surgical residents is unreliable , despite active and focused training . Hence , surgery should be evaluated by dedicated personnel",
"The objective of this study is to investigate if a comprehensive geriatric assessment is useful for predicting morbimortality , functional impairment and the risk for institutionalization for elderly patients after major surgery . A prospect i ve study was carried out at a tertiary hospital , between April and June 1993 , including those elderly surgical in patients for whom a preoperative assessment of the Geriatric Department was dem and ed . Beside traditional parameters of surgical risk ( ASA clas , Goldman index , respiratory and nutritional risk ) , other medical , functional and social parameters were evaluated . A perioperative follow-up was made and a new functional evaluation one month after discharge . 49.5 % of the patients presented perioperative complications and the mortality rate was 10 % . 11 % needed residential accommodation after discharge . Traditional surgical risks as well as previous functional capacity were predictors of perioperative morbimortality . But only previous functional capacity and nutritional status predict institutionalization . No predictors of functional impairment were found , with the exception of perioperative complications",
"The aim was to compare a number of risk scoring systems prospect ively in a cohort of patients who underwent non‐elective surgery",
"OBJECTIVE To assess the prognostic value of the APACHE II score and the American Society of Anesthesiologists ( ASA ) classification system in preoperative evaluation of patients . DESIGN Prospect i ve study . SETTING University hospital , Italy . SUBJECTS 187 consecutive patients undergoing elective or emergency major general surgical operations . INTERVENTIONS Patients were evaluated preoperatively using both indices . MAIN OUTCOME MEASURES Morbidity and mortality within 30 days . RESULTS Logistic regression and ROC curve analyses showed that the APACHE II score predicted morbidity and mortality well ; it was superior to the ASA system in predicting outcome ( area under the curve 0.894 for the APACHE II index , 0.777 for the ASA system ; p score without its age points ( area 0.888 ) had the same prognostic value as the complete score ( area 0.894 ; p = 0.55 ) . CONCLUSIONS The APACHE II score may help clinicians to evaluate preoperatively the risk of postoperative morbidity and death after major general surgical operations . Age does not seem to have a specific weight",
"BACKGROUND There is a need for an accurate measure of surgical outcomes so that hospitals and surgeons can be compared properly regardless of case mix . POSSUM ( Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ) uses a physiological score and an operative severity score to calculate risks of mortality and morbidity . In a previous small study it was found that Portsmouth POSSUM ( P-POSSUM ; a modification of the POSSUM system ) provided a more accurate prediction of mortality . METHODS Some 10000 general surgical interventions ( excluding paediatric and day cases ) were studied prospect ively between August 1993 and November 1995 . The POSSUM mortality equation was applied to the full 10000 surgical episodes . The 10000 patients were arranged in chronological order and the first 2500 were used as a training set to produce the modified P-POSSUM predictor equation . This was then applied prospect ively to the remaining 7500 patients arranged chronologically in five groups of 1500 . RESULTS The original POSSUM logistic regression equation for mortality overpredicts the overall risk of death by more than twofold and the risk of death for patients at lowest risk ( 5 per cent or less ) by more than sevenfold . The P-POSSUM equation produced a very close fit with the observed in-hospital mortality . CONCLUSION P-POSSUM provides an accurate method for comparative surgical audit",
"BACKGROUND Surgical teams have not had a routine , reliable measure of patient condition at the end of an operation . We aim ed to develop an Apgar score for the field of surgery , an outcomes score that teams could calculate at the end of any general or vascular surgical procedure to accurately grade a patient 's condition and chances of major complications or death . STUDY DESIGN We derived our surgical score in a retrospective analysis of data from medical records and the National Surgical Quality Improvement Program for 303 r and omly selected patients undergoing colectomy at Brigham and Women 's Hospital , Boston . The primary outcomes measure was incidence of major complication or death within 30 days of operation . We vali date d the score in two prospect i ve , r and omly selected cohorts : 102 colectomy patients and 767 patients undergoing general or vascular operations at the same institution . RESULTS A 10-point score based on a patient 's estimated amount of blood loss , lowest heart rate , and lowest mean arterial pressure during general or vascular operations was significantly associated with major complications or death within 30 days ( p general and vascular surgery patients , 29 ( 3.8 % ) had a surgical score Major complications or death occurred in 17 of these 29 patients ( 58.6 % ) within 30 days . By comparison , among 220 patients with scores of 9 or 10 , only 8 ( 3.6 % ) experienced major complications or died ( relative risk 16.1 ; 95 % CI , 7.6 - 34.0 ; p blood loss , heart rate , and blood pressure can be useful in rating the condition of patients after general or vascular operations",
"Objective : This study was undertaken to evaluate a modified form of Estimation of Physiologic Ability and Surgical Stress ( E-PASS ) for surgical audit comparing with other existing models . Background : Although several scoring systems have been devised for surgical audit , no nation-wide survey has been performed yet . Methods : We modified our previous E-PASS surgical audit system by computing the weights of 41 procedures , using data from 4925 patients who underwent elective digestive surgery , design ated it as mE-PASS . Subsequently , a prospect i ve cohort study was conducted in 43 national hospitals in Japan from April 1 , 2005 , to April 8 , 2007 . Variables for the E-PASS and American Society of Anesthesiologists ( ASA ) status-based model were collected for 5272 surgically treated patients . Of the 5272 patients , we also collected data for the Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity ( P-POSSUM ) in 3128 patients . The area under the receiver operative characteristic curve ( AUC ) was used to evaluate discrimination performance to detect in-hospital mortality . The ratio of observed to estimated in-hospital mortality rates ( OE ratio ) was defined as a measure of quality . Results : The numbers of variables required were 10 for E-PASS , 7 for mE-PASS , 20 for P-POSSUM , and 4 for the ASA status-based model . The AUC ( 95 % confidence interval ) values were 0.86 ( 0.79–0.93 ) for E-PASS , 0.86 ( 0.79–0.92 ) for mE-PASS , 0.81 ( 0.75–0.88 ) for P-POSSUM , and 0.73 ( 0.63–0.83 ) for the ASA status-based model . The OE ratios for mE-PASS among large-volume hospitals significantly correlated with those for E-PASS ( R = 0.93 , N = 9 , P = 0.00026 ) , P-POSSUM ( R = 0.96 , N = 6 , P = 0.0021 ) , and ASA status-based model ( R = 0.83 , N = 9 , P = 0.0051 ) . Conclusion : Because of its features of easy use , accuracy , and generalizability , mE-PASS is a c and i date for a nation-wide survey",
"Objectives : To examine the sensitivity of the performance of the latest Mortality Probability Model at intensive care unit admission ( MPM0-III ) to case-mix variations and to determine how specialized models for these subgroups would affect intensive care unit performance assessment . MPM0-III is an important benchmarking tool for intensive care units in Project IMPACT . Overall , MPM0-III has excellent discrimination and calibration but its performance varies on six common patient subsets . Design : A total of 124,171 patients in six subgroups ( complex cardiovascular , trauma , elective surgery , medical , neurosurgery , and emergency surgery ) were divided r and omly into development ( 60 % ) and validation ( 40 % ) groups . A logistic regression model was developed to predict hospital mortality for each subgroup , using MPM0-III variables . Model performance was evaluated on the validation sets , using Hosmer-Lemeshow and receiver operating characteristic statistics . Intensive care unit st and ardized mortality ratios , using the subgroup models and MPM0-III , were compared . A sensitivity analysis was used to identify the occurrence of each subgroup associated with de grade d MPM0-III performance . Setting : One hundred thirty-five intensive care units at 98 hospitals participating in Project IMPACT between 2001 and 2004 . ICUs with Patients : Consecutive intensive care unit patients in the Project IMPACT data base who were eligible for MPM0-II scoring . Interventions : None . Measurements and Main Results : Hospital mortality and st and ardized mortality ratio values by intensive care unit . All six subgroup models had good performance on their validation sets . Intensive care unit st and ardized mortality ratios calculated with MPM0-III and the subgroup models were nearly identical , with MPM0-III identifying 33 of 135 as significant st and ardized mortality ratio outliers and the subgroup models identifying 35 of 135 , with 33 overlapping . Sensitivity analysis indicated that MPM0-III calibration de grade d substantially only when patient mix varied significantly from that of the data set on which MPM0-III was based . Conclusion : We recommend users of MPM make MPM0-III their primary model . Subgroup models may have utility when evaluating highly specialized intensive care units or in research on specific , homogeneous population",
"Background : Tools to accurately estimate the risk of death following emergency surgery are useful adjuncts to informed consent and clinical decisions . This prospect i ve study compared the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity ( POSSUM ) and Portsmouth POSSUM ( P‐POSSUM ) scoring systems with clinical judgement in predicting mortality from emergency surgery",
"The basic objective of this paper is to evaluate an age-comorbidity index in a cohort of patients who were originally enrolled in a prospect i ve study to identify risk factors for peri-operative complications . Two-hundred and twenty-six patients were enrolled in the study . The participants were patients with hypertension or diabetes who underwent elective surgery between 1982 and 1985 and who survived to discharge . Two-hundred and eighteen patients survived until discharge . These patients were followed for at least five years post-operatively . The estimated relative risk of death for each comorbidity rank was 1.4 and for each decade of age was 1.4 . When age and comorbidity were modelled as a combined age-comorbidity score , the estimated relative risk for each combined age-comorbidity unit was 1.45 . Thus , the estimated relative risk of death from an increase of one in the comorbidity score proved approximately equal to that from an additional decade of age . The combined age-comorbidity score may be useful in some longitudinal studies to estimate relative risk of death from prognostic clinical covariates",
"OBJECTIVES To compare pediatric intensive care unit ( ICU ) mortality risk using models from two distinct time periods ; and to discuss the implication s of changing mortality risk for severity systems and quality -of-care assessment . DATA SOURCES AND SETTING Consecutive admissions ( n = 10,833 ) from 16 pediatric ICUs across the United States that participate in the Pediatric Critical Care Study Group were recorded prospect ively . Data collection occurred during a 12-mo period beginning in January 1993 . METHODS Data collection for the development and validation of the original Pediatric Risk of Mortality ( PRISM ) score occurred from 1980 to 1985 . The original PRISM coefficients were used to calculate mortality probabilities in the current data set . Up date d estimates of mortality probabilities were calculated , using coefficients from a logistic regression analysis using the original PRISM variable set . Quality -of-care tests were performed using st and ardized mortality ratios . RESULTS Risk of mortality from pediatric ICU admission improved considerably between the two periods . Overall , the reduction in mortality risk averaged 15 % ( p Analysis of mortality risk by age indicated a large improvement for younger infants . The mortality risk for infants Mortality risk improved by 28 % ( p mortality risk by principal diagnosis indicated substantial improvement in respiratory diseases , including respiratory diseases developing in the perinatal period . The mortality risk for respiratory diseases improved by 45 % ( p improvement in mortality risk substantially deteriorated the calibration of the original PRISM severity system ( p risk of mortality over time that are consistent with a general improvement in the quality of pediatric intensive care . Despite continued widespread use of the original PRISM , recent improvements in pediatric ICU quality of care have negated its usefulness for many intended applications , including quality -of-care assessment",
"INTRODUCTION Outcome prediction in critical surgical patients admitted to intensive care units ( ICU ) has been established using several scoring systems . To evaluate the predictive performance of the Acute Physiology , Age and Chronic Health Evaluation ( APACHE III ) scoring system in these patients , we studied a population admitted to a surgical ICU in our University Hospital . METHODS We collected prospect i ve data on 220 consecutive patients admitted over a period of 12 months . APACHE III ( A3 ) scores were obtained over the first 24 hours of ICU admission ( APACHE II scores were also calculated ) ; data also included age , sex , acute and chronic diseases , ICU and hospital length of stay ( LOS ) , patient location prior to ICU admission and outcome . The relationship of hospital mortality with A3 scores was analyzed using logistic regression , with the discriminatory power of these systems being assessed by the area under the ROC curve and percentage of correct classification . RESULTS Patient 's mean age was 57 + /- 17 years and 44 % were male ; 53.6 % were elective and 46.4 % were emergency postoperative patients ; 5 % of patients had co-morbidities ; ICU mortality rate was 10 % and in-hospital mortality rate ( HMR ) was 15 % ; mean ICU LOS was 3.9 + /- 5.6 days and mean hospital LOS was 9.4 + /- 8.2 days ; mean scores were : APACHE III = 33 + /- 2 and APACHE II = 9 + /- 6 points . There was a significant relationship between ascending A3 scores and HMR . APACHE III had a correct classification rate of 87.3 % and an area under the ROC curve of 0.830 . CONCLUSIONS In a population of critical surgical patients admitted to our ICU the APACHE III scoring system demonstrated an excellent prognostic performance as measured by contingency tables and areas under the ROC curve ; this system can be a useful tool for outcome prediction in critical surgical patients",
"POSSUM , a Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity , is described . This system has been devised from both a retrospective and prospect i ve analysis and the present paper attempts to vali date it prospect ively . Logistic regression analysis yielded statistically significant equations for both mortality and morbidity ( P morbidity and mortality rates could be defined which could be of value in surgical audit . The scoring system produced assessment s for morbidity and mortality rates which did not significantly differ from observed rates",
"Background : The Project Perioperative Risk in Gothenburg is a prospect i ve clinical ‐epidemiological study design ed to eluci date factors affecting the perioperative risk in unselected adult patients undergoing elective general or orthopaedic surgery . In this report on postoperative adverse events of varying severity , the predictive ability of four simple classification systems , ASA physical status , patient age , surgical stress and a visual analogue scale for intuitively appreciated global risk ( RISK‐VAS ) , is described",
"POSSUM and APACHE II scores from 117 consecutive admissions to a high‐dependency unit after major surgery were correlated with 30‐day morbidity and mortality rates . Thirteen patients ( II per cent ) died and 59 ( 50 per cent ) developed a postoperative complication . Receiveroperating characteristic curve analysis showed POSSUM to have good predictive value for mortality ( area under curve 0.75 ) and morbidity ( area under curve 0.82 ) . APACHE II scores had a significantly inferior predictive value for mortality ( area under curve 0.54 ) ( P POSSUM was superior to APACHE II in prediction of mortality in patients admitted to a high‐dependency unit after general surgery . Prediction of postoperative complications by POSSUM is accurate and may be useful for audit",
"OBJECTIVE To study the usefulness of the Acute Physiology and Chronic Health Evaluation II ( APACHE II ) scoring system for prognostication of inhospital mortality in acute myocardial infa rct ion . DESIGN A prospect i ve validation study . SETTING A medical intensive care unit ( ICU ) at a university hospital . PATIENTS Over a 3-yr period , 2,007 admissions of 1,714 patients with acute myocardial infa rct ion were studied . In readmissions to the medical ICU during the same hospital stay , only the first admission was studied . MEASUREMENTS AND MAIN RESULTS Mean age of the patients was 72 + /- 10 yrs . The medical ICU mortality rate was 13 % and total hospital mortality rate was 16 % . Mean APACHE II score was 11.6 + /- 6.5 . There was a close correlation between observed and predicted mortality rates in classes of patients with various APACHE II scores . Observed mortality in patients with scores of 20 to 24 was higher than the predicted mortality ( p length of stay in the medical ICU of Inhospital mortality in patients with acute myocardial infa rct ion could be accurately predicted with APACHE II scores . Prognostication was not as good in patients with a length of stay in the medical ICU of < 8 hrs"
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Bipolar disorder is characterized by chronic and recurrent symptoms including mania , hypomania , and depressive and mixed episodes , with approximately 5.7 million Americans over age 18 , or 2.6 % of the U.S. population , suffering from the illness . The prevalence of the disorder may be higher due to its chronic and recurrent nature . Individuals with bipolar disorder often first present in general medical setting s with depressive symptomatology . Long-term management typically occurs in mental health setting s by psychiatrists or other mental health specialists . While there have been major advances in pharmacotherapy for bipolar disorder , evidence -based information on drug effectiveness is not always easily accessible to prescribers in daily practice . Available information has sometimes led to inappropriate use of various classes of drugs , specifically antiepileptic drugs ( AEDs ) , for bipolar disorder . Originally approved in 1993 by the U.S. Food and Drug Administration ( FDA ) only for adjunctive treatment of partial complex seizures , the manufacturer of gabapentin ( Neurontin ) , an AED , promoted its off-label use for treatment of psychiatric disorders , including bipolar disorder . The efficacy of the drug for this indication had not been demonstrated , nor had the manufacturer sought FDA approval for the indication . In 2004 , 50 Attorneys General settled consumer protection cl aims regarding alleged deceptive off-label marketing practice s of Pfizer subsidiary Warner-Lambert . At about the same time , a consortium of State Medicaid agencies funded a drug class review to compare effectiveness and adverse event profiles of AEDs in the treatment of bipolar mood disorder , neuropathic pain , and fibromyalgia . This article presents a summary of the findings from the drug class review related to prescription of the AEDs in bipolar disorder | [
"Clinical practice guidelines have improved in quality over the past 10 years by adhering to a few basic principles , such as conducting thorough systematic review s of relevant evidence and grading the recommendations and the quality of the underlying evidence . The large number of systems of measuring the quality of evidence and recommendations that have emerged are , however , confusing.1 The mission of the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) working group is to help resolve the confusion among the different systems of rating evidence and recommendations . The group has wide representation from many organisations including the Agency for Healthcare Research and Quality in the US , the National Institute for Clinical Excellence for Engl and and Wales , and the World Health Organization . Developing a new uniform rating system is challenging because all systems have limitations and because many organisations have invested a great deal of time and effort to develop their rating systems and are underst and ably reluctant to adopt a new system . The GRADE working group first published the results of its work in 2004 in the BMJ.2 A simpler , clinical ly oriented description will soon be published.3 GRADE has taken care to ensure its suggested system is simple to use and applicable to a wide variety of clinical recommendations that span the full spectrum of medical specialties and clinical care . The GRADE system classifies recommendations in 1 of 2 levels — strong and weak— and quality of evidence into 1 of 4 levels — high , moderate , low , and very low . Evidence based on r and omised controlled trials ( RCTs ) begins with a top rating on GRADE ’s 4 level quality of evidence classification ( table",
"OBJECTIVE To evaluate the efficacy and tolerability of topiramate monotherapy in adults with acute manic or mixed episodes of bipolar I disorder . METHODS In four trials , adults hospitalized with acute mania , a diagnosis of bipolar I disorder , history of > or = 1 previous manic or mixed episodes , and > or = 20 Young Mania Rating Scale ( YMRS ) score were r and omized to double-blind treatment with topiramate ( target doses : 200 , 400 , or 600 mg/day ) or placebo ; two trials included an active comparator ( lithium , 1500 mg/day ) . The core study duration in all trials was 3 weeks ; three trials also had 9-week double-blind extensions . The primary efficacy variable was mean change from baseline in YMRS in the core 3-week study . RESULTS Changes in YMRS score during 3 weeks were not significantly different for topiramate versus placebo ( mean YMRS reductions , -5.1 to -8.4 ) . Mean YMRS reductions in lithium-treated groups were significantly greater ( p placebo and topiramate ) . A similar pattern was observed after 12 weeks of double-blind treatment in studies with double-blind extensions . Paresthesia , appetite decrease , dry mouth , and weight loss were more frequently associated with topiramate than with placebo . CONCLUSIONS These studies do not support the efficacy of topiramate as monotherapy in acute mania or mixed episodes in adults with bipolar I disorder . Topiramate was not associated with mood destabilization measured as mania exacerbation or treatment-emergent depression . Lithium was confirmed as an effective therapy in this population",
"OBJECTIVES To survey the frequency of use of indirect comparisons in systematic review s and evaluate the methods used in their analysis and interpretation . Also to identify alternative statistical approaches for the analysis of indirect comparisons , to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within review s. DATA SOURCES Electronic data bases . REVIEW METHODS The Data base of Abstract s of Review s of Effects ( DARE ) was search ed for systematic review s involving meta- analysis of r and omised controlled trials ( RCTs ) that reported both direct and indirect comparisons , or indirect comparisons alone . A systematic review of MEDLINE and other data bases was carried out to identify published methods for analysing indirect comparisons . Study design s were created using data from the International Stroke Trial . R and om sample s of patients receiving aspirin , heparin or placebo in 16 centres were used to create meta-analyses , with half of the trials comparing aspirin and placebo and half heparin and placebo . Methods for indirect comparisons were used to estimate the contrast between aspirin and heparin . The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results . Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken . RESULTS Of the review s identified through DARE , 31/327 ( 9.5 % ) included indirect comparisons . A further five review s including indirect comparisons were identified through electronic search ing . Few review s carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest . Few method ological papers were identified . Some valid approaches for aggregate data that could be applied using st and ard software were found : the adjusted indirect comparison , meta-regression and , for binary data only , multiple logistic regression ( fixed effect models only ) . Simulation studies showed that the naive method is liable to bias and also produces over-precise answers . Several methods provide correct answers if strong but unverifiable assumptions are fulfilled . Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly r and omised comparisons . Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies , but the direction of such discrepancy is unpredictable . CONCLUSIONS Direct evidence from good- quality RCTs should be used wherever possible . Without this evidence , it may be necessary to look for indirect comparisons from RCTs . However , the results may be susceptible to bias . When making indirect comparisons within a systematic review , an adjusted indirect comparison method should ideally be used employing the r and om effects model . If both direct and indirect comparisons are possible within a review , it is recommended that these be done separately before considering whether to pool data . There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect . Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons . Research into how evidence from indirect comparisons compares to that from non-r and omised studies may also be warranted . Investigations using individual patient data from a meta- analysis of several RCTs using different protocol s and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful"
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Hypertension , an elevation of systemic arterial blood pressure ( BP ) , is a very common chronic disease in the United States . The overall prevalence of hypertension among U.S. adults is 29.0 % , and it increases to 64.9 % in adults aged 60 years or older ( 1 ) . Hypertension was associated with a total of $ 46 billion in health care services , medications , and missed days of work in the United States in 2011 ( 2 ) . Appropriate management of hypertension reduces the risk for cardiovascular disease , renal disease , cerebrovascular disease , and death ( 36 ) . However , determining the most appropriate BP targets , particularly for adults aged 60 years or older , has been controversial . Debate about the goal for systolic BP ( SBP ) among adults treated for hypertension has intensified , especially in light of recent recommendations ( 7 ) . In addition , when selecting BP targets for adults aged 60 years or older , clinicians need to consider comorbid conditions that could affect treatment choice . Treatments for hypertension include lifestyle modifications , such as weight loss , dietary modification , and increased physical activity , and antihypertensive medications , which commonly include thiazide-type diuretics , angiotensin-converting enzyme inhibitors ( ACEIs ) , angiotensin-receptor blockers ( ARBs ) , calcium-channel blockers , and -blockers . Supplement . Original Version ( PDF ) Guideline Focus and Target Population The purpose of this American College of Physicians ( ACP ) and American Academy of Family Physicians ( AAFP ) joint guideline is to present evidence -based recommendations on the benefits and harms of higher ( Hg ) SBP targets for the treatment of hypertension in adults aged 60 years or older . The target audience for this guideline includes all clinicians , and the target patient population includes adults aged 60 years or older with hypertension . These recommendations are based on a background evidence review ( 8) and systematic review sponsored by the U.S. Department of Veterans Affairs ( VA ) ( 9 ) . Methods Systematic Review of the Evidence The evidence review was conducted by the Portl and VA Health Care System Evidence -based Synthesis Program . The summary of methods for the evidence review can be found in the Appendix . Additional details are included in the accompanying background evidence review ( 8) and the full evidence report ( 9 ) . Grading the Evidence and Developing Recommendations This guideline was jointly developed by ACP 's Clinical Guidelines Committee and representatives from AAFP according to ACP 's guideline development process , details of which can be found in the methods paper ( 10 ) . The committee used the evidence tables in the accompanying systematic review ( 8) and full report ( 9 ) when reporting the evidence and grade d the recommendations using the GRADE ( Grading of Recommendations Assessment , Development , and Evaluation ) method ( Table ) . Table . The American College of Physicians ' Guideline Grading System * Peer Review The VA evidence review was peer review ed and posted on the VA Web site for public comments , and the published review article was peer review ed through the journal . The guideline had a peer- review process through the journal and was posted online for comments from ACP Regents and Governors , who represent physician members at the national and international level . The guideline was also review ed by members of AAFP 's Commission on Health of the Public and Science . Benefits of Treating Higher Versus Lower BP Targets in Older Adults Across all trials , treating high BP in older adults was beneficial . However , most of the evidence came from studies of patients with moderate or severe hypertension ( SBP > 160 mm Hg ) at baseline and , with treatment , achieved SBP targets greater than 140 mm Hg . Differing BP Targets Moderate- quality evidence showed a reduction in all-cause mortality among patients with a baseline SBP of 160 mm Hg or greater who achieved a target SBP of less than 150 mm Hg , although the reductions did not quite reach statistical significance ( relative risk [ RR ] , 0.93 [ 95 % CI , 0.85 to 1.00 ] ; absolute risk reduction [ ARR ] , 1.13 ) . High- quality evidence showed reductions in stroke ( RR , 0.77 [ CI , 0.64 to 0.91 ] ; ARR , 0.92 ) , and cardiac events ( RR , 0.83 [ CI , 0.71 to 0.96 ] ; ARR , 0.72)(1121 ) . In studies with lower SBP targets ( reduction in all-cause mortality ( RR , 0.93 [ CI , 0.75 to 1.14 ] ; ARR , 0.21),cardiac events ( RR , 0.91 [ CI , 0.77 to 1.04 ] ; ARR , 0.35),or stroke ( RR , 0.86 [ CI , 0.64 to 0.1.07 ] ; ARR , 0.19 ) ( 1113 , 20 , 22 , 23 ) . For studies with lower BP targets , moderate- quality evidence showed a reduced risk for stroke ( RR , 0.79 [ CI , 0.59 to 0.99 ] ; ARR , 0.49 ) compared with higher BP targets ( 1113 , 20 , 22 , 23 ) . Many of these studies , however , did not achieve the targeted BP , and there was little difference between the intensive treatment and control groups . Therefore , these studies may not have been able to detect differences in clinical outcomes . A subgroup analysis compared studies that achieved lower SBP targets ( with those that achieved higher SBP targets ( 140 mm Hg ) ( 1113 , 20 , 2225 ) . For these subgroups , high- quality evidence showed a similar risk reduction for mortality ( RR for target 140 mm Hg , 0.91 [ CI , 0.84 to 0.99 ] vs. RR for target cardiac events ( RR for target 140 mm Hg , 0.78 [ CI , 0.68 to 0.93 ] vs. RR for target The relative reduction in stroke events was slightly larger for studies that achieved a target SBP of 140 mm Hg or greater ( RR , 0.72 [ CI , 0.62 to 0.82 ] ) than those that achieved a target SBP of less than 140 mm Hg ( RR , 0.81 [ CI , 0.66 to 0.96 ] ) . These studies had marked clinical differences and significant statistical heterogeneity , which should temper confidence in the pooled results . Use of antihypertensive agents varied widely across studies : 7 used ACEIs or ARBs , 5 used calcium-channel blockers , and 6 used thiazide-like diuretics . Differing BP Targets in Patients With Transient Ischemic Attack or Stroke Among patients with a history of stroke or transient ischemic attack ( TIA ) , moderate- quality evidence showed that treating to an SBP of 130 to 140 mm Hg reduced stroke recurrence ( RR , 0.76 [ CI , 0.66 to 0.92 ] ; ARR , 3.02 ) but not cardiac events ( RR , 0.78 [ CI , 0.61 to 1.08 ] ) or all-cause mortality ( RR , 0.98 [ CI , 0.85 to 1.19 ] ) ( 26 , 27 ) . Heterogeneity for this analysis was low . Differing BP Targets Based on Age Low- quality evidence showed similar effects across different age groups ( 1214 , 16 , 1820 , 22 , 24 , 26 , 28 , 29 ) . A subgroup analysis of SPRINT ( Systolic Blood Pressure Intervention Trial ) that was not included in the evidence review showed that patients aged 75 years or older had lower all-cause mortality and nonstatistically significantly lower cardiovascular mortality , morbidity , and incidence of stroke with treatment to SBP targets less than 120 mm Hg compared with SBP targets less than 140 mm Hg ( 30 ) . Differing BP Targets Based on Multiple Chronic Conditions No trials assessed the effect of comorbidity on the benefits of more aggressive BP treatment . Low- quality evidence from subgroup analyses showed greater absolute benefit from more intensive BP treatment in patients with high cardiovascular risk ( 22 , 2931 ) . However , patients with a high comorbidity burden were probably not included in the overall group of studies ( 8) . Of the 21 trials included in the review , 14 excluded patients with heart failure , 11 excluded those with recent cardiovascular events , 17 excluded those with abnormal renal function , 12 excluded those with cancer or other life-limiting illness , 15 had criteria that would implicitly or explicitly exclude those with dementia or diminished functional status , and 7 excluded either all diabetic patients or those who required insulin . Although findings from ACCORD ( Action to Control Cardiovascular Risk in Diabetes ) , which limited enrollment to patients with type 2 diabetes , found no reduction in mortality or major cardiovascular events with more intensive treatment , a subgroup analysis of 7 studies ( 12 , 14 , 1820 , 28 , 29 ) in diabetic patients suggested that they were at least as likely to benefit from BP-lowering treatment . This is probably related to the higher frequency of cardiovascular events seen in these patients . Treatment Effects According to Diastolic BP Evidence was insufficient to determine the benefit of treating diastolic hypertension in the absence of systolic hypertension . Most trials assessed treatment outcomes based on SBP , and no trials included patients with a mean diastolic BP ( DBP ) greater than 90 mm Hg and a mean SBP less than 140 mm Hg . Harms of Higher Versus Lower BP Targets in Older Adults Studies showed mixed findings for withdrawal due to adverse events . Treatment to lower BP targets increased withdrawals due to adverse events in 4 out of 10 trials ( RR , 44 % to 100 % ) ; cough and hypotension were the most frequently reported adverse events ( 13 , 15 , 17 , 18 , 20 , 24 , 27 , 29 , 31 , 32 ) . Low- quality evidence showed an increased risk for syncope associated with treatment to lower BP targets ( achieved SBP range , 121.5 to 143 mm Hg ) ( RR , 1.52 [ CI , 1.22 to 2.07 ] ) ( 18 , 23 , 28 ) . Low- quality evidence showed no difference in renal outcomes ( including end-stage renal disease ) for treatment to higher versus lower BP targets ( 13 , 15 , 16 , 18 , 20 , 2225 , 28 , 29 , 3234 ) . Moderate- quality evidence showed no differences between treatment to higher versus lower BP targets in the degree of cognitive decline or dementia ( 18 , 27 , 3539 ) , fractures ( 40 , 41 ) , or quality of life ( 17 , 4244 ) . Low- quality evidence showed no difference for treatment to higher versus lower BP targets on functional status ( 42 ) or the risk for falls ( 23 , 40 ) . A subgroup analysis of SPRINT showed a nonstatistically significant increase in the rate of serious adverse events , hypotension , syncope , electrolyte abnormalities , or acute | [
"Background In the Systolic Hypertension in Europe trial ( NCT02088450 ) , we investigated whether systolic blood pressure variability determines prognosis over and beyond level . Methods Using a computerised r and om function and a double-blind design , we r and omly allocated 4695 patients ( ≥60 years ) with isolated systolic hypertension ( 160–219/ active treatment or matching placebo . Active treatment consisted of nitrendipine ( 10–40 mg/day ) with possible addition of enalapril ( 5–20 mg/day ) and /or hydrochlorothiazide ( 12.5–25.0 mg/day ) . We assessed whether on-treatment systolic blood pressure level ( SBP ) , visit-to-visit variability independent of the mean ( VIM ) or within-visit variability ( WVV ) predicted total ( n = 286 ) or cardiovascular ( n = 150 ) mortality or cardiovascular ( n = 347 ) , cerebrovascular ( n = 133 ) or cardiac ( n = 217 ) endpoints . Findings At 2 years , mean between-group differences were 10.5 mm Hg ( p ) cardiovascular ( −28 % ) , cerebrovascular ( −40 % ) and cardiac ( −24 % ) endpoints . In analyses dichotomised by the median , patients with low vs. high VIM had similar event rates ( p≥0.14 ) . Low vs. high WVV was not associated with event rates ( p≥0.095 ) , except for total and cardiovascular mortality on active treatment , which were higher with low WVV ( p≤0.0003 ) . In multivariable-adjusted Cox models , SBP predicted all endpoints ( p≤0.0043 ) , whereas VIM did not predict any ( p≥0.058 ) . Except for an inverse association with total mortality ( p = 0.042 ) , WVV was not predictive ( p≥0.15 ) . Sensitivity analyses , from which we excluded blood pressure readings within 6 months after r and omisation , 6 months prior to an event or both were confirmatory . Conclusions The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP . Higher blood pressure level , but not higher variability , predicted risk . Trial Registration Clinical Trials.gov",
"No adverse effect upon cognitive function has been detected during the first 9 months of treatment by a thiazide diuretic ( Moduretic ; Merck Sharp & Dohme , Hoddesdon , UK ) or a beta-blocking agent ( atenolol ) of moderately elevated blood pressure in a cohort of 2630 men and women aged between 65 and 74 years . Furthermore , no association was discovered between levels of systolic or diastolic blood pressure at outset and responses to st and ard tests of cognitive function . This study was carried out in general practice s as part of the current Medical Research Council Treatment Trial of Mild Hypertension in the Elderly",
"Nine-hundred- and -twenty-two hypertensive patients were included in a sub study to the Hypertension Optimal Treatment study , which aim ed to investigate the impact on quality of life of lowering the pressure and of intensified therapy . Seven-hundred- and -eighty-one patients completed both baseline and follow-up question naires ( intention-to-treat population ) , while 610 patients were included in a per protocol analysis . Patients were r and omized to three diastolic BP levels ( DBPs ) , i.e. . Two self-administered vali date d question naires , the Psychological General Well-Being index and the Subjective Symptoms Assessment Profile ( SSA-P ) were completed at baseline and after 6 months . The lower the DBP achieved , the greater the improvement in well-being ( p increase in well-being from baseline to 6 months was significant in target groups SSA-P domains , cardiac symptoms and dizziness improved in all groups but the sex life score deteriorated in the headaches were reduced ( p swollen ankles ( p dry cough in the < or = 80 mmHg group ( p < 0.001 ) increased . Although more intensive antihypertensive therapy is associated with a slight increase in subjective symptoms , it is nonetheless still associated with improvements in patients ' well-being",
"OBJECTIVE To assess the effectiveness of nifedipine treatment in elderly hypertensives . METHODS A single-blind trial was conducted under the direction of the Shanghai Institute of Hypertension in 1632 subjects aged 60 - 79 years alternatively allocated to either nifedipine or placebo after a 4-week placebo run-in period between 1987 and 1990 with mean follow-up of 30 months . Clinical events and risk modification were analysed in collaboration with the University of Montreal . Seventy-four patients with severe hypertension were reallocated to active nifedipine treatment after placebo run-in . RESULTS Cox 's proportional hazards model accounting for covariates demonstrated a highly significant decrease in the probability of events : ' original treatment assignment ' analysis indicated that 77 events occurred in the placebo and 32 in the nifedipine group . Similar significance s were achieved with ' actual treatment ' or ' changes excluded ' ( excluding reallocated subjects ) analyses . A significant reduction in relative risk was observed for strokes and severe arrhythmia with an overall decrease from 1.0 to 0.41 ( 95 % confidence interval 0.27 - 0.61 ) . CONCLUSION Nifedipine treatment diminished the number of severe clinical outcomes in elderly hypertensives significantly",
"In this prospect i ve , r and omized , open-label , blinded end point study , we aim ed to establish whether strict blood pressure control ( moderate blood pressure control ( ≥140 mm Hg to cardiovascular mortality and morbidity in elderly patients with isolated systolic hypertension . We divided 3260 patients aged 70 to 84 years with isolated systolic hypertension ( sitting blood pressure 160 to 199 mm Hg ) into 2 groups , according to strict or moderate blood pressure treatment . A composite of cardiovascular events was evaluated for ≥2 years . The strict control ( 1545 patients ) and moderate control ( 1534 patients ) groups were well matched ( mean age : 76.1 years ; mean blood pressure : 169.5/81.5 mm Hg ) . Median follow-up was 3.07 years . At 3 years , blood pressure reached 136.6/74.8 mm Hg and 142.0/76.5 mm Hg , respectively . The blood pressure difference between the 2 groups was 5.4/1.7 mm Hg . The overall rate of the primary composite end point was 10.6 per 1000 patient-years in the strict control group and 12.0 per 1000 patient-years in the moderate control group ( hazard ratio : 0.89 ; [ 95 % CI : 0.60 to 1.34 ] ; P=0.38 ) . In summary , blood pressure targets of 140 mm Hg are safely achievable in relatively healthy patients ≥70 years of age with isolated systolic hypertension , although our trial was underpowered to definitively determine whether strict control was superior to less stringent blood pressure targets",
"Objective To compare quality of life in elderly patients with isolated systolic hypertension allocated r and omly to groups to receive placebo or active treatment in the Systolic Hypertension in the Elderly Trial . Design Double-blind r and omized controlled trial . Methods Patients aged 60 years were allocated r and omly to groups to receive first-line treatment with nitrendipine ( with second- and third-line enalapril and hydrochlorothiazide ) or placebo . Trained interviewers administered trail-making tests ( Trail A and B ) , Brief Assessment Index ( a measure of depressed mood ) and four subscales from the Sickness Impact Profile ( Ambulation , Social Interaction , Sleep and Rest , and Home work ) . Results Six hundred and ten patients completed a baseline and at least one follow-up question naire . Trail-making scores were slower in actively treated patients , especially in the first 6 months of follow-up when the between-group effect sizes were 0.25 [ 95 % confidence interval ( CI ) 0.07 to 0.43 ] for Trail-making A and 0.13 ( 95 % CI −0.05 to 0.31 ) for Trail-making B. Across the 4 years of follow-up , patients receiving active treatment were more likely to report problems on the Social Interaction scale than were placebo-treated patients ( odds ratio 1.32 , 95 % CI 1.02 to 1.69 ) , equivalent to a 7 % difference . There were no significant differences between active and placebo treatment in the other Sickness Impact Profile dimensions or in the measure of depression . Conclusions Active treatment in the Systolic Hypertension in Europe trial was associated with some small adverse impacts on quality of life",
"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 ] . )",
"BACKGROUND Observational epidemiological studies have shown a positive association between hypertension and risk of incident dementia ; however , the effects of antihypertensive therapy on cognitive function in controlled trials have been conflicting , and meta-analyses of the trials have not provided clear evidence of whether antihypertensive treatment reduces dementia incidence . The Hypertension in the Very Elderly trial ( HYVET ) was design ed to assess the risks and benefits of treatment of hypertension in elderly patients and included an assessment of cognitive function . METHODS Patients with hypertension ( systolic pressure 160 - 200 mm Hg ; diastolic pressure in this double-blind , placebo-controlled trial . Participants were r and omly assigned to receive 1.5 mg slow release indapamide , with the option of 2 - 4 mg perindopril , or placebo . The target systolic blood pressure was 150 mm Hg ; the target diastolic blood pressure was 80 mm Hg . Participants had no clinical diagnosis of dementia at baseline , and cognitive function was assessed at baseline and annually with the mini-mental state examination ( MMSE ) . Possible cases of incident dementia ( a fall in the MMSE score to stroke and total mortality . Analysis was by intention to treat . The trial is registered with Clinical Trials.gov , number NCT00122811 . FINDINGS 3336 HYVET participants had at least one follow-up assessment ( mean 2.2 years ) and were included : 1687 participants were r and omly assigned to the treatment group and 1649 to the placebo group . Only five reports of adverse effects were attributed to the medication : three in the placebo group and two in the treatment group . The mean decrease in systolic blood pressure between the treatment and placebo groups at 2 years was systolic -15 mm Hg , p dementia . The rates of incident dementia were 38 per 1000 patient-years in the placebo group and 33 per 1000 patient-years in the treatment group . There was no significant difference between treatment and placebo groups ( hazard ratio [ HR ] 0.86 , 95 % CI 0.67 - 1.09 ) ; however , when these data were combined in a meta- analysis with other placebo-controlled trials of antihypertensive treatment , the combined risk ratio favoured treatment ( HR 0.87 , 0.76 - 1.00 , p=0.045 ) . INTERPRETATION Antihypertensive treatment in elderly patients does not statistically reduce incidence of dementia . This negative finding might have been due to the short follow-up , owing to the early termination of the trial , or the modest effect of treatment . Nevertheless , the HYVET findings , when included in a meta- analysis , might support antihypertensive treatment to reduce incident dementia",
"Objective To compare the incidence of stroke and other cardiovascular events in hypertensive patients receiving a low-dose diuretic and low-dose calcium antagonist combination with those receiving low-dose diuretic monotherapy , and assess the effects of a small blood pressure difference at achieved levels lower than those achieved in previous placebo-controlled trials . Methods The Felodipine Event Reduction ( FEVER ) trial was an investigator- design ed , prospect i ve , multicentre , double-blind , r and omized , placebo-controlled , parallel group trial . It enrolled 9800 Chinese patients , of either sex , aged 50–79 years , with one or two additional cardiovascular risk factors or disease , whose blood pressure , 6 weeks after switching from previous antihypertensive therapy to low-dose ( 12.5 mg a day ) hydrochlorothiazide , was in the range 140–180 mmHg ( systolic ) or 90–100 mmHg ( diastolic ) . These patients were r and omly assigned either to low-dose felodipine extended release or placebo , and followed at 3-month intervals for an average of 40 months . Results The intention-to-treat analysis included 9711 r and omly selected patients with only 30 ( 0.3 % ) lost to follow-up . A total of 31 842 patient-years of follow-up were accumulated , with 85.9 % of patients remaining on blinded r and omized treatment . Add-on therapy was given to 33.9 % of the hydrochlorothiazide – felodipine patients and to 42.3 % of the hydrochlorothiazide – placebo patients . In the felodipine group , systolic blood pressure (SBP)/diastolic blood pressure ( DBP ) decreased ( from r and omization to study end ) from 154.2/91.0 to 137.3/82.5 mmHg , and in the placebo group from 154.4/91.3 to 142.5/85.0 mmHg , with an average difference throughout the trial of 4.2/2.1 mmHg . In the felodipine group , the primary endpoint ( fatal and non-fatal stroke ) was reduced by 27 % ( P = 0.001 ) . Among secondary endpoints , all cardiovascular events were reduced by 27 % ( P by 35 % ( P = 0.012 ) , death by any cause by 31 % ( P = 0.006 ) , coronary events by 32 % ( P = 0.024 ) , heart failure by 30 % ( P = 0.239 ) , cardiovascular death by 33 % ( P = 0.019 ) , cancer by 36 % ( P = 0.017 ) in the felodipine group . No significant differences were found in new-onset diabetes . Both treatments were very well tolerated . Conclusions In moderately complicated hypertensive patients from China even a difference in SBP/DBP as small as 4/2 mmHg , such as that induced by adding low-dose felodipine to low-dose hydrochlorothiazide , is associated with very substantial reductions in the incidence of most types of cardiovascular events . As the SBP achieved in the felodipine group was below the recommended goal of less than 140 mmHg , and SBP in the placebo group was slightly above that level , FEVER provides the required evidence in support of the guidelines recommended goal , even for a hypertensive population not entirely consisting of patients with diabetes or previous cardiovascular events ",
"BACKGROUND Blood pressure is an important determinant of the risks of macrovascular and microvascular complications of type 2 diabetes , and guidelines recommend intensive lowering of blood pressure for diabetic patients with hypertension . We assessed the effects of the routine administration of an angiotensin converting enzyme ( ACE ) inhibitor-diuretic combination on serious vascular events in patients with diabetes , irrespective of initial blood pressure levels or the use of other blood pressure lowering drugs . METHODS The trial was done by 215 collaborating centres in 20 countries . After a 6-week active run-in period , 11 140 patients with type 2 diabetes were r and omised to treatment with a fixed combination of perindopril and indapamide or matching placebo , in addition to current therapy . The primary endpoints were composites of major macrovascular and microvascular events , defined as death from cardiovascular disease , non-fatal stroke or non-fatal myocardial infa rct ion , and new or worsening renal or diabetic eye disease , and analysis was by intention-to-treat . The macrovascular and microvascular composites were analysed jointly and separately . This trial is registered with Clinical Trials.gov , number NCT00145925 . FINDINGS After a mean of 4.3 years of follow-up , 73 % of those assigned active treatment and 74 % of those assigned control remained on r and omised treatment . Compared with patients assigned placebo , those assigned active therapy had a mean reduction in systolic blood pressure of 5.6 mm Hg and diastolic blood pressure of 2.2 mm Hg . The relative risk of a major macrovascular or microvascular event was reduced by 9 % ( 861 [ 15.5 % ] active vs 938 [ 16.8 % ] placebo ; hazard ratio 0.91 , 95 % CI 0.83 - 1.00 , p=0.04 ) . The separate reductions in macrovascular and microvascular events were similar but were not independently significant ( macrovascular 0.92 ; 0.81 - 1.04 , p=0.16 ; microvascular 0.91 ; 0.80 - 1.04 , p=0.16 ) . The relative risk of death from cardiovascular disease was reduced by 18 % ( 211 [ 3.8 % ] active vs 257 [ 4.6 % ] placebo ; 0.82 , 0.68 - 0.98 , p=0.03 ) and death from any cause was reduced by 14 % ( 408 [ 7.3 % ] active vs 471 [ 8.5 % ] placebo ; 0.86 , 0.75 - 0.98 , p=0.03 ) . There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline . INTERPRETATION Routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events , including death . Although the confidence limits were wide , the results suggest that over 5 years , one death due to any cause would be averted among every 79 patients assigned active therapy",
"The Systolic Hypertension in Europe ( Syst-Eur ) trial proved that blood pressure ( BP ) lowering therapy starting with nitrendipine reduces the risk of cardiovascular complications in older ( ⩾60 years ) patients with isolated systolic hypertension ( systolic BP ⩾160 mm Hg and diastolic BP after the completion of the syst-eur trial on 14 february 1997 , 3506 consenting patients ( 93.0 % of those eligible ) were enrolled in phase 2 of the syst-eur trial . this open follow-up study aims to confirm the safety of long-term antihypertensive therapy based on a dihydropyridine . to lower the sitting systolic bp below 150 mm hg ( target bp ) , the first-line agent nitrendipine ( 10–40 mg/day ) may be associated with enalapril ( 5–20 mg/day ) , hydrochlorothiazide ( 12.5–25 mg/day ) , both add-on study drugs , or if required any other antihypertensive agent . on 1 november 1998 , 3248 patients were still being followed , 86 patients had proceeded to non-supervised follow-up , and 43 had died . the median follow-up in syst-eur 2 was 14.3 months . at the last available visit , systolic/diastolic bp in the patients formerly r and omised to placebo ( n = 1682 ) or active treatment ( n = 1824 ) , had decreased by 13.2/5.2 mm Hg and by 4.6/1.6 mm Hg , respectively , so that the between-group BP difference was 1.7 mm Hg systolic ( 95 % Cl : 0.8 to 2.6 mm Hg ; P the goal bp was reached by 25.4 % and 50.6 % of the former placebo and active-treatment groups ; at the last visit these proportions were 55.9 % and 63.1 % , respectively . at that moment , 45.9 % of the patients were on monotherapy with nitrendipine , 29.3 % took nitrendipine in combination with other study drugs . until the end of 2001 , bp control of the syst-eur 2 patients will be further improved . cardiovascular complications and adverse events , such as cancer or gastro-intestinal bleeding , will be monitored and vali date d by blinded experts",
"BACKGROUND After the double-blind , placebo-controlled Systolic Hypertension in Europe ( Syst-Eur ) trial ended in February 1997 , r and omized patients were offered active study medication for a further period of observation . OBJECTIVE To refine the estimates of the long-term effects of antihypertensive therapy on the incidence of dementia . METHODS Eligible patients had no dementia and were at least 60 years old . Their systolic blood pressure at entry was 160 to 219 mm Hg , with diastolic blood pressure below 95 mm Hg . Antihypertensive therapy was started immediately after r and omization in the active treatment group , but only after termination of the double-blind trial in the control patients . Treatment consisted of nitrendipine ( 10 - 40 mg/d ) , with the possible addition of enalapril maleate ( 5 - 20 mg/d ) , hydrochlorothiazide ( 12.5 - 25 mg/d ) , or both add-on drugs . RESULTS Median follow-up increased from 2.0 years in the double-blind trial to 3.9 years overall . The incidence of dementia doubled from 32 to 64 cases , 41 of whom had Alzheimer disease . Throughout follow-up , systolic/diastolic blood pressure was 7.0/3.2 mm Hg higher in the 1417 control patients than in the 1485 subjects r and omized to active treatment . At the last examination , the blood pressure difference was still 4.2/2.9 mm Hg ; 48.1 % , 26.4 % , and 11.4 % of the control patients were taking nitrendipine , enalapril , and /or hydrochlorothiazide , whereas in the active treatment group these proportions were 70.2 % , 35.4 % , and 18.4 % , respectively . Compared with the controls , long-term antihypertensive therapy reduced the risk of dementia by 55 % , from 7.4 to 3.3 cases per 1000 patient-years ( 43 vs 21 cases , P relative hazard rate associated with the use of nitrendipine was 0.38 ( 95 % confidence interval , 0.23 - 0.64 ; P dementia ( 95 % confidence interval , 7 - 33 ) . CONCLUSION The extended follow-up of Syst-Eur patients reinforces the evidence that blood pressure-lowering therapy initiated with a long-acting dihydropyridine protects against dementia in older patients with systolic hypertension ",
"Background The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago , but are less clear in those with mildly to moderately elevated blood pressure . Objective To assess whether c and esartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events , cognitive decline and dementia . Design Prospect i ve , double-blind , r and omized , parallel-group study conducted in 1997–2002 . Setting and participants The study was of 4964 patients aged 70–89 years , with systolic blood pressure 160–179 mmHg , and /or diastolic blood pressure 90–99 mmHg , and a Mini Mental State Examination ( MMSE ) test score ⩾ 24 . A total of 527 centres in 15 countries participated in the study . Intervention Patients were assigned r and omly to receive the angiotensin receptor blocker c and esartan or placebo , with open-label active antihypertensive therapy added as needed . As a consequence , active antihypertensive therapy was extensively used in the control group ( 84 % of patients ) . Mean follow-up was 3.7 years . Main outcome measures The primary outcome measure was major cardiovascular events , a composite of cardiovascular death , non-fatal stroke and non-fatal myocardial infa rct ion . Secondary outcome measures included cardiovascular death , non-fatal and fatal stroke and myocardial infa rct ion , cognitive function measured by the MMSE and dementia . Results Blood pressure fell by 21.7/10.8 mmHg in the c and esartan group and by 18.5/9.2 mmHg in the control group . A first major cardiovascular event occurred in 242 c and esartan patients and in 268 control patients ; risk reduction with c and esartan was 10.9 % [ 95 % confidence interval ( CI ) , −6.0 to 25.1 , P = 0.19 ] . C and esartan-based treatment reduced non-fatal stroke by 27.8 % ( 95 % CI , 1.3 to 47.2 , P = 0.04 ) , and all stroke by 23.6 % ( 95 % CI , −0.7 to 42.1 , P = 0.056 ) . There were no significant differences in myocardial infa rct ion and cardiovascular mortality . Mean MMSE score fell from 28.5 to 28.0 in the c and esartan group and from 28.5 to 27.9 in the control group ( P = 0.20 ) . The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups . Conclusions In elderly hypertensive patients , a slightly more effective blood pressure reduction during c and esartan-based therapy , compared with control therapy , was associated with a modest , statistically non-significant , reduction in major cardiovascular events and with a marked reduction in non-fatal stroke . Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions . Both treatment regimens were generally well tolerated",
"BACKGROUND Little information has been published on the impact of antihypertensive medications on quality of life in older persons . Particular concern has existed that lowering systolic blood pressure in older persons might have adverse consequences on cognition , mood , or leisure activities . METHODS A multicenter double-blind r and omized controlled trial was conducted over an average of 5 years ' followup involving 16 academic clinical trial clinics . Participants consisted of 4736 persons ( 1.06 % ) selected from 447,921 screenees aged 60 years and older . Systolic blood pressure at baseline ranged from 160 to 219 mm Hg , while diastolic blood pressure was less than 90 mm Hg . Participants were r and omized to active antihypertensive drug therapy or matching placebo . Active treatment consisted of 12.5 to 25 mg of chlorthalidone for step 1 , while step 2 consisted of 25 to 50 mg of atenolol . If atenolol was contraindicated , 0.05 to 0.10 mg of reserpine could be used for the second-step drug . The impact of drug treatment on measures of cognitive , emotional , and physical function and leisure activities was assessed . RESULTS Our analyses demonstrate that active treatment of isolated systolic hypertension in the Systolic Hypertension in the Elderly Program cohort had no measured negative effects and , for some measures , a slight positive effect on cognitive , physical , and leisure function . The positive findings in favor of the treatment group were small . There was no effect on measures related to emotional state . Measures of cognitive and emotional function were stable in both groups for the duration of the study . Both treatment groups showed a modest trend toward deterioration of some measures of physical and leisure function over the study period . CONCLUSIONS The overall study cohort exhibited decline over time in activities of daily living , particularly the more strenuous ones , and some decline in certain leisure activities . However , mood , cognitive function , basic self-care , and moderate leisure activity were remarkably stable for both the active and the placebo groups throughout the entire study . Results of this study support the inference that medical treatment of isolated systolic hypertension does not cause deterioration in measures of cognition , emotional state , physical function , or leisure activities",
"BACKGROUND Despite treatment , there is often a higher incidence of cardiovascular complications in patients with hypertension than in normotensive individuals . Inadequate reduction of their blood pressure is a likely cause , but the optimum target blood pressure is not known . The impact of acetylsalicylic acid ( aspirin ) has never been investigated in patients with hypertension . We aim ed to assess the optimum target diastolic blood pressure and the potential benefit of a low dose of acetylsalicylic acid in the treatment of hypertension . METHODS 18790 patients , from 26 countries , aged 50 - 80 years ( mean 61.5 years ) with hypertension and diastolic blood pressure between 100 mm Hg and 115 mm Hg ( mean 105 mm Hg ) were r and omly assigned a target diastolic blood pressure . 6264 patients were allocated to the target pressure Felodipine was given as baseline therapy with the addition of other agents , according to a five-step regimen . In addition , 9399 patients were r and omly assigned 75 mg/day acetylsalicylic acid ( Bamycor , Astra ) and 9391 patients were assigned placebo . FINDINGS Diastolic blood pressure was reduced by 20.3 mm Hg , 22.3 mm Hg , and 24.3 mm Hg , in the major cardiovascular events occurred at a mean achieved diastolic blood pressure of 82.6 mm Hg ; the lowest risk of cardiovascular mortality occurred at 86.5 mm Hg . Further reduction below these blood pressures was safe . In patients with diabetes mellitus there was a 51 % reduction in major cardiovascular events in target group Acetylsalicylic acid reduced major cardiovascular events by 15 % ( p=0.03 ) and all myocardial infa rct ion by 36 % ( p=0.002 ) , with no effect on stroke . There were seven fatal bleeds in the acetylsalicylic acid group and eight in the placebo group , and 129 versus 70 non-fatal major bleeds in the two groups , respectively ( p patients with hypertension was associated with a low rate of cardiovascular events . The HOT Study shows the benefits of lowering the diastolic blood pressure down to 82.6 mm Hg . Acetylsalicylic acid significantly reduced major cardiovascular events with the greatest benefit seen in all myocardial infa rct ion . There was no effect on the incidence of stroke or fatal bleeds , but non-fatal major bleeds were twice as common",
"BACKGROUND In 1988 , the Systolic Hypertension in China ( Syst-China ) Collaborative Group initiated the placebo-controlled Syst-China trial to investigate whether antihypertensive drug treatment could reduce the incidence of fatal and nonfatal stroke in older Chinese patients with isolated systolic hypertension . OBJECTIVES To explore ( 1 ) whether the benefits of active treatment were evenly distributed across 4 strata , prospect ively defined according to sex and previous cardiovascular complications , and ( 2 ) whether the morbidity and mortality results were influenced by age , level of systolic or diastolic blood pressure ( BP ) , smoking or drinking habits , or diabetes mellitus at enrollment . METHODS Eligible patients had to be 60 years or older with a sitting systolic BP of 160 to 219 mm Hg and diastolic BP less than 95 mm Hg . After stratification for center , sex , and previous cardiovascular complications , 1253 patients were assigned to active treatment starting with nitrendipine ( 10 - 40 mg/d ) , with the possible addition of captopril ( 12.5 - 50.0 mg/d ) , and /or hydrochlorothiazide ( 12.5 - 50 mg/d ) . In the 1141 control patients , matching placebos were used similarly . RESULTS Male sex , previous cardiovascular complications , older age , higher systolic BP or lower diastolic BP , living in northern China , smoking , and diabetes mellitus significantly and independently increased the risk of 1 or more of the following end points : total or cardiovascular mortality , all fatal and nonfatal cardiovascular end points , all strokes , and all cardiac end points . In the placebo-control group diabetes raised the risk of all end points 2- to 3-fold ( P excess risk associated with diabetes to a nonsignificant level ( P values ranging from .12-.86 ) except for cardiovascular mortality ( P = .04 ) . Cox regression with adjustments applied for significant covariates suggested that active treatment may reduce total mortality more ( P = .06 ) in women and stroke more ( P = .07 ) in men and that it may provide better protection against cardiac end points in nonsmokers than smokers ( P = .04 ) . Otherwise , the benefits of active treatment were equally manifest , regardless of the enrollment characteristics of the patients , and regardless of whether active treatment consisted of only nitrendipine or of nitrendipine associated with other active drugs . CONCLUSIONS In elderly Chinese patients with isolated systolic hypertension , stepwise antihypertensive drug treatment , starting with the dihydropyridine calcium channel blocker nitrendipine , improved prognosis . The benefit was particularly evident in diabetic patients ; for cardiac end points it tended to be larger in nonsmokers . Otherwise , the benefit of active treatment was not significantly influenced by the characteristics of the patients at enrollment in the trial",
"ABSTRACT BACKGROUND There are few rigorous studies to confirm or refute the commonly cited concern that control of blood pressure to lower thresholds may result in an increased risk of falls and fractures . OBJECTIVE To compare falls and fractures in participants with type 2 diabetes in the intensive ( targeting a systolic blood pressure of arms of the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) r and omized trial ( N = 4,733 ) . PARTICIPANTS A subset of 3,099 participants self-reported annually on the occurrence of falls and non-spine fractures . Fractures were central ly adjudicated . MAIN MEASURES The incidence of falls in the two treatment groups was compared using a r and om-effects negative binomial model , and fracture risk was compared using Cox proportional hazards models . KEY RESULTS At enrollment in both groups , the mean age was 62 years , 44 % were women , 25 % were Black , and mean blood pressure was 138/75 mmHg . During follow-up , all classes of medications , particularly thiazide diuretics , were more commonly prescribed in the intensive group . After 1 year of follow-up , the mean systolic blood pressure was 133 ± 15 mmHg in the st and ard group and 119 ± 14 mmHg in the intensive group . The adjusted rate of falls did not differ in the intensive and st and ard groups ( 62.2/100 person-years vs. 74.1/100 person-years , RR = 0.84 , 95 % CI 0.54–1.29 , p = 0.43 ) . The risk of non-spine fractures was nonsignificantly lower in the intensive than in the st and ard blood pressure group ( HR 0.79 , 95 % CI 0.62–1.01 , p = 0.06 ) . CONCLUSIONS We conclude that intensive antihypertensive treatment that lowered mean systolic blood pressure to below 120 mmHg was not associated with an increased risk of falls or non-spine fractures in patients age 40 to 79 years with type 2 diabetes",
"OBJECTIVE To assess the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal ( total ) stroke in isolated systolic hypertension . DESIGN Multicenter , r and omized , double-blind , placebo-controlled . SETTING Community-based ambulatory population in tertiary care centers . PARTICIPANTS 4736 persons ( 1.06 % ) from 447,921 screenees aged 60 years and above were r and omized ( 2365 to active treatment , 2371 to placebo ) . Systolic blood pressure ranged from 160 to 219 mm Hg and diastolic blood pressure was less than 90 mm Hg . Of the participants , 3161 were not receiving antihypertensive medication at initial contact , and 1575 were . The average systolic blood pressure was 170 mm Hg ; average diastolic blood pressure , 77 mm Hg . The mean age was 72 years , 57 % were women , and 14 % were black . INTERVENTIONS -- Participants were stratified by clinical center and by antihypertensive medication status at initial contact . For step 1 of the trial , dose 1 was chlorthalidone , 12.5 mg/d , or matching placebo ; dose 2 was 25 mg/d . For step 2 , dose 1 was atenolol , 25 mg/d , or matching placebo ; dose 2 was 50 mg/d . MAIN OUTCOME MEASURES Primary . Nonfatal and fatal ( total ) stroke . Secondary . Cardiovascular and coronary morbidity and mortality , all-cause mortality , and quality of life measures . RESULTS Average follow-up was 4.5 years . The 5-year average systolic blood pressure was 155 mm Hg for the placebo group and 143 mm Hg for the active treatment group , and the 5-year average diastolic blood pressure was 72 and 68 mm Hg , respectively . The 5-year incidence of total stroke was 5.2 per 100 participants for active treatment and 8.2 per 100 for placebo . The relative risk by proportional hazards regression analysis was 0.64 ( P = .0003 ) . For the secondary end point of clinical nonfatal myocardial infa rct ion plus coronary death , the relative risk was 0.73 . Major cardiovascular events were reduced ( relative risk , 0.68 ) . For deaths from all causes , the relative risk was 0.87 . CONCLUSION In persons aged 60 years and over with isolated systolic hypertension , antihypertensive stepped-care drug treatment with low-dose chlorthalidone as step 1 medication reduced the incidence of total stroke by 36 % , with 5-year absolute benefit of 30 events per 1000 participants . Major cardiovascular events were reduced , with 5-year absolute benefit of 55 events per 1000",
"The benefits of lowering a systolic blood pressure below 140 mmHg in elderly hypertension remain controversial . This study is a prospect i ve , r and omized , open-label study with blinded assessment of endpoints to compare the 2-year effect of strict treatment to maintain systolic blood pressure below 140 mmHg with that of mild treatment to maintain systolic blood pressure below 160 but at or above 140 mmHg in elderly hypertensive patients . Patients with essential hypertension ( 65–85 years old , with a pretreatment systolic blood pressure of above 160 mmHg ) were r and omly assigned to receive strict treatment ( n=2,212 ) or mild treatment ( n=2,206 ) . The baseline drug was efonidipine hydrochloride , a long-acting calcium antagonist . The primary endpoint was the combined incidence of cardiovascular disease and renal failure , and the secondary endpoints were total deaths and any safety problems . Although final blood pressures ( systolic/diastolic ) were significantly lower in the strict-treatment group compared with the mild-treatment group ( 135.9/74.8 vs. 145.6/78.1 mmHg ; p ) . Total deaths were 54 in the strict-treatment group vs. 42 in the mild-treatment group ( p=0.22 ) , and treatment was withdrawn because of adverse events in 36 patients in each group ( p=0.99 ) . An interaction between age and treatment for the primary endpoints ( p=0.03 ) was seen . Complex clinical features associated with aging seem to have obscured the difference in effect between the two treatments . Further studies are needed to assess the optimal treatment strategy for hypertension in the elderly",
"Background In the outcome trials that provided information on renal function in older hypertensive patients , diuretics and β-blockers were mostly used as first-line drugs . The long-term renal effects of calcium-channel blockers remain unclear . Objective To compare the changes in renal function in 2258 treated and 2148 untreated patients with isolated systolic hypertension , of whom 455 had diabetes mellitus and 390 had proteinuria . Methods We performed a post-hoc analysis of the double-blind placebo-controlled Systolic Hypertension in Europe ( Syst-Eur ) Trial . Active treatment was initiated with nitrendipine ( 10–40 mg/day ) with the possible addition of enalapril ( 5–20 mg/day ) , hydrochlorothiazide ( 12.5–25 mg/day ) , or both , titrated or combined to reduce the sitting systolic blood pressure by at least 20 mmHg , to less than 150 mmHg . The main outcome measures were serum creatinine concentration and creatinine clearance calculated by the formula of Cockroft and Gault . Results Serum creatinine concentration at the time when participants were r and omly allocated to study groups was less than 176.8 μmol/l ( 2.0 mg/dl ) , averaging 88 μmol/l . At the time of the last serum creatinine measurement , the blood pressure difference ( P ) , serum creatinine and the calculated creatinine clearance were not influenced by active treatment . However , in the patients assigned r and omly to receive active treatment , the incidence of mild renal dysfunction ( serum creatinine at least 176.8 mmol/l ) decreased by 64 % ( P = 0.04 ) and that of proteinuria by 33 % ( P = 0.03 ) . Active treatment reduced the risk of proteinuria more in diabetic than in non-diabetic patients : by 71 % , compared with 20 % ( P = 0 . 04 ) . In non-proteinuric patients , active treatment did not influence serum creatinine , whereas in patients with proteinuria at entry to the study , serum creatinine decreased on active treatment ( P , serum creatinine concentration did not change ( P = 0.98 ) in patients continuing to receive monotherapy with nitrendipine , whereas it increased by 6.73 mmol/l ( P older patients with isolated systolic hypertension , antihypertensive treatment starting with the dihydropyridine calcium-channel blocker , nitrendipine , did not decrease blood pressure at the expense of renal function and prevented the development of proteinuria , especially in diabetic patients",
"The objective of this study was to determine the relationship between prescribed daily dose frequency and patient medication compliance . The medication compliance of 105 patients receiving antihypertensive medications was monitored by analyzing data obtained from special pill containers that electronically record the date and time of medication removal . Inaccurate compliance estimates derived using the simple pill count method were thereby avoided . Compliance was defined as the percent of days during which the prescribed number of doses were removed . Compliance improved from 59.0 % on a three-time daily regimen to 83.6 % on a once-daily regimen . Thus , compliance improves dramatically as prescribed dose frequency decreases . Probably the single most important action that health care providers can take to improve compliance is to select medications that permit the lowest daily prescribed dose frequency",
"BACKGROUND fractures may have serious implication s in an elderly individual , and fracture prevention may include a careful choice of medications . DESIGN the Hypertension in the Very Elderly Trial ( HYVET ) was a double-blind placebo-controlled trial of a thiazide-like diuretic ( indapamide 1.5 mg SR ) with the optional addition of the angiotensin-converting enzyme ( ACE ) inhibitor ( perindopril 2 - 4 mg ) . Fracture was a secondary end point of the trial . SETTING HYVET recruited participants from Eastern and Western Europe , China , Australasia , and Tunisia . SUBJECTS all participants were > or = 80 years of age and hypertensive . METHODS participants were r and omised to receive a thiazide-like diuretic ( indapamide 1.5 mg SR ) + /- ACE inhibitor ( perindopril 2 - 4 mg ) or matching placebos . Incident fractures were vali date d and analysed based on time to first fracture . RESULTS there were 3,845 participants in HYVET and a total 102 reported fractures ( 42 in the active and 60 in the placebo group ) . When taking only vali date d first fractures , 90 were included in the analyses ( 38 in the active and 52 in the placebo group ) . Cox proportional hazard regression , adjusted for key baseline risk factors , result ed in a point estimate of 0.58 ( 95 % CI 0.33 - 1.00 , P = 0.0498 ) . CONCLUSIONS despite the lowering of blood pressure , treatment with a thiazide-like diuretic and an ACE inhibitor does not increase and may decrease fracture rate",
"OBJECTIVE --To establish whether treatment with diuretic or beta blocker in hypertensive older adults reduces risk of stroke , coronary heart disease , and death . DESIGN --R and omised , placebo controlled , single blind trial . SETTING --226 general practice s in the MRC general practice research framework . SUBJECTS--4396 patients aged 65 - 74 r and omised to receive diuretic , beta blocker , or placebo . Patients had mean systolic pressures of 160 - 209 mm Hg and mean diastolic pressures less than 115 mm Hg during an eight week run in and were not taking antihypertensive treatment . INTERVENTION-- Patients were r and omised to atenolol 50 mg daily ; hydrochlorothiazide 25 mg or 50 mg plus amiloride 2.5 mg or 5 mg daily ; or placebo . The regimens were adjusted to achieve specified target pressures . Mean follow up was 5.8 years . MAIN OUTCOME MEASURES --Strokes , coronary events , and deaths from all causes . RESULTS --Both treatments reduced blood pressure below the level in the placebo group . Compared with the placebo group , actively treated subjects ( diuretic and beta blocker groups combined ) had a 25 % ( 95 % confidence interval 3 % to 42 % ) reduction in stroke ( p = 0.04 ) , 19 % ( -2 % to 36 % ) reduction in coronary events ( p = 0.08 ) , and 17 % ( 2 % to 29 % ) reduction in all cardiovascular events ( p = 0.03 ) . After adjusting for baseline characteristics the diuretic group had significantly reduced risks of stroke ( 31 % ( 3 % to 51 % ) p = 0.04 ) , coronary events ( 44 % ( 21 % to 60 % ) , p = 0.0009 ) , and all cardiovascular events ( 35 % ( 17 % to 49 % ) , p = 0.0005 ) compared with the placebo group . The beta blocker group showed no significant reductions in these end points . The reduction in strokes was mainly in non-smokers taking the diuretic . CONCLUSION --Hydrochlorothiazide and amiloride reduce the risk of stroke , coronary events , and all cardiovascular events in older hypertensive adults ",
"Objectives To address whether nondihydropyridine calcium-channel blocker added-on angiotensin-converting-enzyme inhibitor therapy ameliorates albuminuria and cardiovascular outcomes in type 2 diabetes patients . Design The Bergamo Nephrologic Diabetes Complications Trial-B was a multicentre , prospect i ve , double-blind , parallel-group trial comparing renal and cardiovascular outcomes in 281 hypertensive type 2 diabetes patients with microalbuminuria r and omized to at least 2-year VeraTran ( verapamil/tr and olapril 180 mg/2 mg daily ) or tr and olapril ( 2 mg daily , identical image ) treatment . Main outcome was persistent macroalbuminuria ( albuminuria > 200 μg/min in two consecutive visits ) . Treatment targets were SBP/DBP less than 120/80 mmHg and HbA1C less than 7 % . Results Over a median follow-up of 4.5 years , 18 patients ( 13 % ) on VeraTran vs. 15 ( 10.5 % ) on tr and olapril [ unadjusted hazard ratio ( 95 % confidence interval [ CI ] ) 1.07 ( 0.54–2.12 ) , P = 0.852 ] progressed to macroalbuminuria , respectively ; 62 ( 44.9 % ) vs. 71 ( 49.7 % ) [ 0.80 ( 0.57–1.12 ) , P = 0.198 ] regressed to normoalbuminuria ( urinary albumin excretion had major cardiovascular events . BP and metabolic control were similar between groups . Patients with cardiovascular events were significantly less [ 13 ( 9.8 % ) vs. 28 ( 18.9 % ) , hazard ratio : 0.37 ( 0.19–0.71 ) , P = 0.003 ] among those regressing to normoalbuminuria than those without regression . Difference was independent of treatment allocation and was significant also after adjusting for baseline characteristics [ 0.40 ( 0.20–0.79 ) , P = 0.009 ] , follow-up SBP [ 0.40 ( 0.20–0.80 ) , P = 0.010 ] or DBP [ 0.36 ( 0.18–0.73 ) , P = 0.004 ] BP or HbA1C [ 0.43 ( 0.21–0.88 ) , P = 0.021 ] . Conclusion In hypertensive type 2 diabetes patients with microalbuminuria , verapamil added-on tr and olapril did not improve renal or cardiovascular outcomes . Independent of verapamil , tr and olapril normalized albuminuria in half of patients and this translated into significant cardioprotection ",
"BACKGROUND The level to which systolic blood pressure should be controlled in hypertensive patients without diabetes remains unknown . We tested the hypothesis that tight control compared with usual control of systolic blood pressure would be beneficial in such patients . METHODS In this r and omised open-label trial undertaken in 44 centres in Italy , 1111 non-diabetic patients with systolic blood pressure 150 mm Hg or greater were r and omly assigned to a target systolic blood pressure of less than 140 mm Hg ( usual control ; n=553 ) or less than 130 mm Hg ( tight control ; n=558 ) . After stratification by centre , we used a computerised r and om function to allocate patients to either group . Observers who were unaware of r and omisation read electrocardiograms and adjudicated events . Open-label agents were used to reach the r and omised targets . The primary endpoint was the rate of electrocardiographic left ventricular hypertrophy 2 years after r and omisation . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00421863 . RESULTS Over a median follow-up of 2.0 years ( IQR 1.93 - 2.03 ) , systolic and diastolic blood pressure were reduced by a mean of 23.5/8.9 mm Hg ( SD 10.6/7.0 ) in the usual-control group and by 27.3/10.4 mm Hg ( 11.0/7.5 ) in the tight-control group ( between-group difference 3.8 mm Hg systolic [ 95 % CI 2.4 - 5.2 ] , p usual-control group and in 55 of 484 patients ( 11.4 % ) of the tight-control group ( odds ratio 0.63 ; 95 % CI 0.43 - 0.91 ; p=0.013 ) . A composite cardiovascular endpoint occurred in 52 ( 9.4 % ) patients in the usual-control group and in 27 ( 4.8 % ) in the tight-control group ( hazard ratio 0.50 , 95 % CI 0.31 - 0.79 ; p=0.003 ) . Side-effects were rare and did not differ significantly between the two groups . INTERPRETATION Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension . FUNDING Boehringer-Ingelheim , Sanofi-Aventis , Pfizer",
"BACKGROUND There is no evidence from r and omized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus . We investigated whether therapy targeting normal systolic pressure ( i.e. , participants with type 2 diabetes at high risk for cardiovascular events . METHODS A total of 4733 participants with type 2 diabetes were r and omly assigned to intensive therapy , targeting a systolic pressure of less than 120 mm Hg , or st and ard therapy , targeting a systolic pressure of less than 140 mm Hg . The primary composite outcome was nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS After 1 year , the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the st and ard-therapy group . The annual rate of the primary outcome was 1.87 % in the intensive-therapy group and 2.09 % in the st and ard-therapy group ( hazard ratio with intensive therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.73 to 1.06 ; P=0.20 ) . The annual rates of death from any cause were 1.28 % and 1.19 % in the two groups , respectively ( hazard ratio , 1.07 ; 95 % CI , 0.85 to 1.35 ; P=0.55 ) . The annual rates of stroke , a prespecified secondary outcome , were 0.32 % and 0.53 % in the two groups , respectively ( hazard ratio , 0.59 ; 95 % CI , 0.39 to 0.89 ; P=0.01 ) . Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group ( 3.3 % ) and 30 of the 2371 participants in the st and ard-therapy group ( 1.3 % ) ( P patients with type 2 diabetes at high risk for cardiovascular events , targeting a systolic blood pressure of less than 120 mm Hg , as compared with less than 140 mm Hg , did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events . ( Clinical Trials.gov number , NCT00000620 .",
"IMPORTANCE Persons with type 2 diabetes mellitus ( T2DM ) are at increased risk for decline in cognitive function , reduced brain volume , and increased white matter lesions in the brain . Poor control of blood pressure ( BP ) and lipid levels are risk factors for T2DM-related cognitive decline , but the effect of intensive treatment on brain function and structure is unknown . OBJECTIVE To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume ( TBV ) in patients with T2DM . DESIGN , SETTING , AND PARTICIPANTS A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c ( HbA1c ) levels less than 7.5 % r and omized to a systolic BP goal of less than 120 vs less than 140 mm Hg ( n = 1439 ) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL ( n = 1538 ) . Participants were recruited from August 1 , 2003 , through October 31 , 2005 , with the final follow-up visit by June 30 , 2009 . MAIN OUTCOME MEASURES Cognition was assessed at baseline and 20 and 40 months . A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health . RESULTS Baseline mean HbA1c level was 8.3 % ; mean age , 62 years ; and mean duration of T2DM , 10 years . At 40 months , no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial . At 40 months , TBV had declined more in the intensive vs st and ard BP-lowering group ( difference , -4.4 [ 95 % CI , -7.8 to -1.1 ] cm(3 ) ; P = .01 ) . Fibrate therapy had no effect on TBV compared with placebo . CONCLUSIONS AND RELEVANCE In participants with long-st and ing T2DM and at high risk for cardiovascular events , intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up . Intensive BP control was associated with greater decline in TBV at 40 months relative to st and ard therapy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000620",
"Summary The latter was due to a reduction in cardiac mortality ( −38 % , p=0.036 ) and a nonsignificant decrease in cerebrovascular mortality ( −32 % , p=0.16 ) . In the double-blind part of the trial , the total mortality rate was not significantly reduced ( −26 % , p=0.077 ) . However , cardiovascular mortality was reduced in the actively treated group ( −38 % , p=0.023 ) , owing to a reduction in cardiac deaths ( −47 % , p=0.048 ) and a non-significant decrease in cerebrovascular mortality ( −43 % , p=0.15 ) . Deaths from myocardial infa rct ion were reduced ( −60 % , p=0.043 ) , and study -terminating morbid cardiovascular events were significantly reduced by active treatment ( −60 % , p=0.0064 ) . Non-terminating cerebrovascular events were reduced ( −52 % , p=0.026 ) , but the non-terminating cardiac events were not ( + 3 % , p=0.98 ) . In the patients r and omised to active treatment there were 29 fewer cardiovascular events and 14 fewer cardiovascular deaths per 1000 patient years during the double-blind part of the trial . A double-blind r and omised placebo-controlled trial of antihypertensive treatment was conducted in patients over the age of 60 . Entry criteria included both a sitting diastolic blood pressure on placebo treatment in the range 90 to 119 mm Hg and a systolic pressure in the range 160 to 239 mm Eg . 840 patients were r and omised either to active treatment ( hydrochlorothiazide and triamterene ) or to matching placebo . If the blood pressure remained raised , methyldopa was added to the active regimen and matching placebo in the placebo group . An overall intention-to-treat analysis , combining the double-blind part of the trial and all subsequent follow-up , revealed a non-significant change in total mortality rate ( −9 % , p=0.41 ) but a significant reduction in cardiovascular mortality rate ( −27 % , p=0.037 )",
"BACKGROUND Diabetic nephropathy is the leading cause of end-stage renal disease . Interruption of the renin-angiotensin system slows the progression of renal disease in patients with type 1 diabetes , but similar data are not available for patients with type 2 , the most common form of diabetes . We assessed the role of the angiotensin-II-receptor antagonist losartan in patients with type 2 diabetes and nephropathy . METHODS A total of 1513 patients were enrolled in this r and omized , double-blind study comparing losartan ( 50 to 100 mg once daily ) with placebo , both taken in addition to conventional antihypertensive treatment ( calcium-channel antagonists , diuretics , alpha-blockers , beta-blockers , and central ly acting agents ) , for a mean of 3.4 years . The primary outcome was the composite of a doubling of the base-line serum creatinine concentration , end-stage renal disease , or death . Secondary end points included a composite of morbidity and mortality from cardiovascular causes , proteinuria , and the rate of progression of renal disease . RESULTS A total of 327 patients in the losartan group reached the primary end point , as compared with 359 in the placebo group ( risk reduction , 16 percent ; P=0.02 ) . Losartan reduced the incidence of a doubling of the serum creatinine concentration ( risk reduction , 25 percent ; P=0.006 ) and end-stage renal disease ( risk reduction , 28 percent ; P=0.002 ) but had no effect on the rate of death . The benefit exceeded that attributable to changes in blood pressure . The composite of morbidity and mortality from cardiovascular causes was similar in the two groups , although the rate of first hospitalization for heart failure was significantly lower with losartan ( risk reduction , 32 percent ; P=0.005 ) . The level of proteinuria declined by 35 percent with losartan ( P patients with type 2 diabetes and nephropathy , and it was generally well tolerated",
"Background — The effect of intensive blood pressure ( BP ) lowering on kidney function among individuals with established cerebrovascular disease and preserved estimated glomerular filtration rate ( eGFR ) is not established . Methods and Results — Among 2610 participants r and omized to a lower ( with repeated measures of serum creatinine , we evaluated differences by study arm in annualized eGFR decline and rapid decline ( eGFR decline > 30 % ) using linear mixed models and logistic regression , respectively . We assessed associations of both treatment and kidney function decline with stroke , major vascular events , and the composite of stroke , death , major vascular events , or myocardial infa rct ion using multivariable Cox regression , separately and jointly including a test for interaction . Analyses were conducted by treatment arm . Mean age was 63±11 years ; 949 participants ( 36 % ) were diabetic ; and mean eGFR was 80±19 mL·min−1·1.73 m−2 . At 9 months , achieved systolic BP was 137±15 versus 127±14 mm Hg in the higher versus lower BP group , and differences were maintained throughout follow-up ( mean , 3.2 years ) . Compared with the higher target , the lower BP target had a −0.50–mL·min−1·1.73 m−2 per year ( 95 % confidence interval [ CI ] , −0.79 to −0.21 ) faster eGFR decline . Differences were most pronounced during the first year ( −2.1 mL·min−1·1.73 m−2 ; 95 % CI , −0.97 to −3.2 ) , whereas rates of eGFR decline did not differ after year 1 ( −0.095 ; 95 % CI , −0.47 to 0.23 ) . A total of 313 patients ( 24 % ) in the lower BP group had rapid kidney function decline compared with 247 ( 19 % ) in the higher BP group ( odds ratio , 1.4 ; 95 % CI , 1.1–1.6 ) . Differences in rapid decline by treatment arm were apparent in the first year ( odds ratio , 1.4 ; 95 % CI , 1.1–1.8 ) but were not significant after year 1 ( odds ratio , 1.0 ; 95 % CI , 0.73–1.4 ) . Rapid decline was associated with higher risk for stroke , major vascular events , and composite after full adjustment among individuals r and omized to the higher BP target ( stroke hazard ratio , 1.93 ; 95 % CI , 1.15–3.21 ) but not the lower BP arm ( stroke hazard ratio , 0.93 ; 95 % CI , 0.50–1.75 ; all P for interaction In patients with prior lacunar stroke and relatively preserved kidney function , intensive BP lowering was associated with a greater likelihood of rapid kidney function decline . Differences were observed primarily during the first year of antihypertensive treatment . Rapid kidney function decline was not associated with increased risk for clinical events among those undergoing intensive BP lowering . Clinical Trial Registration — URL : http://www . clinical Trials.gov . Unique identifier : NCT00059306",
"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",
"IMPORTANCE The appropriate treatment target for systolic blood pressure ( SBP ) in older patients with hypertension remains uncertain . OBJECTIVE To evaluate the effects of intensive ( st and ard ( SBP targets in persons aged 75 years or older with hypertension but without diabetes . DESIGN , SETTING , AND PARTICIPANTS A multicenter , r and omized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial ( SPRINT ) . Recruitment began on October 20 , 2010 , and follow-up ended on August 20 , 2015 . INTERVENTIONS Participants were r and omized to an SBP target of less than 120 mm Hg ( intensive treatment group , n = 1317 ) or an SBP target of less than 140 mm Hg ( st and ard treatment group , n = 1319 ) . MAIN OUTCOMES AND MEASURES The primary cardiovascular disease outcome was a composite of nonfatal myocardial infa rct ion , acute coronary syndrome not result ing in a myocardial infa rct ion , nonfatal stroke , nonfatal acute decompensated heart failure , and death from cardiovascular causes . All-cause mortality was a secondary outcome . RESULTS Among 2636 participants ( mean age , 79.9 years ; 37.9 % women ) , 2510 ( 95.2 % ) provided complete follow-up data . At a median follow-up of 3.14 years , there was a significantly lower rate of the primary composite outcome ( 102 events in the intensive treatment group vs 148 events in the st and ard treatment group ; hazard ratio [ HR ] , 0.66 [ 95 % CI , 0.51 - 0.85 ] ) and all-cause mortality ( 73 deaths vs 107 deaths , respectively ; HR , 0.67 [ 95 % CI , 0.49 - 0.91 ] ) . The overall rate of serious adverse events was not different between treatment groups ( 48.4 % in the intensive treatment group vs 48.3 % in the st and ard treatment group ; HR , 0.99 [ 95 % CI , 0.89 - 1.11 ] ) . Absolute rates of hypotension were 2.4 % in the intensive treatment group vs 1.4 % in the st and ard treatment group ( HR , 1.71 [ 95 % CI , 0.97 - 3.09 ] ) , 3.0 % vs 2.4 % , respectively , for syncope ( HR , 1.23 [ 95 % CI , 0.76 - 2.00 ] ) , 4.0 % vs 2.7 % for electrolyte abnormalities ( HR , 1.51 [ 95 % CI , 0.99 - 2.33 ] ) , 5.5 % vs 4.0 % for acute kidney injury ( HR , 1.41 [ 95 % CI , 0.98 - 2.04 ] ) , and 4.9 % vs 5.5 % for injurious falls ( HR , 0.91 [ 95 % CI , 0.65 - 1.29 ] ) . CONCLUSIONS AND RELEVANCE Among ambulatory adults aged 75 years or older , treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg result ed in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01206062"
] | 41166ac8-06ff-11f0-808a-c43d1ab1c353 |
Pain is a common side-effect of dermatological laser procedures . Non-invasive anaesthetic drugs and anaesthetic procedures can be used to provide pain relief and increase patient satisfaction and treatment efficacy . However , it remains unclear which method provides the best pain relief . The objective of this systematic review was therefore to assess the efficacy and safety of non-invasive anaesthetic methods during dermatological laser procedures . A systematic literature search was conducted . R and omized and non-r and omized controlled clinical trials ( RCTs and CCTs ) were included . Two authors independently assessed study eligibility , extracted data and assessed the risk of bias . The quality of evidence was rated using Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) . Twenty RCTs and 12 CCTs were included , involving nine different laser indications : hair removal ( n = 9 ) , resurfacing/rejuvenation ( n = 5 ) , port wine stains ( n = 8) , leg telangiectasia ( n = 3 ) , facial telangiectasia ( n = 2 ) , tattoo removal ( n = 2 ) , naevus of Ota ( n = 1 ) , solar lentigines ( n = 1 ) and HPV lesions ( n = 1 ) . The non-invasive anaesthetic methods ( i.e. topical anaesthetic drugs , skin cooling , and pneumatic skin flattening [ PSF ] ) , types of lasers , laser setting s , application time , and types of pain scales varied widely among the included studies . All of the studies had an unclear or high risk of bias , and the overall quality of evidence was rated as low . In general , active non-invasive anaesthetic methods seemed to provide favourable results compared to placebo or no anaesthesia , and topical anaesthetic drugs and PSF seemed to result in a better pain reduction than skin cooling . However , the current evidence is insufficient to provide recommendations for daily clinical practice . There is a need for more high- quality ( head-to-head ) RCTs . Future studies should also evaluate sex differences in pain perception , have uniformity with regard to vali date d pain measurement scales and address clinical ly significant differences in pain reduction besides statistically significant differences | [
"The aim of this study was to compare the efficacy of topical piroxicam and EMLA cream on pain control and subsequent inflammation in neodymium : yttrium – aluminum – garnet ( Nd : YAG ) 1,064 nm laser hair removal in female volunteers . Fifty female volunteers were enrolled in this prospect i ve , r and omized , double-blind , clinical study over a 6-month period . Patients were r and omly assigned to receive topical piroxicam as group Piroxicam or EMLA cream as group EMLA . Topical analgesics were applied to the treatment sites for 60 min . The pain scores [ on a visual analog scale ( VAS ) ] and side effects were recorded before the hair removal , during the hair removal , at the end of the hair removal , and 1 h , 2 h and 24 h after the hair removal . Patients ’ characteristics and the treatment setting s of the Nd : YAG 1,064 nm laser were similar in the two groups . The pain scores ( VAS ) were similar , and satisfaction was high in both groups after the hair removal . The number of blanching and erythema episodes were significantly higher in group E than in group P ( P Inflammatory side effects were less frequent in group P than in group E after the procedure ( P pain relief after Nd : YAG 1,064 nm laser hair removal in female volunteers . Topical piroxicam was associated with fewer inflammatory side effects than was EMLA cream , because of its anti-inflammatory effect after the procedure",
"Background . The C and ela alex and rite and the Coherent diode laser systems come equipped with built‐in skin cooling systems that are design ed to both protect the epidermis , allowing higher fluences , and to alleviate discomfort . Nevertheless , pain can be a significant problem especially with treatment of larger areas . Scatter of the laser beam is reportedly affected by the spot size . It is cl aim ed that larger spot sizes are more effective at identical fluences . Objective . This study evaluated the effectiveness of a topical 5 % lidocaine cream ( ELA‐Max ) to control pain and compared pain levels at identical fluences between the 8 mm and 12 mm spot size of the alex and rite laser and between the alex and rite and diode laser with its 9 mm spot size . Methods . The study was conducted in the axillae of 12 patients . Each axilla was divided in half for side‐by‐side comparison . Half of the right axilla was treated with the alex and rite 8 mm and the other half with the 12 mm spot size at identical fluences . The left axilla was treated at the maximum tolerated fluences with the alex and rite 12 mm spot size and the diode 9 mm spot size . Results . At identical fluences and other parameters , there was significantly more pain with the alex and rite 12 mm spot size than with the alex and rite 8 mm spot size , both with or without topical anesthesia . The alex and rite laser was significantly less painful than the diode laser both with and without topical anesthetic . The difference was most noticeable between the alex and rite 8 mm spot size and the diode 9 mm spot size . Topical 5 % lidocaine anesthesia was effective in reducing pain , though not completely , for both the alex and rite and the diode lasers . Conclusion . Topical 5 % lidocaine cream is a simple and effective method for reducing patient discomfort during laser hair removal procedures , even when a skin cooling device is being used . A larger spot size causes more pain than a smaller spot size at identical fluences . The 800 nm diode laser causes greater discomfort than the 755 nm alex and rite laser",
"BACKGROUND AND OBJECTIVES Cold air cooling is widely used in dermatological laser therapy . We investigated the influence of cold air cooling at different skin temperatures on therapeutic outcome and side effects of pulsed dye laser treatment of facial telangiectasia . STUDY DESIGN / MATERIAL S AND METHODS From September 2002 to February 2003 , 17 patients with previously untreated facial telangiectasia underwent a single treatment session with flash-lamp pulsed dye laser ( 3.5 J/cm(2 ) , 585 nm , 0.45 milliseconds pulse length , 10 mm beam diameter , Cynosure V ) . The treatment area was divided into three sub- areas : no cooling , cold air cooling to 20 degrees C and to 17 degrees C skin temperature . The skin temperature was monitored by a prototype infrared sensor system which controlled the temperature of the cold air stream ( Cryo5 ) . In a prospect i ve study , we collected data on purpura , pain , clearance , and patient satisfaction on numerical analog scales ( NAS ) from 0 ( meaning \" no \" ) to 3 ( meaning \" high \" ) . RESULTS Without cooling , purpura ( 2.53 ) , pain ( 2.41 ) , and clearance ( 2.35 ) were rated medium to high . Cooling to 20 degrees C reduced purpura ( 1.12 ) and pain ( 1.06 ) , whereas the clearance ( 2.12 ) was only slightly affected . Cooling to 17 degrees C reduced purpura ( 0.88 ) and pain ( 0.76 ) even more , the clearance ( 2.06 ) was lowered marginally . Most patients preferred cooling to 20 degrees C skin temperature . CONCLUSION In dermatological laser therapy of facial telangiectasia , the use of cold air cooling can significantly reduce side effects and increase patient satisfaction while only slightly affecting clearance . Cooling to 20 degrees C skin temperature proved to be a well-balanced middle course . For the practical use of cold air cooling , we thus recommend cooling to a level which the patient can tolerate without problems and to try to increase the energy densities",
"BACKGROUND AND OBJECTIVES The use of the long-pulsed 755-nm alex and rite laser has been an effective tool in hair removal . A dynamic cooling device ( DCD ) is commonly used with this laser in order to minimize epidermal damage . No studies have examined how fine changes in DCD duration may affect comfort and epidermal damage during laser hair removal . This study was design ed to determine what effect , changes in the duration of dynamic cooling would have on pain and epidermal damage with laser hair removal ( 755 nm alex and rite ) in patients with darker skin types . STUDY DESIGN / MATERIAL S AND METHODS Ten volunteers with Fitzpatrick skin types III-V were enrolled . A 755-nm alex and rite laser with a pulse duration of 3 milliseconds and equipped with a DCD was used with the 12 mm spot size on matched treatment sites . We compared cryogen spurt duration s of 0 , 20 , 40 , 60 , 80 , and 100 milliseconds on pain and epidermal changes . The spray delay was set at 1 millisecond . Pain rating scales and epidermal changes ( skin sloughing , hyperpigmentation , hypopigmentation and scarring ) were assessed . RESULTS Overall a decrease in pain was seen with increases in spurt duration . A spurt duration of 20 milliseconds was beneficial for pain reduction in all patients . Longer spurt duration s were associated with additional pain relief especially when geographic spacing of pulses was maximized to prevent thermal build-up . In regards to epidermal protection , most patients benefited with shorter cryogen duration s of 20 - 60 milliseconds . There was little advantage with longer spurt duration s. Some patients treated at higher fluences without cooling had no detectable side effects . CONCLUSIONS Increasing DCD spurt duration in laser hair removal provides its strongest benefit in the area of pain reduction , particularly in type V patients . Increasing cryogen spurt duration s above a protective threshold shows no significant benefit in terms of epidermal protection . Changing the spurt duration may not be as important in some patients with darker skin types",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences",
"BACKGROUND A variety of topical anesthetic compounds are available for use prior to minimally or moderately painful cutaneous laser procedures . A novel lidocaine/tetracaine-based peel has recently been developed that is applied to the skin as a cream and , once air dried , is removed as a flexible film that may prove useful in providing adequate dermal anesthesia for dermatologic laser surgery . OBJECTIVE To evaluate the clinical efficacy of a novel topical anesthetic peel preparation for induction of local anesthesia prior to full-face cutaneous laser resurfacing . METHODS A series of 20 patients undergoing full-face single-pass CO2 laser resurfacing were enrolled in a double-blind institutional review board (IRB)-approved study protocol in which two different topical anesthetic products were compared . A 4 cm × 4 cm area of one cheek was r and omized to receive the novel lidocaine/tetracaine-based cream peel ( S-Caine ) while a 4 cm × 4 cm area on the contralateral side received EMLA cream with occlusion for 30 minutes prior to laser treatment . Patients rated the level of pain experienced during laser treatment on each side using a visual analog scale . Independent assessment s of observed discomfort and side effects were recorded RESULTS Pain scores were significantly lower using the novel lidocaine/tetracaine-based cream peel formulation compared with the EMLA cream . Side effects associated with application of the anesthetic peel were limited to mild transient erythema and skin blanching . CONCLUSION A novel topical lidocaine/tetracaine-based cream peel provides safe and effective dermal anesthesia for single-pass CO2 laser skin resurfacing",
"Background : Energy densities utilized in the treatment of pigmented lesions such as solar lentigines with intense pulsed light systems are often limited by pain and post‐treatment erythema and edema . The sensation of pain associated with the treatment is immediate and acute . Application of topical anesthesia is time‐consuming , with only very moderate pain relief . Objective : ( a ) To test pain reduction as well as the reduction of post‐treatment erythema and edema when using pneumatic skin flattening ( PSF ) . This new technology utilizes an evacuation chamber to generate skin compression and activates tactile neural receptors in the skin . The result is an afferent inhibition of pain transmission in the dorsal horn ( the ‘ gate theory ’ ) . ( b ) To test the efficacy of PSF . Methods : Twenty patients were treated for solar lentigines . The patients were treated by three different IPLs . The evaluation of acute pain and post‐treatment erythema and edema was performed on all 20 patients : one to three sites per patient treated with PSF and the same number of control sites without PSF . Identical energies and IPL were applied to both sites on each patient . The pain evaluation was performed on a 10‐level scale modified McGill Pain Question naire . The clinical response to treatment was also evaluated . Results : All 20 patients completed the study and preferred the PSF treatment side over the non‐PSF side . Substantial pain reduction was observed in 19/20 patients ( 95 % ) . The average reduction of pain was by two levels , from very painful to very mild pain . Erythema reductions were observed on 14/18 ( 77 % ) patients and edema reduction on 8/9 ( 88 % ) patients . Treatment efficacy on PSF sites was identical to that of non‐PSF sites . Conclusion : The pneumatic skin flattening ( PSF ) technology considerably reduces pain , erythema and edema in the treatment of solar lentigines by IPLs . Treatment efficacy is preserved . The enhanced safety of PSF enables the increase of energy density and the acceleration of results",
"The purpose of this study was to vali date the changes in acute pain measurement scales that are most strongly associated with a patient-determined indicator of clinical importance . Measures of pain intensity and pain relief are commonly used outcomes in therapeutic clinical trials . Recent studies of the properties of acute pain measures have provided data defining the cut-off points that are best associated with clinical ly important differences . Validation of these findings in another clinical trial data set is important . Data were obtained from the titration phase of a recently conducted r and omized controlled clinical trial of oral transmucosal fentanyl citrate ( OTFC ) , which compared OTFC to immediate release morphine sulfate ( MSIR ) for the treatment of cancer-related acute breakthrough pain . Changes in pain intensity and pain relief were recorded every 15 minutes for 60 minutes and global medication performance recorded at the end of each study pain episode . At any titration step , if the patient felt that the first dose of the study medication did not provide adequate relief within 30 minutes , an additional rescue medication could be taken . To find the level of each pain scale best associated with this measure of the adequacy of pain relief , the calculated sensitivity , specificity , and accuracy for different cut-off points of the measured pain scales were compared to whether or not the patient needed rescue medication . The overall ability of the pain measures to discriminate episodes for which a rescue was not needed was calculated using area under the receiver operating characteristics ( ROC ) curves . Data were analyzed from 134 OTFC-naive patients who collected data on 1307 episodes of breakthrough pain . Using the criteria of a balanced sensitivity and specificity , the best cut-off points were determined to be : 33 % for the percent pain intensity difference ; > or = 2 for the raw pain intensity difference on a 0 - 10 numeric rating scale ; > or = 2 ( i.e. , moderate or better ) for pain relief ; > or = 33 % for the percent maximum total pain relief ; and > or = 2 ( good or better ) for global medication performance . ROC area under the curve ranged from 0.839 to 0.862 for each of the pain measures listed above , calculated at 60 minutes . These data indicate that the pain scale cut-off points that are best associated with a patient-derived measure of a clinical ly important difference closely approximate those found in an earlier study . ROC analysis provided evidence that the overall pain measures were strongly associated with not requiring an \" additional dose of rescue medication . \" Thus , the cut-off points determined for these pain scales provide a good surrogate measure of a patient-determined clinical ly important response . This provides support for the usefulness of these values in future clinical trials of pain therapy",
"OBJECTIVES To determine the minimum clinical ly significant difference in visual analog scale ( VAS ) pain scores for acute pain in the ED setting and to determine whether this difference varies with gender , age , or cause of pain . METHODS A prospect i ve , descriptive study of 152 adult patients presenting to the ED with acute pain . At presentation and at 20-minute intervals to a maximum of three measurements , patients marked the level of their pain on a 100-mm , nonhatched VAS . At each follow-up they also gave a verbal rating of their pain as \" a lot better , \" \" much the same , \" \" a little worse , \" or \" much worse . \" The minimum clinical ly significant difference in VAS pain scores was defined as the mean difference between current and preceding scores when pain was reported as a little worse or a little better . Data were compared based on gender , age more than or less than 50 years , and traumatic vs nontraumatic causes of pain . RESULTS The minimum clinical ly significant difference in VAS pain scores is 9 mm ( 95 % CI , 6 to 13 mm ) . There is no statistically significant difference between the minimum clinical ly significant differences in VAS pain scores based on gender ( p=0.172 ) , age ( p=0.782 ) , or cause of pain ( p=0.84 ) . CONCLUSIONS The minimum clinical ly significant difference in VAS pain scores was found to be 9 mm . Differences of less than this amount , even if statistically significant , are unlikely to be of clinical significance . No significant difference in minimum significant VAS scores was found between gender , age , and cause-of-pain groups",
"Port-wine stains may be effectively ablated using the pulsed dye laser emitting at a wavelength of 577 or 585 nm . However , the discomfort of this therapy may be severe enough to require reduction of treatment duration thereby increasing the need for repeat sessions . Currently available methods of anesthesia or sedation for pulsed dye laser therapy have drawbacks to their use . We performed a prospect i ve double-blind , placebo-controlled evaluation of the iontophoresis of lidocaine HCl 4 % and lidocaine HCl 4 % with epinephrine 1:50,000 for local anesthesia during pulsed dye laser ablation of port-wine stains . Eleven patients with port-wine stains completed the initial phase of the study . Pain scale evaluation by patients demonstrated significant decreases in the discomfort of pulsed dye laser impulses by the iontophoresis of lidocaine HCl 4 % and lidocaine HCl 4 % with epinephrine 1:50,000 ( P less than .0001 ) , with no significant difference between these treatments . Follow-up evaluation suggests that iontophoresis has no detrimental effect on pulsed dye laser ablation of port-wine stains , despite significant decreases in perfusion , as measured by laser Doppler velocimetry , of port-wine stain areas receiving iontophoresis of lidocaine with epinephrine . Iontophoresis of lidocaine HCl 4 % with or without epinephrine is a safe and effective method of local anesthesia for pulsed dye laser therapy",
"BACKGROUND AND OBJECTIVES Advancements in laser treatment of leg veins necessitate concurrent investigations in topical anesthesia to minimize treatment-related pain . To evaluate the efficacy of the S-Caine Peel for providing topical anesthesia after a 60-minute application . STUDY DESIGN / PATIENTS AND METHODS A r and omized , double-blinded , placebo-controlled trial was performed in two centers . Sixty patients received S-Caine Peel and placebo vehicle on different treatment sites for 60 minutes prior to laser treatment of leg veins using a 1,064 nm long-pulsed Nd : YAG laser . Patients rated their level of pain using a visual analog scale . Adequacy of anesthesia and expressed pain at each site were rated by the investigator . RESULTS The mean visual analog scale ( VAS ) was 27 mm for active sites compared to 43 mm for placebo ( P Improved pain relief was noted for 67 % of active versus 30 % of placebo sites ( P Anesthesia was judged adequate by the investigator for 55 % of active compared with 12 % of placebo sites ( P S-Caine Peel is safe and effective when applied for 60 minutes prior to laser therapy of leg veins",
"BACKGROUND The use of cryogen spray cooling in the course of dye laser treatment of port-wine stains has established itself in recent years because of its good analgesic and epidermally protective effects . The disadvantages of this kind of evaporative cooling are the cost and , in the case of dichlorodifluoromethane , the effects on the ozone layer . Cold air is an innovative cooling method that costs nearly nothing to use , is environmentally friendly , and can be easily adapted to existing laser systems . OBJECTIVE To examine and evaluate cold air cooling as an alternative method of cooling in laser treatment . METHODS In a prospect i ve study , 13 patients ( 9 female , 4 male ) with port-wine stains were treated with a pulsed dye laser ( λ = 585 nm , τp = 450 μsec ) . In every case , either the entire area or a sample area of the port-wine stain was treated with cold air cooling on 50 % of the surface and without on the other 50 % . Clearance , analgesia , and adverse and concomitant effects were assessed . RESULTS In nine patients ( 69 % ) there were similar results in terms of clearance . In four cases , better lightening results ( in two patients ) and worse lightening results ( in two other patients ) were achieved in the area treated with cold air . Nine of the patients ( 69 % ) felt that the laser impulses accompanied by cold air were significantly less painful . Adverse effects ( purpura , erythema , edema ) and concomitant effects ( hypopigmentation , hyperpigmentation , scars ) were much less marked in the cooled areas . CONCLUSION Cold air is a safe and effective alternative to cryogen spray cooling . It is easy to use , economical , and environmentally friendly . Continuing studies are necessary to determine if there are interactions which affect the tissue",
"BACKGROUND The measurement of spasticity as a symptom of neurologic disease is an area of growing interest . Clinician-rated measures of spasticity purport to be objective but do not measure the patient 's experience and may not be sensitive to changes that are meaningful to the patient . In a patient with clinical spasticity , the best judge of the perceived severity of the symptom is the patient . OBJECTIVES The aim of this study was to assess the validity and reliability , and determine the clinical importance , of change on a 0 - 10 numeric rating scale ( NRS ) as a patient-rated measure of the perceived severity of spasticity . METHODS Using data from a large , r and omized , doubleblind , placebo-controlled study of an endocannabinoid system modulator in patients with multiple sclerosis-related spasticity , we evaluated the test-retest reliability and comparison-based validity of a patient-reported 0 - 10 NRS measure of spasticity severity with the Ashworth Scale and Spasm Frequency Scale . We estimated the level of change from baseline on the 0 - 10 NRS spasticity scale that constituted a clinical ly important difference ( CID ) and a minimal CID ( MCID ) as anchored to the patient 's global impression of change ( PGIC ) . RESULTS Data from a total of 189 patients were included in this assessment ( 114 women , 75 men ; mean age , 49.1 years ) . The test-retest reliability analysis found an interclass correlation coefficient of 0.83 ( P 0 - 10 NRS spasticity scores recorded over a 7- to 14-day period before r and omization . A significant correlation was found between change on 0 - 10 NRS and change in the Spasm Frequency Scale ( r = 0.63 ; P 0 - 10 NRS and the PGIC ( r = 0.47 ; P spasticity 0 - 10 NRS score best represented the CID and a change of 18 % the MCID . CONCLUSIONS The measurement of the symptom of spasticity using a patient-rated 0 - 10 NRS was found to be both reliable and valid . The definitions of CID and MCID will facilitate the use of appropriate responder analyses and help clinicians interpret the significance of future results",
"The time of onset and duration of local anesthesia of a lidocaine/prilocaine cream ( EMLA ) applied to the genital mucosa were assessed in a double-blind study . Eighty women with condylomata on their genital mucosa were r and omly allocated to either EMLA ( N = 60 ) or placebo cream ( N = 20 ) between 1 - 75 minutes before CO2 laser treatment . The pain was evaluated by the patient on a visual analogue scale . The most effective degree of anesthesia was achieved after 5 - 15 minutes ' application of EMLA . The patients given EMLA , regardless of application time , felt significantly less pain than the patients given placebo . EMLA could provide an alternative to general anesthesia in patients with extensive condylomata on the genital mucosa",
"We have used EMLA , 4 % amethocaine gel and placebo for facial portwine stains , for a period of 1 h , in a double-blind study . After removal of the preparations from the skin surface , each area was treated with six pulses of the laser , each 5 mm in diameter . Any pain noted immediately after treatment was recorded using both visual analogue ( VAS ) and verbal rating ( VRS ) scores . Twenty nine patients completed the study and statistical analysis of the results indicated that both EMLA and 4 % amethocaine gel were superior to placebo ( P EMLA and 4 % amethocaine gel were compared , the amethocaine preparation was significantly better ( P EMLA in reducing pain caused by the laser treatment",
"BACKGROUND Penetration through the stratum corneum limits effectiveness of topical anesthetics . OBJECTIVE Our aim was to evaluate the effectiveness of 5 % lidocaine ( ELA-Max ) cream applied after erbium : yttrium-aluminum-garnet ( Er : YAG ) laser ablation of the stratum corneum . METHODS R and omized , controlled , split-face comparison of anesthesia was performed on 12 volunteers . The stratum corneum was painlessly ablated with a low-fluence Er : YAG laser on half of the face , then the whole face was covered with ELA-Max cream for 60 minutes . Full-face laser resurfacing was performed , and visual analog pain scores ( 0 to 10 ) were recorded during each of 2 passes . RESULTS Laser-assisted topical anesthesia demonstrated significantly lower mean pain scores than topical anesthesia alone . This was more pronounced during the more painful second pass . Resurfacing after laser-assisted topical anesthesia was well tolerated by 72 % of subjects in pass 1 and 58 % in pass 2 . CONCLUSION Laser-assisted topical anesthesia is fast , painless , and substantially more effective than conventional topical anesthesia but does not provide adequate anesthesia for full-face resurfacing in all subjects",
"Port-wine stains ( PWS ) are benign , congenital vascular malformations found in approximately 0.3 % of newborns . PWS may be effectively treated with the flashlamp pulsed dye laser ( FPDL ) at 585 nm . However , laser therapy of vascular lesions often produces pain . We performed a prospect i ve double-blind , placebo-controlled evaluation of the iontophoresis of lidocaine 5 % with epinephrine 1:50,000 and mepivacaine 2 % with epinephrine 1:50,000 . Thirty-six patients with facial PWS were included in the study ; 13 of them were treated with lidocaine 5 % with epinephrine , another 13 were treated with mepivacaine 2 % with epinephrine , and the other 13 were treated with preservative-free 0.9 % NaCl . The pain was grade d by the patient on a visual analog scale from 0 to 10 , comparing the iontophoretically treated area with an adjacent area treated without anesthesia . Pain evaluation by patients demonstrated a significant decrease in the pain of pulsed dye laser impulses using the iontophoresis of lidocaine 5 % with epinephrine . No change in the efficacy of pulsed dye laser treatment of PWS or important side effects were observed in our patients . Iontophoresis of lidocaine 5 % with epinephrine is a safe and effective method of local anesthesia for pulsed dye laser and it is more effective than the iontophoresis of mepivacaine 2 % with epinephrine ",
"BACKGROUND Laser-assisted hair removal is a variably uncomfortable and painful procedure . OBJECTIVE The aim of this study was to investigate the efficacy of piroxicam gel on pain control and subsequent inflammation in Nd : YAG 1064 nm laser hair removal in women volunteers . METHODS Fifty women volunteers were enrolled in this prospect i ve , r and omised , placebo-controlled study over a 6-month period . Subjects were r and omly assigned to receive piroxicam gel as Group P or saline as a control group . Topical analgesic and saline were applied to the treatment sites for 45 minutes . The pain scores ( VAS ) and side effects were recorded before the hair removal , during the hair removal , at the end of the hair removal , and after 1 hour , 2 hours and 24 hours after the hair removal . RESULTS Subject characteristics and treatment setting s in Nd : YAG 1064 nm laser were similar in both groups . The pain scores ( VAS ) were significantly lower in the Group P than those of the control group during the hair removal ( p Inflammatory side effects such as erythema , edema , and folliculitis , were more frequent in the control group than those of Group P during the procedure ( p piroxicam gel provided adequate pain relief after Nd : YAG 1064 nm laser hair removal in women volunteers . Piroxicam gel was associated with lesser inflammatory side effects when compared to placebo because of its anti-inflammatory effect after the procedure",
"BACKGROUND Advancements in nonablative laser technology necessitate concurrent developments in topical anesthesia , as patients have reported varying degrees of discomfort during these procedures . Although topical anesthetics have proven efficacious , they possess inherent limitations related to ease of use . OBJECTIVE To evaluate the efficacy of the S-Caine Peel ( ZARS Inc. , Salt Lake City , UT ) , a novel topical anesthetic that dries to form a flexible membrane , for induction of anesthesia after only a 30-minute application period . METHOD Twenty patients received concurrent 30-minute applications of both the S-Caine Peel and a placebo cream r and omized to the right and left cheeks in a double-blinded manner . After one pass of the 1450-nm diode laser ( Smoothbeam , C and ela Corp. , Wayl and , MA ) , patients ' pain levels were recorded on a visual analog scale ( VAS ) . Both the investigator and an independent observer rated perceived discomfort and immediate skin reaction based on a numerical scale . RESULTS Differences in VAS scores between active sites ( average rating of 15 mm ) and placebo sites ( average rating of 47 mm ) were statistically significant ( P painless procedure was noted at 50 % and 65 % of active sites by the independent observer and investigator , respectively . This was statistically different ( P pain-free procedure at the placebo site , 0 % and 5 % , respectively . CONCLUSION The S-Caine Peel provided effective and safe dermal anesthesia after only a 30-minute application period for nonablative laser treatment with the 1450-nm diode laser . The unique vehicle readily delivers anesthetic to contoured regions of the body and eliminates the need for occlusion",
"Laser hair removal is an effective therapy for the treatment of hirsutism , hypertrichosis , and pseudofolliculitis barbae . Although side effects are uncommon , pain is described by most patients undergoing long-pulsed neodymium : yttrium-aluminum-garnet ( Nd : YAG ) 1,064 nm laser therapy . objectives To compare the efficacy of topical eutectic mixture of local anesthetics ( EMLA ) versus topical lidocaine ( LMX ) in pain control for Nd : YAG 1,064 nm laser hair removal . Methods Sixty-four patients were enrolled in a double-blind r and omized study over a 6-month period . Each patient had half of the treatment area covered with EMLA and the other half with LMX 30 minutes prior to treatment . Neither was applied under occlusion . Immediately following their treatment session , patients completed a visual analog pain scale . Results There was no statistically significant difference in pain control between EMLA and LMX . However , female test subjects demonstrated lower pain scores than male test subjects . Conclusions Nd : YAG 1,064 nm laser hair removal is a painful procedure . Topical anesthetics have been proven to reduce pain for laser hair removal . There is no statistically significant difference between the two most commonly used topical anesthetics for pain control in laser hair removal . Therefore , cost and minimizing potential side effects should guide the physician in selecting the appropriate anesthetic",
"BACKGROUND AND OBJECTIVE The long-pulse dye laser ( PDL ) at 595 nm and pulse duration of 1.5 msec has been shown to improve clearance of larger vessels such as those seen in leg telangiectasia . The objectives of this study are twofold . First , to determine the effect of the dynamic cooling device ( DCD ) in clearance of leg telangiectasia by using a long-pulse PDL at 595 nm . Next , to determine the effect of the DCD in reducing transient discomfort associated with treatment and in reducing epidermal damage ( blistering , hyper/hypopigmentation , scarring ) caused by the laser . STUDY DESIGN / MATERIAL S AND METHODS Matched treatment sites were compared at energy densities of 20 and 24 J/cm(2 ) with and without the use of the cryogen spray in 18 patients . In areas treated without the DCD , the laser pulse was delivered through a single layer of Spenco Second Skin . Patients received two treatments 6 weeks apart . Discomfort ratings , clearance of leg telangiectasia , and complications were assessed at 6 weeks , 12 weeks , and 6 months . RESULTS A reduction in discomfort ratings was found in most patients using the DCD . Six-month follow-up data revealed at the 20 J/cm(2 ) treatment sites , with or without the DCD , 76.9 % showed greater than 50 % clearance . At the 24 J/cm(2 ) treatment sites , with or without the DCD , 84.6 % showed greater than 50 % clearance . CONCLUSION The long-pulse dye laser at 595 nm with a 1.5-msec pulse duration cleared leg telangiectasia an average of 67.5 % with two treatments at 6 months . The major effect of the DCD was on pain reduction . There was no difference in clearance rates when using the DCD vs. cooled Second Skin . Further studies with longer cooling times with the DCD are needed to optimize treatment parameters",
"BACKGROUND AND OBJECTIVE Pulsed KTP lasers effectively treat facial telangiectasia without purpura production . Transient side effects following treatment include erythema , edema , and vesiculation leading to crust formation . The aim of this study was to investigate the utility of an aqueous gel in reducing side effects associated with pulsed KTP laser treatment of facial telangiectasia . STUDY DESIGN / MATERIAL S AND METHODS Nineteen patients with extensive facial telangiectasias were treated with a pulsed KTP laser ( Versapulse , Coherent , Palo Alto , CA ) . The laser was used with the water cooled h and piece chilled to 4C , a 4 mm spot size , a 10-millisecond pulse duration and a fluence of 9.5 J/cm2 . One side of the face was treated with the laser using the cooling h and piece alone . The other side was treated using the cooling h and piece applied to a 2-mm film of aqueous gel spread over the treatment area . RESULTS Treatment side effects , including pain , erythema , edema , vesiculation , and crusting were scored following treatment with and without the aqueous gel . Use of the aqueous gel in conjunction with the cooling h and piece decreased the incidence and severity of pain , erythema , edema , and crusting following pulsed KTP laser treatment of facial telangiectasia . Most patients demonstrated 50 - 75 % clearance of their telangiectasias 1 month after one treatment session , and use of the gel did not alter the treatment efficacy . CONCLUSIONS The application of an aqueous gel during pulsed KTP laser treatment of facial telangiectasia improves treatment associated side effects without affecting vessel clearance",
"BACKGROUND Topical anesthetics are valuable tools for many dermatologic procedures . OBJECTIVE To evaluate the efficacy and safety of S-Caine Peel composed of 1:1 ( wt : wt ) mixture of 7 % lidocaine and 7 % tetracaine in the induction of local anesthesia before long-pulsed Nd : YAG laser therapy for leg veins . METHODS Two r and omized , double-blinded , placebo-controlled trials were performed . In study 1 , 60 adults received S-Caine Peel and placebo cream for 30 or 60 minutes . Efficacy was evaluated by a patient visual analog scale and impression . The pain scale and impression were evaluated by the investigator and an independent observer . In study 2 , 40 adults received 60- and 90-minute applications . RESULTS In study 1 , the 30- and 60-minute application times were grouped : Patients had adequate pain relief in 48 % of S-Caine sites versus 23 % of placebo sites ( P none-to-mild pain in 50 % of active sites versus 33 % of placebo sites ( P = 0.007 ) , with adequate anesthesia in 65 % of active sites versus 43 % of placebo sites ( P = 0.002 ) . The independent witness assessed none-to-mild pain in 52 % of active sites versus 37 % of placebo sites ( P = 0.067 ) . In study 2 , investigators rated none-to-mild pain in 75 % of 60-minute and 85 % of 90-minute S-Caine sites versus 30 % and 50 % of placebo sites ( P = 0.012 and P = 0.002 , respectively ) , with adequate anesthesia in 70 % and 85 % of 60- and 90-minute of active sites versus 25 % and 20 % of placebo sites ( P = 0.029 and P = 0.001 , respectively ) . The independent witness rated none to mild pain in 80 % and 85 % of 60 and 90 minute of S-Caine sites versus 35 % and 50 % of placebo sites ( P = 0.008 and P = 0.004 ) . CONCLUSION The S-Caine Peel provides safe and highly effective local anesthesia when applied for at least 60 minutes for laser therapy of leg veins . Facile removal of the peel provides a unique advantage and ease in administration",
"Background Topical anesthetics are important tools for many dermatologic procedures . The S-Caine Peel is composed of a 1:1 ( w : w ) eutectic mixture composed of lidocaine base 7 % , USP , and tetracaine base 7 % , USP . It is applied as a cream , dries on exposure to air , and forms a flexible membrane , which can be easily peeled off . Objective To evaluate the effectiveness of the S-Caine Peel in providing clinical ly useful local dermal anesthesia for laser-assisted tattoo removal and to monitor the nature and frequency of adverse events associated with the safety of the S-Caine Peel . Methods Thirty adult patients undergoing laser-assisted tattoo removal were enrolled in this multicentered , r and omized , double-blind , placebo-controlled study . Each subject received both the S-Caine Peel and placebo simultaneously for 60 minutes . The primary efficacy parameter was a 100 mm visual analog scale ( VAS ) for patient self- assessment of pain . Secondary efficacy parameters included both the investigator 's and an independent observer 's evaluation of subject pain ( 4-point categorical scale : no pain through severe pain ) and the patient 's and the investigator 's overall impression of the local anesthetic . Results Mean VAS scores were 42 mm for the S-Caine Peel and 66 mm for placebo treatment sites ( p= .001 ) . Patients received adequate pain relief in 50 % of S-Caine Peel sites versus 7 % of placebo sites ( p= .002 ) . The percentage of those who would like to use the S-Caine Peel again were 43 % for the S-Caine Peel compared with 7 % for placebo ( p= .005 ) . Investigators ' evaluations revealed that 70 % of patients had less pain at S-Caine Peel treatment sites compared with 10 % with less pain at placebo sites ( p adequate anesthesia versus 10 % of placebo sites ( p less pain in 67 % of S-Caine Peel – treated sites versus 10 % of the placebo sites ( p= .002 ) . One occurrence of moderate to severe erythema was noted at both an S-Caine Peel and a placebo treatment site on removal of the S-Caine Peel after 60 minutes , which self-resolved quickly . There was no statistical difference between the two groups . Other side effects were limited to local mild , transient erythema at the application sites . Conclusion Administration of the S-Caine Peel for 60 minutes prior to laser-assisted tattoo removal was effective in significantly reducing pain levels associated with the procedure"
] | 41166b04-06ff-11f0-808a-c43d1ab1c353 |
Leaders from the Canadian Society for Exercise Physiology convened representatives of national organizations , content experts , method ologists , stakeholders , and end-users who followed rigorous and transparent guideline development procedures to create the Canadian 24-Hour Movement Guidelines for Children and Youth : An Integration of Physical Activity , Sedentary Behaviour , and Sleep . These novel guidelines for children and youth aged 5 - 17 years respect the natural and intuitive integration of movement behaviours across the whole day ( 24-h period ) . The development process was guided by the Appraisal of Guidelines for Research Evaluation ( AGREE ) II instrument and systematic review s of evidence informing the guidelines were assessed using the Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) approach . Four systematic review s ( physical activity , sedentary behaviour , sleep , integrated behaviours ) examining the relationships between and among movement behaviours and several health indicators were completed and interpreted by expert consensus . Complementary compositional analyses were performed using Canadian Health Measures Survey data to examine the relationships between movement behaviours and health indicators . A stakeholder survey was employed ( n = 590 ) and 28 focus groups/stakeholder interviews ( n = 104 ) were completed to gather feedback on draft guidelines . Following an introductory preamble , the guidelines provide evidence -informed recommendations for a healthy day ( 24 h ) , comprising a combination of sleep , sedentary behaviours , light- , moderate- , and vigorous-intensity physical activity . Proactive dissemination , promotion , implementation , and evaluation plans have been prepared in an effort to optimize uptake and activation of the new guidelines . Future research should consider the integrated relationships among movement behaviours , and similar integrated guidelines for other age groups should be developed | [
"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",
"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",
"This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence",
"The purpose of this analytical review was to estimate the direct and indirect economic costs of physical inactivity and obesity in Canada in 2001 . The relative risks of diseases associated with physical inactivity and obesity were determined from a meta- analysis of existing prospect i ve studies and applied to the health care costs of these diseases in Canada . Estimates were derived for both the direct health care expenditures and the indirect costs , which included the value of economic output lost because of illness , injury-related work disability , or premature death . The economic burden of physical inactivity was $ 5.3 billion ( $ 1.6 billion in direct costs and $ 3.7 billion in indirect costs ) while the cost associated with obesity was $ 4.3 billion ( $ 1.6 billion of direct costs and $ 2.7 billion of indirect costs ) . The total economic costs of physical inactivity and obesity represented 2.6 % and 2.2 % , respectively , of the total health care costs in Canada . The results underscore the importance of public health efforts aim ed at combating the current epidemics of physical inactivity and obesity in Canada",
"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"
] | 41166b40-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND The ' off-label ' effect of alprazolam on depression has not been systematic ally evaluated . OBJECTIVES To determine the antidepressant effect , including tolerability and acceptability , of alprazolam as monotherapy for major depression , when compared to placebo and conventional antidepressants in out patients and patients in primary care . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials and the Cochrane Depression , Anxiety and Neurosis Group Register , which includes relevant r and omised controlled trials from the following bibliographic data bases : The Cochrane Library ( all years to February 2012 ) ; EMBASE ( 1970 to February 2012 ) ; MEDLINE ( 1950 to February 2012 ) and PsycINFO ( 1960 to February 2012 ) . Two review authors identified relevant trials by assessing the abstract s of all possible studies . We applied no language restrictions . SELECTION CRITERIA We selected r and omised controlled trials ( RCTs ) of alprazolam versus placebo or conventional antidepressants for depression in adults , excluding studies with in patients only . DATA COLLECTION AND ANALYSIS Two review authors performed the data extraction and ' Risk of bias ' assessment independently with disagreements resolved through discussion with a third review author . Primary outcomes included the mean difference ( MD ) in reduction of depression on a continuous measure of depression symptoms , and the risk ratio ( RR ) of the clinical response based on a dichotomous measure , with 95 % confidence intervals ( CI ) . MAIN RESULTS We identified 21 alprazolam studies ( 22 reports ) with a total of 2693 participants . Seven studies used a placebo ( n = 771 ) and 20 used cyclic antidepressants ( n = 1765 ) . The typical duration of the studies was four to six weeks . We considered six studies to have a high risk of bias . When alprazolam was compared with placebo for reduction in symptoms all estimates indicated a positive effect for alprazolam . Pooled estimates of efficacy data showed a moderately large continuous mean difference ( MD ) at the end of trial ( -5.34 , 95 % CI -7.48 to -3.20 ; I(2 ) = 68 % ) . The risk difference ( RD ) for the dichotomous measure of clinical response ( 50 % improvement ) was 0.32 in favour of alprazolam ( 95 % CI 0.22 to 0.42 ; I(2 ) = 0 % ) , with a number needed to treat to benefit ( NNTB ) of 3 ( 95 % CI 2 to 5 ) . The RD of all-cause withdrawals did not differ between alprazolam and placebo . When depression severity was measured as a continuum the effect of alprazolam did not differ statistically or clinical ly from the effects of any of the conventional antidepressants combined ( MD 0.25 , 95 % CI -0.93 to 1.43 ; I(2 ) = 55 % ) . However , for dichotomised depression severity , alprazolam had less effect than antidepressants ( RR 0.86 , 95 % CI 0.75 to 0.99 ; I(2 ) = 37 % ; RD -0.11 , 95 % CI -0.24 to 0.01 ; I(2 ) = 58 % ; NNTB 9 , 95 % CI 4 to 100 ) . The RD of all-cause withdrawals was -0.04 ( 95 % CI -0.07 to 0.00 ; I(2 ) = 35 % ) , in favour of alprazolam . AUTHORS ' CONCLUSIONS Alprazolam appears to reduce depressive symptoms more effectively than placebo and as effectively as tricyclic antidepressants . However , the studies included in the review were heterogeneous , of poor quality and only addressed short-term effects , thus limiting our confidence in the findings . Whilst the rate of all-cause withdrawals did not appear to differ between alprazolam and placebo , and withdrawals were less frequent in the alprazolam group than in any of the conventional antidepressants combined group , these findings should be interpreted with caution , given the dependency properties of benzodiazepines | [
"Alprazolam is the first of the triazolobenzodiazepines to be studied in a large population of depressed patients . In a six-week , double-blind multicenter comparison of alprazolam , imipramine hydrochloride , and placebo in the treatment of 723 patients with depression , the two active drugs were statistically more effective than placebo . Alprazolam was at least as effective as imipramine in relieving depressive symptoms , significantly more effective in relieving somatic symptoms , and showed an earlier onset of activity in some measurements . Anticholinergic side effects were reported most often by patients receiving imipramine , while drowsiness was the only side effect reported most often in the alprazolam group . The Feighner Diagnostic Criteria and pre study and post study intercenter conferences with videotaped patient interviews ensured interrater reliability",
"In a four-week double-blind study comparing alprazolam with oxazepam , 62 out patients suffering from anxiety with depressive symptoms were evaluated . The average daily doses of alprazolam and oxazepam were 1.48 mg and 44.4 mg , respectively . According to all rating scales applied , both alprazolam and oxazepam were effective in relieving anxiety associated with mild depression ( p less than 0.01 ) . Alprazolam proved somewhat more effective than oxazepam especially with regard to overall performance ( p less than 0.05 ) . Treatment-emergent adverse effects were few and mild for both compounds tested",
"The purpose of this study was to compare the safety and efficacy of a relatively new antidepressant drug , alprazolam ( a triazolobenzodiazepine ) with imipramine in the treatment of 60 depressed symptomatic volunteers . Eligible patients were r and omly assigned after a 1-week washout to one of the medications and followed for 6 treatment weeks . Contrary to the earlier report of Feighner et al. ( 1983 ) , who found alprazolam superior to imipramine and placebo , but consistent with Rush et al. ( 1985 ) we find imipramine superior in efficacy to alprazolam on a variety of symptoms . Both the present study and Rush 's study employed patients with signs indicative of response to tricyclics . Feighner 's patients may have been the type who tend to be less responsive to tricyclics but may be more responsive to alprazolam . Some of our data also show that alprazolam may have a more advantageous effect in the early weeks of treatment but is overtaken in subsequent treatment weeks by imipramine",
"The therapeutic effect and safety of alprazolam and doxepin were studied in 126 out patients suffering from primary unipolar depression . The 6-week study was double-blind with a r and om allocation of treatment . Patients were treated with a flexible dose of 1.0 - 4.5 mg of alprazolam and 50 - 225 mg of doxepin per day . The mean final doses were 2.7 mg for alprazolam and 137.5 mg for doxepin . The results indicate that alprazolam and doxepin were equally efficacious . The incidence of side-effects was lower in the alprazolam treatment group",
"This paper presents findings from a multisite study of 126 subjects meeting DSM-III-R criteria for Panic Disorder who also met criteria for a concurrent Major Depressive Episode , Dysthymia , or Depressive Disorder NOS . The study 's primary aim was to discern the influence of varying degrees of depression on the comparative efficacy of alprazolam , imipramine and placebo on anxiety outcomes . A placebo-controlled , double-blind , parallel r and om assignment design was utilized over a total of 16 weeks . There was no medication effect on panic outcomes . At endpoint , percent of anticipatory anxiety ( i.e. , time spent worrying about having an anxiety attack ) was significantly lower in the patients taking active medications vs. placebo . Phobic measures were significantly improved by alprazolam , vs. both imipramine and placebo early in the study ; however , by week 8 both active medications were equally superior to placebo in the reduction of phobic symptoms . In addition , both active medications were significantly more effective than placebo in reducing depression . The same efficacy pattern ( i.e. , active medications superior to placebo ) was observed on measures of general functioning . Importantly , there were no significant interactions observed between medication and presence of major depression on the depression measures , indicating that both alprazolam and imipramine were equally efficacious in treating the depression in patients with panic disorder and major depression . Since the patients enrolled in this study suffered from major depressive disorder in the mild to moderate severity range , these results may not be transferrable to patients with panic disorder and severe major depression",
"This study examines clinical predictors of outcome for patients with panic disorder and depression in a 16 week , placebo-controlled trial of alprazolam and imipramine ( n = 126 ) . Baseline global severity of illness and phobic avoidance were differentially predictive of acute response to treatment . Patients in the mild to moderate range of global distress experienced smaller degrees of improvement on alprazolam than on imipramine at week 4 . At endpoint , the relative effectiveness of the active medication versus placebo was diminished in patients with higher levels of phobic avoidance . This relationship was not evident for completers , suggesting that the adverse effects of avoidance on outcome after sustained treatment was reduced",
"The efficacy and safety of alprazolam as compared to imipramine or a placebo added to weekly interpersonal psychotherapy was compared in a 6-week double-blind r and omized clinical trial of 35 ambulatory elderly patients with major depression . The average maximum dosage of alprazolam was 2.2 mg and the average maximum dosage of imipramine was 97.5 mg . The findings showed a rapid onset of action of alprazolam within 1 week on symptoms of depression and anxiety . The effects for imipramine were seen later in the study . There were no serious side effects that interfered with treatment . The anticholinergic effects of imipramine were the ones that most commonly interfered with treatment . Alprazolam produced the greatest number of symptoms with discontinuation , most of which were alleviated within a week . We conclude that alprazolam may be useful as an antidepressant for the elderly . More clinical trials are needed to test its efficacy in the depressed elderly with concomitant medical problems , using plasma levels . A double-blind discontinuation study of alprazolam is needed to determine the degree of symptom return",
"This study was design ed to compare the antidepressant effects of alprazolam and amitriptyline in a group of 30 in patients suffering from a severe major endogenous depression , diagnosed by Research Diagnostic Criteria and the Newcastle Rating scale , and to examine the effects of alprazolam and amitriptyline on two biological markers of depression , the dexamethasone suppression test and sleep EEG parameters . The 6-week study was double-blind with a r and om allocation of treatment . Patients were treated with flexible doses of 4 - 9 mg of alprazolam and 100 - 225 mg of amitriptyline . After 4 weeks of treatment the antidepressant effects of amitriptyline significantly exceeded those of alprazolam , as measured on the Hamilton Rating Scale for Depression . There was a high drop-out rate in the alprazolam group because of ineffectiveness of treatment . Alprazolam showed similar effects on sleep parameters as amitriptyline : lengthening of the REM latency and a tendency to shorten stages 3 and 4 and stage REM . These negative clinical results should be interpreted with caution , because of the severity of our selection criteria , and should not be extended to all depressive disorders",
"One hundred patients with mixed symptoms of anxiety and depression were enrolled into a prospect i ve , multi-centre , r and omized , double-blind study comparing the response to , and the side-effects of , alprazolam and dothiepin hydrochloride over 4 weeks of treatment . Mean daily doses were 2.33 mg alprazolam and 115 mg dothiepin . Data on 96 patients were evaluated for tolerance , and data for 85 patients were analyzed for therapeutic response . In each case , the groups were similar in numbers , mean ages and sex ratios . Both groups experienced satisfactory responses to therapy , with highly statistically significant changes ( p less than 0.001 ) in the means of all efficacy measures within each group . No statistical difference was demonstrated in favour of either treatment group . Both dothiepin and alprazolam exhibited a similar profile of mild minor side-effects , but more patients suffered moderate to severe reactions to dothiepin , leading to a greater drop-out rate in the dothiepin-treated group . It is concluded that , as both treatments produced equally satisfactory responses in this study , alprazolam should be considered for the treatment of anxiety associated with depression in patients for whom tricyclic antidepressant drugs are either contra-indicated or poorly tolerated",
"SUMMARY This report describes the results of a multicentre collaborative study comparing the safety and efficacy of alprazolam with imipramine in patients suffering from major depressive disorder . Two hundred and eight patients diagnosed as major depression as per DSM-III criteria were r and omly allocated to alprazolam ( N= 105 ) or imipramine ( N = 103 ) in a double-blind fashion . Detailed assessment s were carried out for a period of six weeks . Results revealed that alprazolam was as effective as imipramine as an antidepressant . Side effects were less frequently reported with alprazolam",
" Forty-three out- patients with depression of a moderate degree were enrolled in a r and omized , double-blind parallel group study comparing amitriptyline and alprazolam for 6 weeks of treatment . Patients were evaluated at the end of placebo washout and at Weeks 1 , 2 , 3 and 6 of drug therapy using the Hamilton Depression Rating Scale ( HAM-D ) , Hamilton Anxiety Rating Scale ( HAM-A ) , Beck Depression Inventory ( BDI ) and Clinical Global Impression ( CGI ) . Drug dosage was determined in a fixed-flexible design result ing in mean final doses of alprozalam 3.2 mg/day and of amitriptyline 115 mg/day . Although both drug groups improved there were statistically significant differences in favour of amitriptyline at the end of the study on the HAM-D , BDI and HAM-A scales . Patients on amitriptyline reported more side effects overall than patients taking alprazolam with significantly more reports of dry mouth in the amitriptyline group",
"The usefulness of the Zung Self-Rating Depression Scale as a screening instrument to uncover masked depression , and the benefits of early identification and treatment with alprazolam , were evaluated in a general medical practice population . There was a 95 % scale acceptance by patients and a 12 % overall prevalence of depression based on SDS results . Patients who scored in the depressed range on the SDS were , on a r and omized basis , either identified immediately to their physicians and treated with alprazolam ( N = 21 ) or identified after 4 weeks ( natural history controls , N = 20 ) . Treatment result ed in improvement in 66 % of the identified group versus a 35 % spontaneous improvement in the control group ( p less than .05 )",
"The objectives of this prospect i ve study were to calculate incidence rates for fall-related hospitalization , to compare the effect of risk factors among benzodiazepine ( BZD ) users and unexposed controls , and to examine variations in risks according to length of time following a BZD prescription . Data were derived from Saskatchewan Health linked data bases , leading to information on 468 hospitalizations for injury due to falls among a study population of 321422 . Incidence rates per 10000 within 28 days of the prescription fill date were 26.2 , 12.1 and 9.0 for BZD sedative users , BZD tranquillizer users and for unexposed controls , respectively . Incidence rates increased with age , and were higher for women than for men . Results from multivariate logistic regression models also showed a greater risk of falling for BZD users but the odds ratio was higher for men than for women . A history of treatment for alcohol abuse was a very strong risk factor for falls among both men ( odds ratio , 10.7 ) and women ( odds ratio , 4.3 ) . The highest risk of serious injury due to falls was within 15 days of filling the prescription , with an odds ratio of 3.6 for BZD sedatives and 2.6 for BZD tranquillizers . Risk decreased with further increase of time after the BZD fill date . For the individual BZD , flurazepam and triazolam showed the highest increase in risk with odds ratios of 3.4 and 2.7 , respectively , while oxazepam , lorazepam and diazepam showed odds ratios of 2.2 , 2.0 and 1.8 ( all odds ratios mentioned are statistically significant at p < 0.05 )",
"ABSTRACT — In a double‐blind r and omized study the therapeutic effect and safety of alprazolam was compared with amitriptyline in 81 out patients suffering from major depression . Variable dosages of both drugs were used , the mean final dose of alprazolam being 3.05 and that of amitriptyline 130 mg . Both treatment groups improved steadily , assessed weekly with the use of the Hamilton Rating Scale for Depression , and no significant differences were found between the groups , either on comparison between single items or total scores . On several of the criteria used for assessment of treatment response , however , more patients responded to amitriptyline than to alprazolam . In an analysis of specific subgroups , patients whose depression was accompanied by retardation , those in whom there were no precipitating factors and those with low levels of anxiety , responded better to amitriptyline . Considerably fewer side effects were reported by patients receiving alprazolam . In particular , there was a significantly lower incidence of dry mouth , light‐headedness , tremor and tachycardia in patients receiving alprazolam compared with amitriptyline",
"This r and omized double-blind study in 342 mildly to moderately depressive out patients investigated the antidepressant effectiveness and speed of action of lorazepam , alprazolam and amitriptyline versus placebo . Six weeks of drug treatment were followed by a drug taper period , a control period with placebo and a control period without placebo , of 2 weeks duration each . Clinical improvement was assessed by rating scales ( Clinical Global Impressions , Hamilton Rating Scales for Depression and Anxiety ) and patient 's self-ratings ( Patient 's Global Impressions , Self-rating Depression Scale and Visual Analogue Scale ) . At the end of week 6 all active drugs showed similar efficacy which was significantly superior to placebo . Compared to placebo , onset of efficacy was earlier on benzodiazepines than on amitriptyline . While tapering by decreasing the dosage , replacing drug with placebo and finally discontinuing placebo , clear withdrawal phenomena were not seen , but 20 % of patients , equally distributed to all treatment groups , did not want to stop taking tablets after replacing drug with placebo . Drop-out rate during the treatment period was very low ( 9 % ) . Significantly interfering adverse effects were seen in 27 patients , without predominance in one of the active drug groups",
"Summary 104 patients suffering from neurotic or reactive depressioDDn were treated with either alprazolam or amitriptyline in r and omised , double-blind fashion . Seventeen patients were either lost to follow-up3 or withdrawn before week 2 ( 13 due to side effects and 1 because she was feeling better ) . A further 7 patients did not comply with the protocol , giving a total of 24 patients whose data were not considered suitable for inclusion in the analysis of therapeutic assessment s . Evaluation of the 80 patients ( 40 in each group ) who completed at least 2 weeks of the 4-week study demonstrate that both treatments produced a statistically significant response rate . There was a more rapid effect in those patients who received amitriptyline , but there was no significant difference in response between the treatment groups after 4 weeks treatment . Analysis of safety and side effect data on 101 patients ( 50 treated with alprazolam and 51 with amitriptyline ) shows no statistically significant difference in the overall number of side effects experienced in each group , although 11 of those patients who received amitriptyline withdrew because of adverse reactions before completing the study compared to 6 in the alprazolam group . These results suggest that alprazolam may be a useful treatment for patients with neurotic or reactive depression not requiring hospitalisation",
"This study was design ed to compare the antidepressant effects of alprazolam , a triazolobenzodiazepine , with amitriptyline hydrochloride in a group of patients with nonpsychotic , major depressions diagnosed by Research Diagnostic Criteria . A mean rapid eye movement latency of less than 65 minutes was required to enter this study . Dexamethasone suppression tests were conducted before treatment . By strictly applied Research Diagnostic Criteria , 83.6 % of the subjects were endogenous , and 34.7 % were in patients . A significantly greater percentage of alprazolam-treated patients responded within the first seven days of treatment . By the end of this six-week trial , alprazolam was associated with significant reductions in Hamilton , Beck , Covi , Raskin , and Carroll Rating scores ( pretreatment to posttreatment ) . However , by the end of treatment the effects of amitriptyline exceeded those of alprazolam on both the Hamilton and Beck scales . These data indicate that alprazolam is not as effective as amitriptyline in major depressions with a shortened rapid eye movement latency",
"The antidepressant efficacy of alprazolam ( ALP ) was tested in a double-blind controlled comparison with desipramine ( DMI ) and an ALP-DMI combination in out patients diagnosed with major depressive disorder by Research Diagnostic Criteria ( 90 % met criteria for endogenous subtype ) . Following a placebo period of at least 1 week , subjects who continued to meet severity criteria defined by Hamilton Depression Rating Scale ( HDRS ) scores were administered oral doses of the active medication ( N = 79 ) , in a dose ratio of 1 mg ALP:50 mg DMI:1 mg ALP + 50 mg DMI . Treatment continued for 6 weeks , and all subjects who completed at least 2 weeks ( N = 69 ) were included in endpoint analyses . Following the placebo baseline , symptoms were rated again at day 5 and at the end of weeks 1 , 2 , 4 , and 6 . Final doses averaged 4.6 ± 1.3 mg for the ALP group , 230 ± 61 mg for the DMI group , and 4.6 ± 1.2 mg ALP + 229.5 ± 1.2 mg DMI for the combination group . The final outcome was a comparable degree of improvement at the end-point among the three treatment groups on measures of depression ( HDRS and Beck Depression Inventory ) , anxiety ( Hamilton Anxiety Rating Scale ) , and global improvement ( Global Assessment Scale , and Physician and Patient Global Impressions ) . A similar outcome was found for the subgroup of patients who completed all 6 weeks ( N = 56 ) . Endpoint analyses also showed that ALP-treated subjects responded sooner and continued to show improvement throughout the course of the study on measures of depression , anxiety , and global status . These results suggest that ALP alone is as effective as a st and ard tricyclic for the acute treatment of patients with major depressive disorder and that significant improvement may occur within the first week of medication . Side effect profiles were compared among treatment groups and are discussed , as are other clinical studies that have investigated ALP 's potential antidepressant efficacy . ( J Clin Psychopharmacol 1987;7:295—310",
"Fifty-four patients ( 34 out patients , 20 in patients ) fulfilling Research Diagnostic Criteria for Definite Major Depressive Disorder were enrolled in a double-blind study comparing the antidepressant effects of alprazolam versus desipramine . The mean daily dose of alprazolam and desipramine at study termination was 3.78 mg and 208 mg respectively . As there were no significant demographic or clinical differences between out patients and in patients , both groups were combined in data analysis . Using the Hamilton Depression Rating Scale ( HAM-D ) both drug groups showed highly significant improvement beginning with the first week of active drug treatment . HAM-D scores continued to decrease through study termination ( six weeks of active drug ) . There were no significant differences when comparing alprazolam and desipramine ( out patients , in patients , or both groups combined ) on any of the subjective or objective psycho-metrics used in this study . Clinical ly , only twelve of thirty-four out patients ( 35.3 % ) were felt to be “ markedly or moderately ” improved , suggesting that neither the outpatient alprazolam nor desipramine patients did particularly well with drug treatment . In terms of drug safety there was no difference between the alprazolam and desipramine in the number of excessive or serious drug side effects . However , five of twenty-nine alprazolam patients had to discontinue therapy because of excessive drowsiness , and two of the alprazolam out patients had motor vehicle accidents directly related to this adverse event . Alprazolam appeared as effective as desipramine in the pharmacotherapy of this group of depressed outpatient and in patients . Alprazolam appeared well-tolerated by most subjects although drowsiness was a common — and at times serious — medication side effect",
"Two hundred forty-one out patients with a DSM-III diagnosis of major depressive disorder participated in a six-week double-blind therapeutic trial of alprazolam , diazepam , imipramine hydrochloride , and placebo . Side effects were given as a major reason for attrition by patients taking the three active compounds and ineffectiveness was the reason given by patients taking placebo . Imipramine-treated patients reported the most and placebo patients the least number of adverse effects . Imipramine and alprazolam , but not diazepam , produced significantly more improvement in depressed symptomatology than did placebo . Mean diazepam scores frequently assumed an intermediate position between those of imipramine or alprazolam and placebo . These treatment differences were found to be independent of initial severity levels of anxiety and depression",
"We compared the effect of abrupt discontinuation of therapeutic doses of short half-life and long half-life benzodiazepines in 57 benzodiazepine-dependent patients ( daily use , greater than 1 year ) . Despite the use of a mean daily dose of 14.1 mg of diazepam equivalents , there were notable residual symptoms of anxiety and depression present at intake ( Hamilton Rating Scale for Anxiety score , 17.0 ; Hamilton Rating Scale for Depression score , 14.0 ) . Benzodiazepine intake was stabilized for 3 weeks before double-blind assignment to placebo ( n = 47 ) , or continued benzodiazepine use ( n = 10 ) . Clinical assessment s were performed daily , including benzodiazepine plasma levels . Depending on the outcome criteria used , anywhere from 58 % to 100 % of patients were judged to have experienced a withdrawal reaction , with a peak severity at 2 days for short half-life and 4 to 7 days for long half-life benzodiazepines . Relapse onto benzodiazepines occurred in 27 % of patients who were receiving long half-life benzodiazepines and in 57 % of patients who were receiving short half-life benzodiazepines . Baseline predictors of relapse were nonpanic diagnoses , a higher benzodiazepine dose , and a higher Eysenck neuroticism score . A short half-life and higher daily doses were associated with greater withdrawal severity , as were personality traits , such as dependency and neuroticism , less education and higher baseline levels of anxious and depressive symptoms . Patients who were able to remain free of benzodiazepines for at least 5 weeks obtained lower levels of anxiety than before benzodiazepine discontinuation . These results provide a detailed picture of the symptoms , time course , and multidimensional determinants of the benzodiazepine withdrawal syndrome",
" Five hundred four out patients suffering from a major depressive episode were r and omly assigned to receive either amitriptyline , doxepin , alprazolam , or placebo . The study was conducted in three treatment centers during a six-week period . All three active medications produced significantly more clinical improvement than did placebo , irrespective of the patient 's initial anxiety , depression , and psychomotor retardation and irrespective of the patient 's assignment to various subtypes of depression , including the DSM-III melancholia subtype . Compared with placebo , sedation was reported more frequently with all three medications , whereas anticholinergic effects were reported more frequently only for the two tricyclic antidepressants , but not for alprazolam",
" Ninety-eight out patients with major depressive disorder were treated with alprazolam , imipramine , or placebo in a 6-week , double-blind study . Average doses were 3.67 mg of alprazolam and 167 mg of imipramine , given at bedtime . Fifty percent of patients taking alprazolam , 38.2 % taking imipramine , and 17.7 % receiving placebo improved their HAM-D scores by more than 50 % . Eight patients on imipramine , 6 on alprazolam , and 1 on placebo dropped out because of side effects . The most common side effects for imipramine were tachycardia , constipation , light-headedness , and sedation ; common side effects of alprazolam were light-headedness , sedation , and unsteadiness",
"Fifty-two adult depressed out patients fulfilling Research Diagnostic Criteria for Definite Major Depressive Disorder were enrolled in a double-blind study comparing the antidepressant effects of alprazolam versus desipramine . Twenty-nine patients completed the seven week ( one week placebo followed by six weeks of active drug ) study . The mean daily dose of alprazolam and desipramine at study termination was 3.34 mg and 192 mg respectively . Based on psychometric ratings of depression ( Hamilton Scale ) and severity of illness ( Clinical Global Impressions ) there was no significant difference between alprazolam and desipramine at the end of six weeks of active drug treatment . Both medications were well tolerated with drowsiness being the most common side effect of alprazolam , and insomnia , dry mouth , and constipation , the complaints most associated with desipramine",
"We compared the effect on withdrawal severity and acute outcome of a 25 % per week taper of short half-life vs long half-life benzodiazepines in 63 benzodiazepine-dependent patients . Patients unable to tolerate taper were permitted to slow the taper rate . Ninety percent of patients experienced a withdrawal reaction , but it was rarely more than mild to moderate . Nonetheless , 32 % of long half-life and 42 % of short half-life benzodiazepine-treated patients were unable to achieve a drug-free state . The most difficulty was experienced in the last half of taper . Baseline personality , high Eysenck neuroticism , female sex , and mild-to-moderate alcohol use were found to be more significant predictors of withdrawal severity than the daily benzodiazepine dose or benzodiazepine half-life . These findings suggest that personality factors contribute significantly to the patient 's difficulties with gradual benzodiazepine discontinuation of therapeutic doses of benzodiazepines",
"Despite the fact that there is a high prevalence of depression among the elderly , little research on the efficacy of psychotherapy or pharmacotherapy with the elderly has been reported in the literature . This paper describes a sample of 18 elderly patients who received both psychotherapy and pharmacotherapy for the treatment of depression . Psychotherapy involved weekly 30 - 50 minutes sessions of interpersonal psychotherapy with a treating psychiatrist . The drug treatment consisted of r and om assignment , double-blind , to either alprazolam , imipramine , or pill-placebo for six weeks . The focus of therapy was on the attendance , compliance , and symptomatic relief in elderly depressed patients , as well as on the major life problems identified by these patients in psychotherapy . Results indicated that elderly patients respond to community publicity regarding a psychotherapy treatment program . However , the majority are inappropriate referrals for diagnostic reasons . If accepted , elderly patients showed good compliance with drugs , and attendance was comparable to that in younger population s. The elderly patients responded well to treatment , with immediate and marked improvement on the Hamilton and Raskin Depression Scales , which was maintained after treatment . Grief and role transitions specific to life changes were frequent antecedents to depression in this elderly population and thus were the major foci in psychotherapy",
"In this report , which is an up date of a guideline published in 2002 ( B and elow et al. 2002 , World J Biol Psychiatry 3:171 ) , recommendations for the pharmacological treatment of anxiety disorder , obsessive-compulsive disorder ( OCD ) and post-traumatic stress disorder ( PTSD ) are presented . Since the publication of the first version of this guideline , a substantial number of new r and omized controlled studies of anxiolytics have been published . In particular , more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs . The recommendations , developed by the World Federation of Societies of Biological Psychiatry ( WFSBP ) Task Force for the Pharmacological Treatment of Anxiety , Obsessive-Compulsive and Post-traumatic Stress Disorders , a consensus panel of 30 international experts , are now based on 510 published r and omized , placebo- or comparator-controlled clinical studies ( RCTs ) and 130 open studies and case reports . First-line treatments for these disorders are selective serotonin reuptake inhibitors ( SSRIs ) , serotonin-noradrenaline reuptake inhibitors ( SNRIs ) and the calcium channel modulator pregabalin . Tricyclic antidepressants ( TCAs ) are equally effective for some disorders , but many are less well tolerated than the SSRIs/SNRIs . In treatment-resistant cases , benzodiazepines may be used when the patient does not have a history of substance abuse disorders . Potential treatment options for patients unresponsive to st and ard treatments are described in this overview . Although these guidelines focus on medications , non-pharmacological were also considered . Cognitive behavioural therapy ( CBT ) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders , OCD , and PTSD to support them being recommended either alone or in combination with the above medicines",
"A 6-week double-blind comparison of the therapeutic efficacy of alprazolam and imipramine in 90 depressed psychiatric out patients revealed a significantly superior response to alprazolam in the first 2 weeks of treatment as measured by total scores on the Hamilton Rating Scale for Depression and the Brief Psychiatric Rating Scale . Further analyses revealed that all significant differences could be accounted for by the superior effect of alprazolam on sleep disturbance . By the end of Weeks 4 and 6 , no significant differences in therapeutic response between the two treatment groups were noted , with patients in both groups evidencing improvement on all measures . A differentially high dropout rate among patients in the imipramine treatment group posed a problem for interpretation of results in the latter weeks of treatment",
"In a six week , double-blind , parallel study of alprazolam and amitriptyline hydrochloride in 130 out patients suffering from moderate to severe nonpsychotic depression , alprazolam was as effective as amitriptyline hydrochloride in relieving depressive symptoms and significantly more effective in relieving symptoms of anxiety and somatization . Alprazolam showed an earlier onset of activity in most measurements of efficacy and produced fewer side effects than amitriptyline hydrochloride . Anticholinergic side effects were reported more frequently by patients taking amitriptyline hydrochloride , while drowsiness was reported more frequently by patients taking alprazolam . At the end of the study , the average daily doses were 2.4 mg alprazolam and 135 mg amitriptyline hydrochloride . The Hamilton Psychiatric Rating Scale for Depression , Hamilton Anxiety Rating Scale , Physician 's Global Impressions , Patients ’ Global Impressions , Hopkins Self-Rating Symptom Scale , and Symptom and Side Effects Checklist were evaluated at the end of weeks 1 , 2 , 3 and 6 to determine and compare the efficacy and safety of the two study drugs",
"The authors analyzed the relative contributions of improvement in depressive and anxiety symptoms , as measured by the Hamilton Rating Scale for Depression ( HRSD ) and the Hamilton Rating Scale for Anxiety ( HRSA ) , respectively , after 1 week of treatment to the prediction of improvement in HRSD score after 6 weeks of antidepressant pharmacotherapy . Fifty-six subjects completed 6 weeks of treatment with either desipramine ( n = 20 ) , alprazolam ( n = 18 ) , or a desipramine-alprazolam combination ( n = 18 ) . The results showed that early improvement in the HRSD was a moderately strong predictor of the total 6-week improvement in HRSD score , and a better predictor than early improvement in the HRSA . Partial correlations showed that early HRSD improvement was significantly related to total HRSD improvement within the alprazolam group . This pattern of response differed from those observed for the other treatment groups . Desipramine-treated subjects showed gradual improvement over the course of the study , and the improvement in week 1 was not so strongly predictive of overall improvement . The relationship between early and total HRSD improvement for the combination treatment group was intermediate to the other two groups . These findings are discussed in the context of the relationship between depression and anxiety , and potential implication s for the treatment of these overlapping and often mixed syndromes",
"To investigate the effectiveness of a new benzodiazepine , alprazolam , and to compare this with amitriptyline ( AMT ) and with placebo , a trial was undertaken in 65 patients in whom depression was considered to be the dominating feature but not considered to be the primary cause of their condition ; it was design ed to exclude endogenous depressions . A consistent pattern was found favouring alprazolam over AMT both in rate of response and in total response , as well as significant differences in favour of both alprazolam and AMT over placebo . A comparison of side effects showed a definite trend in favour of alprazolam and placebo over AMT",
"A MAJOR aim of the present study was to examine the differential effects of chlorpromazine and imipramine among various depression subgroups . Tests were made of differential drug effects among Overall et al 's 1 three empirically derived depressive subtypes , ie , anxious , hostile , and withdrawn-retarded depressives . These investigators found a tranquilizer , thioridazine , best for their anxious depressives and imipramine best for the withdrawn-retarded depressives . An examination was also made of differential drug effects among psychotic depressives , neurotic depressives , and schizophrenics with depression . As there is a tendency in this country to equate psychotic depression with endogenous depression , study findings may have some relevance for the endogenous-neurotic distinction . Proponents of this distinction have reported that imipramine is especially efficacious for endogenous depression and of little value in neurotic depressions . 2 - 12 Finally , tests were made of differential drug effects among depressed patients categorized on the basis of sex and age ( below 40 and 40"
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PURPOSE There are many anecdotal cl aims and research reports that coloured lenses and overlays improve reading performance . Here we present the results of a systematic review of this literature and examine the quality of the evidence . METHODS We systematic ally review ed the literature concerning the effect of coloured lenses or overlays on reading performance by search ing the PsychInfo , Medline and Embase data bases . This revealed 51 published items ( containing 54 data sets ) . Given that different systems are in use for issuing coloured overlays or lenses , we review ed the evidence under four separate system headings ( Intuitive , Irlen , Harris/Chromagen and Other ) , classifying each published item using the Cochrane Risk of Bias tool . RESULTS Although the different colour systems have been subjected to different amounts of scientific scrutiny , the results do not differ according to the system type , or whether the sample under investigation was classified as having visual stress ( or a similarly defined condition ) , reading difficulty , or both . The majority of studies are subject to ' high ' or ' uncertain ' risk of bias in one or more key aspects of study design or outcome , with studies at lower risk from bias providing less support for the benefit of coloured lenses/overlays on reading ability . While many studies report improvements with coloured lenses , the effect size is generally small and /or similar to the improvement found with a placebo condition . We discuss the strengths and shortcomings of the published literature and , whilst acknowledging the difficulties associated with conducting trials of this type , offer some suggestions about how future trials might be conducted . CONCLUSIONS Consistent with previous review s and advice from several professional bodies , we conclude that the use of coloured lenses or overlays to ameliorate reading difficulties can not be endorsed and that any benefits reported by individuals in clinical setting s are likely to be the result of placebo , practice or Hawthorne effects | [
"Additional unpublished data are presented from a study by Cotton and Evans in 1990 on the use of Irlen ( tinted ) lenses as an intervention for 22 children with a reading disability . These data reinforce rhe earlier conclusion that the r and om facilitatory effects of the lenses are very likely attributional and motivational in nature",
"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 We explore whether the number of None results in large National Heart Lung , and Blood Institute ( NHLBI ) funded trials has increased over time . Methods We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease . Trials were included if direct costs > $ 500,000/year , participants were adult humans , and the primary outcome was cardiovascular risk , disease or death . The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000 , whether they registered in clinical trials.gov prior to publication , used active or placebo comparator , and whether or not the trial had industry co-sponsorship . We tabulated whether the study reported a positive , negative , or None result on the primary outcome variable and for total mortality . Results 17 of 30 studies ( 57 % ) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 ( 8 % ) trials published after 2000 ( χ2=12.2,df= 1 , p=0.0005 ) . There has been no change in the proportion of trials that compared treatment to placebo versus active comparator . Industry co-sponsorship was unrelated to the probability of reporting a significant benefit . Pre- registration in clinical trials.gov was strongly associated with the trend toward None findings . Conclusions The number NHLBI trials reporting positive results declined after the year 2000 . Prospect i ve declaration of outcomes in RCTs , and the adoption of transparent reporting st and ards , as required by clinical trials.gov , may have contributed to the trend toward None findings",
"Aim : To test a theory of visual stress by investigating the inter-relationships between ( 1 ) the threshold contrast/saturation at which individuals first report discomfort when viewing colored gratings of progressively increasing contrast and decreasing saturation ; ( 2 ) the choice of a colored overlay for reading ; ( 3 ) any increase in reading speed when the overlay is used . Method : Ninety-five young adults , with normal color vision , reported illusions from square-wave gratings ( Pattern Glare Test ) , chose any colored overlays that improved clarity ( Intuitive Color Overlays ) and read aloud r and omly ordered common words ( Wilkins Rate of Reading Test ) . This was followed by an automated choice of tints for text using various screen colors on a tablet , and a test of discomfort from patterns of progressively increasing contrast and decreasing saturation , using software developed for this study . All participants wore their optimal refractive correction throughout the procedure . Results : Fifty-eight participants chose a colored overlay and reported that it made text easier and more comfortable to read . On average , these individuals had a greater improvement in reading speed with their overlays ( p = 0.003 ) , a lower contrast threshold at which discomfort from achromatic gratings was first reported ( p = 0.015 ) , and a tendency to report more pattern glare ( p = 0.052 ) , compared to the other participants . Participants who chose both a most and least preferred tint for text using the automated procedure reported discomfort from colored gratings at a significantly higher contrast with their most preferred color compared to their least preferred color ( p = 0.003 ) . The choice of a colored tint was moderately consistent across tests . The most and least preferred colors tended to be complementary . Conclusion : Colored tints that improved reading speed reduced pattern glare both in terms of the illusion susceptibility and in terms of discomfort contrast threshold , supporting a theory of visual stress . An automated test that incorporates colored gratings and a choice of most and least preferred color might better identify individuals whose reading speed improves with colored overlays",
"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",
"Abstract Purpose : Visual disturbances that make it difficult to read text are often termed “ visual stress ” . Coloured filters in spectacles may help some children overcome reading problems that are often caused by visual stress . It has been suggested that for optimal effect each child requires an individually prescribed colour for each eye , as determined in systems such as the “ Harris Foundation ” coloured filters . Alternatively , it has been argued that only blue or yellow filters , as used in the “ Dyslexia Research Trust ” ( DRT ) filter system , are necessary to affect the underlying physiology . Method : A r and omised , double blind trial with 73 delayed readers , was undertaken to compare changes in reading and spelling as well as irregular and non-word reading skills after 3 months of wearing either the Harris or the DRT filters . Results : Reading improved significantly after wearing either type of filter ( t = −8.4 , p their reading age by 6 months or more during the 3 month trial . However , spelling ability ( t = 2.1 , p = 0.05 ) and non-word reading ( f = 4.7 , p the DRT than with the Harris filters . Conclusion : Education and rehabilitation professionals should therefore , consider coloured filters as an effective intervention for delayed readers experiencing visual stress . Implication s for Rehabilitation Any disability that impacts on a child ’s capacity to read has serious implication s for academic development as well as the ability to participate independently in activities of daily living . One reading disability , generally termed “ visual stress ” , is related to visual disturbances that make it difficult to read text . This research demonstrates the beneficial use of coloured filters for promoting visual reading capacity for children with visual stress . Professionals who are involved in the needs of children with reading delay , may like to consider the benefits that coloured filters can afford children with visual reading problems",
"PURPOSE To investigate the impact of colored overlays on the accommodative response of individuals , with and without pattern-related visual stress ( PRVS ) , a condition in which individuals manifest symptoms of perceptual distortion and discomfort when viewing a 3-cyc/deg square-wave grating . METHODS Under double-masked conditions , 11 individuals who reported PRVS selected an overlay with a color individually chosen to reduce perceptual distortion of text and maximize comfort ( PRVS group ) . Two groups of control subjects individually matched for age , sex , and refractive error were recruited . Control group 1 similarly chose an overlay to maximize comfort . Control group 2 used the same overlays as the paired PRVS participant . The overlay improved reading speed by 10 % ( P remote eccentric photorefractor was used to record accommodative lag while participants viewed a cross on a background . The background was uniform or contained a grating and was either gray or had a chromaticity identical with that of the chosen overlay . There were therefore four background s in all . RESULTS Overall , the accommodative lag was 0.44 D greater in the participants with PRVS . When the background had the chosen chromaticity , the accommodative lag was reduced by an average of 0.16 D ( P = 0.03 ) in the PRVS group , but not in the symptom-free groups : in control group 2 the colored background slightly increased the accommodative lag . CONCLUSIONS Accommodative lag was greater in individuals susceptible to pattern-related visual stress and was reduced by a colored background",
"Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT",
"Some individuals read more fluently when the text is coloured : i.e. , when coloured sheets of plastic ( overlays ) are placed upon the page , or when coloured lenses are worn . Overlays provide a surface colour whereas lenses mimic a change in the colour of a light source . The neural mechanisms that underlie colour constancy ensure that the chromaticity of overlays and lenses is processed differently by the visual system . We investigated ( 1 ) the relationship between the optimal colours of overlays and lenses , and ( 2 ) how reading rate is affected by a particular colour in overlays and lenses . In 100 patients we noted ( 1 ) the overlay(s ) chosen from among the 29 combinations of the 10 IOO Intuitive Overlays which sample chromaticity systematic ally and ( 2 ) the chromaticity co-ordinates of the lenses subsequently chosen using the intuitive Colorimeter , a device providing a light source that can be adjusted in hue , saturation and luminance independently . The relationship between the chromaticities of the overlays and the lenses showed considerable variation . In a second study , patients attending the Specific Learning Difficulties clinic at the Institute of Optometry , London , were given overlays to use for two months . Seventeen who derived benefit were examined using the Intuitive Colorimeter . Patients were asked to read aloud r and omly ordered common words ( Wilkins Rate of Reading Test ) : ( 1 ) with no colour , ( 2 ) with the chosen overlay , ( 3 ) with lenses matching the chosen overlay and ( 4 ) with lenses matching the Colorimeter setting . The aids increased reading rate significantly only in conditions ( 2 ) and ( 4 ) . There was no significant improvement when lenses matching the overlay colour were used , and under this condition the reading rate was significantly poorer than in conditions ( 2 ) and ( 4 ) . The colour of a lens will improve reading only if it is selected under conditions that mimic a change in the colour of a light source : coloured overlays give no clinical ly reliable guide to optimal lens colour",
"A simple reading test that can be undertaken by disabled readers is described . The test is suitable for use in the optometric clinic , taking less than 2 minutes to administer per passage . Test-retest scores are acceptably reliable . The test reveals increases in the speed of reading when coloured overlays are used both ( 1 ) in children who have made long-term use of coloured overlays for reading , and ( 2 ) in children who will subsequently do so",
"Ninety-three children in a primary school and 59 children in two first-year classes of a secondary school were asked individually to observe a paragraph of r and om letters arranged to resemble text , and to compare the perceptual effects on its clarity of coloured plastic sheets overlaid on the text . A total of 29 colours were compared using 10 coloured plastic sheets and 19 pairwise combinations of sheets , one superimposed on another . The result ing colours sample d CIE 1976 hue angle ( huv ) and saturation ( suv ) systematic ally and efficiently . All the children who reported beneficial perceptual effects ( 53 per cent ) were given their preferred overlay or combination of overlays to use as and when they wished . When the children were examined three months later the children tended to choose a colour similar to one they had chosen previously . Ten months later , 22 per cent of those offered the overlaps were still using them of their own volition . These children , but not those who had ceased to use their overlay(s ) , read r and omly ordered simple words more quickly with their overlay than without . In a second independent group of children referred to the Norfolk Sensory Support Service , who used overlays routinely , the reading speed was similar with a grey or clear overlay ; and slower than with the chosen coloured overlay , suggesting that reduction of contrast was not the critical factor . In a third independent group of children in a primary school in Kent , the increase in reading speed with the chosen overlay predicted the children who continued to use their overlay during the ensuing eight weeks",
"The efficacy of a controversial treatment , using colored filters to remediate reading disabilities , was measured empirically , with colored overlays placed over reading material on white paper . Irlen 's ( 1983 ) method is to prescribe specific tinted filters as lenses that she cl aims filter specific light frequencies and remove a range of perceptual disorders that adversely affect reading and related learning performance . Irlen calls this condition \" scotopic sensitivity \" and cl aims it is a significant factor in a high percentage of people with learning disabilities . Ninety-two children with significant reading disabilities were classified as either scotopic or nonscotopic using the Irlen Differential Perceptual Schedule , and were r and omly assigned to one of six treatment groups using colored or clear overlays . Reading performance ( rate , accuracy , and comprehension ) as measured by the Neale Analysis of Reading Ability ( Neale , 1987 ) and the Formal Reading Inventory ( Wiederholt , 1986 ) improved significantly when the scotopic children read with the preferred colored overlay filter compared to clear or different-colored overlay filters . Nonscotopic children showed no change",
"Background Possible beneficial effects of yellow-tinted spectacle lenses on binocular vision , accommodation , oculomotor scanning , reading speed and visual symptoms were assessed in children with reading difficulties . Methods A longitudinal prospect i ve study was performed in 82 non-dyslexic children with reading difficulties in grade s 3–6 ( aged 9–11 years ) from 11 elementary schools in Madrid ( Spain ) . The children were r and omly assigned to two groups : a treatment ( n = 46 ) and a without-treatment group ( n = 36 ) . Children in the treatment group wore yellow spectacle lenses with best correction if necessary over 3 months ( in school and at home ) . The tests were first undertaken without the yellow filter . With best spectacle correction in each subject , measurements were made of : distance and near horizontal heterophoria , distance and near horizontal fusional vergence ranges , the accommodative convergence/accommodation ( AC/A ) ratio , near point of convergence ( NPC ) , stereoacuity , negative relative accommodation ( NRA ) and positive relative accommodation ( PRA ) , monocular accommodative amplitude ( MAA ) , binocular accommodative facility ( BAF ) , oculomotor scanning , and reading speed ( words per minute ) . The Convergence Insufficiency Symptom Survey ( CISS ) question naire was completed by all children . After the 3-month period , measurements were repeated with the yellow lenses ( treatment group ) or without the yellow lenses ( without-treatment group ) but with refractive correction if needed . Results Over the 3 months , the two groups showed similar mean changes in the variables used to assess binocular vision , accommodation , oculomotor scanning , and reading speed . However , mean relative changes in convergence insufficiency symptoms differed significantly between the groups ( p = 0.01 ) . Conclusion No effects of wearing yellow spectacles emerged on binocular vision , accommodation , oculomotor scanning , and reading speed in children with reading difficulties . The yellow filter had no effect even in children with low MAA and BAF . The reduction in visual symptoms observed in children with reading difficulties using the yellow filters was clinical ly insignificant",
" We selected 68 children who reported benefit from individually chosen sheets of coloured plastic placed upon the page when reading , and who used these regularly without prompting . These children viewed text illuminated by coloured light in an apparatus that allowed the separate manipulation of hue ( colour ) and saturation ( depth of colour ) , at constant luminance . Many of the children reported improvements in perception when the light had a chromaticity within a limited range , which was different for each individual . A pair of plastic spectacle lenses ( ' experimental ' lenses ) was dyed so as to provide the appropriate chromaticity under conventional white ( F3 ) fluorescent light . An additional pair was prepared having very similar colour but with a chromaticity outside the range in which perception was reported to improve ( ' control ' lenses ) . Each pair was provided for 1 month in r and om order . The children kept diaries ( 36 completed ) recording symptoms of eye-strain and headache . The children and those responsible for their assessment were unable reliably to distinguish ' experimental ' from ' control ' lenses . Nevertheless , symptoms were less frequent on days when the ' experimental ' lenses were worn ( P < 0.003 )",
"BACKGROUND This study was design ed to address a perceived major flaw in past studies investigating tinted lenses and dyslexia ; i.e. , the lack of a direct , scientifically vali date d means of diagnosing the type and severity of dyslexia . METHODS Sixteen 5th and 8th grade students , found to be dyslexic based on testing via the Dyslexia Determination Test ( DDT ) , were r and omly divided into two groups of eight . One group was tested first with blue filters ( then , 2 to 5 weeks later , no filters ) using the Gates MacGinitie Reading Test for reading comprehension . The other group of eight was tested in the same way , first with no filters , then 2 to 5 weeks later with blue filters . The grade level of the test used for each subject was in accord with the DDT decoding level . RESULTS There was no significant difference in reading comprehension level or reading speed when the blue filter condition was compared to the no filter condition . CONCLUSIONS Using DDT classification , subjects were found to have mostly dysphoneidetic ( mixed pattern ) dyslexia . Among this population of dyslexic students , tinted lenses appeared to provide no beneficial effect . We offer an explanation based on neuro-anatomical relationships between the visual system and reading centers in the brain . The hypothesis states that the transient system defect may be an epiphenomenon , which can coincidentally occur in cases of reading disability",
"A r and omised controlled trial has demonstrated that , for selected children with reading difficulties , individually prescribed coloured filters reduce symptoms of asthenopia . In the present study , we investigate the effect of individually prescribed coloured overlays on the rate of reading . Subjects were 33 children and adults who : had consulted a specific learning difficulties clinic ; had received treatment to normalise any conventional optometric and orthoptic anomalies ; and subsequently reported symptomatic relief from coloured filters . These subjects carried out the Wilkins Rate of Reading Test ( which assesses visual rather than linguistic factors ) under two conditions : with their chosen coloured overlay and with a control filter . Steps were taken to ensure that a strong placebo effect was associated with the control overlay and , when asked which they preferred , subjects were not significantly more likely to prefer their coloured overlay than the control filter ( p=0.11 ) . Nonetheless , the rate of reading was significantly faster with the coloured overlay than with the control ( p=0.0019 ) . Further analyses support the conclusion that individually prescribed coloured filters can improve reading performance for reasons that can not be solely attributed to conventional optometric factors or to placebo effects",
"BACKGROUND Many patients with dyslexia report distortion to text when they are reading . After a successful pilot trial of an improvement in reading rate using ChromaGen haploscopic filters in comparison with the Intuitive Colorimeter , a full-scale , r and omized , cross-over , double-masked , placebo-based trial was undertaken . METHOD The Wilkins rate of reading test was used to produce a baseline score , against which scores with ChromaGen lenses , placebo lenses , and a control were compared . Exclusion criteria included no formal dyslexia diagnosis , contraindications to contact lens wear , and uncorrected visual causes for reading difficulty . RESULTS Forty-seven individuals successfully completed the trial , of which 41 reported distortion to the text ( e.g. , words appeared to move , were blurred , or patterns or spaces seemed to form in the text ) when the patients were reading , and nine were color deficient . A comparison trial of ChromaGen lenses with placebo lenses demonstrated a significant improvement in the reading rate with ChromaGen lenses in individuals who reported distortion to text ( p = 0.05 ) and a highly significant improvement in non-color-deficient individuals who reported distortion ( p = 0.006 ) . T-tests of the repeated measures showed that ChromaGen lenses produced a highly significant improvement in the rate of reading -- over and above the placebo -- in non-color-deficient individuals who reported distortion ( p reading rate amongst those who reported distortion suggests that by decreasing the distortion to text , a substantial proportion of dyslexic patients --in combination with their normal reading programs -- would benefit from this aid",
"This study investigated the long-term effects of using coloured filters on the frequency and type of errors in oral reading . A double-masked , placebo-controlled crossover experimental design was used , with subjects being assessed over a period of 20 months . There were three experimental groups ( Placebo tints , Blue tints , and Diagnosed tints ) involving 113 subjects with reading difficulties , ranging in age from 9.2 yr to 13.1 yr . The 35 controls ( ranging in age from 9.4 yr . to 12.9 yr . ) had reading difficulties but did not require coloured filters . There was a significant improvement for all groups in the accuracy of miscues over the period , although experimental groups over-all did not improve at a significantly different rate than the control group . The failure to find significantly greater improvement for the experimental groups over the control group for the total period , despite subjects ' reports of improved print clarity , may be partly related to the lack of effective letter-sound analysis and synthesis skills and to the use of a word- identification strategy of guessing based on partial visual analysis",
"This study investigated the effects of using coloured filters on reading speed , accuracy , and comprehension as well as on perception of academic ability . A double-masked , placebo-controlled crossover design was used , with subjects being assessed over a period of 20 mo . There were three treatment groups ( Placebo filters , Blue filters , and Optimal filters ) involving 113 subjects with “ reading difficulties ” , ranging in age from 9.2 yr . to 13.1 yr . and with an average discrepancy between chronological age and reading age of 1.8 yr . The 35 controls ( who did not use coloured filters ) ranged in age from 9.4 yr . to 12 9 yr . , with an average discrepancy between chronological age and reading age of 21 yr The treatment groups increased at a significantly greater rate than the control group in reading accuracy and reading comprehension but not for speed of reading . For self-reported perception of academic ability , two of the three treatment groups showed significantly greater increases than the control group . The larger improvements for treatment groups in reading comprehension may be related to a reduction in print and background distortions allowing attention to be directed to the processing of continuous text rather than to the identification of individual words . A reduction in print distortion , however , may not be sufficient to generate improved word- identification skills without additional remedial support , and this may be indicated by the nonsignificant increase in rate of reading",
"The objectives of this pilot study were to investigate the effectiveness of Irlen filters for improving comfort and reading performance and to determine whether traditional optometric intervention would be effective in relieving the symptoms commonly reported by people seeking help through the use of Irlen filters . Thirty subjects were included in the study : 12 males and 18 females . The ages of the subjects ranged from 9 to 51 ( mean = 23.6 ) . They were r and omly placed in either an Irlen filter treatment group ( n = 11 ) , a vision therapy treatment group ( n = 11 ) , or a control group ( n = 8) . Pre- and posttesting on all subjects included a vision evaluation , reading and intelligence testing , the Irlen scotopic sensitivity screening test , and a symptom question naire . Results revealed that subjects in both treatment groups were more comfortable after treatment , although only the vision therapy group showed improvement in vision functioning . The subjects in the Irlen filter group did not show any significant gains in reading rate , word recognition in context , or comprehension",
"In four studies children were asked to read aloud a passage of r and omly ordered common words with and without a coloured sheet of plastic ( overlay ) placed upon the page . The children 's rate of reading increased with the overlay , for some children more than for others . The children were also asked to undertake a test of texture segmentation in which targets consisting of a structured texture had to be distinguished from within a r and om background texture . The texture segmentation was improved when the overlay was used , again for some children more than for others . The improvement in texture segmentation was , in general , correlated with the improvement in rate of reading . Slower readers were generally poorer at texture segmentation . The implication s for reading , for texture segmentation , and for clinical tests of vision are discussed",
"This study tested the predictions derived from two explanatory theoretical models of the effects of colored filters on reading speed : the theory of attributional bias and the theory of visual stress associated with reading . The experimental group consisted of 27 secondary school students ( 14 boys , 13 girls ) diagnosed with the Meares-Irlen syndrome ; the control group had 27 students paired in age and sex with the experimental group . The mean age of the sample was 12 years , 10 months ( SD = 8.9 mo . ) . The effects of colored filters on reading speed and accuracy were tested using a word reading test and a visual stress induction text . The presentation method tapped individuals ' visual sensitivity and response criteria . The results support some predictions of the theory of attributional bias , but more research is needed to assess each theory of reading speed",
"Visual stress-a condition in which unpleasant visual symptoms are experienced when reading-has been reported to be more prevalent in dyslexic individuals but at the present time the relationship between dyslexia and visual stress remains controversial . ViSS , a computerized visual stress screener that incorporates reading-like visual search , has recently shown promise in studies with unselected sample s of primary and secondary school children . This study investigated the use of ViSS with dyslexic children . Dyslexic children identified as having high visual stress showed significantly higher per cent increases in reading rate with a coloured overlay and reported significantly higher critical symptoms of visual stress , compared to dyslexic children with low visual stress . The same results were found for reading-age controls , indicating that ViSS can be equally effective with normal readers as well as with children with dyslexia . Compared to reading-age controls , dyslexic children were found to have significantly higher susceptibility to visual stress , significantly larger per cent increases in reading rate with an overlay , and significantly higher critical and non-critical symptoms of visual stress . Extrapolated to unselected population sample s , the data also suggest that visual stress is more likely to be found in people with dyslexia than in people who do not have dyslexia . These results , which point to an important link between the two conditions , are discussed in relation to current theories that attribute visual stress to either a magnocellular dysfunction or cortical hyperexcitability",
"The efficacy and side effects of the synthetic cannabinoid nabilone were compared with those of the weak opioid dihydrocodeine in the treatment of chronic neuropathic pain . A r and omised , double blind , crossover trial study design was used . Participants received a maximum daily dose of 2 mg nabilone or 240 mg dihydrocodeine . The trial lasted for 14 weeks and comprised two treatment periods , each of six weeks ’ duration , separated by a two week washout period . Participants were patients with chronic neuropathic pain aged 23 - 84 years , who were recruited using convenience sampling from outpatient units at three hospitals in the United Kingdom . The sample comprised 96 patients , who were r and omised to nabilone ( n=48 ) and dihydrocodeine ( n=48 ) in the first treatment period.1 The main outcome was pain as measured on a visual analogue scale over the final two weeks of each treatment period . Side effects were measured by a question naire . The research ers reported that dihydrocodeine provided better pain relief than nabilone and had slightly fewer side effects , although no major adverse events occurred for either drug . Which of the following statements , if any , are true ? Statements a , b , c , d , and e are all true . The aim of the trial was to compare the efficacy and side effects of nabilone with dihydrocodeine in the treatment of chronic neuropathic pain . A r and omised double blind crossover trial was conducted . Participants received both treatments in succession ,",
"The Transient Channel Deficit ( TCD ) model of reading disability was evaluated by examining the effects of color overlays on the reading ability of four groups of children ( n = 15 each ) with reading disability and comorbid conditions involving math and ADHD . These 60 children were evaluated for reading accuracy and rate on measures of word decoding and reading comprehension under three color transparency conditions ( blue , red , no overlay ) . Results indicated that color overlays did not differentially affect the reading performance of individuals with and without reading disabilities . However , blue transparencies significantly improved reading comprehension in all groups , and reduced reading rate . These findings indicate that the TCD model may need to be reexamined . An alternative hypothesis for the observed effects , involving facilitation of attention processes , was posted",
"Abstract Background : Meares Irlen Syndrome ( MIS ) , otherwise known as “ visual stress ” , is one condition that can cause difficulties with reading . Aim : This study aim ed to compare the effect of two coloured-filter systems on the symptoms of visual stress in children with reading delay . Methods : The study design was a pre-test , post-test , r and omized head-to-head comparison of two filter systems on the symptoms of visual stress in school children . A total of 68 UK mainstream schoolchildren with significant impairment in reading ability completed the study . Results : The filter systems appeared to have a large effect on the reported symptoms between pre and post three-month time points ( d = 2.5 , r = 0.78 ) . Both filter types appeared to have large effects ( Harris d = 1.79 , r = 0.69 and DRT d = 3.22 , r = 0.85 ) . Importantly , 35 % of participants ’ reported that their symptoms had resolved completely ; 72 % of the 68 children appeared to gain improvements in three or more visual stress symptoms . Conclusion and significance : The reduction in symptoms , which appeared to be brought about by the use of coloured filters , eased the visual discomfort experienced by these children when reading . This type of intervention therefore has the potential to facilitate occupational engagement"
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PURPOSE The aim of this systematic review was to evaluate how etching modes affect the nanoleakage of universal adhesive from in vitro studies . MATERIAL S AND METHODS PubMed / MEDLINE , Web of Science , Scopus and Science Direct electronic data bases were search ed for in vitro studies that evaluated the nanoleakage of universal adhesives . A total of 511 ( after duplicate removal ) potentially relevant records were identified in the literature search . The titles and abstract s of the retrieved studies were screened by two independent research ers according to the main concept . Subsequently , the full text of potentially relevant studies was screened using the exclusion criteria . Thirteen studies were subjected to qualitative analysis , and 5 of them were selected for a detailed meta- analysis . RESULTS Seven universal adhesives were evaluated in this review . The meta- analysis demonstrated that the etch- and -rinse technique significantly reduced the nanoleakage of the Peak Universal and G-Bond Plus adhesives , whereas the self-etch mode reduced the nanoleakage of All-Bond Universal . In comparison , the etching technique did not significantly alter the nanoleakage of either Prime&Bond Elect or Scotchbond Universal which was characterized by the smallest nanoleakage . CONCLUSIONS Etching modes significantly , in various ways , influence the nanoleakage of universal adhesives . CLINICAL SIGNIFICANCE Contrary to the drive to simplify bonding technologies , an appreciation of their adhesive components and how these perform according to bonding technique could yield a knowledge-based practical approach that ultimately improves the longevity of direct composite restorations | [
"OBJECTIVE To evaluate the microtensile bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal or multi-mode adhesives , applied with increasing solvent evaporation times . METHODS One-hundred and forty caries-free extracted third molars were divided into 20 groups for bond strength testing , according to three factors : ( 1 ) Adhesive - All-Bond Universal ( ABU , Bisco , Inc. ) , Prime&Bond Elect ( PBE , Dentsply ) , and Scotchbond Universal Adhesive ( SBU , 3 M ESPE ) ; ( 2 ) Bonding strategy - self-etch ( SE ) or etch- and -rinse ( ER ) ; and ( 3 ) Adhesive solvent evaporation time - 5s , 15s , and 25s . Two extra groups were prepared with ABU because the respective manufacturer recommends a solvent evaporation time of 10s . After restorations were constructed , specimens were stored in water ( 37 ° C/24h ) . Resin-dentin beams ( 0.8mm(2 ) ) were tested at 0.5mm/min ( μTBS ) . For NL , forty extracted molars were r and omly assigned to each of the 20 groups . Dentin disks were restored , immersed in ammoniacal silver nitrate , sectioned and processed for evaluation under a FESEM in backscattered mode . Data from μTBS were analyzed using two-way ANOVA ( adhesive vs. drying time ) for each strategy , and Tukey 's test ( α=0.05 ) . NL data were computed with non-parametric tests ( Kruskal-Wallis and Mann-Whitney tests , α=0.05 ) . RESULTS Increasing solvent evaporation time from 5s to 25s result ed in statistically higher mean μTBS for all adhesives when used in ER mode . Regarding NL , ER result ed in greater NL than SE for each of the evaporation times regardless of the adhesive used . A solvent evaporation time of 25s result ed in the lowest NL for SBU-ER . SIGNIFICANCE Residual water and /or solvent may compromise the performance of universal adhesives , which may be improved with extended evaporation times",
"OBJECTIVE To test the influence of a hydrophobic resin coating ( HC ) on the immediate ( 24h ) and 6-month ( 6 m ) microtensile dentin bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal adhesives applied in self-etch ( SE ) or in etch- and -rinse ( ER ) mode . METHODS Sixty caries-free extracted third molars were assigned to 12 experimental groups result ing from the combination of the factors \" adhesive system \" ( Scotchbond Universal Adhesive [ SBU ] , 3 M ESPE ; All-Bond Universal [ ABU ] , Bisco Inc. ; and G-Bond Plus [ GBP ] , GC Corporation ) ; \" adhesive strategy \" ( SE or ER ) ; \" hydrophobic resin coating \" [ HC ] ( with or without Heliobond , Ivoclar Vivadent ) ; and \" storage time \" ( 24h or 6 m ) . Specimens were prepared for μTBS testing - ( 24h ) half of the beams were immediately tested under tension ; and ( 6 m ) the other half was stored in distilled water ( 37 ° C ) for 6 m prior to testing . For each tooth , two beams were r and omly selected for NL evaluation for both evaluation times . Data were analyzed for each adhesive system using three-way ANOVA and Tukey 's post-hoc test ( α=0.05 ) . RESULTS μTBS : ( 24h ) : In SE mode , HC result ed in statistically greater mean μTBS for all adhesives . ( 6 m ) : When HC was not used the mean μTBS for SBU/ER , ABU/ER , GBP/ER and SBU/SE decreased significantly . NL : ( 24h ) : SBU/ER , ABU/ER and GBP/SE result ed in a significant reduction in NL when HC was applied . ( 6 m ) : No significant reduction was observed for SBU/ER or for SBU/SE regardless of the use of HC . SIGNIFICANCE The application of a hydrophobic resin coating improved the 24h and the 6 m performances of all three adhesives systems in SE mode",
"BACKGROUND The durability of restorations bonded with one-step self-etching ( OSSE ) adhesive systems is inferior compared with that of restorations bonded with conventional adhesives . The authors conducted an 18-month r and omized clinical study to evaluate the clinical performance of two OSSE systems in noncarious cervical lesions applied as recommended or with an extra layer of hydrophobic adhesive layer after 18 months of clinical service . METHODS Thirty participants , each of whom had at least two pairs of similar-sized noncarious cervical lesions , took part in this study . The authors placed 120 restorations , 30 in each of four groups : Clearfil S3 Bond ( Kuraray , Osaka , Japan ) ( CS ) and iBond Gluma inside ( Heraeus Kulzer , Hanau , Germany ) ( IB ) , and Clearfil S3 Bond ( CSB ) and iBond Gluma inside ( IBB ) with an extra layer of hydrophobic adhesive applied on top of them . They placed the restorations incrementally , using a resin-based composite . The authors evaluated the restorations at baseline and at 18 months following modified U.S. Public Health Service criteria . RESULTS At 18 months , the retention rate for the IB group was statistically lower than those for the CS , IBB and CSB groups . Marginal discoloration occurred in all groups and was statistically worse in the IB group . CONCLUSIONS The conversion of the iBond Gluma inside and Clearfil S3 Bond adhesive systems into two-step systems by means of applying an extra hydrophobic adhesive layer improved the clinical performance of these material s after 18 months of clinical service . CLINICAL IMPLICATION S The application of an extra hydrophobic adhesive layer over OSSE adhesive systems , layers improved the OSSE systems clinical performance , mainly in terms of retention rate",
"PURPOSE To investigate the bonding of a new universal adhesive applied using different etching strategies on sound and caries-affected dentin of primary teeth . MATERIAL S AND METHODS Flat dentin surfaces from 50 primary molars were r and omly assigned to 10 groups according to substrate ( sound dentin [ SD ] vs caries-affected dentin [ CAD ] pH cycled for 14 days ) and bonding approach ( Scotchbond Universal Adhesive : self-etching , vs dry or wet-bonding etch- and -rinse strategies ; Adper Single Bond Plus [ two-step etch- and -rinse adhesive ] and Clearfil SE Bond [ two-step self-etching system ] as controls ) . After 24 h of water storage , bonded sticks with cross-sectional areas of 0.8 mm2 were tested for microtensile bond strength ( μTBS ) . Two sticks from each tooth were immersed in silver nitrate solution in order to evaluate nanoleakage ( NL ) with SEM . The μTBS means were analyzed using two-way ANOVA and Tukey 's tests . For NL , the Kruskal-Wallis and Mann-Whitney tests were used ( α = 0.05 ) . RESULTS The influence of the etching strategy on the bonding performance of the universal adhesive was substrate dependent . The self-etching approach result ed in lower μTBS values and higher silver nitrate uptake into hybrid layers for Scotchbond Universal Adhesive on SD , while no difference among experimental groups was observed in CAD . CONCLUSION It is preferable to use the universal adhesive following either a dry- or wet-bonding etch- and -rinse approach on both sound and caries-affected primary dentin "
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Background Lameness in dairy cows has been an ongoing concern of great relevance to animal welfare and productivity in modern dairy production . Many studies have examined associations between various factors related to housing , management , and the individual animal and the occurrence of lameness . The objective of this systematic review was to answer the research question “ what are risk factors associated with lameness in dairy cows that are housed in free stall barns or tie stall facilities ” . Furthermore , we performed a synthesis of current evidence on certain risk factors by means of a meta- analysis to illustrate the strength of their association with bovine lameness . Results Following pre-defined procedures and inclusion criteria in accordance with the PRISMA statement , two observers independently included 53 articles out of a pool of 1941 articles which had been retrieved by a broad literature research in a first step . 128 factors that have been associated with lameness were identified in those papers . Meta-analyses were conducted for five factors presented in six different studies : Body condition score , presence of claw overgrowth , days in milk , herd size , and parity . Results indicated that a body condition score of ≤2.5/5 is associated with increased odds of lameness . A higher risk of being lame was found for the presence of claw overgrowth , the first 120 days in milk , larger herd sizes , and increasing parity . Throughout the study , we encountered profound difficulties in retrieving data and information of sufficient quality from primary articles as well as in recovering comparable studies . Conclusions We learned that an abundance of literature on bovine lameness exists . To adequately address a problem of this importance to both animal welfare and economic viability , solid evidence is required in the future to develop effective intervention strategies . Therefore , a consistent working definition of lameness and specific risk factors should be an option to consider | [
"The main objectives of this prospect i ve cohort study were a ) to describe lameness prevalence at drying off in large high producing New York State herds based on visual locomotion score ( VLS ) and identify potential cow and herd level risk factors , and b ) to develop a model that will predict the probability of a cow developing claw horn disruption lesions ( CHDL ) in the subsequent lactation using cow level variables collected at drying off and /or available from farm management software . Data were collected from 23 large commercial dairy farms located in upstate New York . A total of 7,687 dry cows , that were less than 265 days in gestation , were enrolled in the study . Farms were visited between May 2012 and March 2013 , and cows were assessed for body condition score ( BCS ) and VLS . Data on the CHDL events recorded by the farm employees were extracted from the Dairy-Comp 305 data base , as well as information regarding the studied cows ’ health events , milk production , and reproductive records throughout the previous and subsequent lactation period . Univariable analyses and mixed multivariable logistic regression models were used to analyse the data at the cow level . The overall average prevalence of lameness ( VLS > 2 ) at drying off was 14 % . Lactation group , previous CHDL , mature equivalent 305-d milk yield ( ME305 ) , season , BCS at drying off and sire PTA for strength were all significantly associated with lameness at the drying off ( cow-level ) . Lameness at drying off was associated with CHDL incidence in the subsequent lactation , as well as lactation group , previous CHDL and ME305 . These risk factors for CHDL in the subsequent lactation were included in our predictive model and adjusted predicted probabilities for CHDL were calculated for all studied cows . ROC analysis identified an optimum cut-off point for these probabilities and using this cut-off point we could predict CHDL incidence in the subsequent lactation with an overall specificity of 75 % and sensitivity of 59 % . Using this approach , we would have detected 33 % of the studied population as being at risk , eventually identifying 59 % of future CHDL cases . Our predictive model could help dairy producers focusing their efforts on CHDL reduction by implementing aggressive preventive measures for high risk cows",
"This paper describes the development and testing of a lameness control programme ( LCP ) for heifers on dairy farms . The LCP , which is based on the analysis of hazards and critical control points ( HACCP ) , was tested via a r and omised intervention study on 60 farms . Tangible hazards for each farm were identified , allotted to 11 categories of proximate hazard and scored on each farm to quantify the risks presented by each hazard . Feet were inspected for signs of claw horn disease and infection , such as digital dermatitis . Intervention was generally ineffective , primarily through failure to implement the LCP . However , retrospective analysis was able to demonstrate highly significant associations between risks attached to proximate hazards and probabilities of lameness and foot lesions , allowing the severity of these hazards to be ranked . The most significant proximate hazards of environmental origin were prolonged st and ing on concrete , st and ing in wet slurry and factors that cause claw trauma . The most severe proximate hazards however were those associated with failures of management , especially poor claw condition and inadequate foot care . Overall farm risks ( OFR ) were estimated by summing the products of the generic severity for proximate hazards with on-farm risks . Changes in OFR were significantly related to changes in outcome ( lameness and lesions )",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"A 2-year experiment on the effect of claw trimming on hoof health was performed in 77 Swedish dairy herds ( 3444 dairy cattle ) selected on herd size , breed composition and membership in the official milk-recording scheme . In the autumn , cows within each herd were blocked according to breed , parity and stage of lactation and allocated to two treatments : autumn trimming ( AT ) or no autumn trimming ( NAT ) . Outcome variables were claw measurements and prevalence of hoof lesions and lameness ( measured at spring trimming ) and the need for hoof treatments between scheduled trimmings . At spring trimming , NAT cows had longer and shallower claws than AT cows . The average net growth of the toe wall was greater for AT than for NAT cattle , with a marked variation between housing systems . Most hoof lesions present at AT had disappeared at the subsequent spring trimming . Controlled for clustering by herd-within-year and for the effects of individual- and herd-level covariates , AT cattle at spring trimmings had significantly lower odds of lameness ( OR=0.66 ) and of haemorrhages of the sole or white-line ( OR=0.86 ) , sole ulcer ( OR=0.59 ) and white-line fissure or double sole (OR=0.71)-but not of moderate-to-severe heel-horn erosion or dermatitis ( OR=0.96 ) . Acute hoof treatments between claw trimmings were more common in the NAT group ( OR=2.02 )",
"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",
"This study was carried out to detect differences in locomotion and feeding behavior in lame ( group L ; n = 41 ; gait score ≥ 2.5 ) and non-lame ( group C ; n = 12 ; gait score ≤ 2 ) multiparous Holstein cows in a cross-sectional study design . A model for automatic lameness detection was created , using data from accelerometers attached to the hind limbs and noseb and sensors attached to the head . Each cow ’s gait was videotaped and scored on a 5-point scale before and after a period of 3 consecutive days of behavioral data recording . The mean value of 3 independent experienced observers was taken as a definite gait score and considered to be the gold st and ard . For statistical analysis , data from the noseb and sensor and one of two accelerometers per cow ( r and omly selected ) of 2 out of 3 r and omly selected days was used . For comparison between group L and group C , the T-test , the Aspin-Welch Test and the Wilcoxon Test were used . The sensitivity and specificity for lameness detection was determined with logistic regression and ROC- analysis . Group L compared to group C had significantly lower eating and ruminating time , fewer eating chews , ruminating chews and ruminating boluses , longer lying time and lying bout duration , lower st and ing time , fewer st and ing and walking bouts , fewer , slower and shorter strides and a lower walking speed . The model considering the number of st and ing bouts and walking speed was the best predictor of cows being lame with a sensitivity of 90.2 % and specificity of 91.7 % . Sensitivity and specificity of the lameness detection model were considered to be very high , even without the use of halter data . It was concluded that under the conditions of the study farm , accelerometer data were suitable for accurately distinguishing between lame and non-lame dairy cows , even in cases of slight lameness with a gait score of 2.5",
"Claw horn disruption lesions ( CHDL ) are a major cause of lameness in dairy cattle and are likely a result of excessive forces being applied to the germinal epithelium that produces the claw horn . The digital cushion is a connective tissue structure , containing depots of adipose tissue , that sits beneath the distal phalanx and has been shown to be thicker in fatter cows . Body condition score ( BCS ) loss is a risk factor for CHDL , and one possible explanation is that fat is mobilized from the digital cushion during negative energy balance , causing the digital cushion to thin and lose force-dissipating capacity , leading to disruption of claw horn growth . This prospect i ve cohort study investigated the association between measures of body fat and sole soft tissue ( SST ) thickness ( a combined measure of the corium and digital cushion beneath the distal phalanx ) in a longitudinal manner . The SST of 179 cows in 2 high-yielding dairy herds were measured at 5 assessment points between 8 wk before and 35 wk postcalving . The BCS , back fat thickness ( BFT ) , and lesion incidence were recorded . Data were analyzed in a 4-level mixed effects regression model , with the outcome being SST thickness beneath the flexor tuberosity of the distal phalanx . Data from 827 assessment points were available for analysis . The overall mean of SST was 4.99 mm ( st and ard deviation : 0.95 ) . The SST was thickest 8 wk before calving ( 5.22 mm , st and ard deviation : 0.91 ) and thinnest 1 wk postcalving ( 4.68 mm , st and ard deviation : 0.87 ) , suggesting an effect of calving on SST . The BFT was positively correlated with SST in the model with a small effect size ( a 10 mm decrease in BFT corresponded with a 0.13 mm decrease in SST ) , yet the nadir of BFT was 11.0 mm at 9 to 17 wk postcalving ( when SST was ∼4.95 mm ) , rather than occurring with the nadir of SST immediately after calving . The SST also varied with other variables [ e.g. , cows that developed a sole ulcer or severe sole hemorrhage during the study had thinner SST ( -0.24 mm ) ] , except when a sole ulcer was present , when it was thicker ( + 0.53 mm ) . Cows that developed lesions had a thinner digital cushion before the lesion occurrence , which became thickened with sole ulcer presence , perhaps representing inflammation . Furthermore , although BFT was correlated with SST over time , SST may also have been influenced by other factors such as integrity of the suspensory apparatus , which could have a major effect on CHDL . Measures of body fat likely contributed to having thin SST , but other factors including calving , herd , and lesion presence also had an effect",
"Lameness is a severe welfare problem and a production-limiting disease in dairy farming . The objectives of this study were to determine prevalence of lameness and investigate cow- and herd-level factors associated with lameness in dairy cows housed in freestall barns in 3 Canadian provinces . A purposive sample of 40 Holstein-Friesian cows was selected from each of 141 dairy farms in Québec , Ontario , and Alberta . In total , 5,637 cows were scored once for lameness ( presence of limping when walking ) . Data collected included information on individual cows ( hock lesions , claw length , body condition score , parity , days in milk , and milk production ) , management practice s ( floor and stall cleaning routine , bedding routine , and footbath practice s ) , and facility design ( stall dimensions , stall base and bedding type , width of feed alley , flooring type , and slipperiness ) hypothesized to be risk factors for lameness . Multilevel mixed logistic regression models were constructed ( including farm as a r and om effect and province as a fixed effect ) . Herd-level lameness prevalence ranged from 0 to 69 % ( mean = 21 % ) . Lameness prevalence increased with increasing parity ; compared with first parity , cows in parity 2 , 3 , and ≥ 4 had 1.6 , 3.3 , and 4 times , respectively , higher odds of being lame . Furthermore , the odds of lameness were 1.6 times greater in cows with low body condition score ( ≤ 2.5 ) than in cows with a higher body condition score . In addition , injured hocks and overgrown claws were associated with 1.4- and 1.7-fold increased odds of being lame , respectively , whereas every 1 kg increase in daily milk production was associated with a 3 % decrease in the odds of being lame . Lameness prevalence was higher in herds with ≤ 100 cows , but lower in barns with a s and or dirt stall base , or with bedding ≥ 2 cm deep . Cows exposed to very slippery floors had 2 times the odds of being lame compared with cows exposed to nonslippery floors . We attributed the wide range of lameness prevalence to the great variability in facilities and management practice s among farms . Finally , we inferred that the prevalence of lameness could be decreased by improving management of multiparous , thin , or injured cows and by adopting management practice s intended to improve cow comfort , namely the floor 's slip resistance and the stall 's lying surface",
"A field study was conducted to examine effects of oral biotin supplementation for up to 18 mo on risks of lameness in dairy cows . The study included a total of 900 cattle from five dairy farms in Gloucestershire , southwest U.K. , in a within-herd r and omized control trial . The data from this trial were used in this paper to investigate the impact of parity and duration of supplementation with oral biotin at 20 mg/d on white line disease ( WLD ) lameness . Analysis of the data indicated that WLD increased with increasing parity independent of biotin supplementation from approximately two cases per 100 cow years in primiparous cows to 15.5 cases per 100 cow years in all multiparous cows , but up to 47.7 cases per 100 cow years for cows in parities > or = 5 . Supplementation with biotin reduced WLD lameness by 45 % in multiparous cows down to 8.5 cases per 100 cow years , whereas the effect of biotin supplementation in primiparous cows was not significant . Although numerical reductions in WLD lameness were observed for shorter periods of supplementation , a supplementation length of at least 6 mo was required to significantly reduce the risk of WLD lameness in multiparous cows . The effect of biotin supplementation in reducing lameness has potential impact for both animal welfare and farm economics",
"Our hypotheses were that cows classified as lame during the first 70 d in milk have more days from calving to conception and a greater hazard of dying or being culled compared with cows that were not classified as lame . Our objective was to estimate the detrimental effects of lameness on calving-to-conception interval and hazard of dying or being culled in lactating Holstein cows . Data were collected from 5 dairy farms located in upstate New York from November 2004 to June 2006 . The design was a prospect i ve observational cohort study . Cows were assigned a visual locomotion score ( VLS ) using a 5-point scale : 1 = normal , 2 = presence of a slightly asymmetric gait , 3 = the cow clearly favored 1 or more limbs ( moderately lame ) , 4 = severely lame , to 5 = extremely lame ( nonweight-bearing lame ) . In total 1,799 cows were enrolled . In 2 alternative categorizations , cows were considered lame if at least 1 VLS was > or =3 during the first 70 d in milk , and if at least 1 VLS was > or = 4 for the same period they were considered lame . Lameness ( VLS > or =3 ) was detected at least once in 26.5 , 54.2 , 33.9 , 51.8 , and 39.3 % of all cows in farms 1 to 5 , respectively . The hazard ratio of being detected pregnant was 0.85 for lame cows ( VLS > or =3 ) vs. nonlame cows ; hence , lame cows were at a 15 % lower risk of pregnancy than nonlame cows . When lameness was redefined as VLS > or = 4 , the hazard ratio of been detected pregnant was 0.76 for lame cows vs. cows with VLS hazard ratio of culling/death , 1.45 and 1.74 for VLS > or =3 and VLS > or = 4 , respectively , vs. cows with VLS hazard of pregnancy and increased the hazard of culling/death . The detrimental effects were amplified when considering only severely lame and non-weight-bearing cows",
"The effect of lameness on the fertility of dairy cattle is well recognized . But , the effect of lameness on the fertility of seasonally breeding cattle in pasture-based systems is less well characterized . This prospect i ve cohort study of 463 cows on 1 farm in the lower North Isl and of New Zeal and was design ed to assess the effect of clinical lameness , as identified by farm staff , on the hazard of conception after the planned start-of-mating date . A Cox proportional hazards model with time-varying covariates was used . After controlling for the effect of parity , breed , body weight at calving , and calving-to-planned start of mating interval , the daily hazard of conception for cows identified as lame was 0.78 ( 95 % confidence interval : 0.68 - 0.86 ) compared with non-lame cows . Lame cows took 12 d longer to get pregnant compared with their non-lame counterparts",
"Background Systematic review s , which assess the risk of bias in included studies , are increasingly used to develop environmental hazard assessment s and public health guidelines . These research areas typically rely on evidence from human observational studies of exposures , yet there are currently no universally accepted st and ards for assessing risk of bias in such studies . The risk of bias in non-r and omised studies of exposures ( ROBINS-E ) tool has been developed by building upon tools for risk of bias assessment of r and omised trials , diagnostic test accuracy studies and observational studies of interventions . This paper reports our experience with the application of the ROBINS-E tool . Methods We applied ROBINS-E to 74 exposure studies ( 60 cohort studies , 14 case-control studies ) in 3 areas : environmental risk , dietary exposure and drug harm . All investigators provided written feedback , and we documented verbal discussion of the tool . We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes . We present a description of each theme . Results We identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the ‘ ideal ’ r and omised controlled trial . ROBINS-E assesses 7 domains of bias , but relevant questions related to some critical sources of bias , such as exposure and funding source , are not assessed . ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias . ROBINS-E is severely limited at determining whether confounders will bias study outcomes . The construct of co-exposures was difficult to distinguish from confounders . Applying ROBINS-E was time-consuming and confusing . Conclusions Our experience suggests that the ROBINS-E tool does not meet the need for an international st and ard for evaluating human observational studies for questions of harm relevant to public and environmental health . We propose that a simpler tool , based on empirical evidence of bias , would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community",
"Previous work has hypothesised that cows in low body condition become lame . We tested this in a prospect i ve longitudinal study . Body condition score ( BCS ) , causes of lameness and milk yield were collected from a 600-cow herd over 44-months . Mixed effect binomial models and a continuous outcome model were used to investigate the associations between lameness , BCS and milk yield . In total , 14,320 risk periods were obtained from 1137 cows . There were 1510 lameness treatments : the most common causes of lameness were sole ulcer ( SU ) ( 39 % ) , sole haemorrhage ( SH ) ( 13 % ) , digital dermatitis ( DD ) ( 10 % ) and white line disease ( WLD ) ( 8 % ) . These varied by year and year quarter . Body condition was scored at 60-day intervals . BCS ranged from 1 to 5 with a mean of 2.5 , scores were higher in very early lactation but varied widely throughout lactation ; approximately 45 % of scores were risk of treatment for lameness in the following 0 - 2 months and > 2 - 4 months for all causes of lameness and also specifically for SU/WLD lameness . BCS risk of treatment for SH in the following 0 - 2 months but not > 2 - 4 months . There was no such association with DD . All lameness , SU/WLD , SH and DD were significantly more likely to occur in cows that had been lame previously , but the effect of BCS was present even when all repeat cases of lameness were excluded from the analysis . Milk yield was significantly higher and fell in the month before treatment in cows lame with SU/WLD but it was not significantly higher for cows that were treated for DD compared with non-lame cows . These findings support the hypothesis that low BCS contributes to the development of horn related claw lameness but not infectious claw diseases in dairy cows . One link between low BCS and lameness is a thin digital cushion which has been proposed as a trigger for claw horn disease . Cows with BCS 2 produced more milk than cows with BCS 2.5 , however , this was only approximately 100 kg difference in yield over a 305-day lactation . Given the increased risk of lameness in cows with BCS 2 , the direct costs of lameness and the small variability in milk yield by BCS , preventing cows from falling to BCS cow welfare and be economically beneficial"
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BACKGROUND Inhibitors of gastric acid ( IGA ) are used for upper gastrointestinal bleeding or gastroesophageal reflux in preterm infants . The result ant increase in gastric pH may enhance the growth of pathogens and increase the risk of necrotizing enterocolitis ( NEC ) . Our systematic review examined the association between IGA and NEC in preterm infants . METHODS St and ard methodology of systematic review s was followed . PubMed , Embase , Cochrane , and Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) data bases were search ed in August 2012 . RESULTS One case-control and one prospect i ve cohort study ( n = 11,346 ) , both evaluating H2-blockers as IGA , were included . Meta- analysis showed a significant association between NEC and IGA ( odds ratio [ OR ] : 1.78 , 95 % confidence interval [ CI ] : 1.4 , 2.27 , p incidence of infection ( sepsis , pneumonia , urinary tract infection ) with IGA ( 37.4 % versus 9.8 % , OR : 5.5 , 95 % CI : 2.9 to 10.4 , p receptor antagonists may be associated with increased risk of NEC and infections in preterm infants | [
"Background And Objective : Gastric acidity is a major nonimmune defense mechanism against infections . The objective of this study was to investigate whether ranitidine treatment in very low birth weight ( VLBW ) infants is associated with an increased risk of infections , necrotizing enterocolitis ( NEC ) , and fatal outcome . Methods : Newborns with birth weight between 401 and 1500 g or gestational age between 24 and 32 weeks , consecutively observed in neonatal intensive care units , were enrolled in a multicenter prospect i ve observational study . The rates of infectious diseases , NEC , and death in enrolled subjects exposed or not to ranitidine were recorded . Results : We evaluated 274 VLBW infants : 91 had taken ranitidine and 183 had not . The main clinical and demographic characteristics did not differ between the 2 groups . Thirty-four ( 37.4 % ) of the 91 children exposed to ranitidine and 18 ( 9.8 % ) of the 183 not exposed to ranitidine had contracted infections ( odds ratio 5.5 , 95 % confidence interval 2.9–10.4 , P risk of NEC was 6.6-fold higher in ranitidine-treated VLBW infants ( 95 % confidence interval 1.7–25.0 , P = .003 ) than in control subjects . Mortality rate was significantly higher in newborns receiving ranitidine ( 9.9 % vs 1.6 % , P = .003 ) . Conclusions : Ranitidine therapy is associated with an increased risk of infections , NEC , and fatal outcome in VLBW infants . Caution is advocated in the use of this drug in neonatal age",
"Background —The effect of histamine H2receptor antagonists on gastric emptying is controversial . Aims —To determine the effects of ranitidine , famotidine , and omeprazole on gastric motility and emptying . Patients and methods —Fifteen normal subjects underwent simultaneous antroduodenal manometry , electrogastrography ( EGG ) , and gastric emptying with dynamic antral scintigraphy ( DAS ) . After 30 minutes of fasting manometry and EGG recording , subjects received either intravenous saline , ranitidine , or famotidine , followed by another 30 minutes recording and then three hours of postpr and ial recording after ingestion of a radiolabelled meal . Images were obtained every 10–15 minutes for three hours to measure gastric emptying and assess antral contractility . Similar testing was performed after omeprazole 20 mg daily for one week . Results —Fasting antral phase III migrating motor complexes ( MMCs ) were more common after ranitidine ( 9/15 subjects , 60 % ) , famotidine ( 12/15 , 80 % ) , and omeprazole ( 8/12 , 67 % ) compared with placebo ( 4/14 , 29 % ; p ranitidine , famotidine , and omeprazole slowed gastric emptying , increased the amplitude of DAS contractions , increased the EGG power , and increased the antral manometric motility index . Conclusions —Suppression of gastric acid secretion with therapeutic doses of gastric acid suppressants is associated with delayed gastric emptying but increased antral motility",
"Objective : To evaluate whether infants treated in neonatal intensive care units have stress-induced bleeding from gastrointestinal tract or gastric lesions and to define risk factors for these findings . Design : Part one : retrospective ; part two : prospect i ve . Setting : Tampere University Hospital , neonatal intensive care unit . Patients and interventions : In part one , 100 consecutive newborn infants treated in intensive care were retrospectively evaluated for gastrointestinal tract bleeding and risk factors , and in part two 89 gastroscopied and mechanically ventilated infants were prospect ively evaluated for further risk factors for gastric mucosal lesions . The statistical evaluation of risk factors was made by multivariate analysis using logistic regression modeling . Main results : Of infants treated in the neonatal intensive care unit 20 % had signs of gastrointestinal bleeding . Mechanical ventilation was the only risk factor ( OR = 4.06 , 95 % confidence interval 1.21–12.3 ) . In part two , when mechanically ventilated infants were prospect ively evaluated , 53 % had remarkable gastric mucosal lesions . The analysis showed three other risk factors : abnormal and delayed delivery and hypotension after birth . Conclusions : Newborn infants treated in the intensive care unit had a high frequency of stress-induced gastric hemorrhage with gastric lesions similar to adults and children treated in intensive care . Mechanical ventilation is the main risk factor . Also mode of delivery and hypotension after birth increase the risk of stress-induced gastric lesions . These infants should be the target for prophylactic gastroprotective treatment",
"BACKGROUND Stress ulcer prophylaxis ( SUP ) using ranitidine , a histamine H2 receptor antagonist , has been associated with an increased risk of ventilator-associated pneumonia . The proton pump inhibitor ( PPI ) pantoprazole is also commonly used for SUP . PPI use has been linked to an increased risk of community-acquired pneumonia . The objective of this study was to determine whether SUP with pantoprazole increases pneumonia risk compared with ranitidine in critically ill patients . METHODS The cardiothoracic surgery data base at our institution was used to identify retrospectively all patients who had received SUP with pantoprazole or ranitidine , without crossover between agents . From January 1 , 2004 , to March 31 , 2007 , 887 patients were identified , with 53 patients excluded ( pantoprazole , 30 patients ; ranitidine , 23 patients ) . Our analysis compared the incidence of nosocomial pneumonia in 377 patients who received pantoprazole with 457 patients who received ranitidine . RESULTS Nosocomial pneumonia developed in 35 of the 377 patients ( 9.3 % ) who received pantoprazole , compared with 7 of the 457 patients ( 1.5 % ) who received ranitidine ( odds ratio [ OR ] , 6.6 ; 95 % confidence interval [ CI ] , 2.9 to 14.9 ) . Twenty-three covariates were used to estimate the probability of receiving pantoprazole as measured by propensity score ( C-index , 0.77 ) . Using this score , pantoprazole and ranitidine patients were stratified according to their probability of receiving pantoprazole . After propensity adjusted , multivariable logistic regression , pantoprazole treatment was found to be an independent risk factor for nosocomial pneumonia ( OR , 2.7 ; 95 % CI , 1.1 to 6.7 ; p = 0.034 ) . CONCLUSION The use of pantoprazole for SUP was associated with a higher risk of nosocomial pneumonia compared with ranitidine . This relationship warrants further study in a r and omized controlled trial",
"OBJECTIVE : The aim of this case-control study was to evaluate the frequency and the type of mucosal lesions in newborn babies with upper GI bleeding ( UGIB ) , the diagnostic role and safety of upper GI endoscopy , and the recognition of risk factors associated with the hemorrhagic event . METHODS : A population of 5180 infants born from June , 1988 to May , 1997 was examined . A case was defined as any patient who had UGIB within 4 days of delivery . The diagnosis was made by endoscopic examination in an endoscopy room . The following parameters were determined : amniotic fluid features , funicular blood pH , Apgar index at 5 min , neonatal weight , body length , gestational age , and the presence of other pathologies . Biochemical profiles were also evaluated . Clinical and demographic data of the mothers of the newborn babies were analyzed . Sera of cases and the respective parents were tested for gastrin and pepsinogen . As a control group , 53 full-term healthy infants matched for sex and age were r and omly selected from the population of infants born in our pediatric department . RESULTS : Sixty-four of 5180 newborn babies ( 1.23 % ) suffered from UGIB within 26.5 ± 20 h of life . In 53 of 64 cases ( mean age = 24.2 ± 25.5 h ) it was possible to carry out an endoscopic examination . In one case , endoscopy was limited to the esophagus because of the presence of multiple mucosal ulcers and substenosis of the viscus . Esophageal damage was observed in 24/53 patients . The esophageal lesions were isolated in nine cases , and occurred jointly with gastric or duodenal damage in 14 cases and one , respectively . Gastric and duodenal lesions were seen in 43/52 and 1/52 patients , respectively . There were 17 cases of gastric ulcers and one case of duodenal ulcer . Blood clots were observed in 14 gastric ulcer patients ; in one case there was evidence of active bleeding at the margins of a gastric ulcer . There was no significant difference with regard to the demographic and clinical characteristics of the cases and controls . Median values of serum gastrin of the cases and controls were similar . Median serum pepsinogen was significantly higher in the case group . CONCLUSIONS : UGIB in the newborn babies is often associated with clinical ly relevant mucosal lesions of the upper GI tract . The evolution , after treatment with antisecretory drugs , is generally rapid and favorable , with clinical recovery usually obtained within 24–48 h. The higher serum pepsinogen levels may only represent a significant risk factor of mucosal lesions and complications",
"Small premature infants are often hypochlorhydric , and frequently their stomachs are colonized by enteric , gram-negative bacteria . We tested a hypothesis that gastric pH affected the colonization of the stomach with enteric bacteria and that this colonization was causally related to the risk or severity of necrotizing enterocolitis . A prospect i ve , double-blind study was conducted that compared a group of infants supplemented with 0.01–0.02 ml of 1 N HCl/ml of milk to a group with a similar supplement of water . Gastric pH , gastric enteric bacteria counts , and the incidence and severity of necrotizing enterocolitis were monitored . The median gastric pH of the HCl-supplemented group was lower ( 3.0 ) than controls ( 4.0 ) throughout the study ( p The gastric enteric bacterial colonization rate and the quantitative bacterial counts were strongly correlated with gastric pH over 4 ( p Somatic growth rates in infants in the HCl-supplemented group were equal to , or exceeded , those in the control group . There was 1 case of necrotizing entero-colitis among the 34 infants in the HCl-supplemented group and 8 cases among the 34 in the control group ( p = 0.02 ) . It appears that acidifying the feedings of small premature infants to a pH low enough to inhibit bacterial proliferation in the stomach significantly lowers the risk of necrotizing enterocolitis ",
"Evaluation of prophylactic effects of omeprazole and /or vitamin E on the formation of free oxygen radicals ( FOR ) and bowel histopathology in the newborn rat model of hypoxia/reoxygenation ( H/R ) that resembles human necrotizing enterocolitis ( NEC ) . Eighty newborn rats were r and omly divided into eight groups . H/R was done using airtight chamber . Rats were exposed to 100 % CO2 for 15 min followed by a reoxygenation for the next 15 min with 100 % O2 . Group 1 ( n = 10 ) was the control group . Group 2 ( n = 10 ) rats received vitamin E. In Group 3 ( n = 10 ) omeprazole was administrated . Group 4 ( n = 10 ) rats received omeprazole and vitamin E. Group 5 ( n = 10 ) rats were subjected to H/R two times for 2 days and one time for 3 days . Group 6 ( n = 10 ) received vitamin E in addition to H/R for 5 days and in Group 7 ( n = 10 ) omeprazole in addition to H/R for 5 days . In Group 8 ( n = 10 ) , vitamin E and omeprazole and H/R were applied for 5 days . Rats were killed at the end of the each process and bowel specimens were harvested for histopathological and biochemical investigations . We administrated vitamin E intramuscularly 300 unit/kg per day and omeprazole orally 20 mg/kg per day . Malondialdehyde ( MDA ) , xanthine oxidase ( XO ) , xanthine dehydogenase ( XDH ) and XO/(XO + XDH ) were measured . Vitamin E and /or omeprazole treated rats had significantly less XO% levels than H/R only group ( 0.36 , 0.38 and 0.57 , respectively ) . Similarly , the MDA levels were significantly lower in vitamin E and /or omeprazole received rats than H/R only rats ( 88.8 , 97.9 and 122.6 , respectively ) . All rats treated with omeprazole and /or vitamin E had better biochemical and histopathological levels compared to H/R rats ( p intestinal damage when compared with Group 6 ( vitamin E + H/R ) , Group 7 ( omeprazole + R/H ) and Group 8 ( vitamin E + omeprazole + H/R ) ( p Grade 2 and 3 intestinal damages were only in Group 5 and there were no statistical difference between in Groups 6 , 7 and 8 ( p > 0.001 ) . Omeprazole and /or vitamin E may protect the biochemical and histopathological intestinal damage of H/R injury in rats . These drugs may be beneficial in the prophylaxis of NEC in humans as well",
"Introduction : Proton pump inhibitor ( PPI ) therapy is increasingly being used to treat premature infants with gastroesophageal reflux disease ( GERD ) ; however , the efficacy of PPI on acid production in this population has yet to be assessed in this patient group . The aim of this study was to determine the effect of 0.7 mg/kg/d omeprazole on gastric acidity and acid gastroesophageal reflux in preterm infants with reflux symptoms and pathological acid reflux on 24-h pH probe . Methods : A r and omized , double blind , placebo-controlled , crossover design trial of omeprazole therapy was performed in 10 preterm infants ( 34–40 weeks postmenstrual age ) . Infants were given omeprazole for 7 d and then placebo for 7 d in r and omized order . Twenty-four-hour esophageal and gastric pH monitoring was performed on days 7 and 14 of the trial . Results : Compared to placebo , omeprazole therapy significantly reduced gastric acidity ( % time pH 0.0005 ) , esophageal acid exposure ( % time pH 0.01 ) and number of acid GER episodes ( 119 vs 60 episodes , P Omeprazole is effective in reducing esophageal acid exposure in premature infants with pathological acid reflux on 24-h pH probe ; however , the far more complex issues of safety and efficacy have yet to be addressed",
"OBJECTIVE To assess endoscopically the effect of prophylactic short-term ranitidine treatment in the prevention of stress-induced gastric lesions in neonatal intensive care unit ( ICU ) patients . DESIGN Prospect i ve , r and omized study . SETTING Department of Neonatal Intensive Care , University Hospital of Tampere . PATIENTS Fifty-three infants were enrolled in a r and omized , controlled study . Forty-eight ( 90 % ) of these patients underwent endoscopic examination and were evaluated . INTERVENTIONS A histamine-2-receptor blocker , ranitidine , was given prophylactically after birth for 4 days to infants mechanically ventilated and treated in the neonatal ICU . The gastric mucosa was both visually and histologically evaluated after 3 to 6 days , and the outcome of the infants was registered . MEASUREMENTS AND MAIN RESULTS In the 23 infants prophylactically treated with ranitidine , the gastric mucosa was visually classified as normal in 14 ( 61 % ) infants as compared with five ( 20 % ) of 25 controls ( p Histologic lesions showed parallel results ( 57 % vs. 16 % , p gastric ulcers were diagnosed endoscopically in the control group vs. none in the treatment group . The ulcers were all clinical ly \" silent \" at the time of endoscopy . According to logistic regression modeling , the decreased risk for gastric mucosal lesions in infants receiving prophylactic ranitidine was 0.03 ( 95 % confidence interval 0.003 to 0.178 ) . Surfactant treatment for infant respiratory distress syndrome also decreased the risk for stress-induced gastric mucosal lesions ( odds ratio 0.083 ; 95 % confidence interval 0.009 to 0.788 ) , whereas other variables ( birth weight , gestational age , Apgar scores , cord blood pH , and duration of intubation ) had no significant effect . No side effects could be attributed to the ranitidine treatment . CONCLUSION We conclude that short-term prophylactic ranitidine treatment prevents gastric mucosal lesions in newborn infants under stress",
"For identification of risk factors for bloodstream infection ( BSI ) among neonatal intensive care unit patients , prospect i ve 6-month studies in three neonatal intensive care units were conducted . BSI was diagnosed in 42 of 376 ( 11.2 % ) enrolled infants . Pathogens included coagulase-negative staphylococci , C and ida sp. , Group B streptococci and Gram-negative species . Patients with BSIs were more likely to die during their neonatal intensive care unit stay than were patients who did not acquire BSIs ( 6 of 42 vs. 11 of 334 , P = 0.007 ) . BSI rate was highest in infants with birth weight ( relative risk ( RR ) = 6.8 , P H-2 blockers ( RR = 4.2 , P BSI were more severely ill on admission than other infants ( median physiologic stability index 13 vs. 10 ( P risk of BSI was independently associated only with very low birth weight , respiratory admission diagnoses and receipt of H-2 blockers . Risk of isolation of a pathogen from blood culture was independently associated with Broviac , umbilical vein or peripheral venous catheterization > 10 , 7 or 3 days , respectively , at one insertion site . Rate of isolation of a pathogen was higher ( 9 of 59 ( 15 % ) ) within 48 hours of a measurable serum interleukin 6 concentration than an interleukin 6 level of 0 pg/ml ( 10 of 159 ( 6 % ) , P = 0.04 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND / AIMS Intra-gastric bacterial proliferation is frequent in patients with hypochlohydria . However , status of gastric bacterial infection in patients receiving proton pump inhibitor or H2-receptor antagonist remains controversial . The purpose of this study was to investigate the microbial condition of the stomach in patients who received H2-receptor antagonist or proton pump inhibitor . METHODOLOGY Between November 2000 and January 2002 , 102 patients were enrolled in this study . Of these , 52 did not receive any treatment ( group I ) , 26 received H2-receptor antagonist ( group II ) , and 24 received proton pump inhibitor ( group III ) . Ten mL of gastric juice were aspirated for culture during endoscopic examination . The aerobic and anaerobic bacterial and fungal cultures were performed immediately . A glass pH meter measured the pH of the gastric juice . RESULTS The intra-gastric pH was 2.91+/-2.06 ( mean + /- SD ) , 4.12+/-2.83 , and 5.11+/-2.47 for groups I , II , and III , respectively ( p=0.001 between groups I and III , p>0.05 between groups I and II , and groups II and III ) . The positive bacterial culture rates were 66.7 % ( 16/24 ) in group III , 46.2 % ( 12/26 ) in group II , and 28.8 % ( 15/52 ) in group I ( p=0.007 between groups III and I , p>0.05 between groups I and II , and groups II and III ) . The positive c and idal culture rates were 12.5 % ( 3/24 ) in group III , 11.5 % ( 3/26 ) in group II , and 17.3 % ( 9/52 ) in group I ( p>0.05 ) . CONCLUSIONS Patients who received proton pump inhibitor had more acid suppression and intra-gastric bacterial infection than those of the control group . The intra-gastric c and idal infection was not related to intra-gastric pH or anti-secretory medication in this study",
"OBJECTIVES To determine the mortality and morbidity for infants weighing 401 to 1500 g ( very low birth weight [ VLBW ] ) at birth by gestational age , birth weight , and gender . STUDY DESIGN Perinatal data were collected prospect ively on an inborn cohort from January 1995 through December 1996 by 14 participating centers of the National Institute of Child Health and Human Development Neonatal Research Network and were compared with the corresponding data from previous reports . Sociodemographic factors , perinatal events , and the neonatal course to 120 days of life , discharge , or death were evaluated . RESULTS Eighty four percent of 4438 infants weighing 501 to 1500 g at birth survived until discharge to home or to a long-term care facility ( compared with 80 % in 1991 and 74 % in 1988 ) . Survival to discharge was 54 % for infants 501 to 750 g at birth , 86 % for those 751 to 1000 g , 94 % for those 1001 to 1250 g , and 97 % for those 1251 to 1500 g . The incidence of chronic lung disease ( CLD ; defined as receiving supplemental oxygen at 36 weeks ' postmenstrual age ; 23 % ) , proven necrotizing enterocolitis ( NEC ; 7 % ) , and severe intracranial hemorrhage ( ICH ; grade III or IV ; 11 % ) remained unchanged between 1991 and 1996 . Furthermore , 97 % of all VLBW infants and 99 % of infants weighing weights less than the 10th percentile at 36 weeks ' postmenstrual age . Mortality for 195 infants weighing 401 to 500 g was 89 % , with nearly all survivors developing CLD . Mortality in infants weighing 501 to 600 g was 71 % ; among survivors , 62 % had CLD , 35 % had severe ICH , and 15 % had proven NEC . CONCLUSIONS Survival for infants between 501 and 1500 g at birth continued to improve , particularly for infants weighing survival was not associated with an increase in major morbidities , because the incidence of CLD , proven NEC , and severe ICH did not change . However , poor postnatal growth remains a major concern , occurring in 99 % of infants weighing Mortality and major morbidity ( CLD , severe ICH , and NEC ) remain high for the smallest infants , particularly those weighing < 600 g at birth",
"To establish the prevalence of upper gastrointestinal mucosal lesions in full-term and preterm infants under stress . Design : A prospect i ve , cohort study . Setting : Neonatal intensive care unit at a university teaching hospital . Patients : Seventeen ( 14 preterm , 3 term ; median gestational age 29.7 wks ; median birth weight 1230 g ) consecutive , unselected infants treated in intensive care . Interventions : Gastroscopy , using a prototype fiberoptic gastroscope design ed for newborns , was performed for the first time at the age of 3 to 7 days . Biopsy specimens were taken when possible . Ranitidine treatment and follow-up endos-copies were performed in selected patients . Blood pressure , heart rate , oxygen saturation by pulse oximeter , and the general condition of the infants were monitored at 1-min intervals during the endoscopy . Central nervous system ultra-sonography examination was repeatedly performed before and after the procedure . Measurements and Main Results : At the time of first endoscopy , 15 of 17 infants were asymptomatic for gastrointestinal tract problems , one had melena , and one hematemesis . Upper gastrointestinal endoscopy revealed pathology in 16 ( 94 % ) infants , macroscopic esophagitis in six infants , hemorrhagic gastritis in nine infants , and gastritis with ulcers in six infants . Microscopically , the lesions were also clear . A peculiar finding was acute gastritis with cystic gl and deformation ( “ cystic gastritis ” ) seen in five of the infants under stress ; one of these infants also had intestinal metaplasia in the gastric mucosa . Seven infants were treated with ranitidine without side-effects . Follow-up endoscopies demonstrated normalization of the lesions in five of six infants studied . The procedure , including biopsies , seemed to be safe , even for very low-birth weight infants . Conclusions : Gastric mucosal lesions are highly prevalent in preterm infants in intensive care before any symptoms occur . Further research on preterm infants under stress is needed in order to determine the risk factors and optimal treatment for the esophageal and gastric mucosal lesions described here . ( Crit Care Med 1993 ; 21:1863–1867",
"OBJECTIVE To characterize the pharmacodynamics and systemic exposure of esomeprazole in 26 preterm infants and term neonates with symptoms of gastroesophageal reflux and pathologic acid exposure . STUDY DESIGN Enrolled patients received oral esomeprazole 0.5 mg/kg once daily for 7 days . Twenty-four-hour esophagogastric pH-impedance monitoring was performed at baseline and on day 7 . Pharmacokinetic analysis was performed on day 7 . Symptoms occurring during the baseline and day 7 studies were recorded on a symptom chart . RESULTS There were no significant differences from baseline to day 7 of therapy in the frequency of bolus reflux , consistency of bolus reflux ( liquid , mixed , or gas ) , extent of bolus reflux , or bolus clearance time . Acid bolus reflux episodes were reduced on therapy ( median 30 vs 8 , P reflux index ( mean % time esophageal pH mean of area under the plasma concentration time curve during the dosing interval and observed maximum plasma concentration was 2.5 micromol x h/L and 0.74 micromol/L , respectively . The number of gastroesophageal reflux symptoms recorded over 24 hours was lower on therapy ( median 22 vs 12 , P preterm infants and term neonates esomeprazole produces no change in bolus reflux characteristics despite significant acid suppression",
"Purpose The pharmacokinetic profile of pantoprazole granules was assessed in neonates and preterm infants with gastroesophageal reflux disease ( GERD ) in a multicenter , r and omized , open-label trial . Methods Patients were r and omly assigned to either the pantoprazole 1.25 mg ( approx . 0.6 mg/kg ) or 2.5 mg ( approx . 1.2-mg/kg ) group and treated for ≥5 consecutive days . Blood was sample d either at 0 , 2 , 8 , and 18 h postdose or at 0 , 1 , 4 , and 12 h postdose on day 1 and at 3 and 6 h postdose after ≥5 consecutive doses . Cytochrome P450 2C19 ( CYP2C19 ) and CYP3A4 genotypes were determined . Safety was monitored . Population pharmacokinetics ( popPK ) analyses were conducted using nonlinear mixed-effects modeling . Results The popPK modeling of the pantoprazole 1.25 mg and 2.5 mg groups obtained mean ( ±st and ard deviation ) estimates for the area under the plasma concentration versus time curve ( AUC ) of 3.54 ( ±2.82 ) and 7.27 ( ±5.30 ) µg h/mL , respectively , and mean estimates for half-life of 3.1 ( ±1.5 ) and 2.7 ( ±1.1 ) h , respectively . Pantoprazole did not accumulate following multiple-dose administration . The two patients with the CYP2C19 poor metabolizer genotype had a substantially higher AUC than extensive metabolizers . No safety-related discontinuations occurred . Conclusions In preterm infants and neonates , pantoprazole granules were generally well tolerated , mean exposures with pantoprazole 2.5 mg were slightly higher than that in adults who received 40 mg . While the half-life was longer , accumulation did not occur",
"OBJECTIVE . We sought to determine if an association exists between the use of histamine-2 receptor ( H2 ) blockers and the incidence of necrotizing enterocolitis ( NEC ) in infants of 401 to 1500 g in birth weight . STUDY DESIGN . Data from the National Institute of Child Health and Human Development Neonatal Research Network very low birth weight ( 401–1500 g ) registry from September 1998 to December 2001 were analyzed . The relation between the diagnosis of NEC ( Bell stage II or greater ) and antecedent H2-blocker treatment was determined by using case-control methodology . Conditional logistic regression was implemented , controlling for gender , site of birth ( outborn versus inborn ) , Apgar score of 11072 infants who survived for at least 12 hours , 787 ( 7.1 % ) developed NEC ( 11.5 % of infants 401–750 g , 9.1 % of infants 751–1000 g , 6.0 % of infants 1001–1250 g , and 3.9 % of infants 1251–1500 g ) . Antecedent H2-blocker use was associated with an increased incidence of NEC ( P H2-blocker therapy was associated with higher rates of NEC , which is in agreement with a previous r and omized trial of acidification of infant feeds that result ed in a decreased incidence of NEC . In combination , these data support the hypothesis that gastric pH level may be a factor in the pathogenesis of NEC",
"OBJECTIVE To study the occurrence of bacterial translocation and to assess the impact of breastfeeding on bacterial translocation in the animal model of necrotizing enterocolitis . METHODS A total of 20 neonate Sprague-Dawley rats were enrolled in the study . Rats were r and omly allocated into either control or study group just after birth . Ten newborn rats in the control group were left with their mother to be breast-fed . In contrary , necrotizing enterocolitis group consisted of neonates that were separated from their mothers , housed in an incubator and were gavaged with a special rodent formula three times daily . Survival rates , weight changes , and morphologic scoring obtained after microscopic evaluation were determined as microbiologic evaluation criteria . RESULTS All the rats in the control group survived , while 1 ( 10 % ) rat died in the necrotizing enterocolitis group . Mortality rates of the two groups were similar . All the formula-fed animals in the necrotizing enterocolitis group had significant weight loss compared to the breast milk-fed rats in the control group ( p coli growths were identified in the bowel lumen , liver , and spleen of necrotizing enterocolitis and control groups , respectively . This difference was statistically significant . In peritoneal smear cultures , a total of 3 ( 30 % ) growths were detected in the necrotizing enterocolitis group and 1 ( 10 % ) growth in the control group . CONCLUSION As the result of a disturbance in the intestinal flora and impairment of the intestinal barrier in necrotizing enterocolitis , microrganisms in the bowel pass through the intestinal barrier and reach the liver and the spleen via the hematogenous route . This condition is closely related to the impairment of physiological and functional features of the intestinal barrier and is independent from the degree of intestinal injury . Bacterial translocation should be remembered in cases suspected of necrotizing enterocolitis , and a rapid and effective treatment algorithm should be applied in such circumstances ( Tab . 3 , Fig. 3 , Ref . 21 ) . Full Text in PDF www.elis.sk",
"OBJECTIVES To determine if the administration of ranitidine to neonates leads to an increase in gastric pH to > or = 4 and if this increase in gastric pH correlates with gastric colonization . STUDY DESIGN 628 pH measurements and 276 gastric cultures were obtained from 86 neonates . Twenty-three patients received ranitidine and 63 patients served as controls . RESULTS Treated patients had a mean gastric pH of 5.6 compared with a control mean pH of 4.4 ( p Gastric pH was significantly affected by feeding and postnatal age . 54 patients were colonized with pathogenic bacteria and /or yeast ( n = 20 treated , n = 34 control ) . Length of hospitalization ( p increase in gastric pH ( p days of antibiotics before culture ( p ranitidine use ( p rate of colonization . CONCLUSIONS The use of ranitidine did lead to a significant increase in gastric pH and with this increase in gastric pH gastric colonization rates increased . No increased frequency of infection was found in ranitidine-treated infants",
"Background : The dramatic inhibitory effect of proton pump inhibitors on acid secretion has raised concern about possible side‐effects , such as small bowel bacterial overgrowth , which may result in further gut dysfunction . The aim of this study was to assess the effect of proton pump inhibitors on duodenal bacteriology , carbohydrate absorption and bowel habit"
] | 41166c6c-06ff-11f0-808a-c43d1ab1c353 |
Selective serotonin reuptake inhibitors ( SSRIs ) are recommended as first-line pharmacological treatment for depression and are the most commonly prescribed class of antidepressants . However , there is substantial evidence that noradrenaline has a role in the pathogenesis and treatment of depression . This review aims to examine the evidence of including noradrenaline reuptake inhibition with serotonin reuptake inhibition with respect to increasing efficacy in the treatment of depression . Evidence from meta- analysis of r and omised controlled trials ( RCTs ) and r and omised pragmatic trials was found in support of greater efficacy of the serotonin noradrenaline reuptake inhibitors ( SNRIs ) , venlafaxine and duloxetine , in moderate to severe depression compared to SSRIs but no evidence was found for superiority of milnacipran . There is sufficient current evidence that demonstrates an increase in efficacy , when noradrenaline reuptake is added to serotonin ( 5-HT ) reuptake , to suggest that patients with severe depression or those who have failed to reach remission with a SSRI may benefit from treatment with a SNRI . However , as these conclusions are drawn from the evidence derived from meta-analyses and pragmatic trials , large adequately powered RCTs using optimal dosing regimens and clinical ly relevant outcome measures in severe depression and SSRI treatment failures are still required to confirm these findings | [
"Antidepressant effects and unintended effects of paroxetine ( 30 mg/day ) and clomipramine ( 150 mg/day ) were compared in a double-blind , r and omized , inpatient , fixed-dose , plasma-level-controlled study . Patients with a DSM-III diagnosis of major depressive disorder participated . After 1 week of single-blind placebo treatment 120 patients fulfilled the criterion of a Hamilton ( 17-item ) score of greater than or equal to 18 and were started on active treatment for 6 weeks . Drop-outs on paroxetine ( n = 12 ) were largely due to lack of effect , and on clomipramine ( n = 19 ) due to lack of effect ( n = 7 ) , adverse reactions or severe side effects ( n = 10 ) and development of mania ( n = 2 ) . According to the protocol , non-responders ( Hamilton total greater than or equal to 16 ) after 4 weeks active treatment were terminated , and this occurred to 23 patients on paroxetine and four patients on clomipramine . Categorical response measures and group averages of rating scores showed a significantly better therapeutic effect of clomipramine from the second week of treatment on . These results are very similar to our earlier results with another selective serotonin reuptake inhibitor ( citalopram ) , but generally at variance with the literature on this class of antidepressants , which , however , mostly deals with outpatient studies",
"This 8-week , r and omised , double-blind study compared the efficacy and tolerability of escitalopram to that of venlafaxine XR in primary care patients with major depressive disorder . The efficacy of escitalopram ( 10– 20 mg ; n = 148 ) was similar to venlafaxine XR ( 75– 150 mg ; n = 145 ) , based on mean change from baseline to week 8 in Montgomery and Åsberg Depression Rating Scale total score . In ad hoc analyses , escitalopram-treated patients achieved sustained remission significantly faster than did venlafaxine-treated patients . More venlafaxine-treated patients had nausea , constipation , and increased sweating ( p venlafaxine-treated patients had discontinuation symptoms ( p Thus escitalopram treatment was similar to venlafaxine treatment with respect to efficacy and was better tolerated by patients in primary care",
"ABSTRACT Objective : This study evaluated the efficacy and tolerability of escitalopram and duloxetine in the treatment of major depressive disorder ( MDD ) . Research design and methods : Patients were r and omised to 24 weeks of double-blind treatment with fixed doses of escitalopram ( 20 mg ) ( n = 143 ) or duloxetine ( 60 mg ) ( n = 151 ) . The primary analysis of efficacy was an analysis of covariance ( ANCOVA ) of change from baseline to endpoint ( week 24 ) in MADRS total score ( last observation carried forward ) . Main outcome measures ; Results : At week 8 , the mean change from baseline in total MADRS score was –19.5 for patients treated with escitalopram ( n = 141 ) and –17.4 for patients treated with duloxetine ( n = 146 ) , a difference of 2.1 points ( p responders ( ≥ 50 % decrease in MADRS ) was 69 % ( escitalopram ) and 58 % ( duloxetine ) ( p % ( escitalopram ) and 48 % ( duloxetine ) ( NS ) . For the primary endpoint , the mean change from baseline in total MADRS score at week 24 was –23.4 for patients treated with escitalopram and –21.7 for patients treated with duloxetine , a difference of 1.7 points ( p = 0.055 , one-sided ) . The difference in mean change from baseline in MADRS total score favoured escitalopram at weeks 1 , 2 , 4 , 8 , 12 and 16 ( p 0.05 ) . The overall withdrawal rates were 22 % ( escitalopram ) and 25 % ( duloxetine ) ( NS ) . The withdrawal rate due to adverse events was lower for escitalopram ( 9 % ) compared to duloxetine ( 17 % ) ( p treated with duloxetine reported insomnia ( 12.6 % vs. 4.9 % ) and constipation ( 8.6 % vs. 2.8 % ) . Conclusion : Escitalopram was superior to duloxetine in acute treatment and at least as efficacious and better tolerated in long-term treatment of MDD",
"Objective : To test the hypothesis that in patients with major depressive disorder ( MDD ) , the response for specific Hamilton Depression Rating Scale items will differ for duloxetine compared with selective serotonin reuptake inhibitors ( SSRIs ) and that patterns of response will differ based on symptom severity at baseline . Method : Data were pooled from all Lilly-sponsored clinical trials where duloxetine was compared with placebo and an SSRI in patients with MDD : 7 r and omized , double-blind , fixed-dose , 8-week studies of duloxetine ( n = 1,133 ) versus SSRI ( n = 689 ) versus placebo ( n = 641 ) . Duloxetine doses were 40 , 60 , 80 and 120 mg/day . SSRI doses were 10 mg/day ( escitalopram ) and 20 mg/day ( fluoxetine and paroxetine ) . Results : Compared to SSRI-treated patients , duloxetine-treated patients had a significantly greater ( p ≤ 0.05 ) reduction in the 17-item Hamilton Depression Rating Scale ( HAMD17 ) total score and HAMD17 items of work and activities , psychomotor retardation , genital symptoms and hypochondriasis . Differences favoring the SSRIs approached significance for middle insomnia ( p = 0.057 ) and late insomnia ( p = 0.06 ) , with effect sizes at least twice the magnitude of the corresponding effect sizes for duloxetine . Similarly , the advantage for duloxetine versus the SSRIs approached significance for general somatic symptoms ( p = 0.056 ) , with an effect size twice that observed for the SSRIs . The HAMD17 total score difference was driven mostly by patients with lower baseline MDD severity ( HAMD17 total score ≤19 ) , where the HAMD17 effect size advantage for duloxetine over combined SSRIs was statistically significant ( p = 0.031 ) . Conclusion : Potentially important differences in symptom response patterns were found between duloxetine and the combined SSRIs depending on symptom severity , and different HAMD17 items responded differently to duloxetine compared with SSRIs . Underst and ing these differences may be useful in tailoring antidepressant therapy for individual patients",
"OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are widely used to treat depression , but the rates , timing , and baseline predictors of remission in \" real world \" patients are not established . The authors ' primary objectives in this study were to evaluate the effectiveness of citalopram , an SSRI , using measurement-based care in actual practice , and to identify predictors of symptom remission in out patients with major depressive disorder . METHOD This clinical study included out patients with major depressive disorder who were treated in 23 psychiatric and 18 primary care \" real world \" setting s. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks . The clinicians were assisted by a clinical research coordinator in the application of measurement-based care , which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures . Remission was defined as an exit score of 17-item Hamilton Depression Rating Scale ( HAM-D ) ( primary outcome ) or a score of 16-item Quick Inventory of Depressive Symptomatology , Self-Report ( QIDS-SR ) ( secondary outcome ) . Response was defined as a reduction of > or=50 % in baseline QIDS-SR score . RESULTS Nearly 80 % of the 2,876 out patients in the analyzed sample had chronic or recurrent major depression ; most also had a number of comorbid general medical and psychiatric conditions . The mean exit citalopram dose was 41.8 mg/day . Remission rates were 28 % ( HAM-D ) and 33 % ( QIDS-SR ) . The response rate was 47 % ( QIDS-SR ) . Patients in primary and psychiatric care setting s did not differ in remission or response rates . A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment . Participants who were Caucasian , female , employed , or had higher levels of education or income had higher HAM-D remission rates ; longer index episodes , more concurrent psychiatric disorders ( especially anxiety disorders or drug abuse ) , more general medical disorders , and lower baseline function and quality of life were associated with lower HAM-D remission rates . CONCLUSIONS The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials . The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results",
"In recent years , the use of the last observation carried forward ( LOCF ) approach in imputing missing data in clinical trials has been greatly criticized , and several likelihood-based modeling approaches are proposed to analyze such incomplete data . One of the proposed likelihood-based methods is the Mixed-Effect Model Repeated Measure ( MMRM ) model . To compare the performance of LOCF and MMRM approaches in analyzing incomplete data , two extensive simulation studies are conducted , and the empirical bias and Type I error rates associated with estimators and tests of treatment effects under three missing data paradigms are evaluated . The simulation studies demonstrate that LOCF analysis can lead to substantial biases in estimators of treatment effects and can greatly inflate Type I error rates of the statistical tests , whereas MMRM analysis on the available data leads to estimators with comparatively small bias , and controls Type I error rates at a nominal level in the presence of missing completely at r and om ( MCAR ) or missing at r and om ( MAR ) and some possibility of missing not at r and om ( MNAR ) data . In a sensitivity analysis of 48 clinical trial data sets obtained from 25 New Drug Applications ( NDA ) su bmi ssions of neurological and psychiatric drug products , MMRM analysis appears to be a superior approach in controlling Type I error rates and minimizing biases , as compared to LOCF ANCOVA analysis . In the exploratory analyses of the data sets , no clear evidence of the presence of MNAR missingness is found",
"BACKGROUND After unsuccessful treatment for depression with a selective serotonin-reuptake inhibitor ( SSRI ) , it is not known whether switching to one antidepressant is more effective than switching to another . METHODS We r and omly assigned 727 adult out patients with a nonpsychotic major depressive disorder who had no remission of symptoms or could not tolerate the SSRI citalopram to receive one of the following drugs for up to 14 weeks : sustained-release bupropion ( 239 patients ) at a maximal daily dose of 400 mg , sertraline ( 238 patients ) at a maximal daily dose of 200 mg , or extended-release venlafaxine ( 250 patients ) at a maximal daily dose of 375 mg . The study was conducted in 18 primary and 23 psychiatric care setting s. The primary outcome was symptom remission , defined by a total score of 7 or less on the 17-item Hamilton Rating Scale for Depression ( HRSD-17 ) at the end of the study . Scores on the Quick Inventory of Depressive Symptomatology - Self Report ( QIDS-SR-16 ) , obtained at treatment visits , determined secondary outcomes , including remission ( a score of 5 or less at exit ) and response ( a reduction of 50 percent or more on baseline scores ) . RESULTS Remission rates as assessed by the HRSD-17 and the QIDS-SR-16 , respectively , were 21.3 percent and 25.5 percent for sustained-release bupropion , 17.6 percent and 26.6 percent for sertraline , and 24.8 percent and 25.0 percent for extended-release venlafaxine . QIDS-SR-16 response rates were 26.1 percent for sustained-release bupropion , 26.7 percent for sertraline , and 28.2 percent for extended-release venlafaxine . These treatments did not differ significantly with respect to outcomes , tolerability , or adverse events . CONCLUSIONS After unsuccessful treatment with an SSRI , approximately one in four patients had a remission of symptoms after switching to another antidepressant . Any one of the medications in the study provided a reasonable second-step choice for patients with depression . ( Clinical Trials.gov number , NCT00021528 . )",
"BACKGROUND The objectives of the study were to compare efficacy and tolerability of venlafaxine ER 75 - 150 mg/day with that of citalopram 10 - 20 mg/day in elderly patients with major depression according to DSM-IV criteria . METHODS A r and omised , double-blind , parallel group 6-month study . Efficacy was assessed by MADRS , CGI Global Improvement , CGI Severity of Illness and GDS-20 scores and safety by physical examinations , vital signs , adverse events and UKU side effect rating . Plasma levels of venlafaxine , its major metabolite O-desmethylvenlafaxine and citalopram were followed . RESULTS One hundred and fifty-one male and female patients ( 64 - 89 years ) were enrolled and 118 patients completed the study . Comparable improvements in MADRS , CGI Severity of Illness , CGI Global Improvement and GDS-20 were observed during venlafaxine and citalopram treatment . The MADRS remission rate was 19 % for venlafaxine and 23 % for citalopram . Side effects were common during both treatments but differed in tremor being more common during citalopram and nausea/vomiting during venlafaxine treatment . There were no clinical ly significant changes in blood pressure or body weight . CONCLUSION The observed benefits of venlafaxine treatment in elderly patients with major depression were similar to those observed in younger adults as were reported adverse events and side effects . Treatment with venlafaxine ER was well tolerated and induced beneficial effects of similar magnitude as those of citalopram",
"Some evidence suggests that medications that modulate both serotonin and norepinephrine may be more effective than selective serotonin-reuptake inhibitors ( SSRIs ) in severe major depressive disorder ( MDD ) . This prospect i ve pragmatic trial tests this hypothesis . Patients with severe MDD were r and omly assigned to either duloxetine ( a serotonin and norepinephrine-reuptake inhibitor ) or physicians ’ choice of four generic SSRIs . Nonblinded , flexibly dosed treatment was used to mimic clinical practice . To address potential investigator bias , the patient-reported Quick Inventory of Depressive Symptomatology Self-Report ( QIDS-SR ) was used as the primary efficacy outcome measure . A total of 750 out patients ( 19.2 % , African descent ; 14.8 % , Hispanic ) were r and omized . The primary outcome , remission at week 12 by QIDS-SR , was numerically greater for duloxetine compared with SSRIs ( 36 vs. 32 % ) , but this difference was not statistically significant . Mean changes in secondary outcomes were significantly superior in favor of duloxetine for the Hamilton Depression Scale-17 item , the Brief Pain Inventory , and the Sheehan Disability Scale . Remission superiority on the QIDS-SR was not achieved . Significantly greater benefit for duloxetine compared with SSRIs was demonstrated on measures of pain and functioning . Study demographics suggest a more generalizable racial and ethnic population than is typical in r and omized clinical trials",
"BACKGROUND Escitalopram is the most selective serotonin reuptake inhibitor ( SRI ) antidepressant available . Venlafaxine is a non-selective SRI that also inhibits noradrenergic re-uptake . This study compared escitalopram and venlafaxine extended release ( XR ) in depressed out patients at the highest doses recommended in the United States . METHOD In this r and omized trial , patients ( diagnosis of DSM-IV-defined major depressive disorder ; baseline Hamilton Rating Scale for Depression score of > /= 20 ) received 1 week of single-blind placebo treatment , followed by 8 weeks of double-blind , fixed-dose treatment with either escitalopram or venlafaxine XR ( rapidly titrated to 20 mg/day and 225 mg/day , respectively , in accordance with prescribing information ) . The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score . Data were collected from May to December 2002 . RESULTS Mean baseline MADRS scores for the escitalopram ( N = 97 ) and venlafaxine XR ( N = 98 ) groups were 30.7 and 30.0 , respectively . There were no significant differences in measures of efficacy between the 2 antidepressants . Mean changes from baseline to endpoint in MADRS total score for escitalopram and venlafaxine XR were -15.9 and -13.6 , respectively . Remission ( MADRS score of venlafaxine XR . Response ( > /= 50 % reduction from baseline MADRS score ) rates for the escitalopram and venlafaxine XR groups were 58.8 % and 48.0 % , respectively . Tolerability measures favored escitalopram over venlafaxine XR treatment . The venlafaxine XR group had a higher incidence than the escitalopram group of treatment-emergent adverse events ( 85.0 % vs. 68.4 % ) and discontinuation due to adverse events ( 16.0 % vs. 4.1 % ; p escitalopram is at least as effective as venlafaxine XR and significantly better tolerated . These results do not support the hypothesis that nonselective SRIs have greater efficacy than selective SRIs",
" The combined serotonin – norepinephrine reuptake inhibitor , venlafaxine XR , has demonstrated significant response and remission in patients diagnosed with depression when measured with the Hamilton Depression Rating Scale ( HAM-D ) . This pooled analysis of data from five studies compared the sustained remission of depressive symptoms in patients treated with venlafaxine XR , the selective serotonin reuptake inhibitors ( SSRIs ) fluoxetine or paroxetine , or placebo . Data from 1391 subjects enrolled in five active and placebo-controlled studies who met the DSM-III-R or DSM-IV criteria for major depressive disorder were analysed . Three treatment groups were compared : venlafaxine XR ( n=560 ) , fluoxetine/paroxetine ( n=298 ) and placebo ( n=496 ) . Mean treatment duration was 8 weeks . Responders were defined as those patients whose HAM-D-21 score decreased by ≥50 % from baseline . Remission was defined as a HAM-D-17 score ≤7 . Sustained remission was defined as maintenance of remission through week 8 or the end of treatment ( if before week 8) and for ≥2 weeks . Between-group rate comparisons in outcome measures were carried out using Fisher 's exact and log-rank tests . Venlafaxine XR produced significantly higher rates of sustained remission in depressed patients compared to fluoxetine/paroxetine or placebo over this 8-week treatment period . As early as week 2 , a significantly greater proportion of patients treated with venlafaxine achieved improved depression scores ( remission and response ) . A significantly greater rate of remission and sustained remission occurred with venlafaxine compared to placebo . Remission was achieved earlier with venlafaxine and lasted throughout the remainder of the study . These results demonstrate that venlafaxine XR is more effective than fluoxetine/paroxetine for sustaining remission of depressive symptoms ",
"Treatment effects are often evaluated by comparing change over time in outcome measures . However , valid analyses of longitudinal data can be problematic when subjects discontinue ( dropout ) prior to completing the study . This study assessed the merits of likelihood-based repeated measures analyses ( MMRM ) compared with fixed-effects analysis of variance where missing values were imputed using the last observation carried forward approach ( LOCF ) in accounting for dropout bias . Comparisons were made in simulated data and in data from a r and omized clinical trial . Subject dropout was introduced in the simulated data to generate ignorable and nonignorable missingness . Estimates of treatment group differences in mean change from baseline to endpoint from MMRM were , on average , markedly closer to the true value than estimates from LOCF in every scenario simulated . St and ard errors and confidence intervals from MMRM accurately reflected the uncertainty of the estimates , whereas st and ard errors and confidence intervals from LOCF underestimated uncertainty",
"Findings from the National Institute of Mental Health 's Sequenced Treatment Alternatives to Relieve Depression trial indicate that approximately 50 % of patients with major depressive disorder do not experience a treatment response after adequate first-line treatment with a selective serotonin reuptake inhibitor ( SSRI ) . This study was design ed to test the hypothesis that , after treatment failure with an SSRI , switching to venlafaxine extended release ( ER ) would offer advantages over switching to another SSRI , citalopram . The objectives of this trial were to compare the efficacy and safety of venlafaxine ER and citalopram in the treatment of moderate-to-severe depression in patients who did not experience a treatment response to an SSRI other than citalopram and to investigate the effects of severity of depression by categorizing treatment groups according to baseline severity . This was a 12-week , double-blind , r and omized , parallel-group , multicenter study . Participants were adult out patients who , following 8 weeks of monotherapy with an adequate dosing regimen of an SSRI other than citalopram and had not responded , met the diagnostic criteria for depression as described in the Diagnostic and statistical manual of mental disorders , fourth edition , and had a score ≥20 on the 21-item Hamilton Rating Scale for Depression ( HAM-D21 ) . After a 7-day screening period , patients were r and omly assigned to receive venlafaxine ER 75 mg/day or citalopram 20 mg/day for the first 2 weeks . Doses could be increased every 2 weeks through week 6 . Treatment lasted 12 weeks and was followed by a 1-week tapering period . Maximum dosages were venlafaxine ER 300 mg/day or citalopram 60 mg/day . The primary end point was the final on-therapy total HAM-D21 score . To investigate the treatment effects of the severity of depression on efficacy , a subgroup analysis was performed for baseline HAM-D21 total score ≤31 and > 31 . The analyses for HAM-D21 , Montgomery – Åsberg Depression Rating Scale ( MADRS ) , Clinical Global Impressions – Severity ( CGI-S ) , and Clinical Global Impressions – Improvement scores were based on intent-to-treat ( ITT ) population , for both the primary analysis and subgroup analysis according to baseline HAM-D21 total scores ≤31 or > 31 . Safety assessment s included the recording of adverse events ( AEs ) . A total of 406 patients ( 200 venlafaxine ER , 206 citalopram ) were r and omly assigned and 396 patients were included in the ITT population ( 194 venlafaxine ER , 202 citalopram ) . Treatment groups were similar in terms of demographics and baseline psychiatric assessment s. Two hundred and eighty-four patients ( 137 venlafaxine ER , 147 citalopram ) were present in the ITT population with a baseline HAM-D21 total score ≤31 and 112 patients ( 57 venlafaxine ER , 55 citalopram ) in the > 31 group . In the primary analysis , there was no statistical difference between groups . The group with a baseline HAM-D21 total score of 20–31 did not differ significantly in any efficacy parameters . In the group with a baseline HAM-D21 total score > 31 , the venlafaxine ER group differed significantly from the citalopram group on the primary end point HAM-D21 total score ( P=0.0121 ) . The secondary end point CGI-S score was statistically significant ( P=0.0359 ) , although the MADRS total score ( P=0.0930 ) was not . AEs were reported by 57.8 and 63.4 % of venlafaxine ER and citalopram patients , respectively . Overall discontinuation rates were 24.5 % for venlafaxine ER and 20.9 % for citalopram . Discontinuation rates owing to an AE as a primary or secondary reason were 5.5 % for venlafaxine ER and 5.3 % for citalopram . Overall , venlafaxine ER and citalopram showed similar efficacy in patients who had an inadequate response to an SSRI . In the subset of more severely depressed patients , venlafaxine ER was significantly more effective on a number of efficacy measures . Patients who remain severely depressed following treatment with an SSRI may gain more benefit from the dual-action drug venlafaxine , rather than switching to another SSRI",
"Serotonin-norepinephrine reuptake inhibitors ( SNRIs ) may be used as an alternative treatment for depressed patients who do not tolerate or respond adequately to treatment with a conventional antidepressant . This r and omized , open-label , multicenter study compared the effectiveness of the SNRI venlafaxine extended release ( VXR ) with that of conventional antidepressants ( CA ) in patients who were referred to an outpatient psychiatric specialty care setting for treatment after failure to tolerate or respond to at least 4 weeks of treatment with a CA in a primary care setting . Patients with a Hamilton Depression Rating Scale ( HAM-D17 ) score > or = 17 were r and omly assigned to treatment with an alternative CA or VXR . Remission was defined as a score Efficacy analyses were carried out on 3,097 patients from the intent-to-treat ( ITT ) population ( 1,632 VXR ; 1,465 CA ) . The antidepressants prescribed most frequently in the CA group were paroxetine ( 21.3 % ) , citalopram ( 20.1 % ) , sertraline ( 19.1 % ) , fluoxetine ( 17.0 % ) , and mirtazapine ( 7.9 % ) . After 24 weeks of treatment , the VXR group demonstrated a significantly higher remission rate than did the CA group ( 59.3 % VXR ; 51.5 % CA ; P<.0001 ; odds ratio : 1.37 ; 95 % CI : 1.19 - 1.58 ; P<.01 ) . Despite the limitations of the open design , the results of this study suggest that venlafaxine extended release may be more effective than the conventional antidepressants used in this study when treating depressed patients who do not tolerate or respond adequately to treatment with a conventional antidepressant",
"BACKGROUND This r and omized , open-label , rater-blinded , multicenter study compared treatment outcomes with the serotonin-norepinephrine reuptake inhibitor ( SNRI ) venlafaxine extended release ( ER ) with selective serotonin reuptake inhibitors ( SSRIs ) in primary care patients with major depressive disorder . METHOD Study data were collected from November 29 , 2000 , to March 4 , 2003 . Out patients who met diagnostic criteria for major depressive disorder according to the Mental Health Screener , a computer-administered telephone interview program that screens for the most common mental disorders , and had a total score on the 17-item Hamilton Depression Rating Scale ( HDRS(17 ) ) ≥ 20 were r and omly assigned to receive up to 6 months of open-label venlafaxine ER 75 - 225 mg/d ( n = 688 ) or an SSRI ( n = 697 ) : fluoxetine 20 - 80 mg/d , paroxetine 20 - 50 mg/d , citalopram 20 - 40 mg/d , and sertraline 50 - 200 mg/d . The primary outcome was remission ( HDRS(17 ) score ≤ 7 ) at study end point using the last-observation-carried-forward method to account for early termination . A mixed-effects model for repeated measures ( MMRM ) analysis evaluated secondary outcome measures . RESULTS Fifty-one percent of patients completed the study . Month 6 remission rates did not differ significantly for venlafaxine ER and the SSRIs ( 35.5 % vs 32.0 % , respectively ; P = .195 ) . The MMRM analysis of HDRS(17 ) scores also did not differ significantly ( P = .0538 ) . Significant treatment effects favoring the venlafaxine ER group were observed for remission rates at days 30 , 60 , 90 , and 135 and a survival analysis of time to remission ( P = .006 ) , as well as Clinical Global Impressions-severity of illness scale ( P = .0002 ) ; Hospital Anxiety and Depression Scale-Anxiety subscale ( P = .03 ) ; 6-item Hamilton Depression Rating Scale , Bech version ( P = .009 ) ; and Quick Inventory of Depressive Symptomatology-Self-Report ( P = .0003 ) . CONCLUSIONS Remission rates for patients treated with venlafaxine ER or an SSRI did not differ significantly after 6 months of treatment . Results of most secondary analyses suggested that SNRI treatment had a greater antidepressant effect versus the SSRIs studied",
"BACKGROUND In nursing home residents and other frail elderly patients , old age and potential drug-drug and drug-disease interactions may affect the relative safety and efficacy of medications . The purpose of this study was to examine the efficacy and tolerability of venlafaxine and sertraline for the treatment of depression among nursing home residents . METHOD The study was a 10-week r and omized , double-blind , controlled trial of venlafaxine ( doses up to 150 mg/day ) versus sertraline ( doses up to 100 mg/day ) among 52 elderly nursing home residents with a DSM-IV depressive disorder and , at most , moderate dementia . The primary measure of outcome was the Hamilton Rating Scale for Depression ( HAM-D ) . Adverse events were monitored and recorded systematic ally during the trial . RESULTS Twelve subjects were discontinued due to serious adverse events ( SAE ) , 5 were discontinued due to other significant side effects , and 2 withdrew consent . Tolerability estimated by the time to termination was lower for venlafaxine than sertraline for serious adverse events ( log rank statistic = 5.28 , p = .022 ) , for serious adverse events or side effects ( log rank statistic = 8.08 , p = .005 ) , or for serious adverse events , side effects , or withdrawal of consent ( log rank statistic = 10.04 , p = .002 ) . Mean ( SD ) HAM-D scores at baseline were 20.2 ( 3.4 ) for sertraline and 20.3 ( 3.7 ) for venlafaxine ; intent-to-treat endpoint HAM-D scores were 12.2 ( 5.1 ) and 15.7 ( 6.2 ) ( F = 3.45 ; p = .069 ) . There were no differences in categorical responses for the intent-to-treat sample or completers . CONCLUSION In this frail elderly population , venlafaxine was less well tolerated and , possibly , less safe than sertraline without evidence for an increase in efficacy . This unexpected finding demonstrates the need for systematic research on the safety of drugs in the frail elderly",
"Abstract Background and objective : Escitalopram is the most selective serotonin reuptake inhibitor antidepressant ; in contrast , duloxetine inhibits both serotonin and norepinephrine reuptake . Double-blind comparison studies may help guide treatment decisions by revealing the relative benefits of different therapeutic approaches . This study evaluated the efficacy and safety of escitalopram versus duloxetine in the acute treatment of patients with moderate to severe major depressive disorder . Methods : A 1-week , single-blind , placebo lead-in period followed by an 8-week , r and omised , double-blind , multicentre , parallel-group comparison was conducted from 20 April 2005 to 10 March 2006 in independent psychiatric research facilities with principal investigators who were board certified in psychiatry . A total of 278 out patients of 382 patients screened with Diagnostic and Statistical Manual of Mental Disorders ( 4th edition)-diagnosed major depressive disorder ( Montgomery-Åsberg Depression Rating Scale [ MADRS ] total score ≥26 ) were r and omised to the two treatment groups . Eight patients received no medication and were excluded from the safety group . Patients were treated with either escitalopram 10–20 mg/day ( fixed at 10 mg/day for the first 4 weeks ) or duloxetine 60 mg/day . The primary efficacy variable was change from baseline at week 8 in MADRS total score using the last observation carried forward ( LOCF ) approach . Efficacy , safety and tolerability measures were prospect ively defined in the statistical analysis plan prior to study initiation unless otherwise specifically noted as conducted post hoc . Results : A significantly greater proportion of escitalopram-treated patients completed the 8-week study compared with duloxetine-treated patients ( 87 % vs 69 % , respectively ; p scores were 31.0 for the escitalopram group and 31.6 for the duloxetine group . At week 8 , escitalopram treatment result ed in significantly greater improvement compared with duloxetine on the prospect ively defined primary efficacy endpoint of mean change from baseline in MADRS total score using the LOCF approach ( least-squares mean difference [ LSMD ] −2.42 ; 95 % CI −4.73 , −0.11 ; p Significantly fewer escitalopram-treated patients discontinued because of adverse events compared with duloxetine ( 2 % vs 13 % , respectively ; p better tolerated and at least as effective as the serotonin-norepinephrine reuptake inhibitor duloxetine in the treatment of major depressive disorder",
"This study compares two methods for h and ling missing data in longitudinal trials : one using the last-observation-carried-forward ( LOCF ) method and one based on a multivariate or mixed model for repeated measurements ( MMRM ) . Using data sets simulated to match six actual trials , I imposed several drop-out mechanisms , and compared the methods in terms of bias in the treatment difference and power of the treatment comparison . With equal drop-out in Active and Placebo arms , LOCF generally underestimated the treatment effect ; but with unequal drop-out , bias could be much larger and in either direction . In contrast , bias with the MMRM method was much smaller ; and whereas MMRM rarely caused a difference in power of greater than 20 % , LOCF caused a difference in power of greater than 20 % in nearly half the simulations . Use of the LOCF method is therefore likely to misrepresent the results of a trial seriously , and so is not a good choice for primary analysis . In contrast , the MMRM method is unlikely to result in serious misinterpretation , unless the drop-out mechanism is missing not at r and om ( MNAR ) and there is substantially unequal drop-out . Moreover , MMRM is clearly more reliable and better grounded statistically . Neither method is capable of dealing on its own with trials involving MNAR drop-out mechanisms , for which sensitivity analysis is needed using more complex methods"
] | 41166ca8-06ff-11f0-808a-c43d1ab1c353 |
Purpose To provide recommendations for the management options for patients with small renal masses ( SRMs ) . Methods By using a literature search and prospect ively defined study selection , we sought systematic review s , meta-analyses , r and omized clinical trials , prospect i ve comparative observational studies , and retrospective studies published from 2000 through 2015 . Outcomes included recurrence-free survival , disease-specific survival , and overall survival . Results Eighty-three studies , including 20 systematic review s and 63 primary studies , met the eligibility criteria and form the evidentiary basis for the guideline recommendations . Recommendations On the basis of tumor-specific findings and competing risks of mortality , all patients with an SRM should be considered for a biopsy when the results may alter management . Active surveillance should be an initial management option for patients who have significant comorbidities and limited life expectancy . Partial nephrectomy ( PN ) for SRMs is the st and ard treatment that should be offered to all patients for whom an intervention is indicated and who possess a tumor that is amenable to this approach . Percutaneous thermal ablation should be considered an option if complete ablation can reliably be achieved . Radical nephrectomy for SRMs should only be reserved for patients who possess a tumor of significant complexity that is not amenable to PN or for whom PN may result in unacceptable morbidity even when performed at centers with expertise . Referral to a nephrologist should be considered if chronic kidney disease ( estimated glomerular filtration rate progressive chronic kidney disease occurs after treatment , especially if associated with proteinuria | [
"BACKGROUND Besides clinical tumour size , other anatomical aspects of the renal tumour are routinely considered when evaluating the feasibility of elective nephron-sparing surgery ( NSS ) . OBJECTIVE To propose an original , st and ardised classification of renal tumours suitable for NSS based on their anatomical features and size and to evaluate the ability of this classification to predict the risk of overall complications result ing from the surgery . DESIGN , SETTING , AND PARTICIPANTS We enrolled prospect ively 164 consecutive patients who underwent NSS for renal tumours at a tertiary academic referral centre from January 2007 to December 2008 . INTERVENTION Open partial nephrectomy without vessel clamping . MEASUREMENTS All tumours were classified by integrating size with the following anatomical features : anterior or posterior face , longitudinal , and rim tumour location ; tumour relationships with renal sinus or urinary collecting system ; and percentage of tumour deepening into the kidney . We generated an algorithm evaluating each anatomical parameter and tumour size ( the preoperative aspects and dimensions used for an anatomical [ PADUA ] score ) to predict the risk of complications . RESULTS AND LIMITATIONS Overall rates of complication were significantly correlated to all the evaluated anatomical aspects , excluding clinical size and anterior or posterior location of the tumour . By multivariate analysis , PADUA scores were independent predictors of the occurrence of any grade complications ( hazard ratio [ HR ] for score 8 - 9 vs 6 - 7 : 14.535 ; HR for score ≥10 vs 6 - 7 : 30.641 ) . Potential limitations were the limited number of patients with T1b tumours included in the study and the lack of laparoscopically treated patients . Further external validation of the PADUA score is needed . CONCLUSIONS The PADUA score is a simple anatomical system that can be used to predict the risk of surgical and medical perioperative complications in patients undergoing open NSS . The use of an appropriate score can help clinicians stratify patients suitable for NSS into subgroups with different complication risks and can help research ers evaluate the real comparability among patients undergoing NSS with different surgical approaches",
"BACKGROUND Partial nephrectomy ( PN ) is a preferred treatment for cT1 renal masses , whereas thermal ablation represents an alternative nephron-sparing option , albeit with higher reported rates of recurrence . OBJECTIVE To review our experience with PN , percutaneous radiofrequency ablation ( RFA ) , and percutaneous cryoablation for cT1 renal masses . DESIGN , SETTING , AND PARTICIPANTS A total of 1803 patients with primary cT1N0M0 renal masses treated between 2000 and 2011 were identified from the prospect ively maintained Mayo Clinic Renal Tumor Registry . INTERVENTION PN compared with percutaneous ablation . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Local recurrence-free , metastases-free , and overall survival rates were estimated using the Kaplan-Meier method and compared with log-rank tests . RESULTS AND LIMITATIONS Of the 1424 cT1a patients , 1057 underwent PN , 180 underwent RFA , and 187 underwent cryoablation . In this cohort , local recurrence-free survival was similar among the three treatments ( p=0.49 ) , whereas metastases-free survival was significantly better after PN ( p=0.005 ) and cryoablation ( p=0.021 ) when compared with RFA . Of the 379 cT1b patients , 326 patients underwent PN , and 53 patients were managed with cryoablation ( 8 RFA patients were excluded ) . In this cohort , local recurrence-free survival ( p=0.81 ) and metastases-free survival ( p=0.45 ) were similar between PN and cryoablation . In both the cT1a and cT1b groups , PN patients were significantly younger , with lower Charlson scores and had superior overall survival ( p cT1 renal masses , we observed that recurrence-free survival was similar for PN and percutaneous ablation patients . Metastases-free survival was superior for PN and cryoablation patients when compared with RFA for cT1a patients . Overall survival was superior after PN , likely because of selection bias . If these results were vali date d , an up date to clinical guidelines would be warranted . PATIENT SUMMARY Partial nephrectomy and percutaneous ablation for small ( < 7-cm ) and localized renal masses are associated with similar rates of local recurrence",
"The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : \" 0 \" , 12 % ( 181 ) ; \" 1 - 2 \" , 26 % ( 225 ) ; \" 3 - 4 \" , 52 % ( 71 ) ; and \" greater than or equal to 5 \" , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : \" 0 \" , 8 % ( 588 ) ; \" 1 \" , 25 % ( 54 ) ; \" 2 \" , 48 % ( 25 ) ; \" greater than or equal to 3 \" , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small",
"CONTEXT Patients with cancer often have other medical ailments , referred to as comorbidity . Comorbidity may impact treatment decision-making , prognosis , and quality of care assessment . OBJECTIVE To assess whether comorbidity information can provide important prognostic information in a hospital-based cancer registry . DESIGN , SETTING , AND PARTICIPANTS An observational prospect i ve cohort study using comorbidity data collected by trained hospital-based cancer registrars . Comorbidity was obtained through medical record review using the Adult Comorbidity Evaluation 27 , a vali date d chart-based comorbidity instrument . A total of 17,712 patients receiving care between January 1 , 1995 , and January 31 , 2001 , for the primary diagnosis of new cancer of the prostate , lung ( nonsmall cell ) , breast , digestive system , gynecological , urinary system , or head and neck were included . MAIN OUTCOME MEASURE Duration in months of overall survival . RESULTS A total of 19,268 patients were included in the study ; median duration of follow-up was 31 months . Of these patients , 1556 ( 8.0 % ) were excluded due to missing or unknown data . Severity of comorbidity strongly influenced survival in a dose-dependent fashion and the impact of comorbidity was independent of cancer stage . Compared with patients without comorbidity , the adjusted hazard ratio associated with mild comorbidity was 1.21 ( 95 % confidence interval [ CI ] , 1.13 - 1.30 ) , moderate comorbidity was 1.86 ( 95 % CI , 1.73 - 2.00 ) , and severe comorbidity was 2.56 ( 95 % CI , 2.35 - 2.81 ) . Adjusted Kaplan-Meier survival curves revealed that at any point in time the patients with more severe levels of comorbidity had worse survival ( partial chi2(3 ) due to comorbidity , 523.54 ; P Comorbidity is an important independent prognostic factor for patients with cancer . The inclusion of comorbidity in hospital-based cancer registries will increase the value and use of observational research",
"BACKGROUND AND OBJECTIVES Prospect i ve r and omized comparison of intermediate-term outcomes of patients with small renal tumors who were treated with partial nephrectomy ( PN ) or microwave ablation . METHODS Of 102 selected patients with solitary small renal tumors who had prospect ively completed at least 2 years of follow-up since December 2004 , r and omizedly , 54 had either open ( 19 ) or laparoscopic ( 35 ) PN and 48 had laparoscopic ( 28 ) or open ( 20 ) microwave ablation . Patient and tumor characteristics , surgical data , complications , histologic and oncologic data , and functional data of the two approaches were compared . RESULTS Patients in microwave ablation group and PN group matched for age , sex , American Society of Anesthesiologists score , body mass index , and tumor size and were respectively followed for median 32 and 36 months . Surgical and hospitalization times were comparable in both groups . Estimated blood loss , complication rates , and decline of postoperative renal function were significantly less in the microwave ablation group ( P = 0.0002 , P = 0.0187 , and P = 0.0092 , respectively ) . The decrease in estimated glomerular filtration rate at the last available follow-up was similar in both groups ( P = 1.0000 ) . There were no disease-specific deaths . Kaplan-Meier estimates of overall local recurrence-free survival at 3 years were 91.3 % for microwave ablation and 96.0 % for PN ( P = 0.5414 ) ; the respective numbers for renal cell carcinomas were 90.4 and 96.6 % ( P = 0.4650 ) . CONCLUSIONS Microwave ablation can be also safely and efficiently done for patients with small renal tumors . This intermediate analysis showed that microwave ablation provides favorable results compared to PN . However , longer term data are still needed",
"BACKGROUND Most early stage kidney cancers are renal cell carcinomas ( RCCs ) , and most are diagnosed incidentally by imaging as small renal masses ( SRMs ) . Indirect evidence suggests that most small RCCs grow slowly and rarely metastasize . OBJECTIVE To determine the progression and growth rates for newly diagnosed SRMs stratified by needle core biopsy pathology . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve phase 2 clinical trial of active surveillance of 209 SRMs in 178 elderly and /or infirm patients was conducted from 2004 until 2009 with treatment delayed until progression . INTERVENTION Patients underwent serial imaging and needle core biopsies . MEASUREMENTS We measured rates of change in tumor diameter ( growth measured by imaging ) and progression to ≥ 4 cm , doubling of tumor volume , or metastasis with histology on biopsy . RESULTS AND LIMITATIONS Local progression occurred in 25 patients ( 12 % ) , plus 2 progressed with metastases ( 1.1 % ) . Of the 178 subjects with 209 SRMs , 127 with 151 SRMs had>12 mo of follow-up with two or more images , with a mean follow-up of 28 mo . Their tumor diameters increased by an average of 0.13 cm/yr . Needle core biopsy in 101 SRMs demonstrated that the presence of RCC did not significantly change growth rate . Limitations included no central review of imaging and pathology and a short follow-up . CONCLUSIONS This is the first SRM active surveillance study to correlate growth with histology prospect ively . In the first 2 yr , the rate of local progression to higher stage is low , and metastases are rare . SRMs appear to grow very slowly , even if biopsy proven to be RCC . Many patients with SRMs can therefore be initially managed conservatively with serial imaging , avoiding the morbidity of surgical or ablative treatment",
"PURPOSE To review complications related to percutaneous renal tumor ablation . MATERIAL S AND METHODS Prospect ively collected data related to renal radiofrequency ( RF ) ablation and cryoablation procedures performed from May 2000 through November 2010 were review ed . This included 573 renal ablation procedures performed in 533 patients to treat 633 tumors . A total of 254 RF ablation and 311 cryoablation procedures were performed ; eight patients underwent simultaneous RF ablation and cryoablation . The mean age of patients at the time of the procedure was 70 years ( range , 24 - 93 y ) , and 382 of 573 procedures ( 67 % ) were performed in male patients . Complications were recorded according to the Clavien-Dindo classification scheme . Duration of hospitalization was also documented . RESULTS Of the 573 procedures , 63 produced complications ( 11.0 % overall complication rate ) . There were 66 reported complications , of which 38 ( 6.6 % of total procedures ) were Clavien-Dindo grade II-IV major complications ; there were no deaths . Major complication rates did not differ statistically ( P = .15 ) between cryoablation ( 7.7 % ; 24 of 311 ) and RF ablation ( 4.7 % ; 12 of 254 ) . Of the complications related to cryoablation , bleeding and hematuria were most common . Bleeding during cryoablation was associated with advanced age , increased tumor size , increased number of cryoprobes , and central position ( P RF ablation , nerve and urothelial injury were most common . Mean hospitalization duration was 1 day for RF ablation and cryoablation . CONCLUSIONS Complications related to percutaneous renal ablation are infrequent . Recognition of potential complications and associated risk factors can allow optimization of periprocedural care",
"Purpose To evaluate the long-term effects of radiofrequency ablation ( RFA ) of renal masses ( RM ) and compare them with surgery . Methods A total of 203 RM ( 193 malignant ; mean size 30 mm ) in 137 patients ( 95 male subjects ; average age 64 years ) underwent RFA . Complications and technique effectiveness were evaluated . Overall survival , cancer-specific survival , and disease-free survival were calculated ( mean follow-up time 39 months ) . Predictors for complications , technique effectiveness , and survival were investigated . Results Seventeen ( 8.4 % ) adverse events were recorded ( 2 % major complications ) . Exophytic development and smaller size were protective against adverse events . Complete ablation was obtained in 87 % RM ( 93 % ≤3 cm , 89 % ≤4 cm ) . T1a threshold was a positive predictor for complete ablation and central location a negative one . Three- and 5-year overall survival were 84 and 75 % ; cancer-specific survival 96 and 91 % ; and disease-free survival 80 and 75 % . Considering only the 79 patients with newly diagnosed renal cell carcinoma , T1a disease stage result ed a positive predictor for both overall survival ( 87 and 83 % at 3 and 5 years ) and cancer-specific survival ( 100 % at 5 years ) . Conclusion RFA of non central small RM is safe and effective , and it provides favorable long-term oncological outcomes . Selection criteria for RFA can also include T1a renal cell carcinoma in patients without surgical contraindications , even though r and omized controlled trials are needed to establish the best treatment",
"BACKGROUND Open partial nephrectomy ( OPN ) remains the gold st and ard for treatment of small renal masses ( SRMs ) . Laparoscopic cryoablation ( LCA ) has provided encouraging outcomes . Robotic partial nephrectomy ( RPN ) represents a new promising option but is still under evaluation . OBJECTIVE Compare the outcomes of RPN and LCA in the treatment of patients with SRMs . DESIGN , SETTING , AND PARTICIPANTS We retrospectively analyzed the medical charts of patients with SRMs ( ≤4 cm ) who underwent minimally invasive nephron-sparing surgery ( RPN or LCA ) in our institution from January 1998 to December 2010 . INTERVENTION RPN and LCA . MEASUREMENTS Perioperative complications and functional and oncologic outcomes were analyzed . RESULTS AND LIMITATIONS A total of 446 SRMs were identified in 436 patients ( RPN , n=210 ; LCA , n=226 ) . Patients undergoing RPN were younger ( p higher baseline preoperative estimated glomerular filtration rate ( eGFR ) ( p ) . Mean tumor size was smaller in the LCA group ( 2.2 vs 2.4 cm ; p=0.004 ) . RPN was associated with longer operative time ( 180 vs 165min ; p=0.01 ) , increased estimated blood loss ( 200 vs 75ml ; p longer hospital stay ( 72 vs 48h ; p and higher morbidity rate ( 20 % vs 12 % , p=0.015 ) . Mean follow-ups for RPN and LCA were 4.8 mo and 44.5 mo , respectively ( p ) . Local recurrence rates for RPN and LCA were 0 % and 11 % , respectively ( p ) . Mean eGFR decrease after RPN and LCA was insignificant at 1 mo , at 6 mo after surgery , and during last follow-up . Limitations include retrospective study design , length of follow-up , and selection bias . CONCLUSIONS Both techniques remain viable treatment options in the management of SRMs . A higher incidence of perioperative complications was found in patients undergoing RPN . However , the technique was not predictive of the occurrence of postoperative complications . Early oncologic outcomes are promising for RPN , which also seems to be associated with better preservation of renal function . Long-term follow-up and well- design ed prospect i ve comparative studies are awaited to corroborate these findings",
"PURPOSE Surgery is the most effective treatment for renal cell carcinoma with tumor thrombus but predictors of outcome and patient survival are variable . Co-morbidity may affect therapeutic decision making and survival , although to our knowledge this factor has not been studied in patients with tumor thrombus . We analyzed the Charlson co-morbidity index as a predictor of outcome after surgery . MATERIAL AND METHODS From 1970 to 1998 , 303 patients underwent surgical resection . The Charlson index , surgical era , completeness of resection , patient age , sex , tumor level , TNM stage , grade and perinephric fat invasion were studied retrospectively as univariate and multivariate predictors of outcome . RESULTS The level of tumor thrombus was 0 ( renal vein only ) in 127 patients , and I to IV in 66 , 58 , 36 and 16 , respectively . At 5 years overall , cause specific and metastasis-free survival were 32 % , 42 % and 41 % , while at 10 years they were 21 % , 32 % and 30 % , respectively . For the whole cohort significant multivariate predictors of cause specific survival were metastasis ( p = 0.0001 ) , grade ( p = 0.0001 ) , perinephric fat involvement ( p = 0.02 ) and tumor levels 0 versus I to IV ( p = 0.048 ) . The Charlson index did not predict outcome ( univariate model p = 0.65 ) . CONCLUSIONS Characteristics of the primary tumor remained the most important predictors of cause specific survival in this cohort . The Charlson index did not predict cause specific survival in this cohort of surgically treated patients . Prospect i ve assessment of co-morbidity in patients treated with surgery versus conservative therapy is warranted",
"The incidence of renal cell carcinoma ( RCC ) is increasing , largely due to the widespread use of cross‐sectional imaging . Most renal tumors are detected incidentally as small , asymptomatic masses . To study their natural history , the authors prospect ively followed a series of patients with this type of lesion who were unsuited for or refused surgery",
"BACKGROUND In the European Organization for Research and Treatment of Cancer ( EORTC ) r and omized trial 30904 , nephron-sparing surgery ( NSS ) was associated with reduced overall survival compared with radical nephrectomy ( RN ) over a median follow-up of 9.3 yr ( hazard ratio : 1.50 ; 95 % confidence interval [ CI ] , 1.03 - 2.16 ) . OBJECTIVE To examine the impact of NSS relative to RN on kidney function in EORTC 30904 . DESIGN , SETTING , AND PARTICIPANTS This phase 3 international r and omized trial was conducted in patients with a small ( ≤5 cm ) renal mass and normal contralateral kidney who were enrolled from March 1992 to January 2003 . INTERVENTION Patients were r and omized to RN ( n=273 ) or NSS ( n=268 ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Follow-up estimated glomerular filtration rates ( eGFR ; milliliters per minute per 1.73 m(2 ) ) were recorded for 259 subjects in the RN arm and 255 subjects in the NSS arm . Percentages of subjects developing at least moderate renal dysfunction ( eGFR ) were calculated for each treatment arm based on the lowest recorded follow-up eGFR ( intent-to-treat analysis ) . RESULTS AND LIMITATIONS With a median follow-up of 6.7 yr , eGFR with RN and 1.6 % with NSS , with a difference of -0.1 % ( 95 % CI , -2.2 to 2.1 ) . Lack of longer follow-up for eGFR is a limitation of these analyses . CONCLUSIONS Compared with RN , NSS substantially reduced the incidence of at least moderate renal dysfunction ( eGFR the incidence of advanced kidney disease ( eGFR the incidence of kidney failure ( eGFR beneficial impact of NSS on eGFR did not result in improved survival in this study population . REGISTRATION EORTC trial 30904 ; Clinical Trials.gov identifier NCT00002473",
"OBJECTIVE To determine if radiographically less complex renal lesions are deemed clinical ly less \" worrisome \" and therefore are more likely to be considered for active surveillance ( AS ) . METHODS We examined our prospect i ve institutional data base to identify and compare patients with localized renal cell carcinoma undergoing an initial period of AS or immediate surgery . Multivariate logistic regression was used to examine covariates associated with receipt of AS . RESULTS Of 1,059 patients with available anatomic complexity data , 195 underwent an initial period of AS ( median duration of AS 25.6 mo [ interquartile range : 11.8 - 52.8 mo ] ) . Compared with patients undergoing immediate surgical treatment , patients selected for AS had lower overall nephrometry scores ( NS ) with tumors that were smaller , further from the sinus or urothelium , more often polar , and less often hilar ( P individual components of NS , total NS , and Charlson comorbidity index , total NS ( odds ratio [ OR ] = 1.9 [ CI : 1.4 - 2.5 ] ) , \" R \" score of 1 ( OR = 5.2 [ CI : 1.8 - 15.2 ] ) , \" N \" score of 1 ( OR = 2.3 [ CI : 1.5 - 3.6 ] ) , \" L \" score of 1 ( OR = 1.4 [ CI : 0.84 - 2.2 ] ) , and nonhilar tumor location ( OR = 2.7 [ CI : 1.2 - 5.8 ] ) increased the probability of being selected for AS compared with immediate surgery . Findings remained significant in a sub analysis of T1a renal masses . CONCLUSIONS Lower tumor anatomic complexity was strongly associated with the decision to proceed with AS in patients with stage I renal mass . Not only may these data afford new insights into renal mass treatment trends , but the findings may also prove useful in the development of objective protocol s to most appropriately select patients for AS ",
"OBJECTIVE The objective of this study was to compare the outcomes of patients > or=70 years of age undergoing laparoscopic partial nephrectomy ( LPN ) , laparoscopic radical nephrectomy ( LRN ) , and laparoscopic ablative techniques ( LAT ) for small renal masses . METHODS From a prospect ively maintained data base we identified 19 ( LRN ) , 28 ( LPN ) , and 19 ( LAT ) patients aged > or=70 who underwent surgery for cT1aN0M0 lesions . Perioperative , surgical , and functional outcomes were compared . RESULTS The three groups were similar in age , race , body mass index , and estimated creatinine clearance . In the LRN group , mean tumor diameter was larger ( 3.3 vs. 2.4 cm [ LPN ] and 2.7 cm [ LAT ] ; p = 0.0005 ) and there was a higher percentage of central tumors ( 73.7 % vs. 25.0 % and 5.3 % ; p LPN and LAT groups , respectively . Although intraoperative and postoperative complication rates were similar , mean estimated blood loss and operative time were highest in the LPN group ( p preoperative stage 3 chronic kidney disease in the LRN , LPN , and LAT groups , respectively . Patients who underwent LRN had a lower follow-up estimated creatinine clearance ( 43.4 vs. 61.4 mL/min [ LPN ] and 59.2 [ LAT ] ; p stage 3 chronic kidney disease after treatment ( 100 % vs. 25.0 % [ LPN ] vs. 18.2 [ LAT ] ; p elderly patients presenting with renal masses . LPN and LAT provide superior preservation of renal function when compared with LRN in this population . In appropriately selected patients > or=70 years of age presenting with T1a renal lesions , laparoscopic nephron-sparing approaches should be considered",
"OBJECTIVE We compared perioperative and short-term outcomes of renal laparoscopic partial nephrectomy ( LPN ) and laparoscopic cryoablation ( LCA ) in patients with small ( METHODS A retrospective analysis from our prospect ively established data base was performed . We identified 92 patients with 95 lesions treated with LPN and 75 patients with 91 lesions treated with LCA . RESULTS The LPN and LCA groups were comparable in mean tumor size and preoperative and postoperative creatinine level ( P=.495 , P=.953 , and P=.101 ) respectively . Patients undergoing LPN were younger in age ( 58.8 versus 69.2 years , P mean estimated blood loss ( 168.4 versus 6 mL , P=.005 ) , and had a prolonged mean operative time ( 151.6 versus 128.6 minutes , P=.01 ) . Six complications occurred in the LCA group and 11 in the LPN group . The median follow-up time was 21.8 months for LPN and 14 months for LCA ( P recurrences were detected in the LCA group , and 1 recurrence was reported after LPN . CONCLUSIONS In the treatment of small renal cortical neoplasms with short-term follow-up , LPN and LCA seem to be equally effective . LCA offers decreased blood loss , shorter operative time , and less morbidity . Longer follow-up is required to establish oncologic efficacy",
"BACKGROUND Percutaneous needle core biopsy has become established in the management of small renal masses ≤ 4 cm ( SRMs ) . Recent series have reported success rates of ≥ 80 % . Nondiagnostic results continue to be problematic . OBJECTIVE To determine the results of SRM biopsy and the outcomes of nondiagnostic biopsy and repeat biopsy . DESIGN , SETTING , AND PARTICIPANTS Patients undergoing renal tumor biopsy ( RTB ) for suspected renal cell carcinoma ( RCC ) were included in a prospect ively maintained data base . MEASUREMENTS The data base was analyzed retrospectively to determine the pathology and outcomes of SRM biopsy . Outcomes of patients with nondiagnostic biopsy were determined . Patients undergoing repeat biopsy were identified and their outcomes analyzed . RESULTS AND LIMITATIONS Three hundred forty-five biopsies were performed ( mean diameter : 2.5 cm ) . Biopsy was diagnostic in 278 cases ( 80.6 % ) and nondiagnostic in 67 cases ( 19.4 % ) . Among diagnostic biopsies , 221 ( 79.4 % ) were malignant , 94.1 % of which were RCC . Histologic subtyping and grading of RCC was possible in 88.0 % and 63.5 % of cases , respectively . Repeat biopsy was performed in 12 of the 67 nondiagnostic cases , and a diagnosis was possible in 10 ( 83.3 % ) . Eight lesions were malignant and two were oncocytic neoplasms . Pathology was available for 15 masses after initial nondiagnostic biopsy ; 11 ( 73 % ) were malignant . Larger tumor size and a solid nature on imaging predicted a successful biopsy on multivariate analysis . Grade 1 complications were experienced in 10.1 % of cases , with no major bleeding and no seeding of the biopsy tract . There was one grade 3a complication ( 0.3 % ) . This is a retrospective study and some data are unavailable on factors that may affect biopsy success rates . Repeat biopsy was not st and ard practice prior to this analysis . CONCLUSIONS RTB can be performed safely and accurately in the investigation of renal masses ≤ 4 cm . A nondiagnostic biopsy should not be considered a surrogate for the absence of malignancy . Repeat biopsy can be performed with similar accuracy , providing a diagnosis for most patients",
"OBJECTIVES Although the classification of cancer has traditionally focused on the gross and microscopic characteristics of the tumor , the overall health of patients can affect their survival . Because patients with renal cell carcinoma often have other medical conditions , we explored the effect of preexisting medical disease on survival after radical and partial nephrectomy . METHODS From January 1995 to August 2003 , the comorbidity status of 697 patients with nonmetastatic renal cell carcinoma who had undergone radical or partial nephrectomy was prospect ively coded using the Adult Comorbidity Evaluation-27 . Histopathologic review of all slides was performed according to the 2004 World Health Organization scheme . Other variables analyzed included age , sex , ethnicity , pathologic stage , Fuhrman grade , and tumor size . The effect of these factors on overall survival ( OS ) was analyzed using Cox proportional hazards regression model . RESULTS The median follow-up was 32.2 months for survivors and 36.5 months for all patients . The OS rate at 1 , 3 , and 5 years was 92.0 % ( 641 patients ) , 75.3 % ( 525 patients ) , and 52.7 % ( 367 patients ) , respectively . Univariate analyses demonstrated that age , comorbidity , tumor size , Fuhrman grade , and pathologic stage were significant predictors of OS . Multivariate analysis revealed that age ( hazard ratio [ HR ] 1.42 , 95 % confidence interval [ CI ] 1.10 to 1.82 , P = .0067 ) , comorbidity ( HR 1.37 , 95 % CI 1.16 to 1.63 , P = .0002 ) , pathologic stage ( HR 1.97 , 95 % CI 1.60 to 2.41 , P grade ( HR 1.83 , 95 % CI 1.28 to 2.59 , P = .0008 ) predicted for OS . CONCLUSIONS The results of this study have demonstrated that comorbidity is an independent prognostic factor for OS in patients with renal cell carcinoma . Capturing the comorbidity information using vali date d instruments can improve the preoperative evaluation of patients by providing more accurate prognostic information",
"OBJECTIVES Treatment decision-making for localized renal lesions remains overly subjective . While the AUA Guidelines list thermal ablation ( TA ) as a treatment option for the clinical T1 renal mass , few data exist regarding the relationship between TA and tumor complexity . The R.E.N.A.L.-Nephrometry Scoring System ( NS ) was introduced to objectify salient renal mass anatomy and st and ardize academic reporting . Here we correlate the salient anatomical attributes of renal masses undergoing TA with technical and oncologic outcomes . MATERIAL S AND METHODS We queried our prospect ively maintained kidney cancer data base of 2,312 patients and identified 39 patients who underwent TA with available nephrometry scores . Patient clinical , technical , functional , and oncologic characteristics were review ed . RESULTS Median patient age , serum creatinine , estimated glomerular filtration rate , and Charlson Comorbidity Index were 71 ( range = 57 - 86 ) years , 1.37 ( range = 0.7 - 3.5 ) mg/dl , 57.1 ( range = 23.3 - 93.8 ) ml/min , and 2 ( range = 0 - 5 ) , respectively . Median Nephrometry Score for patients undergoing tumor ablation was 6 ( 4 - 10 ) . Low ( NS = 4 - 6 ) , moderate ( NS = 7 - 9 ) , and high ( NS = 10 - 12 ) complexity tumors were identified in 20 ( 51.3 % ) , 17 ( 43.6 % ) , and 2 ( 5.1 % ) patients . Six ( 15 % ) patients experienced a tumor recurrence . Of those with a recurrence , 5/6 ( 83.3 % ) had moderate complexity tumors with the remaining tumor being low complexity . Minor and major Clavien complications occurred in 4 ( 10 % ) and 1 ( 3 % ) patients , all of whom had moderate complexity tumors . CONCLUSIONS At our institution , 95 % of tumors undergoing TA were anatomically low or moderate complexity lesions as measured by the R.E.N.A.L.-Nephrometry Scoring System . Nephrometry may help predict disease recurrence and peri-procedural complications , yet multi-institutional analysis is needed to further vali date these findings",
"PURPOSE Factors that determine renal function after partial nephrectomy are not well-defined , including the impact of cold vs warm ischemia , and the relative importance of modifiable and nonmodifiable factors . We studied these determinants in a large cohort of patients with a solitary functioning kidney undergoing partial nephrectomy . MATERIAL S AND METHODS From 1980 to 2009 , 660 partial nephrectomies were performed at 4 centers for tumor in a solitary functioning kidney under cold ( 300 ) or warm ( 360 ) ischemia . Data were collected in institutional review board approved registries and followup averaged 4.5 years . Preoperative and postoperative glomerular filtration rates were estimated via the Chronic Kidney Disease-Epidemiology Study equation . RESULTS At 3 months after partial nephrectomy median glomerular filtration rate decreased by equivalent amounts with cold or warm ischemia ( 21 % vs 22 % , respectively , p = 0.7 ) , although median cold ischemic times were much longer ( 45 vs 22 minutes respectively , p glomerular filtration rate and longer ischemia time were associated with decreased postoperative glomerular filtration rate ( p preoperative glomerular filtration rate proved to be the primary determinants of ultimate renal function , and duration of ischemia lost statistical significance . CONCLUSIONS This nonr and omized , comparative study suggests that within the relatively strict parameters of conventional practice , ie predominantly short ischemic intervals and liberal use of hypothermia , ischemia time was not an independent predictor of ultimate renal function after partial nephrectomy . Long-term renal function after partial nephrectomy is determined primarily by the quantity and quality of renal parenchyma preserved , although type and duration of ischemia remain the most important modifiable factors , and warrant further study",
"PURPOSE Cryoablation and radio frequency ablation are attractive modalities for small renal masses in patients with substantial comorbidities . However , salvage extirpative therapy for local recurrence after thermal ablation can be challenging due to associated perinephric fibrosis . MATERIAL S AND METHODS Patients with thermal ablation refractory tumors requiring surgical salvage from 1997 to 2013 were identified and retrospectively review ed . RESULTS A total of 27 patients were treated surgically after cryoablation ( 18 ) or radio frequency ablation ( 9 ) failed . Subjective assessment indicated moderate/severe fibrosis in 22 cases ( 81 % ) . Partial nephrectomy was preferred in all patients but was not possible in 12 , primarily due to unfavorable tumor size/location . In the intended partial nephrectomy group ( 15 ) open surgery was performed in all patients and completed in 14 , with the procedure aborted in 1 due to extensive perinephric fibrosis . Radical nephrectomy was planned in 12 patients , of whom 8 were treated laparoscopically with 1 requiring conversion to open . Median estimated blood loss was 225 ml . Overall 17 patients experienced no complications and 4 had minor complications . However , 6 patients experienced more significant complications ( Clavien III-IVb ) . Since January 2008 partial nephrectomy was performed more frequently ( 12 of 17 , or 71 % vs 2 of 10 , or 20 % for previous cases , p=0.02 ) . CONCLUSIONS Surgical salvage after failed thermal ablation is feasible in most instances , and partial nephrectomy is often possible but can be challenging due to associated perinephric fibrosis . The difficulty of surgical salvage should be recognized as a potential limitation of the thermal ablation treatment strategy . Prospect i ve studies of thermal ablation vs partial nephrectomy should be prioritized to provide higher quality data about the merits and limitations of each approach"
] | 41166ce4-06ff-11f0-808a-c43d1ab1c353 |
Context An effective application of biofeedback for interventions in older adults with balance and mobility disorders may be compromised due to co-morbidity . Objective To evaluate the feasibility and the effectiveness of biofeedback-based training of balance and /or mobility in older adults . Data Sources PubMed ( 1950 - 2009 ) , EMBASE ( 1988 - 2009 ) , Web of Science ( 1945 - 2009 ) , the Cochrane Controlled Trials Register ( 1960 - 2009 ) , CINAHL ( 1982 - 2009 ) and PsycINFO ( 1840 - 2009 ) . The search strategy was composed of terms referring to biofeedback , balance or mobility , and older adults . Additional studies were identified by scanning reference lists . Study Selection For evaluating effectiveness , 2 review ers independently screened papers and included controlled studies in older adults ( i.e. mean age equal to or greater than 60 years ) if they applied biofeedback during repeated practice sessions , and if they used at least one objective outcome measure of a balance or mobility task . Data Extraction Rating of study quality , with use of the Physiotherapy Evidence Data base rating scale ( PEDro scale ) , was performed independently by the 2 review ers . Indications for (non)effectiveness were identified if 2 or more similar studies reported a (non)significant effect for the same type of outcome . Effect sizes were calculated . Results and Conclusions Although most available studies did not systematic ally evaluate feasibility aspects , reports of high participation rates , low drop-out rates , absence of adverse events and positive training experiences suggest that biofeedback methods can be applied in older adults . Effectiveness was evaluated based on 21 studies , mostly of moderate quality . An indication for effectiveness of visual feedback-based training of balance in ( frail ) older adults was identified for postural sway , weight-shifting and reaction time in st and ing , and for the Berg Balance Scale . Indications for added effectiveness of applying biofeedback during training of balance , gait , or sit-to-st and transfers in older patients post-stroke were identified for training-specific aspects . The same applies for auditory feedback-based training of gait in older patients with lower-limb surgery . Implication sFurther appropriate studies are needed in different population s of older adults to be able to make definitive statements regarding the ( long-term ) added effectiveness , particularly on measures of functioning | [
"Background : The knowledge concerning balance training actually lowering fall rates among frail older persons is limited . Objective : The aim of this study was to examine the effects of a 4-week individualized visual feedback-based balance training on the fall incidence during 1-year follow-up among frail older women living in residential care . Methods : Twenty-seven older women from 2 residential care homes were r and omized into exercise ( n = 20 ) and control ( n = 7 ) groups . Balance measurements were carried out before and after a 4-week training period and falls were monitored by monthly diaries for 1 year . An interview about fear of falling and physical activity was completed before and after the intervention and after the 1-year follow-up . Results : A positive effect of balance training on fall incidence was found . A dynamic Poisson regression model showed that during the follow-up the monthly risk of falling was decreased in the exercise group compared to controls ( risk ratio 0.398 , 95 % CI 0.174–0.911 , p = 0.029 ) . In addition , the exercise group reported a reduced fear of falling and increased physical activity after a training period but these changes declined during the follow-up period . Conclusion : Individualized visual feedback-based balance training was shown to be a promising method for fall prevention among frail older women . High compliance ( 97.5 % ) with the training program showed that carefully targeted training programs can be carried out among older people with health limitations ",
"Background : Controversial findings exist in the literature with respect to the efficacy of visually guided weight-shifting ( WS ) training as a means of improving balance in healthy older adults . Objective : The purpose of this study was to investigate the impact of two direction-specific , visually guided WS training protocol s on st and ing balance of healthy elderly women . Methods : Forty-eight community-dwelling elderly women , all free of any neurological or musculoskeletal impairment , were r and omly assigned into : a group that practice d WS in the anterior/posterior direction ( A/P group , n = 19 ) , a group that practice d WS in the medio/lateral direction ( M/L group , n = 15 ) and a control group ( n = 14 ) . Participants performed 12 training sessions of visually guided WS ( 3 sessions a week for 25 minutes per session ) . Static balance was measured before and after training in normal ( bipedal ) quiet stance ( NQS ) and sharpened-Romberg stance ( SRS ) by recording center of pressure ( CoP ) variations and angular segment kinematics . Results : In NQS , neither of the two training protocol s had a significant impact on postural sway measures , although a significant decrease in interlimb asymmetry of CoP displacement was noted for the A/P group . In SRS , A/P training induced a significant reduction of CoP displacement , lower limb pitch and upper trunk roll rotation . Conclusion : The results of the study stress the importance of using direction-specific WS tasks in balance training , particularly in the A/P direction , in order to improve control of static balance in elderly women",
"Background Motor learning research has had little impact on clinical applications and rarely extended to research about how older adults learn motor skills . There is consistent evidence that motor skill performance and learning can be enhanced by giving learners instructions that direct their attention . The aim of this study was to test whether elderly individuals that receive an external focus instruction during training of dynamic balance skills would learn in a different manner compared to individuals that received an internal focus instruction . Methods This r and omised trial included 26 older persons ( 81 ± 6 years ) that were training functional balance twice a week for the duration of 5 weeks . Learning outcomes were recorded after every training session . Weight shifting score and dynamic balance parameters ( Biodex Balance System ) , components of the Extended Timed-Get-Up- and -Go test , five chair rises , and falls efficacy ( FES-I ) was assessed at baseline and post-intervention . Results Participation for training sessions was 94 % . No differences between groups were found following 5 weeks of training for weight shifting score , dynamic balance index and dynamic balance time ( p Extended Timed-Get-Up- and -Go components Sit-to-st and , p = .036 ; Gait initiation , p = .039 ; Slow down , stop , turnaround , and sit down , p = 0.011 and the Fes-I ( p = 0.014 ) showed improvements for the total group , indicating that function improved compared to baseline . Conclusion A 5-week balance training improved weight shifting scores and dynamic balance parameters as well as functional abilities . The observed improvements were independent from the type of attentional focus instructions . The findings provide support for the proposition of different motor learning principles in older adults compared to younger adults . Trial Registration IS RCT",
"Objective : To assess the balance function of hemiplegic stroke patients and to investigate whether visual feedback rhythmic weight-shift training following acute stroke can decrease falls among patients with hemiplegic stroke . Design : A prospect i ve study , using a Balance Master . Setting : Hospital-based rehabilitation units . Subjects : Fifty-two hemiplegic stroke patients ( 28 in the training group and 24 in the control group ) . Interventions : Conventional stroke rehabilitation programme plus visual feedback rhythmic weight-shift training . Training effect was evaluated by assessing the static and dynamic balance performance as well as comparing the occurrence of falls in the training and control groups at six-month follow-up . Main measures : Occurrence of falls ; static balance in different sensory conditions ; and dynamic balance performance , including on-axis velocity and directional control during rhythmic weight-shift . Results : Significant improvement in dynamic balance performance was found in hemiplegic patients in the training group . The improvement was sustained for six months . With regarding to static balance function , no significant improvement was found . At six-month follow-up , 5 of 28 patients ( 17.8 % ) in the training group had fallen , compared with 10 of 24 patients ( 41.7 % ) in the control group . The occurrence of falls decreased , although not statistically significantly ( p = 0.059 ) . Conclusions : Visual feedback rhythmic weight-shift training may improve dynamic balance function for hemiplegic stroke patients . The effects of training may be sustained for six months . The occurrence of falls decreased in the training group , but not statistically significantly",
"Medical instructions for partial weight-bearing after lower limb surgery and fractures are commonly given . The techniques for instruction are mainly verbal cues . Our aim was to evaluate the efficiency of a new biofeedback device compared with traditional intervention for gait rehabilitation . After orthopedic surgery , 33 patients , r and omly divided into a study group ( n = 15 ) and a control group ( n = 18 ) , completed 10 days of a rehabilitation protocol . A significant difference ( P to follow weight-bearing instructions better . We suggest that gait rehabilitation is more efficient when biofeedback is used to instruct patients regarding partial weight-bearing",
"OBJECTIVE To evaluate the effectiveness of an audio-biofeedback ( ABF ) system for improving balance in patients with bilateral vestibular loss ( BVL ) . DESIGN Before-after trial . SETTING University balance disorders laboratory . PARTICIPANTS Nine subjects with BVL and 9 unaffected subjects as controls . INTERVENTION Trunk acceleration ABF while st and ing on foam with eyes closed . MAIN OUTCOME MEASURE Balance stability was evaluated according to the following parameters : the root mean square of ( 1 ) the center of pressure ( COP ) displacements and of ( 2 ) the trunk accelerations ; the COP b and width ; the time spent by the participant within + /-1 degrees threshold from their baseline COP position ; and the mean accelerations of the trunk while the participant was swaying outside this + /-1 degrees threshold . RESULTS Participants with BVL had significantly larger postural sway than did unaffected participants . Those with BVL , while using ABF , decreased sway area by 23%+/-4.9 % , decreased trunk accelerations by 46%+/-9.9 % , and increased time spent within + /-1 degrees sway threshold by 195%+/-34.6 % . CONCLUSIONS ABF improved stance stability of participants with BVL by increasing the amount of postural corrections",
"Objective : To examine the effects of electromyographic ( EMG ) biofeedback training on the recovery of gait in the acute phase post stroke . Design : Patients were r and omly assigned to EMG biofeedback or control groups . They received treatment three times a week for six weeks . All patients were assessed prior to treatment , after 18 treatment sessions , and at three months follow-up . Setting : The study was carried out at Scunthorpe General Hospital in North Lincolnshire . The subjects were acute stroke patients who had been admitted on to the medical and elderly wards . Interventions : The EMG biofeedback group were treated using EMG as an adjunct to physiotherapy . The patients were encouraged to facilitate or inhibit abnormal muscle tone via auditory or visual signals transmitted from electrodes placed over the appropriate muscles . The control group were treated using the same techniques , electrodes were used with this group of patients , but the EMG machine was turned off and faced away from the patient and the therapist to control the placebo effect . Outcome measures : A large battery of outcome measures was used for physical and psychological assessment . The physical measures consisted of active movement , muscle tone , sensation , proprioception , mobility and activities of daily living ( ADL ) . The psychological measures included orientation , memory , spatial performance , language and IQ . Results : Twenty-one patients were included in the study . Scores were combined into four groups : mild EMG , severe EMG , mild control and severe control . Results showed that there was an improvement in physical scores for active movement , mobility and ADL over time , but there was no significant difference between the EMG and control groups . Scores on the psychological tests were within normal limits , and there was no difference in performance between the EMG and control groups . Conclusions : This study showed no significant differences in the rate of improvement after stroke between the two groups . Although EMG biofeed-back was used as an adjunct to physiotherapy and represented clinical practice , the results provide little evidence to support the clinical significance of using EMG biofeedback to improve gait in the acute phase after stroke",
"Electromyographic biofeedback was compared with simple exercise therapy as to its effectiveness in improving foot-drop in 22 stroke patients . The study was design ed to be a rigorous trial of biofeedback and the patients tested were aged and had stroke of long duration . One group of 11 patients underwent 6 weeks of exercise therapy 2 sessions per week for 15 minutes per session ; the 2nd group of 11 patients underwent similar therapy with EMG feedback . All therapy was conducted by a research assistant who was not a trained therapist . The groups were assessed blind before treatment , after treatment and a 6-week follow-up . The significantly greater improvements in the biofeedback group in terms of muscle strength at the end of treatment were maintained at follow-up . On the range of movement and gait analysis measures , both groups showed some improvement after treatment . However , at follow-up this improvement had relapsed for the exercise group while for the biofeedback group it had been maintained . It is argued that controlled trials are possible in biofeedback and that using patients as their own controls is not justified in view of the present findings and the previously reported literature",
"Background The maintenance of upright equilibrium is essentially a sensorimotor integration task . The central nervous system ( CNS ) has to generate appropriate and complex motor responses based on the selective and rapid integration of sensory information from multiple sources . Since each sensory system has its own coordinate framework , specific time delay and reliability , sensory conflicts may arise and represent situations in which the CNS has to recalibrate the weight attributed to each particular sensory input . The resolution of sensory conflicts may represent a particular challenge for older adults given the age-related decline in the integrity of many postural regulating systems , including musculoskeletal and sensory systems , as well as neural processing and conduction of information . The effects of aging and adaptation ( by repeated exposures ) on the capability of the CNS to select pertinent sensory information and resolve sensory conflicts were thus investigated with virtual reality ( VR ) in the present study . Methods Healthy young and older adults maintained quiet stance while immersed in a virtual environment ( VE ) for 1 hour during which transient visual and /or surface perturbations were r and omly presented . Visual perturbations were induced by sudden pitch or roll plane tilts of the VE viewed through a helmet-mounted display , and combined with or without surface perturbations presented in a direction that was either identical or opposite to the visual perturbations . Results Results showed a profound influence of aging on postural adjustments measured by electromyographic ( EMG ) responses and displacements of the center of pressure ( COP ) and body 's center of mass ( COM ) in the recovery of upright stance , especially in the presence of sensory conflicts . Older adults relied more on vision as compared to young adults . Aging affects the interaction of the somatosensory and visual systems on the control of equilibrium during st and ing and the ability of CNS to resolve sensory conflicts . However , even with a one-hour immersion in VE and exposure to sensory conflicts , it is possible for the CNS to recalibrate and adapt to the changes , while improving balance capability in older adults . Conclusion Preventive and rehabilitation programs targeting postural control in older adults should take into account the possible impairment of sensory organization or sensorimotor integration and include VE training under conditions of sensory conflicts",
"Background and Purpose : Distinguishing between a clinical ly significant change and change due to measurement error can be difficult . The purpose of this study was to determine test-retest reliability and minimal detectable change for the Berg Balance Scale ( BBS ) , forward and backward functional reach , the Romberg Test and the Sharpened Romberg Test ( SRT ) with eyes open and closed , the Activities-specific Balance Confidence ( ABC ) Scale , the Six-Minute Walk Test ( 6MWT ) , comfortable and fast gait speed , the Timed “ Up & Go ” Test ( TUG ) , the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) , and the Unified Parkinson Disease Rating Scale ( UPDRS ) in people with parkinsonism . Subjects : Thirty-seven community-dwelling adults with parkinsonism ( mean age=71 years ) participated . The Hoehn and Yahr Scale median score of 2 was on the lower end of the scale ; however , the scores ranged from 1 to 4 . Methods : Subjects were tested twice by the same raters , with 1 week between tests . Test-retest reliability was calculated using intraclass correlation coefficients ( ICCs ) . Minimal detectable change was calculated using a 95 % confidence interval ( MDC95 ) . Results : The ICCs for test-retest reliability were above .90 for the BBS , ABC Scale , SRT with eyes closed , 6MWT , and comfortable and fast gait speeds . The MDC95 values for those functional tests were : BBS=5/56 , ABC Scale=13 % , SRT with eyes closed=19 seconds , 6MWT=82 m , comfortable gait speed=0.18 m/s , and fast gait speed=0.25 m/s . The ICCs for test-retest reliability of SF-36 scores were above .80 , with the exception of the social functioning subscale . The MDC95 values for the SF-36 ranged between 19 % and 45 % . The MDC95 values for the UPDRS Activities of Daily Living section , Motor Examination section , and total scores were 4/52 , 11/108 , and 13/176 , respectively . Discussion and Conclusion : Minimal detectable change values are useful to therapists in rehabilitation and wellness programs in determining whether change during or after intervention is clinical ly significant . High test-retest reliability of scores for the BBS , ABC Scale , SRT with eyes closed , 6MWT , and gait speed make them trustworthy functional assessment s in people with parkinsonism . The SF-36 and UPDRS provide quality -of-life and disease severity rating values in the ongoing assessment of people with parkinsonism",
"OBJECTIVE To determine the effect on balance and strength of 3 months of intensive balance and /or weight training followed by 6 months of low intensity Tai Chi training for maintenance of gains . DESIGN R and omized control intervention . Four groups in 2 x 2 design : Control , Balance , Strength , Balance + Strength , using blinded testers . SETTING Exercise and balance laboratory at University of Connecticut Health Center . PARTICIPANTS Subjects were 110 healthy community dwellers ( mean age 80 ) who were free of dementia , neurological disease , and serious cardiovascular or musculoskeletal conditions . INTERVENTIONS Short-term training ( 3 months ) occurred 3 times/week ( 45 minutes Balance and Strength , 90 minutes Balance + Strength ) . Balance training included equilibrium control exercises of firm and foam surfaces and center-of-pressure biofeedback . Strengthening consisted of lower extremity weight-lifting . All subjects than received long-term group Tai Chi instruction ( 6 months , 1 hour , 1 time/week ) . MEASUREMENTS Losses of balance during Sensory Organization Testing ( LOB ) , single stance time ( SST ) , voluntary limits of stability ( FBOS ) , summed isokinetic torque of eight lower extremity movements ( ISOK ) , and usual gait velocity ( GVU ) . RESULTS AND CONCLUSIONS Balance training meaningfully improved all balance measures by restoring performance to a level analogous to an individual 3 to 10 years younger : LOB = -2.0 + /- 0.3 ( adjusted paired differences , P ISOK by 1.1 + /- 0.1 Nm kg-1 ( P Tai Chi , although there was some decrement",
"Objective : To investigate the effects of balance training , using force platform biofeedback , on quantitative gait characteristics of hemiparetic patients late after stroke . Design : R and omized , controlled , assessor-blinded trial . Setting : Rehabilitation ward and gait laboratory of a university hospital . Subjects : Forty-one patients ( mean ( st and ard deviation ; SD ) age of 60.9 ( 11.7 ) years ) with hemiparesis late after stroke ( median time since stroke six months ) were r and omly assigned to an experimental or a control group . Interventions : The control group ( n = 19 ) participated in a conventional stroke inpatient rehabilitation programme , whereas the experimental group ( n = 22 ) received 15 sessions of balance training ( using force platform biofeedback ) in addition to the conventional programme . Main outcome measures : Selected paretic side time-distance , kinematic and kinetic gait parameters in sagittal , frontal and transverse planes were measured using a three-dimensional computerized gait analysis system , one week before and after the experimental treatment programme . Results : The control group did not show any statistically significant difference regarding gait characteristics . Pelvic excursion in frontal plane improved significantly ( P = 0.021 ) in the experimental group . The difference between before-after change scores of the groups was significant for pelvic excursion in frontal plane ( P = 0.039 ) and vertical ground reaction force ( P = 0.030 ) in favour of experimental group . Conclusion : Balance training using force platform biofeedback in addition to a conventional inpatient stroke rehabilitation programme is beneficial in improving postural control and weight-bearing on the paretic side while walking late after stroke",
"BACKGROUND AND PURPOSE Visual feedback related to weight distribution and center-of-pressure positioning has been shown to be effective in increasing stance symmetry following stroke , although it is not clear whether functional balance ability also improves . This study compared the relative effectiveness of visual feedback training of center-of-gravity ( CoG ) positioning with conventional physical therapy following acute stroke . SUBJECTS Forty-six people who had strokes within 80 days before the study , result ing in unilateral hemiparesis , and who were in need of balance retraining participated . METHODS AND MATERIAL S Initially , subjects were r and omly assigned to visual feedback or conventional physical therapy groups for balance retraining until 16 subjects per group were recruited . The next 14 subjects were assigned to a control group . All subjects received physical therapy and occupational therapy ( regular therapy ) 2 hours a day , and subjects in the 2 experimental groups received additional balance training 30 minutes a day until discharge . The visual feedback group received information about their CoG position as they shifted their weight during various activities . The conventional therapy group received verbal and tactile cues to encourage symmetrical stance and weight shifting . Static ( postural sway ) and activity-based measures of balance ( Berg Balance Scale , gait speed , and the Timed \" Up & Go \" Test ) were contrasted across the 3 groups at baseline , at discharge , and at 1 month following discharge using an analysis of variance for repeated measures . RESULTS All groups demonstrated marked improvement over time for all measures of balance ability , with the greatest improvements occurring in the period from baseline to discharge . No between-group differences were detected in any of the outcome measures . CONCLUSION AND DISCUSSION Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke",
"The study examined the impact of visually guided weight shifting ( WS ) practice on the postural adjustments evoked by elderly women when avoiding collision with a moving obstacle while st and ing . Fifty-six healthy elderly women ( 70.9+/-5.7 years , 87.5+/-9.6 kg ) were r and omly assigned into one of three groups : a group that completed 12 sessions ( 25 min , 3s/week ) of WS practice in the Anterior/Posterior direction ( A/P group , n=20 ) , a group that performed the same practice in the medio/lateral direction ( M/L group , n=20 ) and a control group ( n=16 ) . Pre- and post-training , participants were tested in a moving obstacle avoidance task . As a result of practice , postural response onset shifted closer to the time of collision with the obstacle . Side-to-side WS result ed in a reduction of the M/L sway amplitude and an increase of the trunk 's velocity during avoidance . It is concluded that visually guided WS practice enhances elderly 's ability for on-line visuo-motor processing when avoiding collision eliminating reliance on anticipatory scaling . Specifying the direction of WS seems to be critical for optimizing the transfer of training adaptations",
"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 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",
"Objective : To determine ( 1 ) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and ( 2 ) whether improvements could be generalized to weight distribution in st and ing . Setting : Inpatient rehabilitation unit . Design : Forty asymmetrical acute stroke subjects were r and omly allocated to one of four groups in this pilot study . Changes in weight distribution were compared between the 10 subjects of each of three treatment groups ( task-specific reach , Bobath , or Balance Performance Monitor [ BPM ] feedback training ) and a no specific treatment control group . One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was r and omly allocated . Measurements were performed using the BPM daily before treatment sessions , two weeks after cessation of treatment and 12 weeks post study . Weight distribution was calculated in terms of mean balance ( percentage of total body weight ) or the mean of 300 balance points over a 30-s data run . Results : In the short term , the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke ( p = 0.004 ) . Training with the BPM and no training were also significant ( p = 0.038 and p = 0.035 respectively ) and task-specific reach training failed to reach significance ( p = 0.26 ) . At 12 weeks post study 83 % of the BPM training group , 38 % of the task-specific reach group , 29 % of the Bobath group and 0 % of the untrained group were found to be distributing their weight to both sides . Some generalization of symmetry training in sitting to st and ing was noted in the BPM training group which appeared to persist long term . Conclusions : Results should be treated with caution due to the small group sizes . However , these preliminary endings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position",
"BACKGROUND AND PURPOSE This study explored whether two exercise programs would affect the ability to minimize postural sway of 72 relatively inactive , older subjects who participated in the Atlanta FICSIT trial . SUBJECTS Subjects were r and omly assigned to ( 1 ) a computerized balance training group , ( 2 ) a tai chi group , or ( 3 ) an educational group serving as a control for exercise . Each group consisted of 24 members . METHODS All subjects were evaluated under four postural conditions before , immediately after , and 4 months following their respective interventions , each of which was given over 15 weeks . RESULTS Platform balance measures revealed greater stability after training among subjects in the balance training group but little change in stability among subjects in the tai chi and educational group . Subjects in the tai chi group were less afraid of falling after training compared with subjects in other groups with similar covariates . CONCLUSION AND DISCUSSION Unlike computerized balance training , tai chi does not improve measures of postural stability . Because tai chi delayed onset to first or multiple falls in older individuals , this effect does not appear to be associated with measures of enhanced postural stability . Tai chi may gain its success , in part , from promoting confidence without reducing sway rather than primarily facilitating a reduction in sway-based measures",
"Summary .The effectiveness of a computer-assisted balance training was compared with a homebased exercise program in healthy elderly subjects . Twenty-four physically active community dwelling elderly ( median age 71 years ) participated in the study . Balance was assessed by a summary performance score , measuring postural stability while st and ing , reaching , stepping and walking . Subjects of the computer-assisted balance training group could considerably improve their performance on the training device ( p = 0.0078 ) as well as in the summary balance score ( p = 0.0176 ) . No improvement of balance was documented in the home-based exercise group . A superiority of the computer-assisted balance training exercise protocol over the home-based exercise group could not be documented ( p = 0.3934 ) . The study indicates that a computer-assisted balance training , focussing on one motor skill , can improve balance . It is suggested that a home-based exercise program is ineffective to improve balance in elderly persons , if there is no direct supervision . Zusammenfassung . Es wurde das Balancetraining mit gesunden Älteren an einem computer-gesteuerten Trainingsgerät mit einem zu Hause durchgeführten Trainingsprogramm verglichen . Es nahmen 24 gesunde , aktive Senioren ( Median 71 Jahre ) an der Studie teil . Untersuchungen der Balance i m ruhigen St and , beim Setzen eines großen Schrittes , beim Gehen und die funktionelle Reichweite wurden mit Hilfe eines Summen-Scores beurteilt . Die Teilnehmer , die auf dem computer-gesteuerten Trainingsgerät trainierten , konnten sich sowohl auf dem Gerät ( p = 0,0078 ) , als auch i m Balance-Summen-Score ( p = 0,0176 ) erheblich verbessern . In der Gruppe der zu Hause trainierenden wurden keine Veränderungen i m Balance-Summen-Score gemessen . Eine Überlegenheit des computer-gesteuerten Trainings konnte allerdings statistisch nicht belegt werden ( p = 0,3934 ) . Die Studie zeigt , dass das Training einer motorischen Fertigkeit auf einem computer-gesteuerten Trainingsgerät zu Verbesserungen der Balance führen kann . Es wird vermutet , dass ein Heimtraining ohne direkte Anleitung bei älterenMenschen nicht zur Verbesserung der Balance führt",
"AIM To investigate the effects of balance training , using force platform biofeedback , on motor recovery , mobility and activity level of hemiparetic patients with stroke . METHODS In this r and omized , controlled , assessor-blinded trial 41 in patients [ mean ( + /-SD ) age of 60.9 ( + /-11.7 ) years ] with hemiparesis after stroke ( median time since stroke 6 months ) were r and omly assigned to an experimental or a control group . The control group ( n=19 ) participated in a conventional stroke inpatient rehabilitation program , whereas the experimental group ( n=22 ) received 15 sessions of balance training ( using force platform biofeedback ) in addition to the conventional program . Main outcome measures were motor recovery of the lower extremity ( Brunnstrom staging ) , mobility ( Rivermead Mobility Index , RMI ) and activity level ( Functional Independence Measure , FIM ) that performed one week before and after the experimental treatment program . RESULTS Both groups were similar in terms of baseline clinical characteristics . Motor recovery , mobility and activity level improved significantly in both groups ( P mean change score was not significant for the Brunnstrom stages ( 0.23 vs 0.26 ) , RMI ( 2.9 vs 2.2 ) and FIM score ( 10.7 vs 11.5 ) . CONCLUSION In our group of stroke patients , balance training combined with a conventional rehabilitation program does not provide additional benefit in terms of lower extremity motor recovery , mobility and activity level",
"OBJECTIVE To determine the short-term effectiveness of a biofeedback-based , computerized intervention that applied the principles of the ecological theory of perception and control of bodily orientation to the rehabilitation of older adults with a history of falling . PARTICIPANTS Forty-five older adults ( X = 78.5 years ) with a history of falls were assigned to either a control ( n = 21 ) or intervention group ( n = 24 ) . DESIGN A 2 x 2 ( Group x Time ) mixed factorial design with repeated measures on the second factor . SETTING A motor control research laboratory in a university setting . MEASUREMENT Impairments in multiple dimensions of balance ( i.e. , dynamic postural control and sensory organization ) were measured before and after an 8-week balance intervention using the 100 % Limits of Stability Test and Sensory Organization Test . More functional limitations in balance and /or mobility were measured using two clinical tests : Berg Balance Scale and Timed Up and Go test . MAIN RESULTS Repeated measures multivariate analyses and follow-up testing indicated significant improvements in the dynamic balance and sensory integration capabilities in the case of the intervention group only ( P clinical measures of balance and mobility evaluated before and after the intervention for the intervention group only . CONCLUSIONS Theory-driven rehabilitation programs that focus on manipulating individual , task , and environmental constraints concurrently can significantly improve the control of bodily orientation of older adults with a previous history of falls in both static and dynamic action environments . Moreover , the significant improvements in functional performance observed for the intervention group suggest that interventions emphasizing task-specific practice are not the only means by which an older adult 's ability to perform daily activities requiring postural control can be improved",
"The purpose of this study was to investigate the effect of feedback information about base of support in gait rehabilitation . Sixteen individuals with hemiparesis result ing in narrow base of support , were r and omly placed into two equal groups , experimental and control . The experimental group was provided with a portable device that provided extrinsic auditory feedback information about base of support incorporated in the functional context of conventional gait therapy , whereas the control group received a conventional gait therapy only . Changes in step width with treatment were assessed with step print technique . The experimental group of subjects improved their step width with treatment from 0.09±0.003 m to 0.16±0.006 m while individuals assigned to the control group showed smaller improvement from 0.099±0.004 m to 0.13±0.003 m. While both groups demonstrated statistically significant improvement ( p level of recovery of step width seen in the experimental group was greater",
"We evaluated the effect of the vibrotactile display of body tilt upon the postural stability of vestibulopathic subjects during st and ing . Two groups were studied : those with moderate and with severe deficits as defined by postural stability test scores . They were studied under conditions of distorted sensory input , and during anterior-posterior perturbations . Seventeen subjects , with uni- or bilateral vestibular deficits , as determined by electronystagmography and vertical axis rotation , were tested using Equitest computerized dynamic posturography ( CDP ) . Based on their performance on the CDP they were divided into two groups having either moderate ( nine subjects ) or severe ( eight subjects ) postural control deficits . Their anterior-posterior ( A/P ) body motion at the waist was measured with a micromechanical rate gyroscope and a linear accelerometer . The result ing tilt estimate was displayed by a vibrotactile array attached to the torso . The vibration served as a tilt feedback to the subject . The subject 's performance was evaluated using the root-mean-square ( RMS ) of both the A/P body motion and center-of-pressure ( CoP ) estimates . Sensory distortions were introduced using the Equitest Sensory Organization Tests ( SOT ) . These tests are design ed to distort A/P sensory inputs while st and ing . The SOT 5 distorts proprioceptive information about ankle joint movement , while the subject st and s eyes-closed on a moving support platform that measures foot pressure . The SOT 6 adds distorted visual information about body movement instead of testing with eyes closed . Perturbations were introduced using the Equitest Motor Control Tests ( MCT ) . These move the support platform forward or backward with small , medium and large displacements in the horizontal plane while measuring subjects ' foot pressure responses . We used the medium and large backward tests . Vibrotactile display of body tilt reduced the subjects ' A/P sway and improved their balance . The finding was more evident for those subjects with severe deficits than those moderate ones . This trend was found for both SOT 5 and 6 , as well as the medium and large MCT . Additionally , during the MCT , the peak deflection and mean recovery time also decreased significantly",
"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 .",
"A force platform with an auditory output consisting of two electronic balances was used to reinforce symmetrical body-weight distribution in stroke patients . Forty patients r and omly assigned to an experimental group or a control group practised rising and sitting down for 15 min , thrice daily , 5 days a week for 6 weeks . The experimental group but not the control group received ground reaction force feedback through the auditory output . Vertical ground reaction forces under each foot were measured with two force plates . Mean difference in improvement of body weight distribution on the paretic leg was 13.2 + /- 10.7 ( M , SD ) per cent total body weight in the experimental group and 5.1 + /- 6.7 per cent in the control group in rising ( p symmetrical body-weight distribution while rising and sitting down . Improvements in physical performance and sit-st and tests were greater in the experimental group ( p performance of activities of daily living . Symmetry in body-weight distribution in rising and sitting down correlated with high scores in physical performance , motor function in rising , and with functional ability",
"OBJECTIVES To evaluate the effects of two exercise approaches , tai chi ( TC ) and computerized balance training ( BT ) , on specified primary outcomes ( biomedical , functional , and psychosocial indicators of frailty ) and secondary outcomes ( occurrences of fall ) . DESIGN The Atlanta Frailty and Injuries : Cooperative Studies and Intervention Techniques , a prospect i ve , r and omized , controlled clinical trial with three arms ( TC , BT , and education ( ED ) ) . Intervention length was 15 weeks , with primary outcomes measured before and after intervention and at 4-month follow-up . Falls were monitored continuously throughout the study . SETTING Persons aged 70 and older living in the community . PARTICIPANTS A total of 200 participants , 162 women and 38 men ; mean age was 76.2 . MEASUREMENTS Biomedical ( strength , flexibility , cardiovascular endurance , body composition ) , functional instrumental activities of daily living ( IADL ) , and psychosocial well-being ( Center for Epidemiological Studies for Depression scale , fear of falling question naire , self-perception of present and future health , mastery index , perceived quality of sleep , and intrusiveness ) variables . RESULTS Grip strength declined in all groups , and lower extremity range of motion showed limited but statistically significant changes . Lowered blood pressure before and after a 12-minute walk was seen following TC participation . Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group ( P=.046 and P=.058 , respectively ) . After adjusting for fall risk factors , TC was found to reduce the risk of multiple falls by 47.5 % . CONCLUSION A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty . This intervention can also have favorable effects upon the occurrence of falls . TC warrants further study as an exercise treatment to improve the health of older people",
"Background : Balance training programs have not shown consistent results among older adults , and it remains unclear how different training methods can be adapted to frail elderly people . Objective : The purpose of this study was to investigate the effects of a 4-week visual feedback-based balance training on the postural control of frail elderly women living in residential care homes . Methods : Elderly women of two residential care facilities were r and omized to an exercise group ( EG , n = 20 ) and to a control group ( CG , n = 7 ) . The EG participated in training sessions three times/week for 4 weeks . The exercises were carried out with a computerized force platform with visual feedback screen . The dimensions of balance function studied were st and ing body sway , dynamic weight shifting , and Berg Balance Scale performance . Results : The EG showed significant improvement in balance functions . The performance time in dynamic balance tests improved on average by 35.9 % compared with a 0.6 % increase in the CG ( p = 0.025–0.193 ) . The performance distance in these tests decreased on average by 28.2 % in the EG as compared with a 9.8 % decrease seen in the CG . The Berg Balance Scale performance improved by 6.9 % compared with a 0.7 % increase in the CG ( p = 0.003 ) . The st and ing balance tests in the more dem and ing st and ing positions showed improvements in the EG , whereas similar changes in the CG were not found . Conclusions : Our findings suggest that balance training based on visual feedback improves the balance control in frail elderly women living in residential care , also enhancing the performance of functional balancing tasks relevant to daily living . The subjects were motivated to participate in the training , as indicated by the high compliance ( 97.5 % ) with the program",
"OBJECTIVE To determine the role of symmetrical body-weight distribution training in preventing falls among patients with hemiplegic stroke . DESIGN A prospect i ve study using a st and ing biofeedback trainer . SETTING Hospital-based rehabilitation units . PATIENTS Fifty-four patients with hemiplegic stroke ( 30 in the training group , 24 in the control group ) . INTERVENTIONS Conventional stroke rehabilitation program , plus symmetrical st and ing training and repetitive sit-to-st and training , with a st and ing biofeedback trainer . Training effect was evaluated by assessing the sit-to-st and performance and comparing the occurrence of falls in the 2 groups at a 6-month follow-up . MAIN OUTCOME MEASURES Occurrence of falls , sit-to-st and performance , including body-weight distribution , rate of rise in force , and sway in center of pressure ( COP ) . RESULTS Significant improvement in sit-to-st and performance was found in patients in the training group . Body weight was distributed more symmetrically in both legs , with less mediolateral sway in the COP when rising and sitting down . The mean difference in body-weight distribution between the left and right legs while subjects were rising from a chair significantly decreased , from 49.5 % + /- 18.9 % to 38.6 % + /- 15.8 % of body weight ( BW ) ( p rate of rise in force while rising from a chair significantly increased , from 28.3 % + /- 13.5%BW/s to 53.6 % + /- 20.5%BW/s ( p fallen , compared with only 5 of 30 patients ( 16.7 % ) in the training group ( p sit-to-st and performance and , consequently , decrease the number of falls by stroke patients",
"A number of before and after and single case design studies of visual feedback have shown improvements in stance symmetry after stroke , an associated improvement in function has been demonstrated . This study examines this promising technique further using a single-blind controlled trial . Twenty-six patients were recruited from a register of consecutive admissions and r and omized into treatment and control groups . Both groups received additional therapy , only the treatment group received visual feedback . Assessment s were carried out independently . Significant improvements were seen in the treatment group in measures of stance symmetry and sway and motor and ADL function . Between group differences had disappeared at three months . The results indicate that feedback training incorporated into functional physiotherapy treatment can improve stance symmetry and sway . Transfer of training was indicated by improvements in ADL and gross motor function . Three months later the improvement was maintained , but did not automatically continue without treatment",
"AIM Gait rehabilitation programs often require either partial weight-bearing ( PWB ) or encourage full weight-bearing ( FWB ) on the affected limb . Until recently , there was no objective and practical way to measure correct weight-bearing during ambulation . The present study evaluates a new in-shoe device ( SmartStep , And ante Medical Devices Ltd. ) for measuring the amount of weight on the affected limb and for biofeedback gait training . METHODS The first part of the study aim ed to establish the validity of the SmartStep by comparing the results obtained from this device with the results obtained from a force plate . The second part aim ed to evaluate the effectiveness of the SmartStep as a biofeedback method in patients who have been referred for FWB gait rehabilitation . Analysis was based on independent sample s t-test and chi squared test for evaluating statistically significant differences between the 2 gait rehabilitation modes . RESULTS The SmartStep could repeat the same results with 0.53 kg error of mean . Statistically significant correlation was found between results obtained from the SmartStep and from the force plate ( R2=0.9067 and P=0.004 ) . The use of the SmartStep auditory biofeedback , significantly ( P=0.00031 ) improved patients ' weight-bearing over the affected limb in the experimental group ( 7.9 kg + /-5.28 ) as compared to the control group ( 0.7+/-2.41 kg ) . CONCLUSIONS The SmartStep proved to be very reliable since it generated significant repeatable results which correlated significantly with those obtained from a force plate . Patients recommended for FWB gait can significantly improve body weight loading over the affected limb by the use of the SmartStep auditory biofeedback",
"A system that estimates and displays , in real-time , the location of the center of gravity of the human body relative to the feet was developed and then used in a biofeedback training program for improving the postural instability caused by deterioration of the proprioceptive system in elderly patients with significant diabetic sensory neuropathy during perturbations of a support platform . Training sessions were scheduled three times a week for four weeks and consisted of continuous perturbations of the support platform for the st and ing subject . Postural stability of each subject was evaluated before , during and after training on a weekly basis . After twelve sessions of training , subjects who received visual feedback showed greater reduction in total number of falls and in fall magnitude defined by force in the body suspension cord , and longer delay in time between perturbation and fall than NFB group"
] | 41166d20-06ff-11f0-808a-c43d1ab1c353 |
Objective : To systematic ally review and summarize the current available literature on prognostic variables relating to upper limb recovery following stroke . To identify which , if any variables predict upper limb recovery following stroke . Data sources : We completed search es in MEDLINE , EMBASE , AMED , CINAHL and Cochrane CENTRAL data bases . Search es were completed in November 2010 . Review methods : Studies were included if predictor variables were measured at baseline and linked to an outcome of upper limb recovery at a future time point . Exclusion criteria included predictor variables relating to response to treatment and outcome measurements of very specific upper limb impairments such as spasticity or pain . Two independent review ers completed data extraction and assessed study quality . Results : Fifty-eight studies met the inclusion criteria . Predictor variables which have been considered within these studies include ; age , sex , lesion site , initial motor impairment , motor-evoked potentials and somatosensory-evoked potentials . Initial measures of upper limb impairment and function were found to be the most significant predictors of upper limb recovery ; odds ratio 14.84 ( 95 % confidence intervals ( CI ) 9.08–24.25 ) and 38.62 ( 95 % CI 8.40–177.53 ) , respectively . Conclusions : Interpretation of these results is complicated by method ological factors including variations in study population s , upper limb motor outcome scales , timing of baseline and outcome assessment s and predictors selected . The most important predictive factors for upper limb recovery following stroke appears to the initial severity of motor impairment or function | [
"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"Background and Purpose — The purpose of this study was to assess the effects of stroke involvement of primary and secondary hemispheric motor systems and corticofugal tracts on arm and h and recovery . Methods — Forty-one patients participating in an inpatient stroke rehabilitation data base , admitted 17±2 ( SEM ) days after initial unilateral hemispheric ischemic stroke , with neuroimaging studies performed > 48 hours after stroke and with minimal upper limb ( UL ) movement ( admission Fugl-Meyer UL motor scores ≤9 ; normal score , 58 ) were studied . Patients were divided into 3 groups according to their UL discharge Fugl-Meyer score : 0 to 9 , no/poor recovery ; 10 to 18 , well-defined flexion-extension synergies ; and > 18 , synergies+isolated movements . Lesions affecting the following structures were recorded : primary motor cortex , premotor area , supplementary motor area , anterior half of the middle third of corona radiata ( secondary motor efferents ) , posterior half of the middle third of corona radiata ( primary motor efferents ) , genu , anterior and posterior limbs of the internal capsule ( PLIC ) , basal ganglia , and thalamus . & khgr;2 Analysis and ANOVA were used to study the significance of stroke location on UL motor recovery . Results — The effect of involvement of primary , premotor , or supplementary motor areas on motor recovery did not reach statistical significance . Patients with purely cortical stroke were likely to recover UL isolated movement ( 3 of 4 ) compared with purely subcortical ( 1 of 17 ) or mixed cortical-subcortical stroke location ( 2 of 20 ) ( P = 0.009 ) . Of those with cortical , subcortical , or mixed cortical plus subcortical lesions sparing the PLIC , 5 of 13 recovered isolated UL movement ( P = 0.01 ) . Only 1 of 28 patients with involvement of the PLIC plus adjacent corona radiata , basal ganglia , or thalamus recovered isolated UL movement ( P = 0.01 ) . Patients with small lacunar strokes affecting only the PLIC did not have sufficient motor deficits 2 weeks after stroke to meet inclusion criteria . Conclusions — The probability of recovery of isolated UL movement decreases progressively with lesion location as follows : cortex , corona radiata , and PLIC . This is consistent with our current underst and ing of redundant cortical motor representation and convergence of corticofugal motor efferents as they pass through the corona radiata to the PLIC",
"Background and Purpose — Prevalence and characteristics of ipsilateral upper limb motor-evoked potentials ( MEPs ) elicited by focal transcranial magnetic stimulation ( TMS ) were compared in healthy subjects and patients with acute stroke . Methods — Sixteen healthy subjects and 25 patients with acute stroke underwent focal TMS at maximum stimulator output over motor and premotor cortices . If present , MEPs evoked in muscles ipsilateral to TMS were analyzed for latency , amplitude , shape , and center of gravity ( ie , preferential coil location to elicit them ) . In stroke patients , possible relationships between early ipsilateral responses and functional outcome at 6 months were sought . Results — With relaxed or slightly contracting target muscle , maximal TMS over the motor cortex failed to elicit ipsilateral MEPs in the first dorsal interosseous ( FDI ) or biceps of any of 16 normal subjects . In 5 of 8 healthy subjects tested , ipsilateral MEPs with latencies longer than contralateral MEPs were evoked in FDI muscle ( in biceps , 6 of 8 subjects ) during strong ( > 50 % maximum ) contraction of the target muscle . In 15 of 25 stroke patients , ipsilateral MEPs in the unaffected relaxed FDI ( in biceps , 6 of 25 stroke patients ) were evoked by stimulation of premotor areas of the affected hemisphere . Their latencies were shorter than those that MEPs evoked in the same muscle by stimulation of the motor cortex of the contralateral unaffected hemisphere . Such responses were never obtained in normal subjects and were mostly observed in patients with subcortical infa rcts . Patients harboring these responses had slightly better bimanual dexterity after 6 months . Conclusions — Ipsilateral MEPs obtained in healthy individuals and stroke patients have different characteristics and probably different origins . In the former , they are probably conveyed via corticoreticulospinal or corticopropriospinal pathways , whereas in the latter , early ipsilateral MEPs could originate in hyperexcitable premotor areas",
"Predictors for the degree of clinical recovery after stroke are still poorly defined . In this study we tried to assess the predictive value of clinical data and of lesion size for motor recovery after ischemic stroke . In 52 hemiparetic patients we monitored the course of clinical recovery by a dedicated score of sensorimotor h and function after their first stroke . The course of the lesion size was measured in proton density magnetic resonance images . Three groups of patients were identified . Patients with moderate initial motor deficit recovered almost completely within 9 days ( 17/17 , group 1 ) . From the patients with severe initial motor deficit , about equal numbers recovered ( 16/35 , group 2 ) or remained severely impaired during the entire observation period of more than 6 months ( 19/35 , group 3 ) . There was no correlation between changes of lesion size and motor deficit . Logistic regression of probability of good clinical outcome on initial lesion size , initial motor score and subcortical versus cortical location of lesion showed that only the initial motor score was predictive ( p = 0.006 ) . A relative improvement of the initial motor score of about 20 % in the first 4 weeks after stroke appeared to be a relevant cut point for good outcome . The data indicate that patients with mild initial motor deficits recover well , whereas severely affected patients may differ in outcome . Since lesion size was not correlated with outcome the amount of spared residual function appeared as major determinant for the capacity for motor recovery",
"BACKGROUND AND PURPOSE To improve the accuracy of early postonset prediction of motor recovery in the flaccid hemiplegic arm , the effects of change in motor function over time on the accuracy of prediction were evaluated , and a prediction model for the probability of regaining dexterity at 6 months was developed . METHODS In 102 stroke patients , dexterity and paresis were measured with the Action Research Arm Test , Motricity Index , and Fugl-Meyer motor evaluation . For model development , 23 c and i date determinants were selected . Logistic regression analysis was used for prognostic factors and model development . RESULTS At 6 months , some dexterity in the paretic arm was found in 38 % , and complete functional recovery was seen in 11.6 % of the patients . Total anterior circulation infa rcts , right hemisphere strokes , homonymous hemianopia , visual gaze deficit , visual inattention , and paresis were statistically significant related to a poor arm function . Motricity Index leg scores of at least 25 points in the first week and Fugl-Meyer arm scores of 11 points in the second week increasing to 19 points in the fourth week raised the probability of developing some dexterity ( Action Research Arm Test > or=10 points ) from 74 % ( positive predictive value [ PPV ] , 0.74 ; 95 % confidence interval [ CI ] , 0.63 to 0.86 ) to 94 % ( PPV , 0.83 ; 95 % CI , 0.76 to 0.91 ) at 6 months . No change in probabilities of prediction dexterity was found after 4 weeks . CONCLUSIONS Based on the Fugl-Meyer scores of the flaccid arm , optimal prediction of arm function outcome at 6 months can be made within 4 weeks after onset . Lack of voluntary motor control of the leg in the first week with no emergence of arm synergies at 4 weeks is associated with poor outcome at 6 months",
"I used leg and arm paresis to predict outcome measured as extremity function in a prospect i ve study of 75 consecutive hemiplegic patients admitted to an inpatient stroke rehabilitation unit . In each patient , extremity paresis was quantified according to the five-point scoring system advised by the Medical Research Council , upper extremity function was quantified using the Barthel Index subscore for feeding and dressing the upper body , and lower extremity function was quantified according to a five-point scoring of the ability to walk . Improvement was recorded for upper extremity function in 52 % of the patients and for lower extremity function in 89 % . Best extremity function was reached a mean + /- SEM of 9 + /- 3 and 10 + /- 4 weeks after stroke for the upper and lower extremities , respectively . In patients experiencing complete recovery , this occurred a mean + /- SEM of 7 + /- 2 weeks ( for both upper and lower extremities ) after the stroke . Only 8 - 11 % of the patients with paresis scores of less than or equal to 2 regained independent extremity function after rehabilitation . Half of the patients with paresis scores of greater than or equal to 3 regained independent extremity function after rehabilitation , while the other half were able to perform extremity function with only minimal assistance . As predictors of extremity function , the Barthel Index subscore was slightly better ( r = 0.64 ) than paresis score ( r = 0.58 ) . However , because evaluation of extremity paresis is easy , it appears to be useful as a preliminary predictor of outcome following stroke",
"Background . Motor recovery after stroke is predicted only moderately by clinical variables , implying that there is still a substantial amount of unexplained , biologically meaningful variability in recovery . Regression diagnostics can indicate whether this is associated simply with Gaussian error or instead with multiple sub population s that vary in their relationships to the clinical variables . Objective . To perform regression diagnostics on a linear model for recovery versus clinical predictors . Methods . Forty-one patients with ischemic stroke were studied . Impairment was assessed using the upper extremity Fugl-Meyer Motor Score . Motor recovery was defined as the change in the upper extremity Fugl-Meyer Motor Score from 24 to 72 hours after stroke to 3 or 6 months later . The clinical predictors in the model were age , gender , infa rct location ( subcortical vs cortical ) , diffusion weighted imaging infa rct volume , time to re assessment , and acute upper extremity Fugl-Meyer Motor Score . Regression diagnostics included a Kolmogorov-Smirnov test for Gaussian errors and a test for outliers using Studentized deleted residuals . Results . In the r and om sample , clinical variables explained only 47 % of the variance in recovery . Among the patients with the most severe initial impairment , there was a set of regression outliers who recovered very poorly . With the outliers removed , explained variance in recovery increased to 89 % , and recovery was well approximated by a proportional relationship with initial impairment ( recovery ≅ 0.70 × initial impairment ) . Conclusions . Clinical variables only moderately predict motor recovery . Regression diagnostics demonstrated the existence of a sub population of outliers with severe initial impairment who show little recovery . When these outliers were removed , clinical variables were good predictors of recovery among the remaining patients , showing a tight proportional relationship to initial impairment",
"OBJECTIVE Focal transcranial magnetic stimulation was used to test prospect ively corticospinal excitability changes and reorganization of first dorsal interosseous ( FDI ) motor cortical representation in 31 patients who experienced a first ischemic stroke in the middle cerebral artery territory . All had severe h and palsy at onset . METHODS Patients were assessed clinical ly with the Medical Research Council , Rankin , the National Institutes of Health stroke scales and Barthel Index at days 1 , 8 , 30 , 90 , 180 and 360 after stroke . The following parameters of FDI motor evoked potential ( MEPS ) to focal transcranial magnetic stimulation were measured at the same delays : motor threshold , MEP amplitude , excitable cortical area , hot spot and center of gravity of FDI motor maps on affected and unaffected hemispheres . Correlations were sought between clinical and electrophysiological parameters . RESULTS In patients whose affected motor cortex remained excitable at day 1 , motor thresholds were not significantly different between sides and were similar to those of controls . Persistence of MEP on the affected side at day 1 was a strong predictor of good recovery . If present at day 1 , MEPs recorded in affected FDI were significantly smaller than of the opposite side or in normals and progressively recovered up to day 360 . In these patients , area of excitable cortex remained stable throughout the entire study . At day 1 , amplitudes of MEPs obtained in unaffected FDI were significantly larger than later . Between days 1 and 360 , we observed a significant displacement of center of gravity of motor maps towards more frontal regions on the affected side while no change was noted on the unaffected side . CONCLUSIONS Our data confirm the early prognosis value of transcranial magnetic stimulation in stroke . They indicate that the brain insult induces a transient hyperexcitability of the unaffected motor cortex . The evolution of FDI motor maps along the course of recovery mostly reflect corticospinal excitability changes but might also reveal some degree of brain plasticity . Most modifications observed occurred within 3 months of stroke onset",
"OBJECTIVE To examine the relationship between individual strength parameters and functional motor ability over time during rehabilitation in stroke patients . DESIGN A multiple-baseline experiment with assessment at inclusion and after 3 and 6 weeks . SETTING Secondary -care rehabilitation center . PARTICIPANTS A convenience sample of 16 subacute stroke patients . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Maximal voluntary force and rate of rise of tension of h and grip , wrist extension , and elbow flexion and extension were recorded at all 3 times . At the same time , functional motor assessment s were evaluated by the Action Research Arm Test ( ARAT ) , Box and Block test , and Rivermead Test . RESULTS We found no correlation between maximal voluntary force increases of various muscle contractions measurements . Neither the increase of grip strength nor that of wrist extension force correlated with improvement in ARAT score . Yet the improvement in the rate of rise of tension of h and grip ( Spearman rho=.91 ) and of wrist extension ( Spearman rho=.73 ) correlated with the improvement of the ARAT score and explained 77 % of the variance of the ARAT . CONCLUSIONS The change in the rate of rise of tension of the h and grip has a better predictive value for the functional recovery compared to the change in maximal voluntary force in patients with moderate arm and h and weakness after stroke . The rate of rise of tension of h and grip seems an adequate quantifiable parameter to detect small improvements during functional recovery",
"BACKGROUND TMS ( transcranial magnetic stimulation ) and DTT ( diffusion tensor tractography ) have different advantages in evaluating stroke patients . TMS has good clinical accessibility and economical benefit . On the contrary , DTT has a unique advantage to visualize neural tracts three-dimensionally although it requires an expensive and large MRI machine . Many studies have demonstrated that TMS and DTT have predictive values for motor outcome in stroke patients . However , there has been no study on the comparison of these two evaluation tools . In the current study , we compared the abilities of TMS and DTT to predict upper motor outcome in patients with ICH ( intracerebral hemorrhage ) . METHODS Fifty-three consecutive patients with severe motor weakness were evaluated by TMS and DTT at the early stage ( 7 - 28 days ) of ICH . Modified Brunnstrom classification ( MBC ) and the motricity index of upper extremity ( UMI ) were evaluated at onset and 6 months after onset . RESULTS Patients with the presence of a motor evoked potential ( MEP ) in TMS or a preserved corticospinal tract ( CST ) in DTT showed better motor outcomes than those without ( p=0.000 ) . TMS showed higher positive predictive value than DTT . In contrast , DTT showed higher negative predictive value than TMS . CONCLUSIONS TMS and DTT had different advantages in predicting motor outcome , and this result could be a reference to predict final neurological deficit at the early stage of ICH",
"OBJECTIVE To investigate the predictive value of paired transcranial magnetic stimulation ( TMS ) at rest in stroke patients in comparison with the predictive value derived from data obtained by single TMS during facilitation . METHODS Fifty-six patients with a single ischemic lesion and no electromyographic responses from single TMS in the resting affected h and muscles participated in the study . TMS assessment was performed 32 days post-stroke . It consisted of a single stimulation at maximal output during facilitation ( controlateral h and grip and elbow flexion ) and a paired-pulse stimulation at rest with two stimuli at maximal output at interstimulus intervals ranging from 15 to 100 ms . Two blind clinical assessment s using the ' motricity index ' were carried out 26 and 76 days post-stroke . RESULTS Thirty-seven percent of patients were responsive to single TMS during facilitation , had better clinical scores at both evaluations and better clinical recovery . Fifty-four percent of patients responded to paired TMS , had better clinical scores at the second evaluation and better clinical recovery . All patients who responded to the single stimulation paradigm also responded to the paired one . CONCLUSIONS A positive correlation was found between the responsiveness to both the TMS paradigms ( facilitation procedure and paired stimulation ) and clinical recovery . This underlines the importance of facilitation during single TMS in stroke patients and suggests that paired TMS at rest might supplement this procedure in stroke studies",
"OBJECTIVE To determine the prognostic value of clinical assessment and motor evoked potentials for upper limb strength and functional recovery after acute stroke , and to establish the possible use of motor evoked potentials in rehabilitation . DESIGN A prospect i ve study . SUBJECTS Fifty-two patients with hemiparesis were enrolled one month post-stroke ; 38 patients concluded the study at 12 months . METHODS Motor evoked potentials were recorded at baseline and after one month . Upper limb muscular strength ( Medical Research Council Scale , MRC ) and functional tests ( Frenchay Arm Test , Barthel Index ) were used as dependent outcome variables 12 months later . Motor evoked potentials were classified as present or absent . Predictive values of motor evoked potentials and MRC were evaluated . RESULTS At 12 months , patients with baseline recordable motor evoked potentials showed a good functional recovery ( positive predictive value 94 % ) . The absence of motor evoked potentials did not exclude muscular strength recovery ( negative predictive value 95 % ) . Motor evoked potentials had a higher positive predictive value than MRC only in patients with MRC Motor evoked potentials could be a supportive tool to increase the prognostic accuracy of upper limb motor and functional outcome in hemiparetic patients , especially those with severe initial paresis ( MRC < 2 ) and /or with motor evoked potentials absent in the post-stroke acute phase",
"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",
"OBJECTIVE To assess the relative responsiveness of 2 commonly used upper-extremity motor scales , the Action Research Arm Test ( ARAT ) and the Fugl-Meyer Assessment ( FMA ) , in evaluating recovery of upper-extremity function after an acute stroke in patients undergoing inpatient rehabilitation . DESIGN Prospect i ve . SETTING An acute stroke rehabilitation unit . PARTICIPANTS One hundred four consecutive admissions ( 43 men , 61 women ; mean age + /- st and ard deviation , 72+/-13y ) to a rehabilitation unit 16+/-9 days after acute stroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The following assessment s were completed within 72 hours of admission and 24 hours before discharge : ARAT , upper-extremity motor domain of the FMA , National Institutes of Health Stroke Scale , FIM instrument total score , and FIM activities of daily living ( FIM-ADL ) subscore . RESULTS The Spearman rank correlation statistic indicated that the 2 upper-limb motor scales ( ARAT , FMA ) correlated highly with one another , both on admission ( rho = .77 , P mean change in score from admission to discharge was 10+/-15 for the ARAT and 10+/-13 for the FMA motor score . The responsiveness to change as measured by the st and ard response mean was .68 for the ARAT and .74 for the FMA motor score . The Spearman rank correlation of each upper-limb motor scale with the FIM-ADL at the time of admission was as follows : ARAT , rho equal to .32 ( P FMA motor score and the ARAT were equally sensitive to change during inpatient acute rehabilitation and could be routinely used to measure recovery of upper-extremity motor function"
] | 41166d5c-06ff-11f0-808a-c43d1ab1c353 |
Background Rehabilitation approaches for people with rheumatoid arthritis include joint protection , exercises and self-management strategies . Health interventions delivered via the web have the potential to improve access to health services overcoming time constraints , physical limitations , and socioeconomic and geographic barriers . The objective of this review is to determine the effects of web-based rehabilitation interventions in adults with rheumatoid arthritis . Methods R and omised controlled trials that compared web-based rehabilitation interventions with usual care , waiting list , no treatment or another web-based intervention in adults with rheumatoid arthritis were included . The outcomes were pain , function , quality of life , self-efficacy , rheumatoid arthritis knowledge , physical activity and adverse effects . Method ological quality was assessed using the Cochrane Risk of Bias tool and quality of evidence with the Grading of Recommendations Assessment , Development and Evaluation approach . Results Six source documents from four trials ( n = 567 ) focusing on self-management , health information or physical activity were identified . The effects of web-based rehabilitation interventions on pain , function , quality of life , self-efficacy , rheumatoid arthritis knowledge and physical activity are uncertain because of the very low quality of evidence mostly from small single trials . Adverse effects were not reported . Conclusion Large , well- design ed trials are needed to evaluate the clinical and cost-effectiveness of web-based rehabilitation interventions in rheumatoid arthritis | [
"Background Regular physical activity ( PA ) is a key contributor to healthy ageing . However , despite known health benefits , only one third of older adults in Germany reach the PA levels recommended for persons aged 65 years and above by the World Health Organization . The aim of the current study is to evaluate the effectiveness of two web-based interventions for the initiation and maintenance of regular PA ( i.e. , intervention groups 1 and 2 ) compared to a delayed intervention control group of older adults aged 65 to 75 years . Methods / Design Study participants will be r and omly assigned to one of three study arms in five communities in the Bremen-Oldenburg metropolitan region : a ) Participants in the first arm will receive access to a web-based intervention for 10 weeks allowing them to track their weekly PA ( subjective self-monitoring , intervention group 1 ) ; b ) participants in the second arm will receive access to the web-based intervention for 10 weeks and , in addition , track PA using Fitbit Zips ( objective self-monitoring , intervention group 2 ) ; c ) participants in the delayed intervention control group will receive access to the intervention implemented in the first study arm after completion of the 12-week follow-up in the other two groups within each community . In addition , weekly group meetings in the communities will be offered to study participants in the intervention groups providing the opportunity to address questions related to the use of the website and to practice PA in groups ( e.g. , neighborhood walks , strength and balance exercises ) . To evaluate short-term effects of the intervention on physical and psychological health , PA , physical fitness , and cognitive and psychological variables will be assessed at baseline and 12-week follow-up . Discussion This study will provide answers regarding acceptance and effectiveness of web-based interventions promoting uptake and maintenance of regular PA in persons aged 65–75 years . Study findings will contribute to a growing body of evidence in Germany concerning the role of community-based interventions for the promotion of PA and healthy ageing in older adults . Trial registration German Clinical Trials Register DRKS00010052 ( Date of registration 07–11 - 2016 )",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"The 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 .",
"Background The evidence that higher levels of physical activity and /or lower levels of physical inactivity are associated with beneficial health-related outcomes stems mainly from observational studies . Findings from these studies often differ from r and omised controlled trials and systematic review s currently demonstrate mixed results , due partly to heterogeneity in physical activity interventions , method ologies used and population s studied . As a result , translation into clinical practice has been difficult . It is therefore essential that an overview is carried out to compare and contrast systematic review s , and to identify those physical activity interventions that are the most effective in preventing and /or treating major chronic disease . This protocol has been registered on PROSPERO 2013 : CRD42013003523 . Methods We will carry out an overview of Cochrane systematic review s. We will search the Cochrane Data base of Systematic Review s for systematic review s of r and omised controlled trials that have a primary focus on disease-related outcomes . We will restrict review s to those in selected major chronic diseases . Two authors will independently screen search outputs , select studies , extract data and assess the quality of included review s using the assessment of multiple systematic review s tool ; all discrepancies will be resolved by discussing and reaching a consensus , or by arbitration with a third author . The data extraction form will summarise key information from each review , including details of the population ( s ) ( for example , disease condition ) , the context ( for example , prevention , treatment or management ) , the participants , the intervention(s ) , the comparison(s ) and the outcomes . The primary outcomes of interest are the prevention of chronic disease and /or improved outcomes , in the treatment or management of chronic disease . These outcomes will be summarised and presented for individual chronic diseases ( for example , any change in blood pressure in hypertension or glucose control in diabetes ) . Secondary outcomes of interest are to describe the structure and delivery of physical activity interventions across chronic disease conditions and adverse events associated with physical activity . Discussion We anticipate that our results could inform research ers , guideline groups and policymakers of the most efficacious physical activity interventions in preventing and /or managing major chronic disease",
"OBJECTIVES To investigate the maintenance of physical activity 12 months after two 1-year Internet-based physical activity interventions in patients with RA . METHODS This follow-up study was a r and omized comparison of an Internet-based individualized training ( IT ) and a general training ( GT ) programme in sedentary RA patients . Outcome measures included physical activity ( meeting public health recommendations for moderate physical activity , i.e. 30 min for at least 5 days/week ; or vigorous physical activity , i.e. 20 min for at least 3 days/week ) , functional ability and quality of life ( QoL ) . RESULTS Of the 152 RA patients who completed the initial study , 110 ( 72 % ) were available at follow-up . At 24 months , the proportions of patients meeting public health recommendations for moderate intensity physical activity were significantly higher compared with baseline in both the IT and GT groups ( 19 and 24 % , respectively , P meeting the recommendation for vigorous activity was only significantly higher compared with baseline in the IT group ( P proportions of patients meeting moderate or vigorous physical activity recommendations at 24 months . Apart from a significantly higher RAQoL score in the IT group at 24 months compared with baseline , there were no significant differences within or between the programmes regarding functional ability or QoL. CONCLUSION In RA patients , the effectiveness of both an individualized and a general 1-year Internet-based physical activity programme is sustained with respect to moderate intensity physical activity up to 12 months after the interventions",
"OBJECTIVE To assess the engagement in and satisfaction with an Internet-mediated physical activity intervention with individual supervision in patients with rheumatoid arthritis ( RA ) . METHODS The intervention studied was one of the two strategies aim ed at enhancing physical activity in RA patients that were being compared in a r and omized controlled trial . A total of 82 patients , all experienced in using Internet and e-mail and registered at three different rheumatology out-patient clinics , were r and omly allocated to the Internet-mediated individualized intervention ( 52 weeks ) . They had access to personal physical activity schedules and received individual supervision by a physical therapist by means of weekly e-mail feedback . In addition , telephone contacts , an online discussion forum , six face-to-face group meetings and electronic newsletters were offered . Besides registration of returned physical activity schedules , engagement and satisfaction were measured through question naires . RESULTS The median physical activity schedule return rate of the 82 participants was 55 % . The mean number of patients logging into the website at least once a week was 53 ( 70 % ) over 12 months . Of all patients , 69 returned the question naires ( response 84 % ) . Telephone contacts were used by 38/67 patients ( 57 % ) , the mean ( SD ) number of attended group meetings was 3.1 ( 1.5 ) and the discussion forum comprised 15 posted messages . Overall , the proportions of patients being ( very ) satisfied with the amount of e-mail contacts , telephone contacts , usefulness of website information , physical activity schedules , group meetings and website layout were > /=85 % . A smaller proportion of patients were satisfied with the links to other websites ( 68 % ) , the newsletters ( 55 % ) and the online discussion forum ( 32 % ) . CONCLUSION Physical activity schedules with weekly feedback by e-mail , telephone contacts and a limited number of group meetings were frequently used website tools and modes of communication of an Internet-based physical activity intervention , with high-satisfaction rates from RA patients . Discussion forum and newsletters were less used and appreciated . Caution should be taken when extrapolating the results found to groups of patients who are not experienced Internet and e-mail users or patients with more severe physical disabilities",
"OBJECTIVE To determine the efficacy of an Internet-based Arthritis Self-Management Program ( ASMP ) as a re source for arthritis patients unable or unwilling to attend small-group ASMPs , which have proven effective in changing health-related behaviors and improving health status measures . METHODS R and omized intervention participants were compared with usual care controls at 6 months and 1 year using repeated- measures analyses of variance . Patients with rheumatoid arthritis , osteoarthritis , or fibromyalgia and Internet and e-mail access ( n = 855 ) were r and omized to an intervention ( n = 433 ) or usual care control ( n = 422 ) group . Measures included 6 health status variables ( pain , fatigue , activity limitation , health distress , disability , and self-reported global health ) , 4 health behaviors ( aerobic exercise , stretching and strengthening exercise , practice of stress management , and communication with physicians ) , 5 utilization variables ( physician visits , emergency room visits , chiropractic visits , physical therapist visits , and nights in hospital ) , and self-efficacy . RESULTS At 1 year , the intervention group significantly improved in 4 of 6 health status measures and self-efficacy . No significant differences in health behaviors or health care utilization were found . CONCLUSION The Internet-based ASMP proved effective in improving health status measures at 1 year and is a viable alternative to the small-group ASMP",
"The objective of this RCT was to assess the efficacy of an online pain self-management program with adults who had a self-reported doctor diagnosis of arthritis pain ( N = 228 ) . Participants were recruited via flyers and online postings then r and omized to the experimental condition or the wait-list control condition . Individuals in the experimental condition reported significantly ( 1 ) increased arthritis self-efficacy and ( 2 ) reduced pain catastrophizing from baseline to follow up compared to those in the control condition . High user engagement ( > 204.5 min on the website ) was also significantly associated with improved self-management outcomes . These findings suggest that use of an online self-management program may positively impact self-efficacy and catastrophizing among adults with arthritis pain at 6 month follow up . Nonsignificant findings for hypothesized variables such as pain intensity and health behaviors are also discussed . Future longitudinal research is needed to assess if cognitive changes associated with participation in an online self-management program leads to reduced pain",
"The Internet provides a medium to administer and evaluate evidence -based interventions for highly prevalent public health problems worldwide . The authors report a series of four Internet smoking cessation studies conducted in English and Spanish . These studies examined both outcome ( self-reported 7-day abstinence ) and mechanisms related to outcome ( the impact of major depressive episodes [ MDEs ] on the likelihood of quitting ) . Over 4,000 smokers from 74 countries entered the studies . Studies 1 and 2 evaluated a st and ard smoking cessation guide ( the \" Guía \" ) . Studies 3 and 4 were r and omized trials comparing the Guía+ITEMs ( individually timed educational messages ) to the Guía+ITEMs+a mood management course . ITEMs were E-mails inviting participants back to the site at specific times . Online follow-up assessment s result ed in completion rates of 44%-54 % at 1 month and 26%-30 % at 6 months in studies 1 and 2 . Incentives and follow-up phone calls increased these rates to 70 % , 66 % , 65 % , and 62 % at 1 , 3 , 6 , and 12 months in study 4 . At 6 months , self-reported 7-day abstinence rates using missing = smoking data were 6 % in studies 1 and 2 , 10%-14 % in study 3 , and 20%-26 % in study 4 . The Guía+ITEMs condition tended to have higher quit rates , which reached significance at the 12-month follow-up in study 3 and at the 3-month follow-up in study 4 . Smokers with past ( but not current ) MDEs tended to be the most likely to abstain and those with current MDEs the least likely . This trend reached significance in studies 1 and 4",
"Background Rheumatoid arthritis ( RA ) is chronic systematic disease that affects people during the most productive period of their lives . Web-based health interventions have been effective in many studies ; however , there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients ’ behavioral and health outcomes . Objective The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity , health care utilization , medication overuse , empowerment , and RA knowledge of RA patients . The effect of gamification on website use was also investigated . Methods We conducted a 5-arm parallel r and omized controlled trial for RA patients in Ticino ( Italian-speaking part of Switzerl and ) . A total of 157 patients were recruited through brochures left with physicians and were r and omly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website . Data were collected at 3 time points through question naires at baseline , posttest 2 months later , and at follow-up after another 2 months . Primary outcomes were physical activity , health care utilization , and medication overuse ; secondary outcomes included empowerment and RA knowledge . All outcomes were self-reported . Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time . Results The best-fit multilevel models ( growth curve models ) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors . The growth curve analyses of experimental conditions were compared to the control group . Physical activity increased over time for patients having access to social support sections plus gaming ( unst and ardized beta coefficient [B]=3.39 , P=.02 ) . Health care utilization showed a significant decrease for patients accessing social support features ( B=–0.41 , P=.01 ) and patients accessing both social support features and gaming ( B=–0.33 , P=.03 ) . Patients who had access to either social support sections or the gaming experience of the website gained more empowerment ( B=2.59 , P=.03 ; B=2.29 , P=.05 ; respectively ) . Patients who were offered a gamified experience used the website more often than the ones without gaming ( t 91=–2.41 , P=.02 ; U=812 , P=.02 ) . Conclusions The Web-based intervention had a positive impact ( more desirable outcomes ) on intervention groups compared to the control group . Social support sections on the website decreased health care utilization and medication overuse and increased empowerment . Gamification alone or with social support increased physical activity and empowerment and decreased health care utilization . This study provides evidence demonstrating the potential positive effect of gamification and online social support on health and behavioral outcomes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 57366516 ; http://www.controlled-trials . com/IS RCT N57366516 ( Archived by webcite at http://www.webcitation.org/6PBvvAvvV )",
"OBJECTIVE To compare the effectiveness of 2 Internet-based physical activity interventions for patients with rheumatoid arthritis ( RA ) . METHODS A total of 160 physically inactive patients with RA who had a computer with Internet access were r and omly assigned to an Internet-based physical activity program with individual guidance , a bicycle ergometer , and group contacts ( individualized training [ IT ] group ; n = 82 ) or to an Internet-based program providing only general information on exercises and physical activity ( general training [ GT ] group ; n = 78 ) . Outcome measures included quantity of physical activity ( question naire and activity monitor ) , functional ability , quality of life , and disease activity ( baseline , 3 , 6 , 9 , and 12 months ) . RESULTS The proportion of physically active patients was significantly greater in the IT than in the GT group at 6 ( 38 % versus 22 % ) and 9 months ( 35 % versus 11 % ; both P in physical activity as measured with an activity monitor , functional ability , quality of life , or disease activity . CONCLUSION An Internet-based physical activity intervention with individually tailored supervision , exercise equipment , and group contacts is more effective with respect to the proportion of patients who report meeting physical activity recommendations than an Internet-based program without these additional elements in patients with RA . No differences were found regarding the total amount of physical activity measured with an activity monitor",
"Abstract For patients with chronic pain conditions such as rheumatoid arthritis ( RA ) , who experience elevated levels of distress , tailored-guided internet-based cognitive-behavioral treatment may be effective in improving psychological and physical functioning , and reducing the impact of RA on daily life . A multicenter , r and omized controlled trial was conducted for RA patients with elevated levels of distress as assessed by a disease-specific measure . The control group ( n = 71 ) received st and ard care and the intervention group ( n = 62 ) additionally received an internet-based tailored cognitive-behavioral intervention . Main analyses were performed using a linear mixed model estimating differences between the intervention and control groups in scores of psychological functioning , physical functioning , and impact of RA on daily life at preassesment and post assessment , and at 3 , 6 , 9 , and 12 months . Patients who received the internet-based intervention reported a larger improvement in psychological functioning compared with the control group , indicating less depressed mood ( P negative mood ( P = 0.01 , d = 0.38 ) , and anxiety ( P physical functioning , a trend was found for the intervention group reporting less fatigue than the control group ( P = 0.06 , d = 0.24 ) , whereas no effect was found on pain . No effects were found for the impact of RA on daily life , except for the intervention group experiencing fewer role limitations due to emotional problems ( P guided internet-based cognitive-behavioral therapy is a promising development to aid patients with psychological distress particularly in improving psychological functioning . Further research on adherence and specific intervention ingredients is warranted"
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BACKGROUND The minimum clinical ly important difference ( MCID ) is used to interpret the relevance of treatment effects , e.g. , when developing clinical guidelines , evaluating trial results or planning sample sizes . There is currently no agreement on an appropriate MCID in chronic pain and little is known about which context ual factors cause variation . METHODS This is a systematic review . We search ed PubMed , EMBASE , and Cochrane Library . Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale , a patient-reported transition scale of perceived improvement , and either a mean change analysis ( mean difference in pain among minimally improved patients ) or a threshold analysis ( pain reduction associated with best sensitivity and specificity for identifying minimally improved patients ) . Main results were descriptively summarized due to considerable heterogeneity , which were quantified using meta-analyses and explored using subgroup analyses and metaregression . RESULTS We included 66 studies ( 31.254 patients ) . Median absolute MCID was 23 mm on a 0 - 100 mm scale ( interquartile range [ IQR ] 12 - 39 ) and median relative MCID was 34 % ( IQR 22 - 45 ) among studies using the mean change approach . In both cases , heterogeneity was very high : absolute MCID I2 = 99 % and relative MCID I2 = 96 % . High variation was also seen among studies using the threshold approach : median absolute MCID was 20 mm ( IQR 15 - 30 ) and relative MCID was 32 % ( IQR 15 - 41 ) . Absolute MCID was strongly associated with baseline pain , explaining approximately two-thirds of the variation , and to a lesser degree with the operational definition of minimum pain relief and clinical condition . A total of 15 clinical and method ological factors were assessed as possible causes for variation in MCID . CONCLUSIONS MCID for chronic pain relief vary considerably . Baseline pain is strongly associated with absolute , but not relative , measures . To a much lesser degree , MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition . Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinical ly important or trivial | [
"Abstract The assessment of clinical ly meaningful changes in patient‐reported pain has become increasingly important when interpreting results of clinical studies . However , proposed response criteria , such as the minimal clinical ly important difference , do not correspond with the growing need for information on truly meaningful , individual improvements . The aim of the present study was to investigate satisfactory improvements in pain from the patient ’s perspective . Data were collected in a 2‐week prospect i ve study of 181 arthritis patients treated with a local corticosteroid injection . Baseline and follow‐up pain were assessed on 100 mm visual analogue scales for pain intensity ( VAS‐PI ) . At baseline , patients also marked a hypothetical level on a VAS‐PI representing a satisfactory improvement in pain . Patient‐perceived satisfactory improvement ( PPSI ) was constructed using a 5‐point categorical rating of change scale at follow‐up as the anchor . PPSI was associated with a minimal reduction of 30 mm or 55 % on the VAS‐PI . Since absolute change in pain associated with satisfactory improvement proved highly dependent on baseline pain , percent change scores performed better in classifying improved patients . The 55 % threshold for satisfactory improvement was consistent over the course of treatment and reasonably consistent across groups of patients . Our data suggest that PPSI is a clinical ly relevant and stable concept for interpreting truly meaningful improvements in pain from the individual perspective",
"Objective To investigate the degree of pain reduction in patients with complex regional pain syndrome type 1 ( CRPS 1 ) that can be defined as “ successful . ” Design All patients rated their pain on a visual analog scale ( VAS ; 0–10 ) before treatment and on three occasions after treatment , at 6 months , 1 year , and 2 years . Patients also rated a Global Perceived Effect ( GPE ) for their pain relief at the same time periods . The GPE items were classified as “ successful ” or “ unsuccessful . ” The mean absolute and relative pain reduction ( using the VAS ) was calculated for both “ successful ” and “ unsuccessful ” GPE classifications for each time period . Sensitivity and specificity analyses were performed . Patients Sixty-one patients with CRPS 1 . Results The patients defined a relative pain reduction of 58 % ( SD , 23.4 ) or more as “ successful , ” whereas in “ successful ” and “ unsuccessful ” patient groups the pain was reduced significantly on the VAS . Furthermore , sensitivity and specificity analyses showed that a cut-off point of 50 % relative pain reduction and a 3-cm absolute pain reduction on the VAS have the highest likelihood that patients will report their treatment “ successful ” on the GPE . Conclusions Relative pain reduction of 50 % or more and an absolute pain reduction of at least 3 cm on the VAS are accurate in predicting a successful pain reduction after a given treatment",
"Abstract Purpose : The purpose of this trial was to investigate changes in pain , the range of motion ( ROM ) and spasticity in people with painful hemiplegic shoulder ( PHS ) after the application of an upper limb neuromuscular taping ( NMT ) . Methods : We conducted a r and omised clinical trial . The study included 32 people , 31 % female ( mean ± SD age : 66 ± 9 years ) , with PHS after stroke with pain at rest and during functional movements . The experimental group received the application of NMT and a st and ard physical therapy programme ( SPTP ) , whereas the control group received SPTP . The groups received four 45-minute long sessions over four weeks . The VAS , ROM and spasticity were assessed before and after the intervention with follow-up at four weeks . Results : The experimental group had a greater reduction in pain compared to the control group at the end of the intervention , as well as at one month after the intervention ( p higher ( i.e. better ) ROM , by 30.0 ° , than the control group in shoulder flexion ( 95 % CI : 37.3–22.7 ) at 4 weeks and by 24.8 ° ( 95 % CI : 32.1–17.6 ) at 8 weeks as well as in abduction by 30.6 ° ( 95 % CI : 37.5–23.7 ) at 4 weeks and 25.1 ° ( 95 % CI : 33.8–16.3 ) at 8 weeks . Conclusion : Our study demonstrates that NMT decreases pain and increases the ROM in subjects with shoulder pain after a stroke . Implication s for Rehabilitation Painful hemiplegic shoulder is a frequent complication after stroke with negative impacts on functional activities and on quality of life of people , moreover restricts rehabilitation intervention . Neuromuscular taping is a technique introduced by David Blow for the treatment of neuromuscoloskeletal problems . This study shows the reduction of pain and the improvement of range of motion after the application of an upper limb neuromuscular taping . Rehabilitation professionals who are involved in the management of painful hemiplegic shoulder may like to consider the benefits that neuromuscular taping can produce on upper limb",
"Study Design . Prospect i ve study of two sample s of patients with acute and chronic low back pain , respectively . Objectives . To compare the responsiveness of four functional status question naires , Rol and Morris Disability Question naire ( RMDQ ) , Oswestry Disability Index ( ODI ) , Disability Rating Index ( DRI ) , and Physical Functioning scale of the SF-36 ( PFSF-36 ) , and two pain scales , a Numerical Pain Rating Scale ( NRS ) and Visual Analogue Scale ( VAS ) . Summary of Background Data . Concurrent comparisons of different outcome measurements in back patients have been requested . Methods . Norwegian versions of the scales and question naires were completed by 54 patients with acute ( 3 months ) . Clinical change was estimated on a global change index . An alternative external criterion was the expected clinical course in the two cohorts . Mean changes , st and ardized response mean ( SRM ) , and area under the receiver operating characteristic ( ROC ) curves with cutoff point for highest sensitivity and specificity were calculated . Results . At the follow-up , 63 % of the acute and 41 % of the chronic sample reported improvement on the global change index . Large SRMs ( 1.3–2.0 ) and areas under the ROC curves ( 0.84–0.93 ) were found for the measurements in the acute sample . In the chronic sample , the SRMs ( 0.4–1.1 ) and areas under the ROC curves ( 0.65–0.83 ) were lower , in particular for the PFSF-36 and the VAS . There was no statistically significant difference between the responsiveness in the measurements , except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change . Conclusion . The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain , whereas among chronic patients the RMDQ , ODI , DRI , and NRS were most appropriate",
"OBJECTIVES Multi-item question naires are frequently used to measure outcomes in r and omized controlled trials ( RCTs ) in patients with sciatica . Knowing the minimaly important change ( MIC ) values for these instruments will facilitate interpretation of change scores . MIC values have been shown to be dependent on baseline values . The question is whether they also depend on the type of intervention . To estimate the MIC of the Rol and Morris Disability Question naire ( modified 23 item version ) ( RMDQ ) and of intensity of leg pain measured by a Visual Analogue Scale ( VAS ) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values . STUDY DESIGN AND SETTING This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica . Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain . We used the receiver operator characteristic ( ROC ) method to assess the MIC . Global Perceived Recovery ( rated 8 weeks after baseline ) was used as anchor . Subgroups were created based on type of treatment and baseline severity . RESULTS The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5 . The values were 8.1 and 6.9 for surgery and conservative treatment , respectively . For high and low baseline values , the MICs were 9.0 and 4.9 , respectively , irrespective of treatment received . The MIC values of the VAS leg pain were 34.4 for the total group . For surgery and conservative treatment , the MIC values were 38.5 and 30.4 , respectively , whereas for groups with high and low baseline values , MIC values of 53.5 and 17.2 were found . CONCLUSION The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values , although the type of intervention appeared to influence the MIC value only slightly",
"BACKGROUND CONTEXT The Neck Disability Index ( NDI ) , the short form-36 ( SF-36 ) physical component summary ( PCS ) , and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery . The minimum clinical ly important difference ( MCID ) is a threshold of improvement that is clinical ly relevant to the patient . However , the true goal is to provide the patient with a substantial clinical benefit ( SCB ) . PURPOSE This study determines the MCID and SCB using common anchor-based methods for NDI , PCS , and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders . STUDY DESIGN / SETTING The study setting is a longitudinal cohort in a multisurgeon spine specialty clinic . PATIENT SAMPLE The sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospect ively collected outcome scores with a minimum 1-year follow-up . OUTCOME MEASURES The outcome measures of the study were NDI , SF-36 , and numeric rating scales for arm and neck pain . METHODS The MCID and SCB values for NDI , PCS , and pain scales for arm and neck pain were determined using receiver operating characteristic ( ROC ) curve analysis with the Health Transition Item of the SF-36 as an anchor . The Health Transition Item asks a patient \" Compared to one year ago , how would you rate your health in general now ? \" with answers ranging from \" Much Better , \" \" Somewhat Better , \" \" About the Same , \" \" Somewhat Worse , \" to \" Much Worse . \" An ROC curve was constructed for each measure . The ROC curve-derived MCID was the change score with equal sensitivity and specificity to distinguish the \" Somewhat Better \" from the \" About the Same \" patients . The ROC curve-derived SCB was the change score with equal sensitivity and specificity to distinguish the \" Much Better \" from the \" Somewhat Better \" patients . Distribution-based methods including the st and ard error of the mean and the minimum detectable change were also used to calculate MCID . RESULTS The calculated MCID is 7.5 for the NDI , 4.1 for SF-36 PCS , and 2.5 for arm and neck pain . The calculated SCB is 9.5 for the NDI , 6.5 for SF-36 PCS , and 3.5 for arm and neck pain . CONCLUSIONS Patients with an eight-point decrease in NDI , a 4.1-point increase in PCS , and a three-point decrease in arm or neck pain can detect a minimally clinical ly important change . Patients with a 10-point decrease in NDI , a 6.5-point increase in PCS , and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion",
"BACKGROUND CONTEXT The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures : Oswestry Disability Index ( ODI ) , the physical component summary ( PCS ) of the Short Form of the Medical Outcomes Study ( SF-36 ) , and pain scales . A minimum clinical ly important difference ( MCID ) is a threshold used to measure the effect of clinical treatments . Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method . PURPOSE This study has three purpose s. First , to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID . Second , to determine a statistically sound and clinical ly meaningful MCID for ODI , PCS , back pain scale , and leg pain scale in lumbar spine surgery patients . Third , to compare the discriminative ability of two anchors : a global health assessment and a rating of satisfaction with the results of the surgery . STUDY DESIGN This study is a review of prospect ively collected patient-reported outcomes data . PATIENT SAMPLE A total of 454 patients from a large data base of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study . OUTCOME MEASURES Preoperative and 1-year postoperative scores for ODI , PCS , back pain scale , leg pain scale , health transition item ( HTI ) of the SF-36 , and Satisfaction with Results scales . METHODS ODI , SF-36 , and pain scales were administered before and 1 year after spinal surgery . Several c and i date MCID calculation methods were applied to the data and the result ing values were compared . The HTI of the SF-36 was used as the anchor and compared with a second anchor ( Satisfaction with Results scale ) . RESULTS Potential MCID calculations yielded a range of values : fivefold for ODI , PCS , and leg pain , 10-fold for back pain . Threshold values obtained with the two anchors were very similar . CONCLUSIONS The minimum detectable change ( MDC ) appears as a statistically and clinical ly appropriate MCID value . MCID values in this sample were 12.8 points for ODI , 4.9 points for PCS , 1.2 points for back pain , and 1.6 points for leg pain",
"& NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies",
"To test the relative merits of administering question naires with previous responses available ( the informed condition ) or unavailable ( the blind condition ) , we administered blind and informed versions of a quality of life question naire ( the Chronic Respiratory Disease Question naire , or CRQ ) in a r and omized , double-blind trial of bronchodilators in chronic airflow limitation . The responsiveness of the two methods , as reflected in the p-values associated with salbutamol and theophylline effects were comparable for three of the four dimensions of the CRQ . The data suggested possible increased responsiveness of the informed method for the emotional function dimension of the question naire . Changes in the informed CRQ dyspnea and fatigue dimensions showed stronger correlations with changes in spirometry , 6 minute walk distance , and rating of dyspnea after the walk test than did blind administration . Further , changes in all four CRQ dimensions showed stronger correlations with corresponding global ratings using the informed question naire . These results suggest that by letting study subjects see their previous responses the validity of subjective measures of health status in clinical trials can be improved",
"UNLABELLED Data on 1,700 patients pooled from 5 r and omized , placebo-controlled duloxetine studies ( 3 in diabetic peripheral neuropathic pain and 2 in fibromyalgia ) were analyzed to determine clinical ly important differences ( CIDs ) in the 0 to 10 Numeric Rating Scale-Pain Intensity ( NRS-PI ) for patient-reported \" worst \" and \" least \" pain intensity while validating the previously published level for \" average \" pain . The correspondence between the baseline-to-endpoint raw and percentage change in the NRS-PI for the worst , least , and average pain were compared to patients ' perceived improvements at endpoint as measured by the 7-point Patient Global Impression of Improvement ( PGI-I ) scales . Stratification by baseline pain separated the raw but not the percent change scores . The PGI-I category of \" much better \" or above was our a priori definition of a CID . Cutoff points for the NRS-PI change scores were determined using a receiver operator curve analysis . A consistent relationship between the worst and average NRS-PI percent change and the PGI-I was demonstrated regardless of the study , pain type , age , sex , or treatment group with a reduction of approximately 34 % . The least pain item CID was slightly higher at 41 % . Raw change CID cutoff points were approximately -2 , -2.5 and -3 for least , average , and worst pain respectively . PERSPECTIVE We determined an anchor-based value for the change in the worst , least , and average pain intensity items of the Brief Pain Inventory that best represents a clinical ly important difference . Our findings support a st and ard definition of a clinical ly important difference in clinical trials of chronic-pain therapies",
"BACKGROUND Outcomes studies use patient-reported outcome ( PRO ) measurements to assess treatment effectiveness , but can lack direct clinical meaning . Minimum clinical ly important difference ( MCID ) calculation provides a point estimate of the critical threshold needed to achieve clinical ly relevant treatment effectiveness . MCID remains uninvestigated for microvascular decompression ( MVD ) , a common surgical procedure for trigeminal neuralgia . OBJECTIVE We aim ed to determine MCID for the most commonly used PRO measures of pain after MVD : Visual Analog Scale ( VAS ) and Barrow Neurological Institute Pain Scale ( BNI-PS ) . METHODS Sixty consecutive patients with classic trigeminal neuralgia who decided to undergo MVD by a single surgeon were prospect ively assessed with VAS and BNI-PS preoperatively and 2 years postoperatively . Three anchors were used to assign each patient 's outcome . We then used 3 well-established , anchor-based methods to calculate MCID . RESULTS Patients experienced significant improvement in both VAS ( 9.9 vs. 2.0 , P MVD . The area under the receiver-operating characteristic curve was greater for BNI-PS than for VAS for all 3 anchors , indicating that BNI-PS is probably better suited for calculating MCID . The 3 MCID calculation methods generated a range of MCID values for each of the PROs ( VAS : 1.40 - 8.87 , BNI-PS : 0.95 - 3.26 ) . CONCLUSION MVD-specific MCID is highly variable based on calculation technique . Some of these calculations appear to either overestimate or underestimate the patients ' preoperative expectations . When the different MCID methods are averaged , the results are clinical ly appropriate and consistent with preoperative expectations . The average MCID for VAS is 6.25 and for BNI-PS is 2.44",
"Evidence -based medicine is built on a foundation of r and omized trials . Interpretation of trials depends on whether a predetermined difference ( effect size ) between intervention and control groups was observed and the likelihood of this being due to chance ( statistical significance ) . It is now generally agreed that the effect size for which a trial is powered should be just large enough to be clinical ly significant . Introduction of the concept of minimal important difference ( MID ) in the 1980s was followed by an emerging stream of research aim ed at assessing this quantity in a variety of disease conditions , followed by rapidly increasing use of MID among research ers and regulators . To date , however , MID methods focus on benefit magnitude alone , ignoring side effects , adverse events , and other harms . This article 1 ) argues that MID should be replaced with ‘ ‘ sufficiently important difference ’ ’ ( SID ) , a concept that includes balancing of benefits against harms , and 2 ) outlines a few pressing research questions and challenges related to this incipient field . Sufficiently important difference was originally defined as ‘ ‘ the smallest amount of patient-valued benefit that an intervention would require to justify associated costs , risks and other harms . ’ ’ SID is understood in the context of existing evidence and is measured at the individual level . Perhaps the concept underlying SID should instead been named ‘ ‘ smallest worthwhile effect ’ ’ ( SWE ) , as that phrase seems to have more intuitive appeal . Because people value various benefits and harms differently , SID/SWE varies across population s. Because the assessment of benefits and harms changes as science evolves , SID/SWE estimates may change . Yet even in relatively evolved and evidence -rich areas , such as preventing and treating cardiovascular disease or screening for breast or colon cancer , questions regarding SID/SWE lie almost completely unexplored . For example , we do n’t know whether closer to 10 % , 50 % , or 90 % of people targeted for cholesterol , blood pressure , or blood sugar – lowering drugs or for cancer screening using colonoscopy or mammography would deem expected benefits sufficient to justify expected harms , should they underst and the evidence . We know that these interventions are widely promoted and that some benefits are expected , but we do n’t know whether or to what degree that associated benefit-harm tradeoffs correspond to target population health values . Although great progress has been made in the evidence -based assessment of benefits and harms , very little is known about how individuals and population s would value and use that evidence in decision making , should it be presented to them in an underst and able manner . The purpose of this article , then , is to call for an expansion of inquiry in this direction , to suggest a few research questions and method ological avenues , and to briefly list some of the challenges that may emerge . Arguably , the era of evidence -based medicine ( EBM ) began with Archie Cochrane , after whom the Cochrane collaboration was named . Cochrane , followed by notables such as Gordon Guyatt , David Sackett , and others , exhorted the medical Received 15 February 2012 from Department of Family Medicine , University of Wisconsin – Madison , Madison , WI ( BB ) . Revision accepted for publication 5 December 2012",
"Background The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes ( PROs ) : Neck Disability Index ( NDI ) , Visual Analog Scale ( VAS ) for pain , and Short Form-36 ( SF-36 ) Physical ( PCS ) and Mental ( MCS ) Component Summary . However , the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear . In this context , the concept of minimum clinical ly important difference ( MCID ) is developing into the st and ard by which to evaluate treatments , patient satisfaction and cost-effectiveness . Methods Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospect i ve blinded data base . PROs ( NDI , PCS , MCS and VAS ) were collected preoperatively , and together with blinded Surgeon Ratings ( SR ) at 3 months and 6 months post-surgery . Four anchor-based approaches were used to calculate different MCIDs . Three anchors ( VAS , HTI ( Health Transition Item of the SF-36 ) and SR ) were used to evaluate surgery outcome . The best clinical ly and statistically relevant MCID was chosen . Results On average , all patients presented with a statistically significant improvement ( p area under the ROC curve was greater for SR . This finding suggests that SR may be a more reliable anchor for MCID calculation . Conclusion The MDC ( minimum detectable change ) approach together with the SR anchor appears to be the most appropriate MCID method . It offers the greatest area under the ROC curve ( threshold above the 95 % CI ) , and the choice of the anchor did not significantly affect this result . MCID values for this data set were 5.6 for PCS , 5.12 for MCS and 2.41 for NDI",
"OBJECTIVE To examine the test-retest reliability , validity , and responsiveness of several outcome measures in the treatment of patellofemoral pain . DESIGN Evaluation of the clinimetric properties of individual outcome measures for patellofemoral pain treatment , using data collected from a previously published r and omized controlled trial ( RCT ) . SETTING General community and private practice . PARTICIPANTS The data from 71 persons enrolled in an RCT of a conservative intervention for patellofemoral pain were used to evaluate the measures ' validity and responsiveness . A subset of this cohort ( n=20 ) was used to assess reliability . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Three 10-cm visual analog scales ( VASs ) for usual pain ( VAS-U ) , worst pain ( VAS-W ) , and pain on 6 aggravating activities ( walking , running , squatting , sitting , ascending and descending stairs ) ( VAS-activity ) ; the Functional Index Question naire ( FIQ ) ; the Anterior Knee Pain Scale ( AKPS ) ; and the global rating of change . RESULTS The test-retest reliability ranged from poor ( intraclass correlation coefficient [ICC]=.49 ) to good ( ICC=.83 ) , and the measures correlated moderately with each other ( r range,.56-.72 ) . Median change scores differed significantly between improved and unimproved persons for all measures . The effect sizes for VAS-U ( .79 ) , VAS-W ( .88 ) , and the AKPS ( .98 ) were large , indicating greater responsiveness than the FIQ ( .37 ) and VAS-activity ( .66 ) . Similarly , the AKPS and VAS-W were the most efficient measures for detecting a treatment effect when compared with a reference measure ( VAS-U , which was assigned a value of 1 ) . The minimal difference that patients or clinicians consider clinical ly important for the AKPS is 10 ( out of 100 ) points and for the VAS it is 2 cm ( out of 10 cm ) . CONCLUSIONS The AKPS and VAS for usual or worst pain are reliable , valid , and responsive and are therefore recommended for future clinical trials or clinical practice in assessing treatment outcome in persons with patellofemoral pain",
"Summary A range of clinical ly important difference values is provided according to the patients ’ baseline pain severity and duration of pain . Abstract The aim of this study was to estimate a range of clinical ly important difference ( CID ) values of the visual analog scale for pain intensity ( VAS‐PI ) , and to assess the effect of patient baseline characteristics on VAS change scores . Data from a prospect i ve cohort study with 678 patients with subacute and chronic temporom and ibular disorder pain were analyzed . Patients were divided into 9 cohorts on the basis of the baseline VAS score and the duration of pain . The CID was estimated over a 12‐week period , and 2 different methods were used : ( 1 ) mean change scores , and ( 2 ) optimal cutoff point in receiver operator characteristic curves . The patient 's global impression of change was used as an external criterion . The general linear model univariate analysis was applied to assess the effect of baseline pain level and duration of pain on the raw VAS change scores , while adjusting for age and sex . The CID mean change ranged from 20.9 to 57.5 mm ( 64.1–76.3 % ) , and the CID optimal cutoff point from 11.5 to 28.5 mm ( 29.9–47.7 % ) . For the VAS change scores , the main effect of the variable baseline pain level was significant ( F = 107.09 , P significant baseline pain level by duration of pain interaction effect ( F = 1.13 , P = .340 ) . On the basis of the results , we advocate the choice of a single CID value according to the context of the patient 's baseline level of pain",
"& NA ; Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments . Perhaps the most important aspect of a pain measure 's validity is its sensitivity , or ability to detect changes in pain over time and due to treatment . Several factors may affect a measure 's sensitivity , including the complexity of the rating task for the measure , the number of pain intensity levels assessed by the measure , the dimension of pain assessed ( e.g. pain intensity vs. pain relief ) , and the number of individual ratings ( e.g. single rating vs. composite score ) used to create the measure . The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two sample s of persons participating in a r and omized controlled trial . One hundred and twenty‐three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery : morphine , ketorolac , or placebo . Two measures of pain intensity ( a visual analog scale ( VAS ) and a 4‐point verbal rating scale ( VRS ) ) were administered at baseline , and these measures plus a 5‐point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery . As predicted , we found variability in the sensitivity of the outcome measures used in these studies , with the 4‐point VRS showing less sensitivity than the VAS or relief ratings . However , contrary to our prediction , a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects . Finally , we found that pain relief ratings were related to , but also distinct from , change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point . These findings have important implication s for the assessment of pain in clinical trials",
"Abstract Underst and ing a change score is indispensable for interpretation of results from clinical studies . One way of determining the relevance of change scores is through the use of transition questions that assesses patients ’ retrospective perception of treatment effect . Unfortunately , results from studies using transition questions are difficult to compare since wording of questions and definitions of important improvements vary between studies . The objectives of this study were to determine the consequence of using different transition questions on pain and disability measures and make proposals for a st and ardised use of such questions . Two hundred and thirty‐three patients with low back pain and /or leg pain were recruited . Participants were followed over an 8‐week period and r and omised to two groups receiving a 7‐ ( TQ1 ) and 15‐point ( TQ2 ) transition question , respectively , in addition to a numeric rating scale evaluating the importance of the perceived change . Four external criteria were generated using both stringent and less stringent st and ards to dichotomise patients . Discrimination was determined using area under the receiver operating characteristic curve ( ROCauc ) and responsiveness using st and ardised response mean ( SRM ) . Results demonstrated small variations in ROCauc across the external criteria for all outcome measures . 7 % more patients were classified as improved in the group receiving the 15‐point TQ compared to the 7‐point TQ ( stringent st and ard ) . SRMs were higher for the retrospective TQs in primary sector patients compared to the serial measures with no difference between TQ1 and TQ2 . On the basis of our findings we have outlined a proposal for a st and ardised use of transition questions",
"BACKGROUND Vali date d health-related quality -of-life measures have become important st and ards in the evaluation of the outcomes of lumbar spine surgery . However , there are few well-defined criteria for clinical success based on these measures . The minimum clinical ly important difference is an important demarcation , but it could be considered a floor value rather than a goal in defining clinical success . Therefore , we sought to define thresholds of substantial clinical benefit for commonly used health-related quality -of-life measures following lumbar spine arthrodesis . METHODS Prospect ively collected preoperative and one-year postoperative health-related quality -of-life measures from 357 patients who were managed with lumbar spine arthrodesis for the treatment of degenerative conditions were identified . C and i date substantial clinical benefit thresholds for the Short Form-36 physical component score , Oswestry Disability Index , and back and leg pain numeric rating scales were identified with use of receiver operating characteristic curve analysis . Receiver operating characteristic curves were used to discriminate between patients who reported being \" much better \" or \" about the same \" with use of the vali date d Short Form-36 health transition item and between those who reported being \" mostly satisfied \" or \" unsure \" with use of a nonvali date d but more surgery-specific satisfaction-with- results survey . For each health-related quality -of-life measure , three response parameters were used : net change , percent change , and raw score at the time of the one-year follow-up . RESULTS Substantial clinical benefit thresholds for the Short Form-36 physical component score were a 6.2-point net improvement , a 19.4 % improvement , or a final raw score of > or = 35.1 points . Substantial clinical benefit thresholds for the Oswestry Disability Index were an 18.8-point net improvement , a 36.8 % improvement , or a final raw score of back pain and leg pain numeric rating scales were a 2.5-point net improvement or a final raw score of back pain numeric rating scale and 38.8 % for the leg pain numeric rating scale . CONCLUSIONS We believe that thresholds of substantial clinical benefit for commonly used health-related quality -of-life measures following lumbar spine arthrodesis are important as they describe a magnitude of change that the patient recognizes as a major improvement",
"The purpose of this prospect i ve , single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale ( NRS ) , Rol and –Morris disability question naire ( RMDQ ) , Oswestry disability index ( ODI ) , pain self-efficacy question naire ( PSEQ ) and the patient-specific functional scale ( PSFS ) in order to determine which would best measure clinical ly meaningful change in a chronic low back pain ( LBP ) population . Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population . However , there is a lack of consensus on what constitutes a “ successful ” outcome , how an important improvement/deterioration has been defined and which outcome measure(s ) best captures the effectiveness of therapeutic interventions for the chronic LBP population . Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study ; 48 of the 63 patients had complete data . Five question naires were administered initially and after the 5-week back class intervention . Also at 5 weeks , patients completed a global impression of change as a reflection of meaningful change in patient status . Score changes in the five different question naires were subjected to both distribution- and anchor-based methods : st and ard error of measurement ( SEM ) and receiver operating characteristic ( ROC ) curves to define clinical improvement . From these methods , the minimal clinical ly important difference ( MCID ) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument . Based on the SEM , a point score change of 2.4 in the NRS , 5 in the RMDQ , 17 in the ODI , 11 on the PSEQ , and 1.4 on the PSFS corresponded to the MCID . Based on ROC curve analysis , a point score change of 4 points for both the NRS and RMDQ , 8 points for the ODI , 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID . The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinical ly important change over time . The NRS was found to be least responsive . The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change . Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme . However , due to the small sample size , the lack of observed worsening of symptoms over time , the single centre and intervention studied these results which need to be interpreted with caution",
"BACKGROUND The Visual Analog Scale ( VAS ) and the Barrow Neurological Institute Pain Scale ( BNI-PS ) are 2 patient-reported outcome ( PRO ) tools frequently used to rate pain from trigeminal neuralgia ( TN ) . Outcomes studies often use these patient-reported outcomes to assess treatment effectiveness , but it is unknown exactly what degree of change in the numerical scores constitutes the minimum clinical ly important difference ( MCID ) . MCID remains uninvestigated for percutaneous stereotactic radiofrequency lesioning ( RFL ) , a common surgical procedure for TN . OBJECTIVE To determine MCID values for the VAS and BNI-PS in patients undergoing RFL . METHODS Forty-three consecutive patients with TN who underwent RFL by a single surgeon were prospect ively assessed with the VAS and BNI-PS preoperatively and 3 years postoperatively . Three anchors were used to assign each patient 's outcome : satisfaction , willingness to have the surgery again , and Health Transition Index . We then used 3 well-established , anchor-based methods to calculate MCID : average change , minimum detectable change , and change difference . RESULTS Patients experienced substantial improvement in both VAS ( 9.81 vs 3.35 ; P BNI-PS ( 4.95 vs 2.44 ; P MCID values for each of the PROs ( VAS , 4.13 - 8.20 ; BNI-PS , 1.03 - 3.30 ) . The area under the receiver-operating characteristic curve was greater for BNI-PS compared with VAS for all 3 anchors , indicating that BNI-PS is probably better suited for calculating MCID . CONCLUSION RFL-specific MCID is variable on the basis of the calculation technique . With the use of the minimum detectable change calculation method with the Health Transition Index anchor , the minimum clinical ly important difference is 4.49 for VAS and 1.16 for BNI-PS after RFL for TN . ABBREVIATIONS AUC , area under the receiver-operating characteristic curveBNI-PS , Barrow Neurological Institute Pain ScaleHTI , Health Transition IndexMCID , minimum clinical ly important differenceMDC , minimum detectable changePRO , patient-reported outcome RFL , percutaneous stereotactic radiofrequency lesioningTN , trigeminal neuralgiaVAS , Visual Analog Scale",
"BACKGROUND The patient acceptable symptom state ( PASS ) is the value beyond which patients can consider themselves well . This concept can help in interpreting results of clinical trials . OBJECTIVE To determine the PASS estimate for patients with knee and hip osteoarthritis ( OA ) by assessing pain , patient 's global assessment of disease activity , and functional impairment . METHODS A 4 week prospect i ve multicentre cohort study of 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment of disease , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . The patients assessed their satisfaction with their current state at the final visit . An anchoring method based on the patient 's opinion was used . RESULTS For patients with knee and hip OA , the estimates of PASS were , respectively , 32.3 and 35.0 mm for pain , 32.0 and 34.6 mm for patient global assessment of disease activity , and 31.0 and 34.4 points for WOMAC function score . The PASS varied moderately across the tertiles of baseline scores but not across age , disease duration , or sex . CONCLUSION The use of PASS in clinical trials would provide more meaningful results expressed as a proportion of patients in an acceptable symptom state",
"Underst and ing changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies . As a consequence the term “ minimal clinical ly important difference ” ( MCID ) was coined in the late 1980s to ease classification of patients into improved , not changed or deteriorated . Several method ological categories have been developed determining the MCID , however , all are subject to weaknesses or biases reducing the validity of the reported MCID . The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain ( LBP ) patients ’ view of an acceptable change ( MCIDpre ) before treatment begins . One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period . Original and modified versions of the Oswestry disability index ( ODI ) , Bournemouth question naire ( BQ ) and numeric pain rating scale ( NRSpain ) were filled in at baseline . The modified question naires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCIDpre . Concurrent comparisons between the MCIDpre , instrument measurement error and a retrospective approach of establishing the minimal clinical ly important difference ( MCIDpost ) were made . The results showed the prospect i ve acceptable outcome method scores to have acceptable reproducibility outside measurement error . MCIDpre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRSpain compared to the MCIDpost . Furthermore , MCIDpre and patients post-treatment acceptable change was almost equal for the NRSpain but not for the ODI and BQ . In conclusion , chronic LBP patients have a reasonably realistic idea of an acceptable change in pain , but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins",
"Abstract Objectives : To assess the level of pain intensity at which patients feel the impetus to ask for a breakthrough cancer pain ( BTcP ) medication , and level of pain intensity at which patients consider they have achieved acceptable pain control after receiving a BTcP medication . Methods : A consecutive sample of patients who were receiving oral morphine equivalents equal to or more than 60 mg daily , and were prescribed rapid onset opioids for the management of episodes of BTcP , were included in the study . Focused educational activities regarding BTcP and numerical scales were established during hospital admission . At discharge patients were interviewed to find out what was the pain intensity level which gave the impetus to take the BTcP medication , what was the pain intensity for acceptable pain control after a BTcP medication had been given , and which factors prevented the patient calling for BTcP medication . A brief COPE ( coping orientation to problems experienced ) question naire was also administered . Results : Fifty-two patients were recruited for this study . The meaningful pain intensity for asking for a BTcP medication was 7.1 ; 77 % of patients had a pain intensity of 7–8 on a numerical scale of 0–10 . The meaningful pain intensity for adequate analgesia after a BTcP medication was 3.5 . Similarly , 77 % of patients had a pain intensity of 3–4 . There was no relationship with the variables examined . Concerns by patients about the use of BTcP medications were minimal . Conclusion : The meaningful BTcP intensity and pain intensity expected after BTcP medication can be useful in selecting patients in studies of BTcP. The principal limitation of this study was the specific setting of an acute unit with specific features and the relatively low number of patients . This observation should be followed up by further surveys with a larger number of patients and different setting",
"AIMS To estimate the clinical ly important change ( CIC ) on a 100-mm visual analog scale for pain intensity ( VAS-PI ) by relating it to the patient 's global impression of change ( PGIC ) in patients with chronic temporom and ibular disorder ( TMD ) pain and to assess the dependency of the CIC on their baseline pain scores . METHODS Data from a prospect i ve cohort study with 588 patients with chronic TMD pain were analyzed . The CIC was estimated over a 3-month period , and receiver operating characteristic methods were used to assess the optimal cut-off point . The PGIC category of \" much improved \" served as an external criterion . Dependency of absolute and percent change on baseline VAS-PI scores was determined by linear regression analysis . RESULTS A VAS-PI change score of -19.5 mm and a percent change score of -37.9 % were best associated with the concept of CIC . Since patients with high baseline pain required greater absolute reductions in pain to reach a clinical ly important improvement , percent change scores performed better in classifying improved patients . CONCLUSION Providing a st and ard definition of the CIC adds to the interpretability of study results , ie , the estimates will aid in underst and ing individual patient outcomes",
"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",
"OBJECTIVE To assess the responsiveness of the Fibromyalgia Impact Question naire ( FIQ ) , patient ratings of pain intensity , number of tender points , and total tender point pain intensity score to perceived changes in clinical status in patients with fibromyalgia ( FM ) . METHODS Using data from a r and omized placebo controlled study evaluating efficacy of magnetic therapy in patients with FM , the ability of primary outcomes to detect clinical ly meaningful changes over a 6 month period was assessed by : ( 1 ) degree of association between outcome change scores and patient global ratings of symptom change ( Spearman rank-order correlations ) ; ( 2 ) ability of these scores to discriminate among groups of patients whose perceived health status had changed to varying degrees ( ANOVA ) ; ( 3 ) ability of these scores , individually and jointly , to discriminate between patients who had reported improvement and those who did not ( logistic regression ) ; ( 4 ) effect size , st and ardized response mean , and Guyatt 's statistic were calculated to quantify responsiveness . RESULTS Correlations showed the outcome measures were moderately responsive to perceived symptomatic change . For FIQ , pain intensity ratings and number of tender points , differences in change scores between globally improved and unchanged groups and between globally improved and worsened groups were significant ; for total tender point pain intensity , the globally improved differed from worsened group . FIQ outperformed the other measures in discriminating between patients who reported improvement from those who did not . Summary statistics were consistent with discriminatory analyses , indicating the measures were sensitive to improvement , but relatively unresponsive to decline . CONCLUSION The FIQ was the most responsive measure to perceived clinical improvement and we recommend its inclusion as a primary endpoint in FM clinical trials",
"Study Design . Prospect i ve , single-cohort study . Objective . To assess the minimal clinical ly important change ( MCIC ) on the Neck Disability Index ( NDI ) and the Numerical Rating Scale ( NRS ) for pain in patients with neck pain . Summary of Background Data . Both measurement instruments are frequently used in research and clinical practice , but which changes are clinical ly relevant is still unknown . Methods . The MCIC was estimated with 2 different methods , both integrating an anchor-based and distribution-based approach : the minimal detectable change ( MDC ) and the optimal cutoff point of the ROC curve . The study population consisted of 183 patients with nonspecific neck pain . Results . The results show an MDC of 10.5 points for the NDI ( scale range , 0–50 ) and 4.3 points for the NRS ( scale range , 0–10 ) , and optimal cutoff points of the ROC curve of 3.5 for the NDI and 2.5 for the NRS . Conclusion . The estimated MCIC should be used as an indication for relevant changes in clinical practice . Using the optimal cutoff point of the ROC curve , false positives and false negatives are equally weighted ; and if there are no objections doing so , the optimal cutoff point of the ROC curve may be a good choice",
"OBJECT Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome ( PRO ) question naires . Although these question naires assess pain , disability , and general health state , their numerical scores lack direct , clinical ly significant meaning . Thus , the concept of minimum clinical ly important difference ( MCID ) has been introduced , which indicates the smallest change in an outcome measure that reflects clinical ly meaningful improvement to patients . The authors set out to determine anterior cervical discectomy and fusion (ACDF)-specific MCID values for the visual analog scale ( VAS ) , Neck Disability Index ( NDI ) , 12-Item Short-Form Health Survey ( SF-12 ) , and EQ-5D ( the EuroQol health survey ) in patients undergoing ACDF for cervical radiculopathy . METHODS Data on 69 patients who underwent ACDF for cervical radiculopathy were collected in the authors ' web-based , prospect i ve registry during the study enrollment period . Patient-reported outcome question naires ( VAS-neck pain [ NP ] ) , VAS-arm pain [ AP ] , NDI , SF-12 , and EQ-5D ) were administered preoperatively and 3 months postoperatively , allowing 3-month change scores to be calculated . Four established calculation methods were used to calculate anchor-based MCID values using the North American Spine Society ( NASS ) patient satisfaction scale as the anchor : 1 ) average change , 2 ) minimum detectable change ( MDC ) , 3 ) change difference , and 4 ) receiver operating characteristic ( ROC ) curve analysis . RESULTS Sixty-one patients ( 88 % ) were available at follow-up . At 3 months postoperatively , statistically significant improvement ( p 19.7 % ) , SF-12 physical component score ( PCS ; 10.7 ± 9.7 ) , and EQ-5D ( 0.20 ± 0.23 QALY ) . Improvement on the SF-12 mental component score ( MCS ) trended toward significance ( 3.4 ± 11.4 , p = 0.07 ) . The 4 MCID calculation methods generated a range of MCID values for each of the PROs : VAS-NP 2.6 - 4.0 , VAS-AP 2.4 - 4.2 , NDI 16.0%-27.6 % , SF-12 PCS 7.0 - 12.2 , SF-12 MCS 0.0 - 7.2 , and EQ-5D 0.05 - 0.24 QALY . The maximum area under the curve ( AUC ) was observed for NDI ( 0.80 ) , and the minimum AUC was observed for SF-12 MCS ( 0.66 ) and EQ-5D ( 0.67 ) . Based on the MDC approach , the MCID threshold was 2.6 points for VAS-NP , 4.1 points for VAS-AP , 17.3 % for NDI , 8.1 points for SF-12 PCS , 4.7 points for SF-12 MCS , and 0.24 QALY for EQ-5D . The mean improvement in patient scores at 3 months surpassed the MCID threshold for VAS-NP , NDI , and SF-12 PCS but not for VAS-AP , SF-12 MCS , and EQ-5D . CONCLUSIONS The ACDF-specific MCID is highly variable depending on the calculation technique used . The MDC approach seems to be most appropriate for MCID calculations in the ACDF population , as it provided a threshold value above the 95 % confidence interval of nonresponders ( greater than the measurement error ) and was closest to the average change of most PROs reported by responders . When the MDC method was applied with the NASS patient satisfaction scale as the anchor , the MCID thresholds were 2.6 points for VAS-NP , 4.1 points for VAS-AP , 17.3 % for NDI , 8.1 points for SF-12 PCS , 4.7 points for SF-12 MCS , and 0.24 QALY for EQ-5D",
"IMPORTANCE Defining clinical ly meaningful success criteria from patient-reported outcome measures ( PROMs ) is crucial for clinical audits , research and decision-making . PURPOSE We aim ed to define criteria for a successful outcome 3 and 12 months after surgery for cervical degenerative radiculopathy ( CDR ) on recommended PROMs . STUDY DESIGN Prospect i ve cohort study with 12 months follow-up . PATIENT SAMPLE Patients operated at one or two levels for cervical radiculopathy included in the Norwegian Registry for Spine Surgery ( NORspine ) from 2011 to 2016 . OUTCOME MEASURES Neck Disability Index ( NDI ) , Numeric Rating Scale for neck pain ( NRS-NP ) and arm pain ( NRS-AP ) , health-related quality -of-life EuroQol 3L ( EQ-5D ) , general health status ( EQ-VAS ) . METHODS We included 2868 consecutive CDR patients operated for cervical radiculopathy in one or two levels and included in the Norwegian Registry for Spine Surgery ( NORspine ) . External criterion to determine accuracy and optimal cut-off values for success in the PROMs was the Global Perceived Effect Scale ( GPE ) . Success was defined as \" much better \" or \" completely recovered \" . Cut-off values were assessed by analyzing the area under the receiver operating curves ( ROC ) for follow-up scores , mean change scores , and percentage change scores . RESULTS All PROMs showed high accuracy in defining success and non-success and only minor differences were found between 3- and 12-month scores . At 12 months , the area under the ROC for follow-up scores were 0.86 - 0.91 , change scores were 0.74 - 0.87 , and percentage change scores were 0.74 - 0.91 . Percentage scores of NDI and NRS-AP showed the best accuracy . The optimal cut-off values for each PROM showed considerable overlap across those operated due to disc herniation and spondylotic foraminal stenosis . CONCLUSIONS All PROMs , especially NDI and NRS-AP , showed good to excellent discriminative ability in distinguishing between a successful and non-successful outcome after surgery due to cervical radiculopathy . Percentage change scores are recommended for use in research and clinical practice"
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ABSTRACT Genotropin ( somatropin ) is licensed for the treatment of children with growth hormone deficiency , Prader-Willi syndrome , Turner syndrome , chronic renal insufficiency and in children born small for gestational age . This systematic review ( SR ) evaluated the clinical efficacy and effectiveness of Genotropin in these conditions to inform a NICE Technology Appraisal of growth hormone for the treatment of growth failure in children . Search terms were used to search seven data bases , including Medline and Embase , for English language studies . R and omised controlled trials ( RCTs ) or observational studies investigating Genotropin in children were included . Out of 30 RCTs identified , one reported final height data . Eleven observational studies reported final height and seven were based on the Pfizer International Growth Survey ( KIGS ) . This SR highlights the lack of long-term RCTs reporting final height data and other important qualitative outcomes , such as quality of life . Observational data , such as those from KIGS , remain vital for informing therapy | [
"BACKGROUND Infants with Prader-Willi syndrome ( PWS ) show abnormalities of body composition . Children with PWS treated with growth hormone ( GH ) demonstrate improved body composition and motor skills . OBJECTIVE To assess body composition and motor changes in infants with PWS following 6 months GH therapy . METHODS Twenty-five infants with PWS ( mean age 15.5 mo ) underwent dual energy X-ray absorptiometry ( DEXA ) assessment of body composition , and motor assessment with the Toddler Infant Motor Evaluation ( TIME ) . Patients were then r and omized to treatment ( Genotropin , 1 mg/m2/day ) or control , with re assessment at 6 months . RESULTS GH treatment significantly increased lean body mass ( 6.4 + /- 2.4 kg to 8.9 + /- 2.7 kg ) and decreased body fat ( 27.6 + /- 9.9 % to 22.4 + /- 10.3 % ) . Age equivalent motor scores improved 4 months in the treated group vs 2 months in controls ( p Infants with PWS show significant body composition and motor development improvement following 6 months GH therapy . We are investigating whether this improvement leads to long-term reductions in obesity",
"A total of 130 short children were included in a French multicentre study and r and omized between a control group ( group A ) and two groups treated with daily subcutaneous injections of GH at doses of 0.7 IU/kg/week ( group B ) and 1.4 IU/kg/week ( group C ) for 2 years . Height velocity was significantly increased ( p 2 years compared with controls was 4.3 cm in group B and 5.9 cm in group C. The rate of bone maturation was not affected by GH therapy . These results led to the conclusion that 2 years of treatment with GH improves final height prognosis in children with short stature secondary to IUGR , and that this effect is dose dependent . The effect on final height has still to be demonstrated",
"Background : In boys with Prader-Labhart-Willi syndrome ( PWS ) , hypogonadism causes pubertal arrest and reduces pubertal muscle growth . Formerly , it was assumed that therapy with gonadal hormones accentuates behaviour abnormalities in PWS . Our aim was to assess the clinical effects of human chorionic gonadotropin ( hCG ) therapy on pubertal development , muscle mass and behaviour in adolescents with PWS . Methods : 6 peripubertal boys with PWS undergoing long-term treatment with growth hormone were examined 6-monthly for at least 2 years before and after pubertal arrest ( 13.5 ± 0.3 years , mean ± SEM ) and the beginning of hCG therapy ( 500–1,500 IU twice weekly , intramuscularly ) . Height , weight , pubertal stage , bone age , body composition ( by dual-energy X-ray absorptiometry ) , testosterone levels and behaviour abnormalities ( obtained from parents ) were assessed . Results : Testicular volume and lean mass were reduced in pubertal boys with PWS . During hCG therapy , testosterone levels and lean mass significantly increased ( at the beginning and after 2 years of hCG therapy : 2.3 ± 0.9 and 10.7 ± 1.3 nmol/l , –3.1 ± 0.3 and –1.4 ± 0.6 SD , respectively ) , and fat mass stabilized at 38 % . The characteristically observed PWS-associated problems , mood instability , aggressiveness and difficulties in social interaction , did not deteriorate during therapy . Conclusion : In the present study , timely application of hCG to treat hypogonadism in boys with PWS promoted virilization and normalized muscle mass without detrimental effects on behaviour . Larger studies comparing hCG therapy with testosterone replacement would be useful",
"Aims : To determine the effectiveness of different doses of r-hGH therapy during puberty in children with growth hormone deficiency ( GHD ) . Methods : R and omized controlled trial of different doses of r-hGH therapy administered during puberty in 49 children with GHD . The patients were allocated r and omly using a r and om number table to one of two groups : group 1 ( 15 IU/m2/week ) or group 2 ( 30 IU/m2/week ) . Patients were included if they had received r-hGH daily at a dose of 15 IU/m2/week ( 0.7 mg/m2/day ) for at least 1 year before r and omization . Results : Height increase st and ard deviation scores ( SDS ) were similar between the two groups ( group 1 : 1.1 ; group 2 : 1.2 ; p = 0.81 ) . Conclusion : A higher dose of r-hGH administered during puberty does not appear to have a significant effect on final height of children with GH deficiency . Altering pubertal tempo or intensifying prepubertal r-hGH therapy may be a more promising approach to improving final height in children with GH deficiency",
"Background / Aim : Since hyper and rogenism in simple obesity is assumed to arise from hyperinsulinism and /or increased insulin-like growth factor I ( IGF-I ) or leptin levels , we examined how in patients with Prader-Willi syndrome ( PWS ) , the most frequent form of syndromal obesity , the accelerated adrenarche can be explained despite hypothalamic-pituitary insufficiency with low levels of insulin and IGF-I. Methods : In 23 children with PWS and a mean age of 5.6 years , height , weight , fat mass , fasting insulin concentration , insulin resistance ( by HOMA-R ; see text ) , and leptin and IGF-I levels were determined to test whether they explain the variance of the levels of dehydroepi and rosterone ( DHEA ) and its sulfate ( DHEAS ) , of and rostenedione , and of cortisol before and during 42 months of therapy with growth hormone . Results : The baseline DHEAS , DHEA , and and rostenedione concentrations were increased as compared with age-related reference values , whereas the cortisol level was always normal . During growth hormone treatment , the DHEA concentration further rose , and the cortisol level decreased significantly . The insulin and IGF-I concentrations were low before therapy , while fat mass and leptin level were elevated . The hormonal covariates provided alone or together between 24 and 60 % of the explanation for the variance of adrenal and rogen levels , but the anthropometric variables did not correlate with them . Conclusions : In children with PWS , elevated and rogen levels correlate with hormones that are usually associated with adiposity . However , the lack of direct correlations between disturbed body composition and and rogen levels as well as the increased sensitivity to insulin and IGF-I are abnormalities specific to PWS , potentially caused by the underlying hypothalamic defect",
"Preliminary results are presented after 2 years of the Canadian long-term multicentre study on the impact of hormone therapy on the final height , sexual development and psychological status of girls with Turner syndrome . Girls entering the study were r and omized either to be treated with recombinant human growth hormone or to act as controls . Both groups received oestrogen replacement therapy in the same dose and format at the age of 13 years . However , for the purpose s of the psychological study at this time , children receiving oestrogen were excluded from analysis . Girls treated with GH for a period of 2 years showed a significant increase in growth rate , which declined with continued treatment , while the growth rate in the control group remained constant throughout . There was a correlation between the higher growth rate and the girls ' perceptions of themselves as more intelligent , more attractive , having more friends , greater popularity and experiencing less teasing than the untreated group . Growth rate was not correlated with family or school functioning",
"Infants with Prader – Willi syndrome ( PWS ) typically display failure to thrive and decreased muscle mass with excess body fat for age . Growth hormone ( GH ) therapy in children with PWS improves , but does not normalize , body composition and muscle strength and agility . The objective of this study was to determine the effects of earlier GH therapy on anthropometric measurements , body composition , and psychomotor development in affected PWS infants and toddlers . Twenty‐five subjects , ages 4–37 months , were r and omized to 2 years of GH therapy ( 1 mg/m2/day ) or 1 year of observation without GH treatment and then placed on GH ( 1.5 mg/m2·day ) for 1 year only . Anthropometric measurements were obtained by st and ard methods : percent body fat , lean body mass , and total body bone mineral density by dual x‐ray absorptiometry ; motor constructs of mobility and stability by the Toddler Infant Motor Evaluation ; and cognitive and language function by the Capute Scales of Infant Language and Cognitive Development . GH‐treated PWS subjects demonstrated normalization of length/height st and ard deviation scores ( SDS ) , faster head growth , increased lean body mass accrual , and decreased percent body fat ( P well as improved language ( P = 0.05 ) and cognitive ( P = 0.02 ) quotient Z‐scores compared with similarly aged untreated PWS subjects after 1 year into the study . PWS subjects treated before their first birthday spoke their first words at a mean age of 14.4 ± 2.8 months and walked independently at 23.3 ± 4.8 months . GH therapy was well‐tolerated ; however , one PWS subject experienced scoliosis progression . As greater benefits were seen in our study with early treatment , prompt referral to a pediatric endocrinologist for consideration of GH therapy is recommended for PWS at an early age . © 2006 Wiley‐Liss ,",
"Background : Concomitant evaluation of the metabolic and growth-promoting effects of growth hormone ( GH ) therapy in Turner syndrome ( TS ) may be used in the prediction of the growth response to GH therapy . Aim : To evaluate the metabolic effects of GH therapy in TS and correlation with the short-term growth response . Patients : 24 prepubertal children with TS , aged 9.4 ± 2.6 years were followed for auxology and IGF-I , IGFBP-3 , leptin , ghrelin , adiponectin , lipids and OGTT results in a prospect i ve multicenter study . Intervention : GH ( Genotropin ® ) in a dose of 50 µg/kg/day for 1 year . Results : Height st and ard deviation score ( SDS ) increased from –3.9 ± 1.5 to –3.5 ± 1.4 ( p = 0.000 ) on therapy . BMI did not change . IGF-I SDS increased from –2.3 ± 0.4 to –1.6 ± 1.1 at 3 and 6 months ( p = 0.001 ) and decreased thereafter . Serum leptin decreased significantly from 2.3 ± 3.9 to 1.7 ± 5.3 ng/ml ( p = 0.022 ) at 3 months and increased afterwards . Serum ghrelin decreased from 1.2 ± 0.8 to 0.9 ± 0.4 ng/ml ( p = 0.005 ) with no change in adiponectin . Basal and stimulated insulin levels also increased significantly . Δ height SDS over 1 year showed a significant correlation with Δ IGF-I0–3 months ( r = 0.450 , p = 0.027 ) . Conclusion : IGF-I may be considered as a marker of growth response in TS at short term . Leptin shows a decrease at short term but does not have a correlation with growth response . The decrease in ghrelin in face of unchanged weight seems to be associated with increase in IGF-I and insulin levels . The unchanged adiponectin levels in spite of an increase in insulin levels indicates that adiponectin is mainly affected by weight , not insulin",
"The aim of this prospect i ve controlled study was to assess the effect of rhGH in short prepubertal children with intrauterine growth retardation and normal growth hormone status . Twenty-six children were r and omized into treatment ( 12F , 4 M ) and control ( 6F , 4 M ) groups . Mean ages were 5.3 ( 1.3 ) yr and 4.3 ( 1.7 ) yr , respectively . rhGH ( Genotropin ) was used at a dose of 0.2 IU/kg/day as daily s.c . injections for two years . In the treated group , mean height SDS increased from -3.0 ( 0.5 ) to -1.9 ( 0.7 ) and height velocity SDS showed a significant increase from -1.3 ( 2.0 ) to 3.7 ( 1.8 ) in the first year ( p height SDS , initially -2.7 ( 1.4 ) , and height velocity SDS , initially -0.9 ( 1.1 ) , remained essentially the same during two years of follow-up . Height SDS for bone age changed by 0.6 in the treated group and 0.4 in the control group . Target height SDS -- initial height SDS in the treated group improved by 1.1 SD but declined in the control group . IGF-I levels increased from 9.5 ( 4.2 ) nmol/l ( 72 [ 31.8 ] ng/ml ) to 32.5 ( 27.0 ) nmol/l ( 244.4 [ 202.8 ] ng/ml ) ( p = 0.004 ) in the treated group while no change was observed in the controls . No adverse effects were encountered during rhGH therapy . It was concluded that rhGH treatment induces a significant increase in growth velocity in the short term . This outcome , as opposed to the unchanged indices in the control group over the same period , may be indicative of an improved height prognosis in short children born with intrauterine growth retardation treated with rhGH",
"The growth-promoting effect of recombinant human growth hormone ( GH ; Genotropin ' ) therapy in short children born small for gestational age was evaluated in a r and omized , open-labelled , multicentre trial . Three parallel groups were recruited : group 1 was an untreated control group ; group 2 received recombinant human GH , 0.2 IU/kg/day s.c . , and group 3 received recombinant human GH , 0.3 IU/kg/day S.C. Treatment was continued for 24 months . The inclusion criteria were : weight and /or length at birth below -2 SD for gestational age ; chronological age 2 - 8 years ; height/chronological age below -2.5 SD ; height velocity below + 1 SD ; and a serum G H concentration of at least 10 & I after exercise , glucagon administration or insulin-induced hypoglycaemia . The dose of G H was adjusted for body weight every 6 months . Preliminary 18-month data from 46 of the 51 children followed are reported here . This cohort consists of short children who suffered from idiopathic or non-syndromic intrauterine growth retardation ( n = 31 ) and children with either Silver-Russell syndrome ( n = 9 ) , Dubowitz syndrome ( n = 3 ) or fetal alcohol syndrome ( n = 3 ) . Weight at birth was 1.99 k 0.08 kg ( mean i SEM ) , length at birth was 42.4 k 0.6 cm and gestational age was 37.9 f 4 weeks . At the start of the study , chronological age was 5.1 k 0.3 years , bone age ( Tanner-Whitehouse 2 method ) 3.9 k 0.3 years , height velocity 6.9 k 0.3 cdyears , height velocity for chronological age -0.7 i 0.1 SD , height for chronological age -3.5 k 0.1 SD , and height for bone age -1.5 k 0.3 SD . At the start , groups 1 , 2 and 3 did not differ significantly for any of the variables assessed . Salient 18-month growth data are summarized in Table 1 . The recombinant human GH therapy did not appear to be associated with any clinical adverse events . All children remained prepubertal during the study period . The fasting serum insulin concentrations were measured after 12 months and were found to be twice as high in children treated with G H ( approximately 20 mU/l ) compared with pretreatment levels or with those of untreated children",
"UNLABELLED The reduction of spontaneous physical activity ( PA ) and of muscle tissue are thought to be major causes of fat accretion and metabolic deterioration in Prader-Labhart-Willi syndrome ( PWS ) . We investigated whether a generalized physical training programme in a home setting improves these parameters . The prospect i ve study included 11 prepubertal children ( mean age 8.7 years , range 5.9 - 11.8 ) with documented PWS and under continuous growth hormone treatment for at least 2.8 years . Seven children were enrolled in a training programme for several muscle groups during 4 - 10 minutes daily . Twelve matched children with PWS served as controls ( average age 8.8 years , 6.1 - 11.3 ) . Before and after training , at 6 months , PA was assessed by measuring walking distance by pedometer registration and by an activity score , and body composition by DEXA expressed as st and ard deviation scores ( SDS ) related to height . After training , lean mass ( LM ) increased from -1.83 to -1.48 SDS , p walking distance and PA increased from 4.2 to 4.7 km/d and from 255 to 266 points , respectively , and these rises significantly exceeded those observed in controls . CONCLUSION Children with PWS can be motivated by their families to follow a short daily training , which has general effects on PA and does increase , but not normalize LM ",
"OBJECTIVES To determine the effect of growth hormone ( GH ) on body composition and motor development in infants and toddlers with Prader-Willi syndrome ( PWS ) . STUDY DESIGN Twenty-nine subjects with PWS ( 4 - 37 months of age ) were r and omized to GH treatment ( 1mg/m 2 /day ) or observation for 12 months . Percent body fat , lean body mass , and bone mineral density were measured by dual x-ray absorptiometry ; energy expenditure was measured by deuterium dilution ; and motor constructs of mobility ( M ) and stability ( S ) were assessed using the Toddler Infant Motor Evaluation ( TIME ) . RESULTS GH-treated subjects , compared with controls , demonstrated decreased percent body fat ( mean , 22.6 % + /- 8.9 % vs 28.5 % + /- 7.9 % ; P lean body mass ( mean , 9.82 + /- 1.9 kg vs 6.3 + /- 1.9 kg ; P height velocity Z scores ( mean , 5 . 0 + /- 1.8 vs 1.4 + /- 1.0 ; P GH before 18 months of age showed higher mobility skill acquisition compared with controls within the same age range ( mean increase in raw score , 284 + /- 105 vs 206 + /- 63 ; P GH treatment of infants and toddlers with PWS for 12 months significantly improves body composition and when begun before 18 months of age increases mobility skill acquisition . These results suggest that GH therapy instituted early in life may lessen deterioration of body composition in PWS while also accelerating motor development",
"CONTEXT The d3/fl-GH receptor ( d3/fl-GHR , exon 3-deleted/full-length GHR ) has recently been associated with responsiveness to GH therapy . OBJECTIVE The objective of the study was to evaluate whether the d3/fl-GHR genotypes influence the intensity of spontaneous and /or GH therapy-stimulated growth in small-for-gestational-age ( SGA ) patients . DESIGN This was a 2-yr prospect i ve , controlled , r and omized trial . SETTING Thirty Spanish hospitals participated . Auxologic and GH secretion evaluation was hospital based , whereas molecular analyses and auxologic data computation were central ized . PATIENTS Patients included 170 short SGA children : 140 remained prepubertal and 30 entered puberty during the second follow-up year . INTERVENTION Eighty-six were treated with GH ( 66 microg/kg.d ) for 2 yr and 84 were not treated . MAIN OUTCOME MEASURES Previous and 2-yr follow-up auxologic data were recorded at each hospital , d3/fl-GHR genotypes determined , and data analyzed for patients who remained prepubertal ( group 1 , 68 GH treated and 72 non-GH treated ) and for all the patients ( group 2 ) . RESULTS In group 1 GH-treated patients , growth velocity , and height-sd score during the first and second years , total 2-yr height gain ( 18.5 + /- 2.4 cm in d3/d3 ; 18.4 + /- 2.6 in d3/fl ; 19.5 + /- 2.3 in fl/fl ) , Delta 2-yr height increase ( 9.1 + /- 2.4 cm in d3/d3 ; 9.4 + /- 3.0 in d3/fl ; 10.4 + /- 2.1 in fl/fl ) , first-year growth prediction and studentized residual values ( 0.08 + /- 1.26 in d3/d3 ; 0.28 + /- 1.21 in d3/fl ; 0.67 + /- 0.95 in fl/fl ) did not differ among the d3/fl-GHR genotypes . In group 1 non-GH-treated patients , neither growth velocity nor height-sd score changed significantly , and values were similar in each d3/fl-GHR genotype . Results in all patients ( group 2 ) were similar to those in group 1 . CONCLUSIONS In short non-GH-deficient SGA children , both spontaneous growth rate and responsiveness to 66 microg/k.d GH therapy were similar for each d3/fl-GHR genotype carried",
"The aim of this observational study was to assess the long-term growth responses to GH treatment of children born small for gestational age ( SGA ) . GH treatment was begun before puberty and continued to final height ( FH ) . Seventy-seven short ( height SD score below −2 ) prepubertal children born SGA ( below −2 SD for birth weight and /or birth length ) , with a broad range of GH secretory capacity , were treated with GH in a daily dose of 33 μg/kg ( 0.1 U/kg ) , beginning before the onset of puberty . We observed a difference between adult and pretreatment projected height of 1.3 SD ( 9 cm ) for the entire group . Among the children treated for > 2 y before puberty , this mean gain ( i.e. difference ) in final height was 1.7 SD , whereas the mean gain was 0.9 SD among those in whom treatment was begun Better catch-up growth was observed in the younger ( r = −0.56 , p that GH treatment improves the final height of short children born SGA . The height gain attained before the onset of puberty is maintained to final height . The younger , shorter , and lighter the child at the start of GH treatment , the better the response . Moreover , most of these SGA individuals treated with GH reach their target height ",
"We report 24-month interim results of two multicenter phase III studies in previously untreated children with growth failure secondary to GH deficiency ( GHD ) that were paramount to the development of a new recombinant human GH ( rhGH , somatropin ) , approved as the first ‘ biosimilar ’ in Europe . Study 1 consisted of 3 parts performed in 89 children . The objective was to compare efficacy and safety of the lyophilized formulation of the new somatropin [ Somatropin Powder ( S and oz ) ] with a licensed reference rhGH preparation and the liquid formulation of the new somatropin [ Somatropin Solution ( S and oz ) ] and to assess long-term efficacy and safety of this ready-to-use Somatropin Solution . Study 2 was performed in 51 children and design ed to demonstrate efficacy and safety of Somatropin Powder and to confirm its low immunogenic potential ; rhGH was given sc at a daily dose of 0.03 mg/kg . Primary [ body height , height SD score ( HSDS ) , height velocity , and height velocity ( HV ) SD score ( HVSDS ) ] and secondary [ IGF-I and IGF binding protein 3 ( IGFBP-3 ) ] efficacy end-points and safety parameters were assessed regularly . In study 1 , all treatments showed comparable increases in growth . The baseline-adjusted difference between Somatropin Powder and the reference rhGH product in mean HV was −0.20 cm/yr ( 95 % confidence interval ( CI ) [ −1.34;0.94 ] ) and in mean HVSDS was 0.76 ( 95 % CI [ −0.57;2.10 ] ) after 9 months . These very small differences demonstrate comparable therapeutic efficacy between the two treatments . The results of study 2 were consistent with those seen in study 1 . Equivalent therapeutic efficacy and clinical comparability in terms of safety and immunogenicity between Somatropin Powder and the reference rhGH product and between Somatropin Powder and Somatropin Solution was demonstrated . The safety and immunogenicity profiles were similar and as expected from experience with rhGH preparations",
"CONTEXT Children with Prader-Willi syndrome ( PWS ) may have obesity and an abnormal body composition with a high body fat percentage , even if they have a normal body weight . Adiponectin has been inversely related to obesity and insulin resistance . OBJECTIVE The objective of the study was to evaluate in prepubertal PWS children the following : 1 ) adiponectin levels , body composition , carbohydrate metabolism , and triglyceride levels ; 2 ) associations between adiponectin and body composition , carbohydrate metabolism , and triglycerides ; and 3 ) effects of GH treatment on these outcome measures . PATIENTS Twenty prepubertal PWS children participated in the study . INTERVENTION The subjects were r and omized into a GH treatment group ( n=10 , 1 mg/m2.d ) and a non-GH-treated control group ( n=10 ) . MAIN OUTCOME MEASURES At baseline , after 1 and 2 yr of GH treatment , fasting levels of adiponectin , glucose , insulin , and triglycerides were assessed . Body composition and fat distribution were measured by dual energy x-ray absorptiometry . RESULTS PWS children had significantly higher median ( interquartile range ) adiponectin levels [ 17.1 mg/liter ( 13.9 - 23.2 ) ] than healthy sex- and age-matched controls [ 11.8 mg/liter ( 9.7 - 12.5 ) , P Body fat percentage was significantly higher than 0 sd score [ 1.8 sd score ( 1.5 - 2.1 ) , P Adiponectin levels were inversely related to triglyceride levels ( r=-0.52 , P=0.03 ) . There was a tendency to an inverse relation with body fat percentage and body mass index , but no correlation with fasting insulin or glucose levels , the insulin to glucose ratio , or homeostasis model assessment index . During GH treatment , adiponectin levels increased significantly and did not change in r and omized controls . CONCLUSION Adiponectin levels were increased , and inversely associated with triglyceride levels , in prepubertal , not overweight PWS children , although they had a relatively high body fat percentage . During GH treatment , adiponectin levels further increased , whereas no change was found in the controls , which is reassuring with respect to the development of insulin resistance during GH treatment",
" Growth-promoting effects and safety of growth hormone ( GH ) treatment in prepubertal short-statured children born small for gestational age ( SGA ) were evaluated in a multicenter , open-label , r and omized parallel-group comparison study . Patients were r and omized to two dose groups ; 34 and 33 patients received GH at 0.033 and 0.067 mg/kg/day for one year , respectively . The increase of the mean height velocity st and ard deviation score ( SDS ) was significantly ( p increase in the mean height SDS was established in the 0.067-mg group ; increases of -3.1 to -2.5 vs -3.1 to -2.2 in the 0.033- and 0.067-mg groups , respectively . The trial was non-eventful . Oral glucose tolerance tests indicated a mostly normal pattern of plasma glucose before and after 12-month GH treatment . The growth-promoting effect was significantly higher with GH treatment at 0.067 mg/kg/day",
"The impact of chronological age on longitudinal body growth from early childhood through adolescence using detailed anthropometric methods has not yet been studied in children with chronic kidney disease ( CKD ) . We have evaluated growth failure by measuring four components of linear growth : body height ( HT ) , sitting height ( SHT ) , arm length ( AL ) and leg length ( LL ) . Data were prospect ively collected for up to 7 years on 190 boys ( 3–21 years old ) with congenital or hereditary CKD ( all had developed at least stage 2 CKD by the age of 10 years ) . Patients showed the most severe growth failure in early childhood , followed by an acceleration in growth in pre-puberty , a slowing-down of growth at puberty , as expected , and thereafter a late speeding-up of growth until early adulthood . This pattern was observed irrespective of the degree of CKD and different treatment modalities , such as conservative treatment , recombinant human growth hormone ( rhGH ) therapy or transplantation . LL showed the most dynamic growth changes of all the parameters evaluated and emerged as the best indicator of statural growth in children with CKD . A specific age-dependent pattern of physical growth was identified in pediatric male CKD patients . This growth pattern should be considered in the evaluation of individual growth and the assessment of treatment efficacy such as rhGH therapy",
"A prospect i ve , multicenter study of patients with Ullrich-Turner syndrome ( UTS ) was conducted to estimate the prevalence of autoantibodies to tissue transglutaminase ( tTg ) , thyroid stimulating hormone receptor ( TSH-R ) , thyroglobulin ( TG ) and thyroid peroxidase ( TPO ) in relation to adult height after long-term growth hormone ( GH ) treatment . Out of 347 near-adult ( > 16 years ) patients with UTS from 96 German centers , whose longitudinal growth was documented within the Pharmacia International Growth Study ( KIGS ) , 188 returned for a st and ardized follow-up visit at a median chronological age of 18.7 ( 16.0 - 23.6 ) years ( bone age > 15 years ) . Serum sample s of 120 patients were obtained for central measurements of TSH , thyroxine ( T4 ) and free T4 and autoantibodies by st and ard immunoassays . Information regarding thyroid disease , karyotype and anthropometric data was extracted from the KIGS data base . Thirty-six percent of the patients with UTS had positive TG and /or TPO autoantibodies and 4 % had positive tTg autoantibodies , whereas 2 % had positive TG and /or TPO autoantibodies as well as positive tTg autoantibodies . TSH-R autoantibodies were undetectable in all patients . The detection of autoantibodies was unrelated to a specific karyotype . Median height st and ard deviation scores ( SDS , UTS ) at start of GH treatment ( 0.43 ; -1.07 , 1.85 ) and at follow-up ( 1.36 ; -0.11 , 2.57 ) were comparable in all patients independent of their antibody status . The total deltaheight SDS , however , was higher in patients with negative autoantibody titers ( 1.08 ; -0.03 , 2.25 ) compared to those with positive antibody titers ( 0.68 ; -0.44 , 1.82 ; p patients with UTS predisposing them to autoimmune thyroid disease and celiac disease , and indicates for the first time that autoimmune pathologies may interfere with GH therapy and thus compromise final height . Therefore , medical care for patients with UTS should routinely include screening for these autoimmune disorders in order to assure early detection and appropriate treatment",
"Most children born small for gestational age ( SGA ) normalize their size through spontaneous catch-up growth within the first 2 yr after birth . Some SGA children fail to do so and maintain an abnormally short stature throughout childhood . We have previously reported that high dose GH treatment ( 66 or 100 microg/kg x day s.c . over 2 yr ; age at start , 2 - 8 yr ; n = 38 ) induces pronounced catch-up growth in short children born SGA , thereby normalizing their height and weight in childhood . Here , we report on the further prepubertal growth course of these children over the first 4 yr after withdrawal of early , high dose GH treatment . Of the 38 treated children , none developed precocious puberty , and 22 remained prepubertal . Mean age of the latter at start of GH was 4.4 yr , height was -3.7 SD score , and height after adjustment for midparental height was -2.9 SD score . Height increased by an average of 2.5 SD during the 2 yr of GH treatment and decreased by 0.4 and 0.3 SD , respectively , during the first and second year after GH withdrawal . Subsequently , when stature was not extremely short at the start ( mean adjusted height SD score , -2.7 ; n = 13 ) , no further GH treatment was given , and the adjusted height was stabilized around -1.0 SD score ; when stature was very short at the start ( mean adjusted height , -3.3 SD score ; n = 9 ) , a second course of GH treatment ( 66 microg/kg x day s.c . ) was initiated either 2 yr ( n = 5 ) or 3 yr ( n = 4 ) after initial GH withdrawal . This second course was associated with renewed catch-up growth and also result ed in a mean adjusted height of -1.0 SD score . In each subgroup , the pattern of the weight course paralleled that of the height course ; GH treatment was well tolerated . In conclusion , early , discontinuous , high dose GH treatment appears to be a safe and efficient option to normalize prepubertal height and weight in the majority of short SGA children . It remains to be examined whether the normalized stature will be maintained during pubertal development , either with or without further GH treatment",
"OBJECTIVE To determine whether in children born small for gestational age ( SGA ) high-dose growth hormone ( GH ) treatment is not only associated with catch-up of growth and with gain of lean mass , but also with a more central fat distribution . STUDY DESIGN Short children who were SGA ( n = 25 ; age [ mean + /- SD ] , 5.3 + /- 1.5 years ) were r and omly assigned to remain untreated ( n = 14 ) or to receive GH ( n = 11 ; sc 66 mug/Kg/d ) . Growth status and body composition were assessed at the study 's start , after 1 year , and after 2 years with anthropometry and absorptiometry . RESULTS Children who were treated with GH gained more height and weight than children who were untreated and developed a less adipose body composition ( all P centripetal distribution of fat mass ( 0 - 2 year change in ratio of trunk fat to limb fat ; 0.26 + /- 0.23 versus 0.02 + /- 0.15 ; P children who are SGA , catch-up growth induced by exogenous GH in high doses is accompanied by a less adipose body composition and a more central fat distribution",
"To assess whether short-term growth hormone ( GH ) treatment can improve the linear growth in children who were born small for gestational age ( SGA ) , we started a r and omized multicenter trial in 26 age- and sex-matched prepubertal children born SGA . During the 1st year of GH therapy , all children received GH 0.23 mg/kg/week , then during the 2nd year , 13 children received the same dose ( group A ) , and in the other 13 children , the dose of GH was doubled , i.e. , 0.46 mg/kg/week ( group B ) . During the 1st year of therapy , the growth velocity significantly ( p growth velocity ( p height in group A children significantly increased during the 1st and the 2nd year of GH therapy ( p height in group B children significantly increased during the 1st and the 2nd year of GH therapy ( p height gain was similar in groups A and B treated with the same GH dosage during the 1st year of therapy . A greater increase in height gain was found in children of group B treated with the higher GH dosage during the 2nd year of therapy as compared with group A ( p insulin-like growth factor I ( p ) , acid-labile subunit ( p and bone/chronological age ratio ( p height velocity of children born SGA significantly increases during the 1st year of GH therapy , diminishes , but can decrease during the 2nd year , if the GH dosage is not raised",
"Using the data base from the Kabi Pharmacia International Growth Study , 105 patients with intrauterine growth retardation ( IUGR ) ( 82 males , 23 females ) and 45 with Silver‐Russell syndrome ( SRS ) ( 32 males , 13 females ) with persistent postnatal growth failure were studied . Patients with IUGR had a birth length and birth weight more than 2 SD below the mean for gestational age . Their height deficit at the start of GH treatment was ‐3.0 SDS at a median chronological age of 8.7 years and a median bone age of 7.0 years . Mean paternal and maternal heights were 166 and 153 cm , respectively . The median dose of GH was 0.5 IU/kg/week , given at a median frequency of five injections/week . The median height SDS for chronological age after 1 , 2 and 3 years of GH treatment were ‐2.5 , ‐2.1 and ‐1.9 , respectively . In the 45 patients with SRS , median chronological age and median bone age at the start of treatment were 6.7 and 3.2 years , respectively , and mean paternal and maternal heights were 167.5 and 160 cm , respectively . The median dose of GH was 0.7 IU/kg/week , given at a median frequency of six injections/week . The median height SDS for chronological age at the start of treatment and after 1 , 2 and 3 years were ‐3.5 , ‐2.9 , ‐2.8 and ‐2.2 , respectively . Although the criteria used by physicians when diagnosing SRS were not controlled or verified in this study , it appears that patients with SRS can be differentiated from those with IUGR with persistent growth failure by their reduced bone age for chronological age at the start of treatment , and by the fact that patients with SRS tended to be born to parents of normal height . GH treatment in both groups induced catch‐up growth , though long‐term follow‐up studies will be required to assess the effects of treatment on final height ",
"The effects of recombinant human growth hormone ( rhGH ) treatment in 69 prepubertal , non-GH deficient children born small for gestational age ( SGA ) were evaluated over 2 years . At start of the study mean age was 5.1 years , mean bone age was 3.8 years and mean height SDS was -4.0 . The children were r and omly allocated to 3 groups receiving no treatment or daily subcutaneous injections of rhGH at a dose of 0.1 IU/kg body weight ( group 0.1 IU ) or 0.2 IU/kg body weight ( group 0.2 IU ) . At start of the study mean height velocity SDS was -1.4 in the control group , -0.7 in group 0.1 IU and -1.4 in group 0.2 IU . After 2 years there was a significant increase in height velocity SDS in children treated with rhGH as compared to untreated children . Mean height velocity SDS after the first year of treatment was -1.2 in the control group , 2.8 in group 0.1 IU and 5.5 in group 0.2 IU . Corresponding values during the second year were -0.9 , 1.6 and 2.9 . A statistically significant difference was observed between the groups receiving 0.1 IU/kg/day and 0.2 IU/kg/day during the first year of treatment , whereas no difference between the treatment groups was found during the second year . Catch-up growth , i.e. a height velocity 1 SD above the mean , was achieved for 86 % of group 0.1 IU and 95 % of group 0.2 IU during the first year of treatment and was maintained for 65 % and 79 % of the patients in group 0.1 IU and 0.2 IU respectively in the second year . GH treatment was associated with a distinct acceleration of bone age . Tolerance of treatment was good . No clear trends were seen in any of the laboratory variables . In conclusion , this study shows that daily rhGH given at a dose of 0.1 - 0.2 IU/kg/day for 24 months is an effective and safe therapy to increase linear growth and induce catch-up growth in short SGA children",
"At least part of the short stature in Prader — Willi syndrome may be explained by a decreased growth hormone ( GH ) secretory capacity , which occurs in most patients . To study the effects of exogenous GH on growth and body composition , 17 prepubertal children with Prader — Willi syndrome , with a short projected final height , were r and omized to a control group ( n = 9 ) or a treatment group ( n = 8) . Children in the treatment group received GH ( 0.15 IU/kg/day s.c . ) for 1 year . One patient in the treatment group developed pseudotumor cerebri , which resolved after discontinuation of GH ; this patient was omitted from further analysis . After 1 year , height velocity in the GH‐treated group was significantly increased ( + 5.5 SD ) compared with reference values for normal healthy children , whereas there was a decrease in the control group ( –2.3 SD ) . The difference in height velocity between the treated and control groups was significant ( p = 0.0012 ) . Concentrations of both insulin‐like growth factor I ( IGF‐I ) and IGF‐binding protein‐3 increased significantly in the GH‐treated group ( p A gain in height was noted for chronological age ( + 1.07 SD ) after 1 year of GH treatment . Height gain ( + 1.02 SD ) remained unchanged when analysed in relation to bone age . No differences between the groups were found for parameters of weight and body composition . In conclusion , although GH appears to have beneficial effects on height , long‐term studies are necessary before recommendations can be made concerning GH treatment in children with Prader — Willi syndrome . □ Body composition , growth , growth hormone treatment , height velocity , insulin‐like growth factor‐binding protein‐3 , insulin‐like growth factor I , Prader — Willi syndrome ,",
"BACKGROUND Turner syndrome accounts for 15–20 % of childhood usage of growth hormone ( GH ) in the UK but final height benefit remains uncertain . The most effective strategy for oestrogen replacement is also unclear . METHODS Fifty eight girls who , at start of treatment , were of mean age 9.1 years and projected final height 142.2 cm were r and omised to receive in year 1 , either low dose ethinyloestradiol 50–75 ng/kg/day , GH 28 IU/m2 surface area/week as a daily injection , or a combination of ethinyloestradiol and GH . After the first year , the ethinyloestradiol treated girls received combination treatment . After two years , girls aged over 12 years were given escalating ethinyloestradiol to promote pubertal development . RESULTS Near final height was available for 49 girls at age 16.5 years , 146.8 cm , representing a gain of 4.6 cm , range −7.9 to + 11.7 cm . Twelve of the 49 girls gaining 7.5 cm or more were less than 13 years at the start and had received GH for at least four years . Height gain was correlated with greater initial height deficit . Fifteen girls ( 31 % ) reached 150 cm or more compared to a predicted 10 % . Early supplementation with ethinyloestradiol provided no final height advantage . CONCLUSIONS Final height gain was modest at 4.6 cm . Younger , shorter girls gained greatest height advantage from GH . Low dosage ethinyloestradiol before planned induction of puberty was not beneficial",
"OBJECTIVE AND DESIGN Children born small for gestational age ( SGA ) are not only at risk for short stature , but also for neurodevelopmental and behavioral problems . In this study , we analyzed the effects of high-dose GH therapy on cognitive development and psychosocial functioning in 34 prepubertal ( 3 - 8 years ) short SGA children , equally r and omized into a GH-treated group ( TRG ) and an untreated group ( UTRG ) . METHODS At start and after 2 years , children underwent st and ardized tests measuring the intellectual abilities ( Wechsler Preschool and Primary Scale of Intelligence-Revised , or Wechsler Intelligence Scale for Children-Revised ) ; their parents completed a st and ardized question naire evaluating psychosocial functioning ( Child Behavior Checklist ; CBCL ) . RESULTS At start , total IQ scores were significantly ( P IQ scores remained unchanged in the TRG , but increased significantly ( P children with developmental problems , however , no significant changes in IQ scores occurred in the UTRG as well as the TRG . At baseline , 24 % ( 8/34 ) children had problematic CBCL total problems scores , equally distributed among the two groups ; no significant changes in the different subscale scores occurred after 2 years . CONCLUSION No beneficial effect of 2 years of GH therapy on cognitive and behavioral profile could be observed in a cohort of rather young short SGA children presenting a variable degree of developmental delay and behavioral problems . Subsequent follow-up could reveal potential long-term effects of GH therapy on development and behavior",
"The aims of this study were to evaluate the efficacy and safety of different doses of growth hormone ( GH ) treatment in prepubertal short children born small‐for‐gestational‐age ( SGA ) . Forty‐eight children born SGA from Sweden , Finl and , Denmark and Norway were r and omly allocated to three groups : a control group of 12 children received no treatment for 2 y , one group was treated with GH at 0.1 IU/kg/d ( n= 16 ) , and one group was treated with GH at 0.2 IU/kg/d ( n= 20 ) . In total 42 children completed 2 y of follow‐up , and 24 children from the treated groups completed 3 y of treatment . Their mean ( SD ) age at the start of the study was 4.69 ( 1.61 ) y and their mean ( SD ) height was ‐3.16 ( 0.70 ) st and ard deviation scores ( SDS ) . The children remained prepubertal during the course of the study . No catch‐up growth was observed in the untreated group , but a clear dose‐dependent growth response was found in the treated children . After the third year of treatment , the group receiving the higher dose of GH , achieved their target height . The major determinants of the growth response were the dose of GH used , the age at the start of treatment ( the younger the child , the better the growth response ) and the family‐corrected individual height deficit ( the higher the deficit , the better the growth response ) . Concentration of insulin‐like growth factor‐I ( IGF‐I ) and IGF‐binding protein‐3 increased during treatment . An increase in insulin levels was found without negative effects on fasting glucose levels or glycosylated haemoglobin levels . GH treatment was well tolerated . In conclusion , short prepubertal children born SGA show a dose‐dependent growth response to GH therapy , and their target height SDS can be achieved within 3 y of treatment given GH at 0.2 IU/kg/d . However , the long‐term benefit of different regimens of GH treatment in children born SGA remains to be established",
"We have compared the growth and the body composition in children with Prader‐Willi syndrome ( PWS ) with and without growth hormone treatment ( recombinant GH 0.1 IU/kg/day ) after a 1‐y period . Twenty‐nine prepubertal children with PWS , with mean body mass index ( BMI ) SDS of 2.2 , and 10 ( control ) healthy obese children with mean BMI SDS of 5.6 , underwent 24‐h frequent blood sampling . Both PWS and control obese children had low and similar GH levels ( 0.7 /ng/l ± 0.4 SD ) . Serum IGF‐I levels , however , were significantly lower in children with PWS ( ‐1.5 SDS ± 0.8 SD vs ‐0.2 SDS ±0.8 SD ) . The 29 PWS children were r and omized into 2 groups of 15 and 14 subjects for GH treatment and no treatment , respectively . Height velocity increased from ‐1.9 SDS to + 6.0 SDS in the treated group ( p year . BMI decreased significantly for the treated group ( + 3.0 SDS to + 2.0 SDS ) . Relative fat mass decreased significantly , while fat‐free mass increased ( p in body composition in the control PWS group . In conclusion , the low spontaneous 24‐h GH secretion , regardless of body weight , and the exceptional response to growth hormone treatment together with the finding of low IGF‐I levels suggest that growth hormone deficiency is a common feature of PWS , as a result of hypothalamic dysfunction . Treatment with growth hormone is beneficial for the majority of PWS children",
"OBJECTIVE In order to ascertain the advantages of early GH treatment in Turner syndrome ( TS ) , we started a prospect i ve study aim ed at evaluating prepubertal height gain in a cohort of 29 girls who were treated with the same pro-kilo GH dose ( 1.0 IU/kg per week ) since they were less than 6 years old and for at least 5 years before entering puberty . PATIENTS AND DESIGN Following a minimum of 6 months of baseline observations , 29 girls with TS were enrolled for this prospect i ve study provided that they ( a ) were less than 6 years old , ( b ) were below -1.0 st and ard deviation score ( SDS ) for height , ( c ) had a projected adult height ( PAH ) lower than the respective target height ( TH ) and ( d ) had a height velocity ( HV ) lower than -1.0 SDS . All the selected girls underwent a 5-year treatment with biosynthetic GH at a stable dose of 1.0 IU/kg per week and were periodically measured during the treatment period in order to evaluate height , HV and PAH . RESULTS After a dramatic acceleration during the 1st year , HV was attenuated during the subsequent years , reaching its nadir at the 5th year . Height deficiency under therapy progressively decreased from entry onwards , shifting from -2.4+/-0.7 to -1.0+/-1.2 SDS . In the same period , mean PAH progressively increased , although after 5 years it remained lower than the average TH . CONCLUSIONS ( a ) An effective growth-promoting strategy in TS should be based on early GH treatment , as suggested by our results . ( b ) This strategy could result in a prepubertal normalization of height , thus allowing the appropriate timing for the induction of puberty . ( c ) An initial GH dose of 1.0 IU/kg per week may be suitable during the first years of therapy , as shown by our data documenting an important waning effect of GH therapy only after the 4th year of treatment . ( d ) No acceleration of bone maturation was observed under this treatment regimen",
"The clinical safety , use and pharmacokinetics of a new needle-free device for delivery of growth hormone ( GH ) were compared with those of conventional needle injection devices . In an open-label , r and omized , 4-period crossover study , 18 healthy adults received single subcutaneous injections of Genotropin administered by the Genotropin ZipTip needle-free device and by conventional injection . Bioequivalence was established between the devices . In a separate open-label , r and omized , multicenter , 2-period crossover study , pediatric patients underwent 2-weeks Genotropin treatment administered by the Genotropin ZipTip and by a fine-gauge needle device ( > 95 % used the Genotropin Pen ) . In total , 128/133 patients who were treated completed the study . Genotropin ZipTip was well tolerated and > 50 % of patients found no difference between the devices for all parameters assessed . After study completion , > 20 % patients preferred to continue using Genotropin ZipTip . Although statistical analyses demonstrated superiority of the Genotropin Pen versus Genotropin ZipTip for bleeding , pain , soreness , and bruising , Genotropin ZipTip was considered to provide a safe and bioequivalent alternative to needle injection",
"The objective of this study was to investigate the effects of GH administration on pulmonary function , sleep , behavior , cognition , linear growth velocity , body composition , and resting energy expenditure ( REE ) in children with Prader-Willi syndrome . The study used a 12-month , balanced , r and omized , double-blind , placebo-controlled , cross-over experimental design . Twelve subjects were r and omized to GH ( 0.043 mg/kg x d ) or placebo intervention for 6 months and then crossed over to the alternate intervention for 6 months . Differences in outcome variables were determined by paired t tests . Peak flow rate , percentage vital capacity , and forced expiratory flow rate improved and number of hypopnea and apnea events and duration of apnea events trended toward improvement after GH intervention . The only difference in cognition or behavior was an increase in hyperactivity scale on the Behavior Assessment System for Children after GH intervention . Linear growth velocity , REE , and lean mass were higher ( 67 % , 19 % , and 7.6 % , respectively ) , and fat mass and percentage body fat were lower ( 10.3 % and 8.1 % , respectively ) after GH intervention . GH administration did not change mean fasting ghrelin concentration . GH intervention improved body composition and REE and may contribute to better sleep quality and pulmonary function . GH administration did not impact fasting ghrelin concentration",
"The effect of growth hormone ( GH ) therapy on renal function was investigated in 203 children who had undergone kidney transplantation . In addition , the efficacy of GH in stimulating growth as well as other aspects of safety were assessed . The patients were r and omized to receive either GH , 1 IU/kg/week , administered subcutaneously once daily , or no treatment during the first year ( controls ) . During the second year , all patients received GH . The change in growth velocity and A height SD score during the first year of GH treatment was statistically significant compared with controls ( p GH during the first year continued to show an increased rate of growth compared with that during the pretreatment period ; however , the mean growth rate was lower than that in the first year of treatment . The mean change in glomerular filtration rate did not differ between the treated and control groups during the first year of the study . However , acute rejection episodes tended to be more frequent during GH treatment , particularly in those patients who had a history of more than one episode . Close monitoring of renal function is therefore recommended",
"OBJECTIVE To determine whether there is evidence for impaired testicular function at final height in short boys treated with growth hormone ( GH ) during their childhood and adolescence . STUDY DESIGN The analysis was restricted to males who had isolated GH deficiency or idiopathic short stature , and who were included in the Swedish National Registry and the Swedish GH trials . The subjects had to have been treated with GH for at least 4 years ; the treatment had to have been started prepubertally , given for at least one year before the onset of puberty and the subjects had to have reached final height . One hundred and eleven boys fulfilled the criteria . METHODS Testicular volumes were determined by orchidometer in each boy when GH treatment was started and at final height . Sample s for testosterone measurements were collected from 77 boys at final height , and were measured by RIA . RESULTS Each subject had normal testicular size ( 15 ml or more ) and for those in whom concentrations were determined , serum testosterone levels and diurnal rhythm were normal . CONCLUSIONS The results of our survey do not show evidence of testicular impairment following GH therapy",
"BACKGROUND Severe GH deficiency ( GHD ) is associated with , increased cardiovascular risk and intima-media thickness ( IMT ) at major arteries . OBJECTIVE The objective of the study was to investigate the 5-yr effects of GH replacement on common carotid IMT and insulin resistance syndrome ( IRS ) ( at least two of the following : triglycerides levels > or = 1.7 mmol/liter , high-density lipoprotein-cholesterol levels Patients included 35 men with severe GHD and 35 age-matched healthy men as controls . INTERVENTION All patients received st and ard replacement therapy ; GH replacement was added in 22 patients ( group A ) and refused by 13 others ( group B ) . MEASUREMENTS Five-year changes in IMT and IRS prevalence were measured . RESULTS At baseline , IMT was higher in the patients with ( P . At study end , use of lipid-lowering drugs ( 92.3 , vs. 13.6 and 34.3 % , P glucose-lowering drugs ( 69.2 vs. 31.4 and 22.7 % ; P = 0.016 ) , and antihypertensive drugs ( 61.5 vs. 20.0 and 4.5 % ; P IGF-I levels normalized in all group A patients and remained lower than -1 sd score in 77 % of group B patients . IMT significantly decreased only in group A and significantly increased in controls and nonsignificantly in group B patients . IRS prevalence significantly reduced only in group A patients . CONCLUSIONS Severely hypopituitary GHD men have more frequently increased IMT at common carotid arteries and IRS than controls . After 5 years , only in GH replaced patients , IMT and prevalence of IRS decreased",
"AIM To compare the growth response to growth hormone ( GH ) treatment in patients with idiopathic GH deficiency ( IGHD ) who were prepubertal with the response of those who were pubertal at the onset of GH therapy on an increased GH dose . PATIENTS AND METHODS Among the Turkish patients enrolled in the Pfizer International Growth Study ( KIGS ) data base with the diagnosis of IGHD , the growth data over 2 years of GH therapy were analyzed longitudinally of 113 ( 79 M ) prepubertal ( Group 1 ) and 44 ( 33 M ) pubertal ( Group 2 ) patients . Pubertal signs were reported to be present initially or to have appeared within 6 months of GH therapy in Group 2 . Mean + /- SD age at onset of therapy was 8.7 + /- 3.5 and 13.5 + /- 1.8 years ; height SDS -4.2 + /- 1.4 and -3.2 + /- 1.1 ( p Mid-parental height ( MPH ) SDS did not show a significant difference between the two groups ( -1.5 + /- 1.1 vs -1.7 + /- 1.1 ) . RESULTS Delta height SDS over 2 years of therapy was significantly higher in Group 1 ( 1.1 + /- 1.0 ) than in Group 2 ( 0.7 + /- 0.6 ) ( p Ht -- MPH SDS showed an increase from -2.4 + /- 1.7 to -1.4 + /- 1.5 in Group 1 and from -1.5 + /- 1.5 to -0.8 + /- 1.3 in Group 2 . Overall delta height SDS showed negative correlations with age ( r = -0.32 ) , height SDS ( r = -0.41 ) and height -- MPH SDS ( r = -0.40 ) at onset of therapy ( p height velocity at the same magnitude as in prepuberty , and thus was not cost effective",
"BACKGROUND Prader-Willi syndrome ( PWS ) is a congenital alteration of chromosome pair 15 . It is characterized by short stature , muscular hypotonia , hyperphagia , obesity , behavioural and emotional disturbances , hypogonadism and partial Growth Hormone ( GH ) deficiency . The aim of this study was to assess the long-term effect of GH treatment on the psychological well-being and Quality of Life ( QoL ) in an adult PWS group . METHODS A total of 13 PWS patients , their diagnosis confirmed by genetic tests , and their parents were recruited for this study . The participants were administered the 36-Items Short Form Health Survey ( SF-36 ) and the Psychological General Well-Being Index ( PGWBI ) , for the assessment of QoL and psychological well-being , at the beginning of GH treatment , and at following intervals of 6 , 12 and 24 months . Modified versions of the same question naires were given to the parents . RESULTS Significant improvement with respect to the baseline was found , on both scales , in the evaluation of both physical and psychological well-being , although the parents ' evaluation was less optimistic than that of the patients . CONCLUSION Our findings suggest that the amelioration of QoL and psychological status is sustained in patients who continue GH treatment",
"OBJECTIVES To assess body composition of infants with Prader-Willi syndrome ( PWS ) by using deuterium dilution and investigating the efficacy of early institution of growth hormone ( GH ) therapy in increasing lean mass ( LM ) and preventing massive obesity . STUDY DESIGN One group of 11 children with PWS GH therapy ( GH group ) was compared with 6 infants administered only coenzyme Q(10 ) for 1 year ( Q10 group ) . LM adjusted for height ( LM(Ht ) ) and relative fat mass ( % FM(Age ) ) st and ard deviation scores ( SDS ) were calculated from data of 95 healthy children . RESULTS Initially , LM(Ht ) of all patients was below the normal average . LM(Ht ) decreased by -0.46 + /- 0.3 SD ( P=.03 ) per year in the Q10 group but rose by 0.25 + /- 0.3 SD ( P=.02 ) per year during GH therapy , normalizing after 30 months ( -0.70 + /- 1.0 SD ) . Despite low to normal weight for height ( WfH ) , % FM(Age ) was above the normal average ( GH group , 31.0 % + /- 4.5 % , Q10 group , 32.4 % + /- 9.5 % ) . In the Q10 infants , % FM(Age ) increased by 0.71 + /- 0.7 SD per year , whereas in the GH group , % FM(Age ) remained more stable up to 30 months . CONCLUSIONS Diminished LM(Ht ) found in infants with PWS further declines during the early years . Early institution of GH therapy lifts LM(Ht ) into the normal range and delays fat tissue accumulation",
"A controlled , r and omized study was conducted to assess the effect of growth hormone ( GH ) treatment on growth , body composition and behaviour in prepubertal children ( 3 - 12 years of age ) with Prader-Willi syndrome . GH treatment was given to one group of 15 patients ( group A ) at a dose of 0.1 IU/kg/day for 2 years . The second group ( group B ; n = 12 ) was not treated for the first year and was then given GH at a dose of 0.2 IU/kg/day for the second year . All patients had low 24-hour levels of GH and insulin-like growth factor I before GH treatment . Height velocity SDS increased from -1.9 + /- 2.0 to 6.0 + /- 3.2 during the first year of GH treatment in group A , and from -1.4 + /- 1.2 to 10.1 + /- 3.9 in the second year of the study in group B. When GH treatment was stopped , height velocity declined dramatically . Height SDS followed a similar pattern . GH treatment reduced the percentage body fat and increased the muscle area of the thigh . Isometric muscle strength was also increased . In addition , GH treatment appeared to have psychological and behavioural benefits , which were reversed after cessation of treatment . It was concluded that GH treatment improves growth , body composition and behaviour in children with Prader-Willi syndrome",
"The aim of this prospect i ve , longitudinal , controlled study is to describe the long-term safety and efficacy of growth hormone ( GH ) administration on craniofacial morphology in boys with short stature . Forty-six boys , who started GH treatment at the Department of Paediatrics Göteborg Paediatric Growth Research Centre , were consecutively included in the study . Twenty-five boys were classified as growth hormone-deficient ( GHD ) and 21 as idiopathic short stature ( ISS ) . The patients were injected with 33 ( n=31 ) or 67 ( n=15 ) microg GH/kg body weight/day . The mean age at the start of treatment was 11.8 years [ st and ard deviation ( SD ) 1.7 ] . To assess craniofacial growth , st and ard lateral cephalometric radiographs were obtained at the start of GH treatment , annually during 4 years , and at the end of GH treatment or when growth was less than 1 cm/year . The mean follow-up period was 6.4 years ( SD 1.4 ) . Growth changes were compared with boys from a semi-longitudinal reference group of 130 healthy subjects , 7 - 21 years of age . t-tests for independent and paired sample s and multiple regression analysis were applied . Age- and gender-specific st and ard deviation scores for the cephalometric variables were calculated . Repeated measures analysis of variance was used to identify significant covariates over time , such as low/high GH dose and GHD/ISS and orthodontic treatment . During the study period , eight ( out of 40 ) boys were treated with fixed orthodontic appliances , three with functional appliances ( activators ) , and three with other appliances ( plates and lingual arches ) . During GH treatment period , an overall enhancement in growth of the facial skeleton was observed in boys with short stature . The changes induced by GH yielded a more prognathic growth pattern , a more anterior position of the jaws in relation to the cranial base , and increased anterior rotation of the m and ible . The m and ibular corpus length and anterior face height of the GH-treated boys were greater at the end of the study compared with the boys in the reference group . No differences in growth response were noted either between the GHD and ISS boys or between those treated with either 33 ( low dose ) or 67 ( high dose ) microg GH/kg body weight/day . The only change that remained significantly correlated with orthodontic treatment was the alteration in m and ibular ramus height , showing a larger change in the boys who had not undergone orthodontic therapy . The findings of this study demonstrate that GH treatment has a favourable influence on the craniofacial growth pattern of boys with short stature without acromegalic features",
"GH therapy variably reduces the height deficit of short children born small for gestational age ( SGA ) but is associated with hyperinsulinemia . Intermittent , higher-dose GH regimens may be alternatives to continuous , lower-dose treatment . We examined whether the growth response to GH therapy is related to pre-treatment indices of endogenous somatotropic activity , and studied the reversibility of the insulin resistant state induced by GH . 13 non-GH deficient short SGA children were r and omised to high-dose GH ( 100 mcg/kg/day ) by daily sc injection ( n = 9 ) , or no GH treatment ( n = 4 ) for 2 years ( 2/4 controls subsequently received GH treatment ) . Overnight GH profiles were performed at baseline ; intravenous glucose tolerance tests were performed at baseline , yearly on GH treatment , and 3 months post-GH treatment . Fasting glucose , insulin and proinsulin levels were measured , insulin sensitivity estimated using Bergman 's minimal model , and glucose tolerance calculated from rate of glucose disappearance . In all GH-treated children , gain in height SDS ( mean gain yr 1 = + 1.2 SDS ) was inversely related to baseline peak overnight GH ( r = -0.88 , n = 10 , p = 0.0008 ) , IFG-I ( r = -0.74 , n = 11 , p = 0.009 ) , and fasting insulin levels ( r = -0.71 , n = 11 , p = 0.014 ) . GH treatment increased fasting glucose ( means : baseline vs. yr 2 : 3.7 vs. 4.4 mmol/l , p = 0.005 ) , insulin ( 3.8 vs. 13.9 mU/l , p = 0.0002 ) , and proinsulin levels ( 1.7 vs. 4.5 pmol/l , p = 0.004 ) , and decreased insulin sensitivity ( 26.9 vs. 4.0 per min/mU/1 x 10(4 ) , p = 0.002 ) . Glucose tolerance initially decreased ( baseline : 2.62 min(-1 ) ; yr 1 : 2.18 , p = 0.02 ; yr 2 : 2.39 , p = 0.12 ) . However , by 3 months post-GH treatment significant improvements were seen in fasting insulin ( post-GH : 5.2 mU/1 , p = 0.0003 vs. yr 2 ) , proinsulin ( 1.7 pmol/l , p = 0.002 ) , and insulin sensitivity ( 17.6 per min/mU/1 x 10(4 ) , p = 0.0001 ) . Post-GH treatment , fasting glucose levels ( 4.1 mmol/l , p = 0.04 ) and glucose tolerance ( 2.49 min(-1 ) , p = 0.4 ) were similar to baseline , and the slight increase in fasting insulin levels ( 5.2 mU/1 , p = 0.04 ) was similar to that observed in non-GH treated children over the 2 yr study period ( baseline vs. 2 years : 3.9 vs. 5.9 mU/1 , n = 4 ) . In conclusion , in this study of 13 short non-GH-deficient SGA children , high-dose GH therapy induced growth responses that were associated with reversible decreases in insulin sensitivity , and that were predicted by pretreatment markers of endogenous , but not stimulated , somatotropic activity",
"Background : The aim of this retrospective analysis was to evaluate the effects of growth hormone ( GH ) treatment on testicular development in boys with idiopathic short stature ( ISS ) and isolated GH deficiency ( IGHD ) followed in the KIGS ( Pharmacia International Growth Data base ) . Methods : For inclusion in the study , the patients had to have received more than 1 year of prepubertal GH treatment , at least 4 consecutive years of GH treatment in total , and to have attained their final height , defined as a height velocity of less than 2 cm/year . Data on 107 boys in the KIGS data base have been analyzed . Results : No significant differences in duration of GH treatment and testicular volume at the start of treatment or at final height were found between the boys with ISS and those with IGHD . The progression of testicular volume in boys with ISS or IGHD during GH treatment did not differ from the reference population . Conclusions : This analysis shows that GH treatment does not alter testicular growth in boys with ISS or IGHD . However , prospect i ve controlled studies are needed to rule out moderate attenuating or stimulating effects"
] | 41166e10-06ff-11f0-808a-c43d1ab1c353 |
Background : African American breast cancer survivors have a higher incidence of estrogen receptor negative and basal-like ( e.g. , triple negative ) tumors , placing them at greater risk for poorer survival when compared to women of other racial and ethnic groups . While access to equitable care , late disease stage at diagnosis , tumor biology , and sociodemographic characteristics contribute to health disparities , poor lifestyle characteristics ( i.e. , inactivity , obesity , and poor diet ) contribute equally to these disparities . Lifestyle interventions hold promise in shielding African American survivors from second cancers , comorbidities , and premature mortality , but they are often underrepresented in studies promoting positive behaviors . This review examined the available literature to document health behaviors and lifestyle intervention ( i.e. , obesity , physical activity , and sedentary behavior ) studies in African American breast cancer survivors . Methods : We used PubMed , Academic Search Premier , and Scopus to identify cross-sectional and intervention studies examining the lifestyle behaviors of African American breast cancer survivors . Identified intervention studies were assessed for risk of bias . Other articles were identified and described to provide context for the review . Results : Our systematic review identified 226 relevant articles . The cross-sectional articles indicated poor adherence to physical activity and dietary intake and high rates of overweight and obesity . The 16 identified intervention studies indicated reasonable to modest study adherence rates ( > 70 % ) , significant reductions in weight ( range -1.9 to -3.6 % ) , sedentary behavior ( -18 % ) , and dietary fat intake ( range -13 to -33 % ) and improvements in fruit and vegetable intake ( range + 25 to + 55 % ) and physical activity ( range + 13 to + 544 % ) . The risk of bias for most studies were rated as high ( 44 % ) or moderate ( 44 % ) . Conclusions : The available literature suggests that African American breast cancer survivors adhere to interventions of various modalities and are capable of making modest to significant changes . Future studies should consider examining ( a ) mediators and moderators of lifestyle behaviors and interventions , ( b ) biological outcomes , and ( c ) determinants of enhanced survival in this population | [
"Objective Research suggests that physical activity is associated with improved breast cancer survival , yet no studies have examined the association between post-diagnosis changes in physical activity and breast cancer outcomes . The aim of this study was to determine whether baseline activity and 1-year change in activity are associated with breast cancer events or mortality . Methods A total of 2,361 post-treatment breast cancer survivors ( Stage I – III ) enrolled in a r and omized controlled trial of dietary change completed physical activity measures at baseline and one year . Physical activity variables ( total , moderate – vigorous , and adherence to guidelines ) were calculated for each time point . Median follow-up was 7.1 years . Outcomes were invasive breast cancer events and all-cause mortality . Results Those who were most active at baseline had a 53 % lower mortality risk compared to the least active women ( HR = 0.47 ; 95 % CI : 0.26 , 0.84 ; p = .01 ) . Adherence to activity guidelines was associated with a 35 % lower mortality risk ( HR = 0.65 , 95 % CI : 0.47 , 0.91 ; p breast cancer events . Conclusions Higher baseline ( post-treatment ) physical activity was associated with improved survival . However , change in activity over the following year was not associated with outcomes . These data suggest that long-term physical activity levels are important for breast cancer prognosis",
"Background : This r and omized controlled trial assessed the safety and effects of twice-weekly weight training among recent breast cancer survivors . Outcomes included body size and biomarkers hypothesized to link exercise and breast cancer risk . Methods : A convenience sample of 85 recent survivors was r and omized into immediate and delayed treatment groups . The immediate group trained from months 0 to 12 ; the delayed treatment group served as a no exercise parallel comparison group from months 0 to 6 and trained from months 7 to 12 . Measures at baseline , 6 and 12 months included body weight , height , body fat , lean mass , body fat % , and waist circumference , as well as fasting glucose , insulin , insulin resistance , insulin-like growth factor-I ( IGF-I ) , IGF-II , and IGF-binding protein-1 , IGFBP-2 , and IGFBP-3 . Injury reporting was st and ardized . Results : The intervention result ed in significant increases in lean mass ( 0.88 versus 0.02 kg , P decreases in body fat % ( −1.15 % versus 0.23 % , P = 0.03 ) and IGF-II ( −6.23 versus 28.28 ng/mL , P = 0.02 ) comparing immediate with delayed treatment from baseline to 6 months . Within-person changes experienced by delayed treatment group participants during training versus no training were similar . Only one participant experienced a study related injury that prevented continued participation . Conclusion : Twice-weekly weight training is a safe exercise program for recent breast cancer survivors that may result in increased muscle mass , as well as decreased body fat % and IGF-II . The implication s of these results on cancer recurrence or survival may become more evident with longer exercise intervention trials among breast cancer survivors",
"A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population ",
"PURPOSE Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer . The Exercise and Nutrition to Enhance Recovery and Good Health for You ( ENERGY ) study is the largest weight loss intervention trial among survivors of breast cancer to date . METHODS In this multicenter trial , 692 overweight/obese women who were , on average , 2 years since primary treatment for early-stage breast cancer were r and omly assigned to either a group-based behavioral intervention , supplemented with telephone counseling and tailored newsletters , to support weight loss or a less intensive control intervention and observed for 2 years . Weight and blood pressure were measured at 6 , 12 , 18 , and 24 months . Longitudinal mixed models were used to analyze change over time . RESULTS At 12 months , mean weight loss was 6.0 % of initial weight in the intervention group and 1.5 % in the control group ( P mean weight loss in the intervention and control groups was 3.7 % and 1.3 % , respectively ( P physical activity and blood pressure were observed . The weight loss intervention was more effective among women older than 55 years than among younger women . CONCLUSION A behavioral weight loss intervention can lead to clinical ly meaningful weight loss in overweight/obese survivors of breast cancer . These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival",
"PURPOSE Walking for health is recommended by health agencies , partly based on epidemiological studies of self-reported behaviors . Accelerometers are now replacing survey data , but it is not clear that intensity-based cut points reflect the behaviors previously reported . New computational techniques can help classify raw accelerometer data into behaviors meaningful for public health . METHODS Five hundred twenty days of triaxial 30-Hz accelerometer data from three studies ( n = 78 ) were employed as training data . Study 1 included prescribed activities completed in natural setting s. The other two studies included multiple days of free-living data with SenseCam-annotated ground truth . The two population s in the free-living data sets were demographically and physical different . R and om forest classifiers were trained on each data set , and the classification accuracy on the training data set and that applied to the other available data sets were assessed . Accelerometer cut points were also compared with the ground truth from the three data sets . RESULTS The r and om forest classified all behaviors with over 80 % accuracy . Classifiers developed on the prescribed data performed with higher accuracy than the free-living data classifier , but these did not perform as well on the free-living data sets . Many of the observed behaviors occurred at different intensities compared with those identified by existing cut points . CONCLUSIONS New machine learning classifiers developed from prescribed activities ( study 1 ) were considerably less accurate when applied to free-living population s or to a functionally different population ( studies 2 and 3 ) . These classifiers , developed on free-living data , may have value when applied to large cohort studies with existing hip accelerometer data",
"Background Our data have indicated that minority breast cancer survivors are receptive to participating in lifestyle interventions delivered via email or the Web , yet few Web-based studies exist in this population . Objective The aim of this study was to examine the feasibility and preliminary results of an email-delivered diet and activity intervention program , “ A Lifestyle Intervention Via Email ( ALIVE ) , ” delivered to a sample of racial and ethnic minority breast cancer survivors . Methods Survivors ( mean age : 52 years , 83 % [ 59/71 ] African American ) were recruited and r and omized to receive either the ALIVE program ’s 3-month physical activity track or its 3-month dietary track . The fully automated system provided tools for self-monitoring and goal setting , tailored content , and automated phone calls . Descriptive statistics and mixed-effects models were computed to examine the outcomes of the study . Results Upon completion , 44 of 71 survivors completed the study . Our “ intention-to-treat ” analysis revealed that participants in the physical activity track made greater improvements in moderate to vigorous activity than those in the dietary track ( + 97 vs. + 49 min/week , P reductions in total sedentary time among those in the physical activity track ( −304 vs. −59 min/week , P the intake of fiber ( + 4.4 g/day ) , fruits and vegetables ( + 1.0 cup equivalents/day ) , and reductions in saturated fat ( −2.3 g/day ) and trans fat ( −0.3 g/day ) ( all P improvements in dietary intake were not significantly different from the changes observed by participants in the physical activity track ( all P>.05 ) . Process evaluation data indicated that most survivors would recommend ALIVE to other cancer survivors ( 97 % ) , were satisfied with ALIVE ( 82 % ) , and felt that ALIVE was effective ( 73 % ) . However , survivors expressed concerns about the functionality of the interactive emails . Conclusions ALIVE appears to be feasible for racial and ethnic minority cancer survivors and showed promising results for larger implementation . Although survivors favored the educational content , a mobile phone app and interactive emails that work on multiple email domains may help to boost adherence rates and to improve satisfaction with the Web-based platform . Trial Registration Clinical Trials.gov NCT02722850 ; https:// clinical trials.gov/ct2/show/NCT02722850 ( Archived by WebCite at http://www.webcitation.org/6tHN9VsPh",
"Background : Given the disproportionately high incidence of early-onset breast cancer and aggressive subtypes , such as estrogen receptor (ER)-negative tumors , in African American ( AA ) women , elucidation of risk factors for early onset of specific subtypes of breast cancer is needed . Methods : We evaluated associations of reproductive , anthropometric , and other factors with incidence of invasive breast cancer by age at onset ( in 57,708 AA women in the prospect i ve Black Women 's Health Study . From 1995 to 2013 , we identified 529 invasive breast cancers among women We used multivariable Cox proportional hazards regression to estimate hazard ratios ( HRs ) for associations by age and ER status . Results : Higher parity , older age at first birth , never having breastfed , and abdominal adiposity were associated with increased risk of early-onset ER− breast cancer : HRs were 1.71 for ≥3 births versus one birth ; 2.29 for first birth after age 25 versus with ER− cancer in older women or with ER+ cancer regardless of age . Conclusions : Differences in risk factors by ER subtype were observed for breast cancer diagnosed before the age of 45 years . Impact : Etiological heterogeneity by tumor subtype in early-onset breast cancer , in combination with a higher prevalence of the risk factors in AA women , may explain , in part , racial disparities in breast cancer incidence . Cancer Epidemiol Biomarkers Prev ; 26(2 ) ; 270–7 . © 2016 AACR",
"OBJECTIVE Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival . As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage , and have higher rates of obesity , effective weight loss strategies are needed . We piloted a r and omized , waitlist-controlled , crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic , African American and Afro-Caribbean breast cancer survivors . DESIGN AND METHODS Women with stage 0-IIIa breast cancer ≥ 6 months posttreatment , sedentary , and BMI ≥ 25 kg/m(2 ) were r and omized to the immediate arm ( IA ) : 6 months of the Curves program followed by 6 months of observation ; or the waitlist control arm ( WCA ) : 6 months of observation followed by 6 months of the Curves program . The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet . RESULTS A total of 42 women enrolled ( 79 % Hispanic , 21 % black ) , mean age 51 ( range 32 - 69 ) and mean BMI 33.2(± 5.9 ) kg/m(2 ) ; 91 % were retained at month 12 . At month 6 , women in the IA lost an average 3.3 % ( ± 3.5 % ) of body weight ( range : 1.7 % gain to 10.6 % loss ) , as compared with 1.8 % ( ± 2.9 % ) weight loss in the WCA ( P = 0.04 ) . At month 12 , on average women in the IA regained some but not all of the weight lost during the first 6 months ( P = 0.02 ) . CONCLUSIONS Minority breast cancer survivors were recruited and retained in a weight loss study . Six months of the Curves program result ed in moderate weight loss , but weight loss was not maintained postintervention . Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors",
"PURPOSE Single-variable analyses have associated physical activity , diet , and obesity with survival after breast cancer . This report investigates interactions among these variables . PATIENTS AND METHODS A prospect i ve study was performed of 1,490 women diagnosed and treated for early-stage breast cancer between 1991 and 2000 . Enrollment was an average of 2 years postdiagnosis . Only seven women were lost to follow-up through December 2005 . RESULTS In univariate analysis , reduced mortality was weakly associated with higher vegetable-fruit consumption , increased physical activity , and a body mass index that was neither low weight nor obese . In a multivariate Cox model , only the combination of consuming five or more daily servings of vegetables-fruits , and accumulating 540 + metabolic equivalent tasks-min/wk ( equivalent to walking 30 minutes 6 d/wk ) , was associated with a significant survival advantage ( hazard ratio , 0.56 ; 95 % CI , 0.31 to 0.98 ) . The approximate 50 % reduction in risk associated with these healthy lifestyle behaviors was observed in both obese and nonobese women , although fewer obese women were physically active with a healthy dietary pattern ( 16 % v 30 % ) . Among those who adhered to this healthy lifestyle , there was no apparent effect of obesity on survival . The effect was stronger in women who had hormone receptor-positive cancers . CONCLUSION A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables-fruits and moderate levels of physical activity . The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival",
"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",
"Introduction The aim of this study was to describe breast tumor subtypes by common breast cancer risk factors and to determine correlates of subtypes using baseline data from two pooled prospect i ve breast cancer studies within a large health maintenance organization . Methods Tumor data on 2544 invasive breast cancer cases subtyped by estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 ( Her2 ) status were obtained ( 1868 luminal A tumors , 294 luminal B tumors , 288 triple-negative tumors and 94 Her2-overexpressing tumors ) . Demographic , reproductive and lifestyle information was collected either in person or by mailed question naires . Case-only odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were estimated using logistic regression , adjusting for age at diagnosis , race/ethnicity , and study origin . Results Compared with luminal A cases , luminal B cases were more likely to be younger at diagnosis ( P = 0.0001 ) and were less likely to consume alcohol ( OR = 0.74 , 95 % CI = 0.56 to 0.98 ) , use hormone replacement therapy ( HRT ) ( OR = 0.66 , 95 % CI = 0.46 to 0.94 ) , and oral contraceptives ( OR = 0.73 , 95 % CI = 0.55 to 0.96 ) . Compared with luminal A cases , triple-negative cases tended to be younger at diagnosis ( P ≤ 0.0001 ) and African American ( OR = 3.14 , 95 % CI = 2.12 to 4.16 ) , were more likely to have not breastfed if they had parity greater than or equal to three ( OR = 1.68 , 95 % CI = 1.00 to 2.81 ) , and were more likely to be overweight ( OR = 1.82 , 95 % CI = 1.03 to 3.24 ) or obese ( OR = 1.97 , 95 % CI = 1.03 to 3.77 ) if premenopausal . Her2-overexpressing cases were more likely to be younger at diagnosis ( P = 0.03 ) and Hispanic ( OR = 2.19 , 95 % CI = 1.16 to 4.13 ) or Asian ( OR = 2.02 , 95 % CI = 1.05 to 3.88 ) , and less likely to use HRT ( OR = 0.45 , 95 % CI = 0.26 to 0.79 ) . Conclusions These observations suggest that investigators should consider tumor heterogeneity in associations with traditional breast cancer risk factors . Important modifiable lifestyle factors that may be related to the development of a specific tumor subtype , but not all subtypes , include obesity , breastfeeding , and alcohol consumption . Future work that will further categorize triple-negative cases into basal and non-basal tumors may help to eluci date these associations further",
"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",
"CONTEXT Physical activity has been shown to decrease the incidence of breast cancer , but the effect on recurrence or survival after a breast cancer diagnosis is not known . OBJECTIVE To determine whether physical activity among women with breast cancer decreases their risk of death from breast cancer compared with more sedentary women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study based on responses from 2987 female registered nurses in the Nurses ' Health Study who were diagnosed with stage I , II , or III breast cancer between 1984 and 1998 and who were followed up until death or June 2002 , whichever came first . MAIN OUTCOME MEASURE Breast cancer mortality risk according to physical activity category ( or = 24 metabolic equivalent task [ MET ] hours per week ) . RESULTS Compared with women who engaged in less than 3 MET-hours per week of physical activity , the adjusted relative risk ( RR ) of death from breast cancer was 0.80 ( 95 % confidence interval [ CI ] , 0.60 - 1.06 ) for 3 to 8.9 MET-hours per week ; 0.50 ( 95 % CI , 0.31 - 0.82 ) for 9 to 14.9 MET-hours per week ; 0.56 ( 95 % CI , 0.38 - 0.84 ) for 15 to 23.9 MET-hours per week ; and 0.60 ( 95 % CI , 0.40 - 0.89 ) for 24 or more MET-hours per week ( P for trend = .004 ) . Three MET-hours is equivalent to walking at average pace of 2 to 2.9 mph for 1 hour . The benefit of physical activity was particularly apparent among women with hormone-responsive tumors . The RR of breast cancer death for women with hormone-responsive tumors who engaged in 9 or more MET-hours per week of activity compared with women with hormone-responsive tumors who engaged in less than 9 MET-hours per week was 0.50 ( 95 % CI , 0.34 - 0.74 ) . Compared with women who engaged in less than 3 MET-hours per week of activity , the absolute unadjusted mortality risk reduction was 6 % at 10 years for women who engaged in 9 or more MET-hours per week . CONCLUSIONS Physical activity after a breast cancer diagnosis may reduce the risk of death from this disease . The greatest benefit occurred in women who performed the equivalent of walking 3 to 5 hours per week at an average pace , with little evidence of a correlation between increased benefit and greater energy expenditure . Women with breast cancer who follow US physical activity recommendations may improve their survival",
"Introduction Breast cancer survival rates are lower for African American women than for white women . Obesity , high-fat diets , and lack of regular physical activity increase risk for breast cancer recurrence , comorbid conditions , and premature death . Eighty-two percent of African American women are overweight or obese , partly because of unhealthy eating and exercise patterns . Although successful weight loss and lifestyle interventions for breast cancer survivors are documented , none has considered the needs of African American breast cancer survivors . This study assessed the feasibility and impact of Moving Forward , a culturally tailored weight loss program for African American breast cancer survivors . Methods The study used a pre-post design with a convenience sample of 23 African American breast cancer survivors . The 6-month intervention was theory-based and incorporated qualitative data from focus groups with the targeted community , urban African American breast cancer survivors . Data on weight , body mass index ( BMI ) , diet , physical activity , social support , and quality of life were collected at baseline and at 6 months . Results After the intervention , we noted significant differences in weight , BMI , dietary fat intake , vegetable consumption , vigorous physical activity , and social support . Conclusion This is the first published report of Moving Forward , a weight loss intervention design ed for African American breast cancer survivors . Although a r and omized trial is needed to establish efficacy , the positive results of this intervention suggest that this weight loss intervention may be feasible for African American breast cancer survivors . Lifestyle interventions may reduce the disparities in breast cancer mortality rates",
"Background : Research on the association between dietary patterns and breast cancer survival is very limited . Methods : A prospect i ve follow-up study was conducted in Germany , including 2522 postmenopausal breast cancer patients diagnosed in 2001–2005 with available food frequency question naire data . Vital status , causes of death , and recurrences were verified through the end of 2009 . Principle component factor analysis was used to identify pre-diagnostic dietary patterns . Hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) were calculated with Cox proportional hazards models . Results : Two major dietary patterns were identified : ‘ healthy ’ ( high intakes of vegetables , fruits , vegetable oil , sauces/condiments , and soups/bouillons ) and ‘ unhealthy ’ ( high intakes of red meat , processed meat , and deep-frying fat ) . Increasing consumption of an ‘ unhealthy ’ dietary pattern was associated with an increased risk of non-breast cancer mortality ( highest vs lowest quartile : HR , 3.69 ; 95 % CI , 1.66–8.17 ; P-trend with breast cancer-specific mortality and breast cancer recurrence were found . The ‘ healthy ’ dietary pattern was inversely associated with overall mortality ( HR , 0.74 ; 95 % CI , 0.47–1.15 ; P-trend=0.02 ) and breast cancer recurrence ( HR , 0.71 ; 95 % CI , 0.48–1.06 ; P-trend=0.02 ) in stage I – IIIa patients only . Conclusion : Increasing intake of an ‘ unhealthy ’ pre-diagnostic dietary pattern may increase the risk of non-breast cancer mortality , whereas increasing intake of a ‘ healthy ’ pattern may reduce the risk of overall mortality and breast cancer recurrence",
"Previous studies suggest that increased physical activity may lower the risk of breast cancer incidence , but less is known about whether levels of physical activity after breast cancer diagnosis can influence survival . We prospect ively examined the relation between postdiagnosis recreational physical activity and risk of breast cancer death in women who had a previous invasive breast cancer diagnosed between 1988 and 2001 ( at ages 20 - 79 years ) . All women completed a question naire on recent postdiagnosis physical activity and other lifestyle factors . Among 4,482 women without history of recurrence at the time of completing the question naire , 109 died from breast cancer within 6 years of enrollment . Physical activity was expressed as metabolic equivalent task-hours per week ( MET-h/wk ) ; hazard ratios ( HR ) and 95 % confidence intervals ( 95 % CI ) were estimated using Cox proportional hazards regression . After adjusting for age at diagnosis , stage of disease , state of residence , interval between diagnosis and physical activity assessment , body mass index , menopausal status , hormone therapy use , energy intake , education , family history of breast cancer , and treatment modality compared with women expending lower risk of dying from breast cancer ( HR , 0.65 ; 95 % CI , 0.39 - 1.08 for 2.8 - 7.9 MET-h/wk ; HR , 0.59 ; 95 % CI , 0.35 - 1.01 for 8.0 - 20.9 MET-h/wk ; and HR , 0.51 ; 95 % CI , 0.29 - 0.89 for ≥21.0 MET-h/wk ; P for trend = 0.05 ) . Results were similar for overall survival ( HR , 0.44 ; 95 % CI , 0.32 - 0.60 for ≥21.0 versus reduced overall mortality and mortality from breast cancer among women who engage in physical activity after breast cancer diagnosis . ( Cancer Epidemiol Biomarkers Prev 2008;17(2):379–86",
"Cohort trials have shown evidence that obesity and a low level of physical activity are not only associated with a higher risk of developing breast cancer , but also with an increased risk for recurrence and reduced survival in breast cancer patients . The SUCCESS C study is the first European trial to evaluate the effect of an intensive lifestyle intervention program on disease-free survival in women with early breast cancer and to examine the predictive value of selected biomarker c and i date s. A total of 3,547 women with early-stage , Her2/neu-negative breast cancer will be included . The first r and omization will compare disease-free survival in patients treated with either 3 cycles of FEC ( epirubicine , fluorouracil , cyclophosphamide ) , followed by 3 cycles of docetaxel or 6 cycles of docetaxel-cyclophosphamide , and thus assess the role of anthracycline-free chemotherapy . The second r and omization compares disease-free survival in patients with a body mass index of 24–40 kg/m2 receiving either a telephone-based individualized lifestyle intervention program aim ing at moderate weight loss or general recommendations for a healthy lifestyle alone . In addition , the study will evaluate the predictive role of cancer-associated and obesity-related biomarkers for the prediction of disease recurrence and survival . This SUCCESS C trial will provide valuable information on the effects of a lifestyle intervention program on the prognosis of early breast cancer patients",
"Purpose Regular exercise and healthy eating are routinely recommended for breast cancer survivors , and past studies show benefits in quality of life and decreased inflammation . However , this has not been tested specifically in triple-negative breast cancer survivors . Increasing physical activity and losing body fat are thought to positively affect inflammatory biomarkers that have been associated with breast cancer . Therefore , the primary purpose of this study was to determine if participation in an exercise and dietary counseling program can improve body fat , physical function , and quality of life in survivors of this aggressive breast cancer . Secondarily , we sought to determine if participation in the program had beneficial effects on obesity-related markers of the adipokine profile . Methods Sixty-six survivors of triple-negative breast cancer with BMI > 25 were invited to participate . Twenty-eight enrolled and 23 completed the r and omized , controlled trial ( 13 intervention , 10 control ) . Moderate-intensity aerobic exercise ( 150 min per week , for 12 weeks ) and diet counseling were compared to usual care , education only . The primary outcome of interest was weight loss ( body mass , BMI , % fat ) , and secondary outcomes included physical function ( exercise capacity ) , quality of life ( Function After Cancer Therapy — Breast ( FACT-B ) ) , cytokines ( C-reactive protein ( CRP ) , TNF-α , IL-6 ) , and adipokine profile ( leptin , adiponectin , insulin ) . Results Participants in the program lost more body fat ( 2.4 % loss vs. 0.4 % gain , p group . The intervention group also improved quality of life ( FACT-B total score + 14 pts ) and decreased sedentary time but did not improve peak exercise capacity . The intervention had no effect on serum cytokines and adipokines after 12 weeks in the program . However , serum leptin and adiponectin and their ratio were significantly correlated with BMI in the intervention group ( p of body fat and improved quality of life in survivors of triple-negative breast cancer . BMI was associated with favorable changes in leptin and adiponectin which may reflect a change in adiposity with intervention . Exercise and healthy eating may be equally effective in this high-risk population as in other breast cancer survivors and should be encouraged as a part of a cancer survivorship program",
"Purpose African American women with breast cancer have higher cancer-specific and overall mortality rates . Obesity is common among African American women and contributes to breast cancer progression and numerous chronic conditions . Weight loss interventions among breast cancer survivors positively affect weight , behavior , biomarkers , and psychosocial outcomes , yet few target African Americans . This article examines the effects of Moving Forward , a weight loss intervention for African American breast cancer survivors ( AABCS ) on weight , body composition , and behavior . Patients and Methods Early-stage ( I-III ) AABCS were r and omly assigned to a 6-month interventionist-guided ( n = 125 ) or self-guided ( n = 121 ) weight loss program supporting behavioral changes to promote a 5 % weight loss . Anthropometric , body composition , and behavioral data were collected at baseline , postintervention ( 6 months ) , and follow-up ( 12 months ) . Descriptive statistics and mixed models analyses assessed differences between groups over time . Results Mean ( ± st and ard deviation ) age , and body mass index were 57.5 ( ± 10.1 ) years and 36.1 ( ± 6.2 ) kg/m2 , respectively , and 82 % had stage I or II breast cancer . Both groups lost weight . Mean and percentage of weight loss were greater in the guided versus self-guided group ( at 6 months : 3.5 kg v 1.3 kg ; P goal . Body composition and behavioral changes were also greater in the interventionist-guided group at both time points . Conclusion The study supports the efficacy of a community-based interventionist-guided weight loss program targeting AABCS . Although mean weight loss did not reach the targeted 5 % , the mean loss of > 3 % at 6 months is associated with improved health outcomes . Affordable , accessible health promotion programs represent a critical re source for AABCS",
"African-American ( AA ) women have higher rates of breast cancer ( BCa ) mortality than Caucasian women , and a recent study using data from the Surveillance , Epidemiology and End Results ( SEER ) registry suggests that this disparity may be due , in part , to the poorer health status of AAs at diagnosis and not treatment related issues . R and omized controlled trials involving supervised aerobic and resistance exercise have shown improved body composition and improvement in cancer-related biomarkers in BCa patients and may lead to improved recurrence and survival rates ; however , most trials have focused on Caucasians and many have been conducted in academic- and clinic-based setting s. We evaluated the feasibility of conducting a 20-week , supervised , resistance training , group exercise intervention coupled with a support group and home walking program utilizing facilities and personnel at a community cancer support center ( The Gathering Place , Beachwood , Ohio ) in AA Stage I-III BCa survivors who were within 12 months of completing treatment ( surgery , chemotherapy , and /or breast irradiation ) ; and , evaluated the potential effects of this intervention on physical measures and cancer-related biomarkers . 27 patients provided informed consent and 19 participated in the program . On average , attendance rates were 70.0 % ± 19.1 % for the exercise sessions and 63.1 % ± 13.8 % for the support group . We observed a significant decrease in circulating C-peptide levels ( B : 893.9 ± 399.1 pg/mL ; EOI : 723.9 ± 319.0 pg/mL ; p=0.01 ) . Although we did not observe a significant decrease in weight in the entire sample , there was a significant decrease in waist circumference and percent total body fat among those who attended 70 % or more of the exercise sessions . In summary , we demonstrated that conducting lifestyle interventions in AA BCa survivors in a community setting is feasible . Future interventions should invoke strategies to enhance adherence and include a structured dietary intervention to enable greater weight loss",
"OBJECTIVE To evaluate whether the evidence -based Body & Soul program , when disseminated and implemented without research er or agency involvement and support , would achieve results similar to those of earlier efficacy and effectiveness trials . DESIGN Prospect i ve group r and omized trial . SETTING Churches with predominantly African American membership . PARTICIPANTS A total of 1,033 members from the 15 churches completed baseline surveys . Of these participants , 562 ( 54.4 % ) completed the follow-up survey 6 months later . INTERVENTION Church-based nutrition program for African Americans that included pastoral involvement , educational activities , church environmental changes , and peer counseling . MAIN OUTCOME MEASURE Daily fruit and vegetable ( FV ) intake was assessed at pre- and posttest . ANALYSIS Mixed-effects linear models . RESULTS At posttest , there was no statistically significant difference in daily servings of FVs between the early intervention group participants compared to control group participants ( 4.7 vs 4.4 , P = .38 ) . Process evaluation suggested that added re sources such as technical assistance could improve program implementation . CONCLUSIONS AND IMPLICATION S The disseminated program may not produce improvements in FV intake equal to those in the earlier efficacy and effectiveness trials , primarily because of a lack of program implementation . Program dissemination may not achieve public health impact unless support systems are strengthened for adequate implementation at the church level",
"PURPOSE Obesity is associated with a higher risk of breast cancer mortality . The gold st and ard approach to weight loss is in-person counseling , but telephone counseling may be more feasible . We examined the effect of in-person versus telephone weight loss counseling versus usual care on 6-month changes in body composition , physical activity , diet , and serum biomarkers . METHODS One hundred breast cancer survivors with a body mass index ≥ 25 kg/m(2 ) were r and omly assigned to in-person counseling ( n = 33 ) , telephone counseling ( n = 34 ) , or usual care ( UC ) ( n = 33 ) . In-person and telephone counseling included 11 30-minute counseling sessions over 6 months . These focused on reducing caloric intake , increasing physical activity , and behavioral therapy . Body composition , physical activity , diet , and serum biomarkers were measured at baseline and 6 months . RESULTS The mean age of participants was 59 ± 7.5 years old , with a mean BMI of 33.1 ± 6.6 kg/m(2 ) , and the mean time from diagnosis was 2.9 ± 2.1 years . Fifty-one percent of the participants had stage I breast cancer . Average 6-month weight loss was 6.4 % , 5.4 % , and 2.0 % for in-person , telephone , and UC groups , respectively ( P = .004 , P = .009 , and P = .46 comparing in-person with UC , telephone with UC , and in-person with telephone , respectively ) . A significant 30 % decrease in C-reactive protein levels was observed among women r and omly assigned to the combined weight loss intervention groups compared with a 1 % decrease among women r and omly assigned to UC ( P = .05 ) . CONCLUSION Both in-person and telephone counseling were effective weight loss strategies , with favorable effects on C-reactive protein levels . Our findings may help guide the incorporation of weight loss counseling into breast cancer treatment and care",
"PURPOSE There is little prior study of major dietary patterns and breast cancer survival . METHODS Patients included 2,619 Nurses ' Health Study participants who were diagnosed with invasive breast cancer between 1982 and 1998 and completed a dietary question naire more than 1 year after diagnosis . Participants were followed through 2002 ( median = 9 years ) . During follow-up , 414 patients died of any cause , 242 patients died of breast cancer , and 172 patients died from causes other than breast cancer . Women with in situ or metastatic disease at diagnosis were excluded . We used Cox proportional hazards models to evaluate prospect i ve associations of prudent and Western dietary patterns assessed both before and after diagnosis with time to event after diagnosis . RESULTS In multivariate-adjusted analyses assessed after diagnosis , the Western and prudent dietary patterns were unrelated to all-cause or breast cancer mortality . However , compared with women with the lowest intake of the prudent dietary pattern , the relative risks ( and 95 % CIs ) of death from causes other than breast cancer were 0.85 ( 95 % CI , 0.53 to 1.35 ) , 0.74 ( 95 % CI , 0.45 to 1.21 ) , 0.70 ( 95 % CI , 0.42 to 1.17 ) , and 0.54 ( 95 % CI , 0.31 to 0.95 ; P = .03 , from lowest to highest quintile of intake ) . In contrast , the Western dietary pattern was positively associated with this outcome ( P = .04 ) . Results for the assessment of dietary patterns before diagnosis were similar , except the prudent dietary pattern was unrelated to mortality . CONCLUSION A higher intake of the prudent pattern and a lower intake of the Western pattern may protect against mortality from causes unrelated to breast cancer",
"BACKGROUND Pre clinical and observational studies suggest a relationship between dietary fat intake and breast cancer , but the association remains controversial . We carried out a r and omized , prospect i ve , multicenter clinical trial to test the effect of a dietary intervention design ed to reduce fat intake in women with resected , early-stage breast cancer receiving conventional cancer management . METHODS A total of 2437 women were r and omly assigned between February 1994 and January 2001 in a ratio of 40:60 to dietary intervention ( n = 975 ) or control ( n = 1462 ) groups . An interim analysis was performed after a median follow-up of 60 months when funding for the intervention ceased . Mean differences between dietary intervention and control groups in nutrient intakes and anthropometric variables were compared with t tests . Relapse-free survival was examined using Kaplan-Meier analysis , stratified log-rank tests , and Cox proportional hazards models . Statistical tests were two-sided . RESULTS Dietary fat intake was lower in the intervention than in the control group ( fat grams/day at 12 months , 33.3 [ 95 % confidence interval { CI } = 32.2 to 34.5 ] versus 51.3 [ 95 % CI = 50.0 to 52.7 ] , respectively ; P relapse events ( local , regional , distant , or ipsilateral breast cancer recurrence or new contralateral breast cancer ) have been reported in 96 of 975 ( 9.8 % ) women in the dietary group and 181 of 1462 ( 12.4 % ) women in the control group . The hazard ratio of relapse events in the intervention group compared with the control group was 0.76 ( 95 % CI = 0.60 to 0.98 , P = .077 for stratified log rank and P = .034 for adjusted Cox model analysis ) . Exploratory analyses suggested a differential effect of the dietary intervention based on hormonal receptor status . CONCLUSIONS A lifestyle intervention reducing dietary fat intake , with modest influence on body weight , may improve relapse-free survival of breast cancer patients receiving conventional cancer management . Longer , ongoing nonintervention follow-up will address original protocol design plans , which called for 3 years of follow-up after completion of recruitment",
"Purpose This study evaluated the feasibility and preliminary efficacy of two 6-month , self-regulation interventions that focused on daily self-weighing ( DSW ) and used objective monitoring and tailored feedback about weight ( ±activity ) , to prevent weight gain among African American breast cancer survivors . Methods Participants ( n = 35 ) were r and omized to an intervention + activity monitoring ( INT+ ) , intervention ( INT ) , or control ( CON ) group . Interventions included a wireless scale ( ±activity tracker ) that transmitted objective data to a mobile app/website , emailed lessons , and tailored feedback based on objective weight ( ±activity data ) . Participants completed in-person and online assessment s at baseline , 3 months , and 6 months . Results Ninety-four percent of participants completed assessment s at 3 months , and 97 % at 6 months . Median ( IQR ) weight change after 6 months was −0.9 % ( −4.4–0.1 ) in the INT+ ( p = 0.075 ; p = 0.067 vs. CON ) and −0.2 % ( −4.2–1.3 ) in the INT groups ( p = 0.463 ; p = 0.357 vs. CON ) , versus a 0.2 % ( −0.7–1.7 ) gain in the CON group . The proportion of INT+ , INT , and CON participants that were at or below baseline weight was 72.7 , 53.8 , and 45.5 % , respectively ( effect sizes d = 0.64 , d = 0.18 ) . Most INT+ participants weighed and wore trackers ≥5 days/week ( INT+ , 81.9 % vs. INT , 38.5 % vs. CON , 0 % ; p intervention focused on DSW as a self-monitoring strategy shows promise for preventing weight gain in breast cancer survivors . Implication s for cancer survivorsDaily self-monitoring of weight and activity may be a feasible and accessible approach to promote weight gain prevention in breast cancer survivors . Clinical trial registration Clinical Trials.gov ,",
"Previous findings suggest that exercise is a safe and efficacious means of improving physiological and psychosocial outcomes in female breast cancer survivors . To date , most research has focused on post-treatment interventions . However , given that the type and severity of treatment-related adverse effects may be dependent on the type of treatment , and that the effects are substantially more pronounced during treatment , an assessment of the safety and efficacy of exercise during treatment is warranted . In this review , we present and evaluate the results of r and omized controlled trials ( RCTs ) conducted during breast cancer treatment . We conducted literature search es to identify studies examining exercise interventions in breast cancer patients who were undergoing chemotherapy or radiation . Data were extracted on physiological and psychosocial outcomes . Cohen 's d effect sizes were calculated for each outcome . A total of 17 studies involving 1,175 participants undergoing active cancer therapy met the inclusion criteria . Findings revealed that , on average , exercise interventions result ed in moderate to large improvements in muscular strength : resistance exercise ( RE , 𝑑 = 0.86 ) , aerobic exercise ( AE , 𝑑 = 0.55 ) , small to moderate improvements in cardiovascular functioning ( RE , 𝑑 = 0.45 ; AE , 𝑑 = 0.17 , combination exercise ( COMB , 𝑑 = 0.31 ) and quality of life ( QoL ; RE , 𝑑 = 0.30 ; AE , 𝑑 = 0.50 ; COMB , 𝑑 = 0.63 ) . The results of this review suggest that exercise is a safe , feasible , and efficacious intervention in breast cancer patients who are undergoing different types of treatment . Additional research addressing the different modes of exercise during each type of treatment is warranted to assess the comparable efficacy of the various exercise modes during established breast cancer treatments",
"Purpose The purpose of this study was to assess the feasibility , acceptability , and impact of a ballroom dance intervention on improving quality of life ( QOL ) and relationship outcomes in cancer survivors and their partners . Methods We conducted a pilot r and omized controlled trial with two arms ( Restoring Health in You ( and Your Partner ) through Movement , RHYTHM ) : ( 1 ) immediate dance intervention and ( 2 ) delayed intervention ( wait-list control ) . The intervention consisted of 10 private weekly dance lessons and 2 practice parties over 12 weeks . Main outcomes were physical activity ( Godin Leisure-Time Exercise Question naire ) , functional capacity ( 6 Minute Walk Test ) , QOL ( SF-36 ) , Couples ’ trust ( Dyadic Trust Scale ) , and other dyadic outcomes . Exit interviews were completed by all participating couples . Results Thirty-one women survivors ( 68 % breast cancer ) and their partners participated . Survivors were 57.9 years old on average and 22.6 % African American . Partners had similar characteristics . RHYTHM had significant positive effects on physical activity ( p = 0.05 ) , on the mental component of QOL ( p = 0.04 ) , on vitality ( p = 0.03 ) , and on the dyadic trust scale ( p = 0.04 ) . Couples expressed satisfaction with the intervention including appreciating the opportunity to spend time and exercise together . Survivors saw this light-intensity physical activity as easing them into becoming more physically active . Conclusions Light intensity ballroom dancing has the potential to improve cancer survivors ’ QOL . Larger trials are needed to build strong support for this ubiquitous and acceptable activity . Implication s for cancer survivorsBallroom dance may be an important tool for cancer survivors to return to a physically active life and improve QOL and other aspects of their intimate life",
"PURPOSE To investigate the association between pre- and postdiagnosis physical activity ( as well as change in prediagnosis to postdiagnosis physical activity ) and mortality among women with breast cancer . PATIENTS AND METHODS This was a prospect i ve observational study of 933 women enrolled onto the Health , Eating , Activity , and Lifestyle Study who were diagnosed with local or regional breast cancer between 1995 and 1998 and observed until death or September 2004 , whichever came first . The primary outcomes measured were total deaths and breast cancer deaths . The primary exposures were physical activity in the year before and 2 years after diagnosis and the pre- to postdiagnosis change in physical activity . RESULTS Compared with inactive women , the multivariable hazard ratios ( HRs ) for total deaths for women expending at least 9 metabolic equivalent hours per week ( approximately 2 to 3 h/wk of brisk walking ) were 0.69 ( 95 % CI , 0.45 to 1.06 ; P = .045 ) for those active in the year before diagnosis and 0.33 ( 95 % CI , 0.15 to 0.73 ; P = .046 ) for those active 2 years after diagnosis . Compared with women who were inactive both before and after diagnosis , women who increased physical activity after diagnosis had a 45 % lower risk of death ( HR = 0.55 ; 95 % CI , 0.22 to 1.38 ) , and women who decreased physical activity after diagnosis had a four-fold greater risk of death ( HR = 3.95 ; 95 % CI , 1.45 to 10.50 ) . CONCLUSION Moderate-intensity physical activity after a diagnosis of breast cancer may improve prognosis",
"BACKGROUND Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life ( QOL ) and physical functioning , creating an urgent need to develop effective , durable , and disseminable interventions . Harvest for Health , a home-based vegetable gardening intervention , holds promise for these domains . METHODS This report describes the methods and recruitment experiences from two r and omized controlled feasibility trials that employ a waitlist-controlled design . Delivered in partnership with Cooperative Extension Master Gardeners , this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12months . The primary aim is to determine intervention feasibility and acceptability ; secondary aims are to explore effects on objective and subjective measures of diet , physical activity and function , and QOL and examine participant factors associated with potential effects . One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham , AL metropolitan area ( BBCS ) ; another broadly throughout Alabama among 46 older cancer survivors aged > 60 ( ASCS ) . RESULTS Response rates were 32.6 % ( BBCS ) and 52.3 % ( ASCS ) . Both trials exceeded 80 % of their accrual target . Leading reasons for in eligibility were removal of > 10 lymph nodes ( lymphedema risk factor ) , lack of physician approval , and unwillingness to be r and omized to the waitlist . CONCLUSION To date , recruitment and implementation of Harvest for Health appears feasible . DISCUSSION Although both studies encountered recruitment challenges , lessons learned can inform future larger-scale studies . Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL",
"PURPOSE This study examines the impact of yoga , including physical poses , breathing , and meditation exercises , on quality of life ( QOL ) , fatigue , distressed mood , and spiritual well-being among a multiethnic sample of breast cancer patients . PATIENTS AND METHODS One hundred twenty-eight patients ( 42 % African American , 31 % Hispanic ) recruited from an urban cancer center were r and omly assigned ( 2:1 ratio ) to a 12-week yoga intervention ( n = 84 ) or a 12-week waitlist control group ( n = 44 ) . Changes in QOL ( eg , Functional Assessment of Cancer Therapy ) from before r and om assignment ( T1 ) to the 3-month follow-up ( T3 ) were examined ; predictors of adherence were also assessed . Nearly half of all patients were receiving medical treatment . RESULTS Regression analyses indicated that the control group had a greater decrease in social well-being compared with the intervention group after controlling for baseline social well-being and covariates ( P 71 patients not receiving chemotherapy during the intervention period indicated favorable outcomes for the intervention group compared with the control group in overall QOL ( P emotional well-being ( P social well-being ( P spiritual well-being ( P distressed mood ( P fatigue ( P age ( P antiestrogen therapy ( P social functioning among a medically diverse sample of breast cancer survivors . Among patients not receiving chemotherapy , yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL",
"AIMS AND BACKGROUND The DIANA ( Diet and And rogens)-5 study is a multi-institutional r and omized controlled trial of the effectiveness of a diet based on Mediterranean and macrobiotic recipes and principles , associated with moderate physical activity , in reducing additional breast cancer events in women with early stage invasive breast cancer at high risk of recurrence because of metabolic or endocrine milieu . The intervention is expected to reduce serum insulin and sex hormones , which were associated with breast prognosis in previous studies . METHODS Between 2008 and 2010 , the study r and omly assigned 1208 patients to an intensive diet and exercise intervention or to a comparison group , to be followed-up through 2015 . General lifestyle recommendations for the prevention of cancer are given to both groups , and the intervention group is being offered a comprehensive lifestyle intervention , including cooking classes , conferences , common meals and exercise sessions . Adherence assessment s occurred at baseline and at 12 months and are planned at 36 and 60 months . They include food frequency diaries , anthropometric measures , body fat distribution assessed with impedance scale , one week registration of physical activity with a multisensor arm-b and monitor , metabolic and endocrine blood parameters . Outcome breast cancer events are assessed through self report at semi annual meetings or telephone interview and are vali date d through medical record verification . RESULTS The r and omized groups were comparable for age ( 51.8 years ) , proportion of ER-negative tumors ( 22 % ) , axillary node metastasis ( 42 % ) , reproductive variables , tobacco smoking , blood pressure , anthropometric measurements and hormonal and metabolic parameters . CONCLUSIONS DIANA-5 has the potential to establish whether a Mediterranean-macrobiotic lifestyle may reduce breast cancer recurrences . We will assess evidence of effectiveness , first by comparing the incidence of additional breast cancer events ( local or distant recurrence , second ipsilateral or contralateral cancer ) in the intervention and in the control group , by an intention-to-treat analysis , and second by analyzing the incidence of breast cancer events in the total study population by compliance assessment score",
"BACKGROUND Physical activity is positively associated with survival and quality of life among breast cancer survivors . Despite these benefits , the majority of breast cancer survivors are insufficiently active . The potential health benefits of reducing sedentary behaviour ( sitting time ) in this population have not been extensively investigated . The ACTIVATE Trial will evaluate the efficacy of an intervention that combines wearable technology ( the Garmin Vivofit2 ® ) with traditional behavioural change approaches to increase physical activity and reduce sedentary behaviour performed by breast cancer survivors . METHODS / DESIGN This r and omised controlled trial includes inactive , postmenopausal women diagnosed with stage I-III breast cancer who have completed their primary treatment . Participants are r and omly assigned to the primary intervention group ( Garmin Vivofit2 ® ; behavioural feedback and goal setting session ; and , five telephone-delivered health coaching sessions ) or to the wait-list control group . The primary intervention is delivered over a 12-week period . The second 12-week period comprises a maintenance phase for the primary intervention group , and an abridged intervention ( Garmin Vivofit2 ® only ) for the wait-list control group . Moderate- to vigorous-intensity physical activity ( MVPA ) and sedentary behaviour are assessed by accelerometry at baseline ( T1 ) , end of intervention ( T2 ) , and end of maintenance phase ( T3 ) . DISCUSSION The ACTIVATE Trial is one of the first studies to incorporate wearable technology into an intervention for cancer survivors . If the use of wearable technology ( in combination with behaviour change strategies , or alone ) proves efficacious , it may become an inexpensive and sustainable addition to the health promotion strategies available to health care providers in the cancer survivorship context . TRIAL REGISTRATION ACTRN12616000175471",
"The primary purpose of the current study was to determine prospect i ve associations of accelerometer‐assessed physical activity intensity and sedentary time with health‐related quality of life ( HRQOL ) indicators among survivors of breast cancer",
"PURPOSE Obesity is associated with poor outcomes in women with operable breast cancer . Lifestyle interventions ( LIs ) that help women reduce their weight may improve outcomes . PATIENTS AND METHODS We conducted a multicenter r and omized trial comparing mail-based delivery of general health information alone or combined with a 24-month st and ardized , telephone-based LI that included diet ( 500 to 1,000 kcal per day deficit ) and physical activity ( 150 to 200 minutes of moderate-intensity physical activity per week ) goals to achieve weight loss ( up to 10 % ) . Women receiving adjuvant letrozole for T1 - 3N0 - 3M0 breast cancer with a body mass index ( BMI ) ≥ 24 kg/m(2 ) were eligible . Weight was measured in the clinic , and self-report physical activity , quality -of-life ( QOL ) , and diet question naires were completed . The primary outcome was disease-free survival . Accrual was terminated at 338 of 2,150 planned patients because of loss of funding . RESULTS Mean weight loss was significantly ( P chemotherapy ) . Weight loss was greatest in those with higher baseline levels of moderate-intensity physical activity or improvement in QOL . Hospitalization rates and medical events were similar . CONCLUSION A telephone-based LI led to significant weight loss that was still evident at 24 months , without adverse effects on QOL , hospitalizations , or medical events . Adequately powered r and omized trials with cancer end points are needed"
] | 41166e4c-06ff-11f0-808a-c43d1ab1c353 |
Importance The increased social and economic burdens for osteoporosis-related fractures worldwide make the prevention of such injuries a major public health goal . Previous studies have reached mixed conclusions regarding the association between calcium , vitamin D , or combined calcium and vitamin D supplements and fracture incidence in older adults . Objective To investigate whether calcium , vitamin D , or combined calcium and vitamin D supplements are associated with a lower fracture incidence in community-dwelling older adults . Data Sources The PubMed , Cochrane library , and EMBASE data bases were systematic ally search ed from the inception date s to December 24 , 2016 , using the keywords calcium , vitamin D , and fracture to identify systematic review s or meta-analyses . The primary r and omized clinical trials included in systematic review s or meta-analyses were identified , and an additional search for recently published r and omized trials was performed from July 16 , 2012 , to July 16 , 2017 . Study Selection R and omized clinical trials comparing calcium , vitamin D , or combined calcium and vitamin D supplements with a placebo or no treatment for fracture incidence in community-dwelling adults older than 50 years . Data Extraction and Synthesis Two independent review ers performed the data extraction and assessed study quality . A meta- analysis was performed to calculate risk ratios ( RRs ) , absolute risk differences ( ARDs ) , and 95 % CIs using r and om-effects models . Main Outcomes and Measures Hip fracture was defined as the primary outcome . Secondary outcomes were nonvertebral fracture , vertebral fracture , and total fracture . Results A total of 33 r and omized trials involving 51 145 participants fulfilled the inclusion criteria . There was no significant association of calcium or vitamin D with risk of hip fracture compared with placebo or no treatment ( calcium : RR , 1.53 [ 95 % CI , 0.97 to 2.42 ] ; ARD , 0.01 [ 95 % CI , 0.00 to 0.01 ] ; vitamin D : RR , 1.21 [ 95 % CI , 0.99 to 1.47 ] ; ARD , 0.00 [ 95 % CI , −0.00 to 0.01 ] . There was no significant association of combined calcium and vitamin D with hip fracture compared with placebo or no treatment ( RR , 1.09 [ 95 % CI , 0.85 to 1.39 ] ; ARD , 0.00 [ 95 % CI , −0.00 to 0.00 ] ) . No significant associations were found between calcium , vitamin D , or combined calcium and vitamin D supplements and the incidence of nonvertebral , vertebral , or total fractures . Subgroup analyses showed that these results were generally consistent regardless of the calcium or vitamin D dose , sex , fracture history , dietary calcium intake , and baseline serum 25-hydroxyvitamin D concentration . Conclusions and Relevance In this meta- analysis of r and omized clinical trials , the use of supplements that included calcium , vitamin D , or both compared with placebo or no treatment was not associated with a lower risk of fractures among community-dwelling older adults . These findings do not support the routine use of these supplements in community-dwelling older people | [
"Summary This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status . The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks , and this dose should be tested in future trials for fracture prevention . Introduction The aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU ( 100 μg ) , 2000 IU ( 50 μg ) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes . Methods This is a r and omized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire , UK . Outcomes included biochemical markers of vitamin D status ( plasma 25-hydroxy-vitamin D [ 25[OH]D ] , parathyroid hormone [ PTH ] , calcium and alkaline phosphatase ) , cardiovascular risk factors and tests of physical function . Results Mean ( SD ) plasma 25(OH)D levels were 50 ( 18 ) nmol/L at baseline and increased to 137 ( 39 ) , 102 ( 25 ) and 53 ( 16 ) nmol/L after 12 months in those allocated 4000 IU , 2000 IU or placebo , respectively ( with 88 % , 70 % and 1 % of these groups achieving the pre-specified level of > 90 nmol/L ) . Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium . The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index , for which the further increase was smaller in overweight and obese participants compared with normal-weight participants . Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function . Conclusions After accounting for average 70 % compliance in long-term trials , doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies",
"UNLABELLED This study of 9605 community-dwelling residents supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in elderly in a northern European region known to be deficient in vitamin D , especially during winter periods . INTRODUCTION We evaluated the effect of two programs for the prevention of osteoporotic fractures leading to acute hospital admission in a population of elderly community-dwelling residents . MATERIAL S AND METHODS This was a factorial , cluster-r and omized , pragmatic , intervention study . We included 9605 community-dwelling residents aged 66 + years . We offered a prevention program of a daily supplement of 1000 mg of elemental calcium as calcium carbonate and 400 IU ( 10 microg ) of vitamin D3 to a total of 4957 participants . Another program with evaluation and suggestions for the improvement of the domestic environment was offered to a total of 5063 participants . Both programs included revision of the resident 's current pharmaceutical treatment . We achieved information on osteoporotic fractures in the study population from the Danish Hospital Registration Data base . We defined osteoporotic fractures as low energy fractures of the proximal humerus , distal forearm , vertebral column , pelvis , cervical femur , and intertrochanteric femur . RESULTS Active participation was 50.3 % in the Calcium and Vitamin D Program and 46.4 % in the Environmental and Health Program . We observed a 16 % reduction in fracture incidence rate ( relative risk [ RR ] , 0.84 ; CI , 0.72 - 0.98 ; p female residents offered the Calcium and Vitamin D Program ( intention-to-prevent analysis ) . CONCLUSIONS This study supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in community-dwelling elderly people in a northern European region known to be deficient in vitamin D , especially during winter periods",
"Conflicting data regarding cardiovascular effects of thiazolidinediones ( TZDs ) and extra-skeletal effects of vitamin D supported the need for a definitive trial . The Thiazolidinedione Intervention with vitamin D Evaluation ( TIDE ) trial aim ed to assess the effects of TZDs ( rosiglitazone and pioglitazone ) on cardiovascular outcomes and the effects of vitamin D ( cholecalciferol ) on cancers and mortality . A large multicentre 3 × 2 factorial double-blind placebo-controlled r and omised trial recruited from outpatient primary care and specialty clinics in 33 countries . From June 2009 to July 2010 , 1,332 people with type 2 diabetes and other cardiovascular risk factors aged ≥50 years whose HbA1c was 6.5–9.5 % ( 48–80 mmol/mol ) when using two or fewer glucose-lowering drugs were r and omised by a central computer system to placebo ( n = 541 ) , rosiglitazone 4–8 mg/day ( n = 399 ) or pioglitazone 30–45 mg/day ( n = 392 ) ; 1,221 participants were r and omised to placebo ( n = 614 ) or vitamin D 1,000 IU/day ( n = 607 ) . Participants and all study personnel were blind to treatment allocation . The primary outcome for the TZD arm was the composite of myocardial infa rct ion , stroke or cardiovascular death , and for the vitamin D arm it was cancer or all-cause death . All r and omised participants were included in the primary analysis . From the study design , 16,000 people were to be followed for approximately 5.5 years . However , the trial was stopped prematurely because of regulatory concerns after a mean of 162 days without consideration of the accrued data . In the TZD arm , the cardiovascular outcome occurred in five participants ( 0.9 % ) in the placebo groups and three participants ( 0.4 % ) in the TZD groups ( two allocated to pioglitazone , one to rosiglitazone ) . In the vitamin D arm , the primary outcome occurred in three participants ( 0.5 % ) in the placebo group and in two participants ( 0.3 % ) receiving vitamin D. Adverse events were comparable in all groups . Uncertainty persists regarding the clinical ly relevant risks and benefits of TZDs and vitamin D because of the early cancellation of this comprehensive trial . Clinical Trials.gov NCT00879970 The study was funded by GlaxoSmithKline",
"BACKGROUND Older people living in residential aged care facilities ( RACFs ) are at a higher risk of suffering fractures than the community-dwelling older population . The first Consensus Conference on Treatment of Osteoporosis in RACFs in Australia , held in Sydney in July 2009 , aim ed to address some of the issues relating to the treatment of older residents with osteoporosis in RACFs . Considering that the field of osteoporosis diagnosis and management has significantly advanced in the last 5 years and that new evidence has been generated from studies performed within RACFs , a Second Consensus Conference was held in Sydney in November 2014 . METHODS An expert panel met in November 2014 in Penrith , NSW , Australia in an attempt to reach a consensus on diverse issues related to the treatment of osteoporosis at RACFs . Participants were selected by the scientific committee on the basis of their practice in an RACF and /or major published articles . The co-chairs distributed topics r and omly to all participants , who then had to propose a statement on each topic for approval by the conference after a short , evidence -based presentation , when possible . RESULTS This article provides an up date on the most relevant evidence on osteoporosis in older people living in RACFs grade d according to its level , quality , and relevance . CONCLUSION As with the first consensus , it is hoped that this statement will constitute an important guide to aid physicians in their decision making while practicing at RACFs",
"This placebo-controlled r and omized trial was conducted to ascertain the value of calcium citrate supplementation in averting bone loss in 63 postmenopausal women , 57 of whom were early postmenopausal ( five years after menopause ) and six of whom were mid-postmenopausal ( five to ten years after menopause ) . Bone density data were available for 25 women who took 800 mg of calcium citrate daily and 31 women who received placebo for one to two years . The two groups were similar in baseline age , years postmenopause ( 3.3 in the calcium citrate group vs 2.7 in the placebo group ) , height , weight , calcium intake , and L2-L4 bone density . L2-L4 bone density did not change during calcium citrate treatment ( + 1.03 % after two years ) , whereas it declined significantly by -2.38 % after two years on placebo ( P Femoral neck bone density did not change in either group . Radial shaft bone density did not change in the calcium citrate group ( -0.02 % after two years ) , but it declined significantly in the placebo group ( -1.79 % after one year and -3.03 % after two years , P in bone density of the L2-L4 vertebrae and radial shaft after two years of treatment was significant between the two groups . An analysis of covariance disclosed no significant effect of calcium citrate on L2-L4 bone density during the first three years after menopause , but a protective effect after three years . Although serum PTH did not change , serum and urinary calcium increased and serum calcitriol and urinary phosphorus decreased in the calcium citrate group , indicative of parathyroid suppression . Serum bone-specific alkaline phosphatase and osteocalcin , and urinary hydroxyproline and N-telopeptide decreased during some calcium citrate treatment periods , indicative of a reduction in bone turnover . Thus , calcium citrate supplementation ( 400 mg of calcium twice daily ) averted bone loss and stabilized bone density in the spine , femoral neck , and radial shaft in women relatively soon after menopause . This bone-sparing action was probably due to the inhibition of bone resorption from parathyroid suppression",
"BACKGROUND AND METHODS Laboratory , clinical , and epidemiologic evidence suggests that calcium may help prevent colorectal adenomas . We conducted a r and omized , double-blind trial of the effect of supplementation with calcium carbonate on the recurrence of colorectal adenomas . We r and omly assigned 930 subjects ( mean age , 61 years ; 72 percent men ) with a recent history of colorectal adenomas to receive either calcium carbonate ( 3 g [ 1200 mg of elemental calcium ] daily ) or placebo , with follow-up colonoscopies one and four years after the qualifying examination . The primary end point was the proportion of subjects in whom at least one adenoma was detected after the first follow-up endoscopy but up to ( and including ) the second follow-up examination . Risk ratios for the recurrence of adenomas were adjusted for age , sex , lifetime number of adenomas before the study , clinical center , and length of the surveillance period . RESULTS The subjects in the calcium group had a lower risk of recurrent adenomas . Among the 913 subjects who underwent at least one study colonoscopy , the adjusted risk ratio for any recurrence of adenoma with calcium as compared with placebo was 0.85 ( 95 percent confidence interval , 0.74 to 0.98 ; P=0.03 ) . The main analysis was based on the 832 subjects ( 409 in the calcium group and 423 in the placebo group ) who completed both follow-up examinations . At least one adenoma was diagnosed between the first and second follow-up endoscopies in 127 subjects in the calcium group ( 31 percent ) and 159 subjects in the placebo group ( 38 percent ) ; the adjusted risk ratio was 0.81 ( 95 percent confidence interval , 0.67 to 0.99 ; P=0.04 ) . The adjusted ratio of the average number of adenomas in the calcium group to that in the placebo group was 0.76 ( 95 percent confidence interval , 0.60 to 0.96 ; P=0.02 ) . The effect of calcium was independent of initial dietary fat and calcium intake . CONCLUSIONS Calcium supplementation is associated with a significant - though moderate - reduction in the risk of recurrent colorectal adenomas",
"Abstract Osteoporosis and related fragility fractures represent a serious and global public health problem . To evaluate whether the modified eighth section of Eight-section Brocade ( MESE ) exercise could improve the symptom and indexes associated with osteoporosis in postmenopausal women . Guangzhou and Liuzhou hospital of traditional Chinese medicine in China . Women ( n = 198 ) aged 50 to 75 years were r and omized into Control , Ca , MESE , and MESE + Ca . Subjects in Ca and MESE groups were separately asked to consume thrice daily Calcium Carbonate Chewable D3 tablet and to perform thrice daily MESE exercise by 7 repetitions per time for 12 months . Subjects in MESE + Ca group performed such the combined treatment project for 12 months . Body height and Hospital for Special Surgery ( HSS ) scores of both knees , chronic back pain visual analogue scale scores ( VAS ) , bone mineral density ( BMD ) at L2 to L4 and the left femoral neck , 3-feet Up and Go Test ( 3′ ) and one-leg Stance ( OLS ) . In our study , the improvement in chronic back pain of the patients in Ca , MESE , and MESE + Ca group was better than that in control group . There was 1.9 % and 1.7 % , 2.3 % , and 2.1 % net profit in left femoral neck and lumbar BMD after the treatment for 12 months in MESE and MESE + Ca groups . For the balance capacity , the subjects in MESE and MESE + Ca groups secured much better performance than those in Ca and control group after the treatment for 12 months ( P treatment of MESE exercise is the most effective for the improvement of the symptom and indexes in postmenopausal women . Importantly , the low attrition and the high exercise compliance indicate that MESE exercise is safe , feasible , and well tolerated by postmenopausal women",
"In a double-blind trial , 327 patients ( 57 men ) over 65 ( mean age 79.5 ) years received all possible combinations of calcium carbonate 3 g , vitamin D3 1000 iu , meth and ienone 2.5 mg and /or placebos daily for 9 months . The higher incidence of bone fractures in the placebo group was not significant . Serum calcium , phosphorus , creatinine , aspartate aminotransferase and alkaline phosphatase were followed : the greatest changes occurred with meth and ienone , which thus reduced osteoporotic activity and increased the muscular mass most effectively ; calcium carbonate had the poorest effect . Surprisingly , coronary mortality was higher among those taking all three active substances . With two treatments the increase was not significant , but when both the groups receiving a combination of any two of the treatments were compared with those taking only one or neither of these two treatments , a significant increase in coronary deaths was seen , most significant ( P less than 0.001 ) in those receiving vitamin D3 and meth and ienone",
"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",
"BACKGROUND The 2009 KDIGO ( Kidney Disease : Improving Global Outcomes ) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 ( 25[OH]D ) levels patients treated with maintenance hemodialysis , but does not provide a specific treatment protocol . STUDY DESIGN 2-center , double-blind , r and omized , 13-week , controlled trial followed by a 26-week open-label study . SETTING & PARTICIPANTS 55 adult maintenance hemodialysis patients with 25(OH)D levels INTERVENTION Cholecalciferol , 25,000IU , per week orally versus placebo for 13 weeks , then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI ( National Kidney Foundation-Kidney Disease Outcomes Quality Initiative ) guidelines . OUTCOMES Primary end point was the percentage of patients with 25(OH)D levels≥30ng/mL at 13 weeks . Secondary outcomes included the percentage of patients with normal calcium , phosphorus , and intact parathyroid hormone ( iPTH ) blood levels . Safety measures included incidence of hypercalcemia and hypervitaminosis D. MEASUREMENTS Blood calcium and phosphate were measured weekly ; iPTH , 25(OH)D , 1,25-dihydroxyvitamin D3 ( 1,25[OH]2D ) , and bone turnover markers , trimonthly ; fetuin A and fibroblast growth factor 23 ( FGF-23 ) serum levels and aortic calcification scores were determined at weeks 0 and 39 . RESULTS The primary end point significantly increased in the treatment group compared with the placebo group ( 61.5 % vs 7.4 % ; P well as 1,25(OH)2D levels ( 22.5 [ IQR , 15 - 26 ] vs 11 [ IQR , 10 - 15]pg/mL ; P proportion of patients achieving the target calcium level ( 76.9 % vs 48.2 % ; P=0.03 ) . Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups . The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level≥30ng/mL in patients issued from the placebo group . LIMITATIONS Small size of the study population . CONCLUSIONS Oral weekly administration of 25,000IU of cholecalciferol for 13 weeks is an effective , safe , inexpensive , and manageable way to increase 25(OH)D and 1,25(OH)2D levels in hemodialysis patients . Further evaluation of clinical end points is suggested",
"CONTEXT Bone health is influenced by the intake of both calcium and vitamin D. OBJECTIVE Our objective was to evaluate the influence of calcium and vitamin D supplementation on PTH and bone turnover . SETTING , PATIENTS , AND DESIGN : At an ambulatory research center , 159 postmenopausal healthy white women participated in this double-blind , placebo-controlled parallel , longitudinal factorial study that was 6 months in duration . INTERVENTIONS Subjects were r and omly allocated to 4 groups : 1 ) double placebo , 2 ) calcium ( 1200 mg daily ) plus placebo , 3 ) vitamin D3 ( 100 μg ) plus placebo , and 4 ) vitamin D3 and calcium . Serum and urine were collected fasting and 2 hours after a calcium load at baseline and at 3 and 6 months . MAIN OUTCOME MEASURES Serum PTH , cross-linked C-telopeptide ( CTX ) , and procollagen type I N-terminal propeptide ( P1NP ) were measured . RESULTS Before study medication , a calcium load result ed in a decline in PTH and CTX and an increase in urinary calcium excretion . Serum CTX and P1NP declined over time with calcium supplementation but did not change with increased vitamin D intake . There was a decline in PTH in the vitamin D groups in the fasting state compared with placebo . Suppression of PTH was greater after a calcium load in the vitamin D groups . A calcium load decreased PTH and CTX and raised urinary calcium . CONCLUSIONS Fasting PTH declines with vitamin D supplementation . PTH declines after calcium intake . Supplementation of the diet with 1200 mg calcium/d reduces bone turnover markers , whereas supplementation with up to100 μg vitamin D3/d does not",
"Abstract Objective : To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community . Design : R and omised double blind controlled trial of 100 000 IU oral vitamin D3 ( cholecalciferol ) supplementation or matching placebo every four months over five years . Setting and participants : 2686 people ( 2037 men and 649 women ) aged 65 - 85 years living in the general community , recruited from the British doctors register and a general practice register in Suffolk . Main outcome measures : Fracture incidence and total mortality by cause . Results : After five years 268 men and women had incident fractures , of whom 147 had fractures in common osteoporotic sites ( hip , wrist or forearm , or vertebrae ) . Relative risks in the vitamin D group compared with the placebo group were 0.78 ( 95 % confidence interval 0.61 to 0.99 , P=0.04 ) for any first fracture and 0.67 ( 0.48 to 0.93 , P=0.02 ) for first hip , wrist or forearm , or vertebral fracture . 471 participants died . The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 ( 0.74 to 1.06 , P=0.18 ) . Findings were consistent in men and women and in doctors and the general practice population . Conclusion : Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community . What is already known in this topic Vitamin D and calcium supplements are effective in preventing fractures in elderly women Whether isolated vitamin D supplementation prevents fractures is not clear What this paper adds Four monthly oral supplementation with 100 000 IU vitamin D reduces fractures in men and women aged over 65 living in the general community Total fracture incidence was reduced by 22 % and fractures in major osteoporotic sites by 33",
"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",
"UNLABELLED Dietary supplementation with vitamin K(1 ) , with vitamin D(3 ) and calcium or their combination , was examined in healthy older women during a 2-year , double-blind , placebo-controlled trial . Combined vitamin K with vitamin D plus calcium was associated with a modest but significant increase in BMC at the ultradistal radius but not at other sites in the hip or radius . INTRODUCTION The putative beneficial role of high dietary vitamin K(1 ) ( phylloquinone ) on BMD and the possibility of interactive benefits with vitamin D were studied in a 2-year double-blind , placebo-controlled trial in healthy Scottish women > or = 60 years of age . MATERIAL S AND METHODS Healthy , nonosteoporotic women ( n = 244 ) were r and omized to receive either ( 1 ) placebo , ( 2 ) 200 microg/day vitamin K(1 ) , ( 3 ) 10 microg ( 400 IU ) vitamin D(3 ) plus 1000 mg calcium/day , or ( 4 ) combined vitamins K(1 ) and D(3 ) plus calcium . Baseline and 6-month measurements included DXA bone mineral scans of the hip and wrist , markers of bone turnover , and vitamin status . Supplementation effects were tested using multivariate general linear modeling , with full adjustment for baseline and potential confounding variables . RESULTS Significant bone mineral loss was seen only at the mid-distal radius but with no significant difference between groups . However , women who took combined vitamin K and vitamin D plus calcium showed a significant and sustained increase in both BMD and BMC at the site of the ultradistal radius . Serum status indicators responded significantly to respective supplementation with vitamins K and D. Over 2 years , serum vitamin K(1 ) increased by 157 % ( p percentage of undercarboxylated osteocalcin ( % GluOC ) decreased by 51 % ( p serum 25-hydroxyvitamin D [ 25(OH)D ] increased by 17 % ( p PTH decreased by 11 % ( p = 0.049 ) . CONCLUSIONS These results provide evidence of a modest synergy in healthy older women from nutritionally relevant intakes of vitamin K(1 ) together with supplements of calcium plus moderate vitamin D(3 ) to enhance BMC at the ultradistal radius , a site consisting of principally trabecular bone . The substantial increase in gamma-carboxylation of osteocalcin by vitamin K may have long-term benefits and is potentially achievable by increased dietary intakes of vitamin K rather than by supplementation",
"Dietary supplements that prevent bone loss at the hip and that can be applied safely in the elderly are likely to reduce hip fractures . A daily dietary supplement of 750 mg calcium or 15 microg 25OH vitamin D3 on bone loss at the hip and other sites , bone turnover and calcium-regulating hormones were studied over 4 yr in elderly volunteers using a r and omized , double-blind , placebo-controlled trial . Bone mineral density ( BMD ) was measured by dual x-ray absorptiometry and bone structure by radiographs . Calcium biochemistry and bone turnover markers were measured in blood and urine . The 316 women entering the trial had a mean age of 73.7 yr and the 122 men of 75.9 yr . Baseline median calcium intake was 546 mg/day , and median serum 25OH vitamin D3 was 59 nmol/L. On placebo , loss of BMD at total hip was 2 % and femoral medulla expansion was 3 % over 4 yr . Calcium reduced bone loss , secondary hyperparathyroidism , and bone turnover . 25OH vitamin D3 was intermediate between placebo and calcium . Fracture rates and drop-out rates were similar among groups , and there were no serious adverse events with either supplement . A calcium supplement of 750 mg/day prevents loss of BMD , reduces femoral medullary expansion , secondary hyperparathyroidism , and high bone turnover . A supplement of 15 microg/day 25OH vitamin D3 is less effective , and because its effects are seen only at low calcium intakes , suggests that its beneficial effect is to reverse calcium insufficiency",
"We tested the spine antifracture and bone sparing efficacy of 1.2 g/day of oral calcium as carbonate in two groups of elderly women , one with prevalent fractures ( PF , n = 94 ) on entry and the other without ( NPF , n = 103 ) . It was a prospect i ve r and omized , double-blind , placebo-controlled trial in mostly rural communities in women over age 60 who were living independently and were consuming calcium . We obtained annual lateral spine radiographs and semiannual forearm bone density over 4.3 + /- 1.1 years and determined vertebral fractures by radiographic morphometry augmented by physician assessment . In the PF group , 15 of 53 subjects on calcium had incident fractures , compared with 21 of 41 on placebo ( p = 0.023 , chi2 ) . Calcium did not reduce the rate of incident fractures in the NPF group . Those with a prevalent fracture on entry and not treated with calcium were 2.8 times more likely to experience an incident fracture than all others . Change in the forearm bone mass on placebo in the PF group was -1.24 + /- 2.41%/year compared with + 0.31 + /- 1.80%/year on calcium ( p elderly postmenopausal women with spine fractures and selfselected calcium intakes of , a calcium supplement of 1.2 g/day reduces the incidence of spine fractures and halts measurable bone loss",
"BACKGROUND The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal . METHODS We recruited 36,282 postmenopausal women , 50 to 79 years of age , who were already enrolled in a Women 's Health Initiative ( WHI ) clinical trial . We r and omly assigned participants to receive 1000 mg of elemental [ corrected ] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo . Fractures were ascertained for an average follow-up period of 7.0 years . Bone density was measured at three WHI centers . RESULTS Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group ( P calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture ( 95 percent confidence interval , 0.72 to 1.08 ) , 0.90 for clinical spine fracture ( 0.74 to 1.10 ) , and 0.96 for total fractures ( 0.91 to 1.02 ) . The risk of renal calculi increased with calcium plus vitamin D ( hazard ratio , 1.17 ; 95 percent confidence interval , 1.02 to 1.34 ) . Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 ( 95 percent confidence interval , 0.52 to 0.97 ) . Effects did not vary significantly according to prer and omization serum vitamin D levels . CONCLUSIONS Among healthy postmenopausal women , calcium with vitamin D supplementation result ed in a small but significant improvement in hip bone density , did not significantly reduce hip fracture , and increased the risk of kidney stones . ( Clinical Trials.gov number , NCT00000611 . )",
"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",
"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",
"Vitamin D deficiency is common in elderly persons , especially those with hip fracture [ 1 , 2 ] . It is caused by low exposure to sunshine , decreased synthesis of vitamin D3 in the aging skin , and a diet low in vitamin D [ 3 , 4 ] . The mean vitamin D intake in elderly persons in the Netherl and s is about 100 IU/d , half that of elderly persons in the United States [ 5 ] . Most of this vitamin D comes from margarine , which is the only vitamin D-supplemented food in the Netherl and s ( 3 IU/g ) . In vitamin D deficiency , the low serum concentration of 25-hydroxyvitamin D [ 25(OH)D ] leads to a low 1,25-dihydroxyvitamin D [ 1,25(OH)2D ] concentration and then to a higher serum parathyroid hormone concentration , especially in the winter [ 6 - 10 ] . Histologically , the increased parathyroid activity is associated with high bone turnover , leading to cortical bone loss and low density bone [ 5 , 11 ] , which may lead to hip fracture . We previously studied the effects of vitamin D supplementation in residents of a home for the elderly and residents of a nursing home [ 10 ] . Vitamin D3 , 400 IU/d , led to an adequate increase of the serum 25(OH)D concentration , to a small but significant increase of the serum 1,25(OH)2D concentration , and to a decrease of the serum concentration of intact parathyroid hormone . It was recently observed [ 12 , 13 ] that bone mineral density at the hip is positively related to serum 25(OH)D concentration in postmenopausal and elderly women . Therefore , it might be expected that vitamin D supplementation would increase bone mineral density in elderly persons deficient in vitamin D. In line with this expectation , it was shown that vitamin D supplementation prevented bone loss from the spine during the winter in postmenopausal women [ 14 ] . These results suggest that vitamin D supplementation may reduce the incidence of hip fractures , because bone strength shows a strong correlation with bone mineral density [ 15 ] . However , increasing bone mineral density through a therapeutic intervention does not necessarily lead to increased bone strength , as has been shown with sodium fluoride [ 16 ] . Bone structure and bone quality are also determinants of bone strength [ 17 ] , and falls are a risk factor for hip fractures [ 18 ] . Therefore , hip fracture should be the outcome criterion in studies on the effect of vitamin D supplementation . Intervention studies on the prevention of osteoporotic fractures necessitate large numbers of patients , because the outcome has an annual incidence of 0.5 % to 4 % in the elderly population [ 19 ] . We report the results of a large-scale , prospect i ve study on the effect of vitamin D supplementation on the incidence of hip and other osteoporotic fractures . Methods Participants The study included 2578 persons ( 1916 women and 662 men ) 70 years of age and older ( mean age SD , 80 6 years ; range , 70 to 97 years ) . Participants were recruited from general practitioners , from apartment houses for elderly persons , and from homes for elderly persons in Amsterdam and its vicinity . Persons recruited from practitioners were living independently ; those recruited from apartment houses and homes were receiving some care , but less than they would have received in a nursing home . Participants had to be reasonably healthy and able to give informed consent . Persons with a history of hip fracture or total hip arthroplasty , known hypercalcemia , sarcoidosis , or recent urolithiasis ( were not excluded . The spontaneous use of vitamin D supplements and multivitamins was discouraged , but the prescription practice s of the general practitioners were not altered . All vitamin use was carefully documented . The study was approved by the Ethical Review Board of the Vrije Universiteit Hospital , and all participants gave informed consent . Study Design After checking the inclusion and exclusion criteria and obtaining informed consent , the participants were r and omly assigned to receive either active treatment with vitamin D3 or placebo . The study was double-blind , and r and omization was done in blocks of 10 per general practice , apartment house , or home . R and omization lists were made using a computerized r and om-number generator . Lists in sealed envelopes were sent to the hospital pharmacy for assignment . Each participant took either one tablet per day that contained vitamin D3 , 400 IU , or one placebo tablet per day that was identical in appearance and taste to the vitamin tablet . After enrollment , the participants received the first container of tablets ( 210 tablets ) . The container was replaced every 6 months with a full container . All participants were also advised in writing to consume at least three servings of dairy products per day ( for example , 1 glass of milk , 1 cup of yogurt , and 1 slice of cheese ) to ensure a calcium intake of at least 800 to 1000 mg/d . The study was started in August 1988 . The last participant was enrolled in December 1990 , and all participants had stopped using study medication by December 1993 . The follow-up period had been planned to last no more than 3 years , but because the number of hip fractures during the study was lower than expected , a 6-month extension was planned . The study participants thus received medication for 3 to 3.5 years ; those who received it for 3.5 years were those who consented to the 6-month extension . Total follow-up was to a maximum of 4 years . Data collected at baseline included an outdoor activity score ( 1 equals going outdoors less than once a week ; 2 equals going outdoors 1 or 2 times per week ; and 3 equals going outdoors 3 times per week or more ) and a score for sunshine exposure ( when outside : 1 equals in the shade as much as possible ; 2 equals sometimes in sunshine ; 3 equals much exposure to sunshine ) . These scores show a positive relation with serum 25(OH)D concentration [ 3 ] . Mobility was estimated by a walking score that ranged from 1 ( unable to walk ) to 5 ( walks independently a fair distance on any surface ) [ 20 ] . The dietary calcium intake from dairy products was estimated in a subset of 348 women by using a question naire , as described previously [ 21 ] . The participants were evaluated annually with a question naire on hip fractures , other peripheral fractures , outdoor score , sunshine exposure score , use of vitamin supplements , and walking score . Each general practitioner or caretaker was asked to immediately report change of address , hip fracture , or death . Hip fracture and death were verified by the general practitioner . All participants were followed for the maximal period of 4 years if possible , even if they had stopped using the trial medication , had sustained a fracture , or had moved to another city . To investigate possible selection bias , 267 potential participants in a home for the elderly and its adjunct apartments ( all residents of the institution ) were studied for baseline characteristics , including age , sex , sunshine exposure score , outdoor score , walking score , and reasons for nonparticipation . Compliance was checked when the tablet containers were replaced ( every 6 months ) , by question naire ( every year ) , and by measurement of the serum 25(OH)D concentration . Serum 25(OH)D concentration was measured at baseline and after 1 year in 270 persons who participated in a sub study investigating the effect of vitamin D supplementation on bone mineral density and bone turnover variables . This sub study included a nonr and om sample of participants from several apartment houses and homes for the elderly and is described in detail elsewhere [ 21 ] . In the same sub study , dietary calcium intake from diary products was assessed . Serum 25(OH)D concentration was also estimated during the third year of the study in February and March in a r and om sample of 96 participants drawn from the remaining study population . These participants received a letter giving them an appointment within 10 days ; the blood sample s were drawn at home . Serum 25(OH)D concentration was measured by competitive protein binding assay after being purified by gradient high-pressure liquid chromatography . The intra- and interassay coefficients of variation were 5 % and 6 % , respectively [ 22 ] . Statistical Analysis Baseline data of the vitamin D group and the placebo group were compared using t-tests ( age , calcium intake ) , chi-square tests ( sex , residence ) , and Wilcoxon rank-sum tests ( scores ) . The serum 25(OH)D concentrations of both groups were compared using t-tests . Data on fractures and mortality were analyzed by survival analysis using log-rank tests , Cox proportional-hazards regression , and hazard rate ratios [ 23 ] . Hip fractures are presented using the Kaplan-Meier method . All participants were kept in the study as long as possible . The data were analyzed in two ways . The intention-to-treat analysis included all r and omly assigned participants for either the total follow-up period or until fracture , death , or loss to follow-up . The active treatment analysis included the participants as long as they stated that they were using the trial medication . Thus , the participants were included in the active treatment analysis until they stopped using the trial medication , regardless of whether a fracture occurred after they had stopped . Age , sex , and residence were added in both analyses as covariates to the Cox regression model . Because outdoor score , sunshine score , and walking score were interrelated ( correlation coefficients ranging from 0.21 to 0.59 ) and were likely to indicate general health or mobility , they were averaged over the years and added up to a sum score . For this purpose , the walking score was simplified ( 1 , 2 , or 3 equals 1 ; 4 equals 2 ; 5 equals 3 ) , because the lower walking scores applied to a few participants only . The result ing total score , ranging from 3 to 9 , was entered as a covariate in the model . The level of compliance ( weekly intake as reported on",
"OBJECTIVES Low trauma fractures in older people incur enormous physical , social and economic costs . Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group . This strategy requires validation in a population setting . METHODS R and omized , double-blind , placebo-controlled trial of 300,000 IU intramuscular ( i.m . ) vitamin D2 ( ergocalciferol ) injection or matching placebo every autumn over 3 years . 9440 people ( 4354 men and 5086 women ) aged 75 yrs and over were recruited from general practice registers in Wessex , Engl and . Primary outcome measure was all non-vertebral fracture . Secondary outcomes were hip and wrist fractures , and all falls . RESULTS 585 subjects had incident non-spine fractures ( hip 110 , wrist 116 , ankle 37 ) . Hazard ratios ( HRs ) for fracture in the vitamin D group were : 1.09 [ 95 % confidence interval ( CI ) 0.93 - 1.28 , P = 0.29 ] for any first fracture , 1.49 ( 95 % CI 1.02 - 2.18 , P = 0.04 ) for hip and 1.22 ( 95 % CI 0.85 - 1.76 , P = 0.28 ) for wrist . There was no effect on falls : HR 0.98 ( 0.93 - 1.04 ) . No protective effect was observed in any subgroup when the cohort was stratified by sex , age , previous fracture or mobility . CONCLUSIONS An annual i.m . injection of 300,000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population",
"BACKGROUND The use of calcium supplements slows bone loss in the forearm and has a beneficial effect on the axial bone density of women in late menopause whose calcium intake is less than 400 mg per day . However , the effect of a calcium supplement of 1000 mg per day on the axial bone density of postmenopausal women with higher calcium intakes is not known . METHODS We studied 122 normal women at least three years after they had reached menopause who had a mean dietary calcium intake of 750 mg per day . The women were r and omly assigned to treatment with either calcium ( 1000 mg per day ) or placebo for two years . The bone mineral density of the total body , lumbar spine , and proximal femur was measured every six months by dual-energy x-ray absorptiometry . Serum and urine indexes of calcium metabolism were measured at base line and after 3 , 12 , and 24 months . RESULTS The mean ( + /- SE ) rate of loss of total-body bone mineral density was reduced by 43 percent in the calcium group ( -0.0055 + /- 0.0010 g per square centimeter per year ) as compared with the placebo group ( -0.0097 + /- 0.0010 g per square centimeter per year , P = 0.005 ) . The rate of loss of bone mineral density was reduced by 35 percent in the legs ( P = 0.02 ) , and loss was eliminated in the trunk ( P = 0.04 ) . Calcium use was of significant benefit in the lumbar spine ( P = 0.04 ) , and in Ward 's triangle the rate of loss was reduced by 67 percent ( P = 0.04 ) . Calcium supplementation had a similar effect whether dietary calcium intake was above or below the mean value for the group . Serum parathyroid hormone concentrations tended to be lower in the calcium group , as were urinary hydroxyproline excretion and serum alkaline phosphatase concentrations . CONCLUSIONS Calcium supplementation significantly slowed axial and appendicular bone loss in normal post-menopausal women",
"BACKGROUND Increased dietary calcium intake has been proposed as a population -based public health intervention to prevent osteoporotic fractures . We have examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action . METHODS Five-year , double-blind , placebo-controlled study of 1460 women recruited from the population and older than 70 years ( mean age , 75 years ) who were r and omized to receive calcium carbonate , 600 mg twice per day , or identical placebo . The primary end points included clinical incident osteoporotic fractures , vertebral deformity , and adverse events ascertained in 5 years . Bone structure was also measured using dual x-ray absorptiometry of the hip and whole body , quantitative ultrasonography of the heel , and peripheral quantitative computed tomography of the distal radius . RESULTS Among our patients , 16.1 % sustained 1 or more clinical osteoporotic fractures . In the intention-to-treat analysis , calcium supplementation did not significantly reduce fracture risk ( hazard ratio , 0.87 ; 95 % confidence interval , 0.67 - 1.12 ) . However , 830 patients ( 56.8 % ) who took 80 % or more of their tablets ( calcium or placebo ) per year had reduced fracture incidence in the calcium compared with the placebo groups ( 10.2 % vs 15.4 % ; hazard ratio , 0.66 ; 95 % confidence interval , 0.45 - 0.97 ) . Calcium-treated patients had improved quantitative ultrasonography findings of the heel , femoral neck and whole-body dual x-ray absorptiometry data , and bone strength compared with placebo-treated patients . Of the 92 000 adverse events recorded , constipation was the only event increased by the treatment ( calcium group , 13.4 % ; placebo group , 9.1 % ) . CONCLUSION Supplementation with calcium carbonate tablets supplying 1200 mg/d is ineffective as a public health intervention in preventing clinical fractures in the ambulatory elderly population owing to poor long-term compliance , but it is effective in those patients who are compliant",
"Antifracture efficacy of high-dose vitamin D ( 800 IU ) and calcium ( 1000 mg ) remains controversial . To determine whether daily 800 IU of vitamin D and 1000 mg of calcium supplementation prevents fractures , we r and omized 3432 women of the population -based Osteoporosis Risk Factor and Prevention ( OSTPRE ) Study cohort ( ages 65 to 71 years ) living in the region of northern Savonia , Finl and ( latitude 62 degrees to 64 degrees N ) for 3 years to receive 800 IU of cholecalciferol and 1000 mg of calcium as calcium carbonate or to a control group that did not receive placebo . The main outcome measure was incident fractures . Fracture data were collected in telephone interviews and vali date d. Data on 3195 women , 1586 in the intervention group and 1609 in the control group , were available for analysis . In adjusted Cox proportional hazards models , the risk of any fracture decreased in the vitamin D and calcium group by 17 % [ adjusted hazard ratio ( aHR ) = 0.83 ; 95 % confidence interval ( CI ) 0.61 - 1.12 ] , and the risk of any nonvertebral fracture decreased by 13 % ( aHR = 0.87 ; 95 % CI 0.63 - 1.19 ) . The risk of distal forearm fractures decreased by 30 % ( aHR = 0.70 ; 95 % CI 0.41 - 1.20 ) , and the risk of any upper extremity fractures decreased by 25 % ( aHR = 0.75 ; 95 % CI 0.49 - 1.16 ) , whereas the risk of lower extremity fractures remained essentially equal ( aHR = 1.02 ; 95 % CI 0.58 - 1.80 ) . None of these effects reached statistical significance . In conclusion , this study did not produce statistically significant evidence that vitamin D and calcium supplementation prevents fractures in a 65- to 71-year-old general population of postmenopausal women",
"Objective This study aims to test the added value of calcium and vitamin D ( CaD ) in fracture prevention among women taking postmenopausal hormone therapy ( HT ) . Methods This is a prospect i ve , partial-factorial , r and omized , controlled , double-blind trial among Women ’s Health Initiative postmenopausal participants aged 50 to 79 years at 40 centers in the United States with a mean follow-up of 7.2 years . A total of 27,347 women were r and omized to HT ( 0.625 mg of conjugated estrogens alone , or 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily ) , and 36,282 women were r and omized to 1,000 mg of elemental calcium ( carbonate ) plus 400 IU of vitamin D3 daily , each compared with placebo . A total of 16,089 women participated in both arms . The predefined outcomes were adjudicated hip fractures and measured bone mineral density . Results Interaction between HT and CaD on hip fracture ( P interaction = 0.01 ) was shown . The effect of CaD was stronger among women assigned to HT ( hazard ratio [ HR ] , 0.59 ; 95 % CI , 0.38 - 0.93 ) than among women assigned to placebo ( HR , 1.20 ; 95 % CI , 0.85 - 1.69 ) . The effect of HT on hip fracture was stronger among women assigned to active CaD ( HR , 0.43 ; 95 % CI , 0.28 - 0.66 ) than among women assigned to placebo ( HR , 0.87 ; 95 % CI , 0.60 - 1.26 ) . CaD supplementation enhanced the antifracture effect of HT at all levels of personal calcium intake . There was no interaction between HT and CaD on change in hip or spine bone mineral density . Conclusions Postmenopausal women at normal risk for hip fracture who are on CaD supplementation experience significantly reduced incident hip fractures beyond HT alone at all levels of personal baseline total calcium intake",
"Summary Daily treatment with 30 mg of sodium fluoride ( NaF ) and 1 g of calcium over a 3-year period increased the bone mineral content ( BMC ) in the spines of women ( n=25 ) with osteoporosis . Determination of the BMC was followed with dual photon absorptiometry ( 137Cs-241Am ) in the third lumbar vertebra . No increase in BMC was found with only 10 mg sodium fluoride in combination with calcium ( n=25 ) , with calcium alone ( n=25 ) , or with placebo ( n=25 ) . No serious side effects were registered . There was , however , minor gastrointestinal distress in one-fifth of the patients taking 30 mg NaF daily",
"We report a 4-year r and omized , double-blind , placebo-controlled clinical trial in 236 normal postmenopausal women ( mean age + /- SE , 66.3+/-0.2 years ) who were r and omized to a calcium ( 1600 mg/day as the citrate ) or placebo group . The women were seen every 6 months ; 177 completed the trial . Net percentage changes in each group are given relative to baseline . The differences in net percentage changes ( calcium group minus placebo group ) in medians were : for lumbar spine bone density , 2.0 % ( p proximal femur bone density , 1.3 % ( p = 0.003 ) at year 1 and 1.3 % ( p = 0.015 ) at year 4 ; and for total body bone mineral , 0.4 % ( p = 0.002 ) at year 1 and 0.9 % ( p = 0.017 ) at year 4 . Similar differences at year 4 were : -18.9 % ( p = 0.002 ) for parathyroid hormone ( PTH ) , -11.9 % ( p = 0.026 ) for serum osteocalcin , and -32.2 % ( p = 0.003 ) for urine free pyridinoline . We conclude that long-term administration of calcium supplements to elderly women partially reverses age-related increases in serum PTH level and bone resorption and decreases bone loss . However , the effects on bone loss were weaker than those reported for estrogen , bisphosphonates , or calcitonin therapy , indicating that calcium supplements alone can not substitute for these in treating established osteoporosis . Nonetheless , because of their safety , high tolerance , and low expense , calcium supplements may be a useful preventive measure for elderly postmenopausal women whose bone mineral density values are normal for their age",
"BACKGROUND survivors of hip fracture are at 5- to 10-fold risk of a second hip fracture . There is little consensus about secondary prevention . Many are given calcium and vitamin D , but the evidence supporting this is circumstantial . OBJECTIVE to compare the effects of different calcium and vitamin D supplementation regimens on bone biochemical markers , bone mineral density and rate of falls in elderly women post-hip fracture . DESIGN r and omised controlled trial . SETTING orthogeriatric rehabilitation ward . METHODS 150 previously independent elderly women , recruited following surgery for hip fracture , were assigned to receive a single injection of 300,000 units of vitamin D(2 ) , injected vitamin D(2 ) plus 1 g/day oral calcium , 800 units/day oral vitamin D(3 ) plus 1 g/day calcium , or no treatment . Follow-up was one year , with measurement of 25-hydroxyvitamin D , parathyroid hormone , bone mineral density , and falls . RESULTS mean 25-hydroxyvitamin D increased and mean parathyroid hormone was suppressed in all the actively treated groups , more so in the group receiving combined oral vitamin D and calcium . Twenty per cent of participants injected with vitamin D were deficient in 25-hydroxyvitamin D a year later . Bone mineral density showed small but statistically significant differences of up to 4.6 % between actively treated groups and placebo . Relative risk of falling in the groups supplemented with vitamin D was 0.48 ( 95 % CI 0.26 - 0.90 ) compared with controls . CONCLUSION Vitamin D supplementation , either orally or with injected vitamin D , suppresses parathyroid hormone , increases bone mineral density and reduces falls . Effects may be more marked with calcium co-supplementation . The 300,000 units of injected vitamin D may not last a whole year",
"Background In r and omized trials there may be no overriding reason whether or not to have a placebo control . Purpose We assessed the effects of an open trial design ( no placebo and people know what tablets they are given ) compared with a blinded , placebo-controlled design on recruitment , compliance and retention within a r and omized trial of secondary osteoporotic fracture prevention . Methods We undertook a r and omized controlled comparison nested within a placebo-controlled trial of nutritional supplementation amongst people aged 70 years or over who had previously sustained a fracture , recruited in a UK teaching hospital . R and omization was 2 : 1 in favour of the blinded , placebo-controlled trial design . Results From 180 eligible participants r and omized to receive information based on the open trial design , 134 ( 74.4 % ) consented to take part , compared with 233 ( 65.1 % ) of 358 people r and omized to the blinded , placebo-controlled design ( difference 9.4 % , 95 % confidence interval 1.3–17.4 % ) . Reluctance to take a placebo and the desire to know tablet allocation were reasons given for not taking part in the blinded , placebo-controlled design . There was no significant difference in tablet compliance . Open trial participants were more likely to remain in the trial for one year ( difference 13.9 % , 95 % confidence interval 3.1–24.6 % ) , mainly reflecting the high retention of the open trial no tablet group compared to the open trial tablet group ( difference 23.6 % , 95 % confidence interval 11.9–35.2 % ) . The odds ratio for reporting an adverse event in the open trial compared to the blinded , placebo-controlled design was 0.64 ( 95 % confidence interval 0.28–1.49 ) , and for reporting a fracture was 0.81 ( 0.36–1.85 ) . Conclusions We conclude that using an open trial design may enhance participant recruitment and retention and thus improve generalizability and statistical power , but withdrawal rates may differ between the study allocations and may threaten the internal validity of the trial",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
"BACKGROUND Elderly people who have a fracture are at high risk of another . Vitamin D and calcium supplements are often recommended for fracture prevention . We aim ed to assess whether vitamin D3 and calcium , either alone or in combination , were effective in prevention of secondary fractures . METHODS In a factorial- design trial , 5292 people aged 70 years or older ( 4481 [ 85 % ] of whom were women ) who were mobile before developing a low-trauma fracture were r and omly assigned 800 IU daily oral vitamin D3 , 1000 mg calcium , oral vitamin D3 ( 800 IU per day ) combined with calcium ( 1000 mg per day ) , or placebo . Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months . Analysis was by intention-to-treat and the primary outcome was new low-energy fractures . FINDINGS 698 ( 13 % ) of 5292 participants had a new low-trauma fracture , 183 ( 26 % ) of which were of the hip . The incidence of new , low-trauma fractures did not differ significantly between participants allocated calcium and those who were not ( 331 [ 12.6 % ] of 2617 vs 367 [ 13.7 % ] of 2675 ; hazard ratio ( HR ) 0.94 [ 95 % CI 0.81 - 1.09 ] ) ; between participants allocated vitamin D3 and those who were not ( 353 [ 13.3 % ] of 2649 vs 345 [ 13.1 % ] of 2643 ; 1.02 [ 0.88 - 1.19 ] ) ; or between those allocated combination treatment and those assigned placebo ( 165 [ 12.6 % ] of 1306 vs 179 [ 13.4 % ] of 1332 ; HR for interaction term 1.01 [ 0.75 - 1.36 ] ) . The groups did not differ in the incidence of all-new fractures , fractures confirmed by radiography , hip fractures , death , number of falls , or quality of life . By 24 months , 2886 ( 54.5 % ) of 5292 were still taking tablets , 451 ( 8.5 % ) had died , 58 ( 1.1 % ) had withdrawn , and 1897 ( 35.8 % ) had stopped taking tablets but were still providing data for at least the main outcomes . Compliance with tablets containing calcium was significantly lower ( difference : 9.4 % [ 95 % CI 6.6 - 12.2 ] ) , partly because of gastrointestinal symptoms . However , potentially serious adverse events were rare and did not differ between groups . INTERPRETATION The findings do not support routine oral supplementation with calcium and vitamin D3 , either alone or in combination , for the prevention of further fractures in previously mobile elderly people",
"BACKGROUND A suboptimal vitamin D and calcium status has been associated with higher risk of type 2 diabetes in observational studies , but evidence from trials is lacking . OBJECTIVE We determined whether vitamin D supplementation , with or without calcium , improved glucose homeostasis in adults at high risk of diabetes . DESIGN Ninety-two adults were r and omly assigned in a 2-by-2 factorial- design , double-masked , placebo-controlled trial to receive either cholecalciferol ( 2000 IU once daily ) or calcium carbonate ( 400 mg twice daily ) for 16 wk . The primary outcome was the change in pancreatic β cell function as measured by the disposition index after an intravenous-glucose-tolerance test . Other outcomes were acute insulin response , insulin sensitivity , and measures of glycemia . RESULTS Participants had a mean age of 57 y , a body mass index ( BMI ; in kg/m(2 ) ) of 32 , and glycated hemoglobin ( Hb A(1c ) ) of 5.9 % . There was no significant vitamin D × calcium interaction on any outcomes . The disposition index increased in the vitamin D group and decreased in the no-vitamin D group ( adjusted mean change ± SE : 300 ± 130 compared with -126 ± 127 , respectively ; P = 0.011 ) , which was explained by an improvement in insulin secretion ( 62 ± 39 compared with -36 ± 37 mU · L(-1 ) · min , respectively ; P = 0.046 ) . Hb A(1c ) increased less , but nonsignificantly , in the vitamin D group than in the no-vitamin D group ( 0.06 ± 0.03 % compared with 0.14 ± 0.03 % , respectively ; P = 0.081 ) . There was no significant difference in any outcomes with calcium compared with no calcium . CONCLUSION In adults at risk of type 2 diabetes , short-term supplementation with cholecalciferol improved β cell function and had a marginal effect on attenuating the rise in Hb A(1c ) . This trial was registered at clinical trials.gov as NCT00436475",
"PURPOSE Calcium has been shown to have positive effects on bone mineral density in postmenopausal women . However , these effects are small , it is unknown whether they are sustained with long-term use , they have not been shown with intention-to-treat analyses , and the evidence for fracture prevention with calcium monotherapy is inconsistent . METHODS A r and omized controlled trial of calcium ( 1 g/day as the citrate ) in 1471 healthy postmenopausal women ( aged 74+/-4 years ) was performed to assess the effects on bone density and fracture incidence over 5 years . RESULTS Follow-up was complete in 90 % of subjects , and average medication compliance was 55 % to 58 % . Calcium had a significant beneficial effect on bone density ( intention-to-treat analysis ) , with between-groups differences at 5 years of 1.8 % ( spine ) , 1.6 % ( total hip ) , and 1.2 % ( total body ) . Effects were greater in a per- protocol analysis ( 5-year differences of 2.3 % , 2.8 % , and 1.8 % , respectively ) . A total of 425 fractures occurred in 281 women . Hazard ratios , based on time to first fracture , were 0.90 ( 95 % confidence interval [ CI ] , 0.71 - 1.16 ) for any symptomatic fracture , 0.72 ( 95 % CI , 0.44 - 1.18 ) for vertebral , 3.55 ( 95 % CI , 1.31 - 9.63 ) for hip , and 0.65 ( 95 % CI , 0.41 - 1.04 ) for forearm fracture . Per- protocol analysis found respective hazard ratios of 0.86 ( 95 % CI , 0.64 - 1.17 ) , 0.62 ( 95 % CI , 0.33 - 1.16 ) , 3.24 ( 95 % CI , 0.65 - 16.1 ) , and 0.45 ( 95 % CI , 0.24 - 0.87 ) . Height loss was reduced by calcium in the per- protocol population ( P=.03 ) . Serum alkaline phosphatase and procollagen type-I N-terminal propeptide were lower in the calcium group at 5 years , but constipation was more common . CONCLUSIONS Calcium results in a sustained reduction in bone loss and turnover , but its effect on fracture remains uncertain . Poor long-term compliance limits its effectiveness",
"Objective To observe the effects of enhanced exercise and combined vitamin D and calcium supplementation on muscular strength and fracture occurrence in postmenopausal women with a high risk of osteoporosis . Methods Totally 614 postmenopausal women at high risk factors of osteoporosis were enrolled in Dongcheng district of Beijing and r and omized into four groups : group A(control group , n=173),group B(regular Tai Chi exercise , n=171),group C(calcium 600 mg/d+VitD3 800 U/d , n=139 ) , and group D[calcium 600 mg/d+25 hydroxyl vitamin D(25OHD ) 0.25 μg/d , n=131].Muscular strength was measured at baseline and one and two years after intervention . Bone turnover markers were measured at baseline and during the two-year follow-up . Falls and fractures were recorded . Results The incidence of 25OHD the left grip strength decreased significantly two years after intervention(t=-3.252,P=0.001)in group A.Right grip strength decreased significantly in group B(t=2.460,P=0.015)while left grip strength improved significantly in group C(t=-2.051,P=0.043)one year after intervention . In group D , muscular strength in both 12-month and 24-month did not change compared with baseline(both P>0.05).Furthermore , serum procollagen type I N-terminal propeptide elevated significantly in group A(t=-2.962,P=0.004),group B(t=-2.888,P=0.005 ) , and group C(t=-2.441,P=0.016),whereas β-C-terminal telopeptide of type I collagen decreased significantly in group B(t=2.285,P=0.024 ) and group D(t=2.596,P=0.011)two years after intervention . Conclusion Enhanced exercise and combined calcium vitamin D supplementation may help sustain muscle strength in postmenopausal women , while calcium and vitamin D supplementation may improve muscular strength within a short period of time",
"IMPORTANCE While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these 2 factors are contradictory . OBJECTIVE To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women . DESIGN , SETTING , AND PARTICIPANTS A 2-year r and omized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April 2010 and March 2013 in Tampere , Finl and . Participants were 409 home-dwelling women 70 to 80 years old . The main inclusion criteria were at least 1 fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise . INTERVENTIONS Four study groups , including placebo without exercise , vitamin D ( 800 IU/d ) without exercise , placebo and exercise , and vitamin D ( 800 IU/d ) and exercise . MAIN OUTCOMES AND MEASURES The primary outcome was monthly reported falls . Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes . In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed . RESULTS Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls . Fall rates per 100 person-years were 118.2 , 132.1 , 120.7 , and 113.1 in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were 13.2 , 12.9 , 6.5 , and 5.0 , respectively . Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( 0.38 ; 95 % CI , 0.17 - 0.83 ) and without vitamin D ( 0.47 ; 95 % CI , 0.23 - 0.99 ) . Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly . However , only exercise improved muscle strength and balance . Vitamin D did not enhance exercise effects on physical functioning . CONCLUSIONS AND RELEVANCE The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls . Exercise improved physical functioning . Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00986466",
"BACKGROUND Adults with low concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in blood have an increased risk of falls and fractures , but r and omised trials of vitamin D supplementation have had inconsistent results . We aim ed to assess the effect of high-dose vitamin D supplementation on fractures and falls . METHODS The Vitamin D Assessment ( ViDA ) Study was a r and omised , double-blind , placebo-controlled trial of healthy volunteers aged 50 - 84 years conducted at one centre in Auckl and , New Zeal and . Participants were r and omly assigned to receive either an initial oral dose of 200 000 IU ( 5·0 mg ) colecalciferol ( vitamin D3 ) followed by monthly 100 000 IU ( 2·5 mg ) colecalciferol or equivalent placebo dosing . The prespecified primary outcome was cardiovascular disease and secondary outcomes were respiratory illness and fractures . Here , we report secondary outcome data for fractures and post-hoc outcome data for falls . Cox proportional hazards models were used to estimate hazard ratios ( HRs ) for time to first fracture or time to first fall in individuals allocated vitamin D compared with placebo . The analysis of fractures included all participants who gave consent and was by intention-to-treat ; the analysis of falls included all individuals who returned one or more question naires . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12611000402943 . FINDINGS Between April 5 , 2011 , and Nov 6 , 2012 , 5110 participants were recruited and r and omly assigned either colecalciferol ( n=2558 ) or placebo ( n=2552 ) . Two participants allocated placebo withdrew consent after r and omisation ; thus , a total of 5108 individuals were included in the analysis of fractures . The mean age of participants was 65·9 years ( SD 8·3 ) and 2971 ( 58 % ) were men . The mean concentration of 25(OH)D in blood was 63 nmol/L ( SD 24 ) at baseline , with 1534 ( 30 % ) having 25(OH)D concentrations lower than 50 nmol/L. Follow-up was until July 31 , 2015 , with a mean treatment duration of 3·4 years ( SD 0·4 , range 2·5 - 4·2 ) . During follow-up , 2638 participants reported having a fall , 1312 ( 52 % ) of 2539 in the vitamin D group compared with 1326 ( 53 % ) of 2517 in the placebo group . The HR for falls-adjusted for age , sex , ethnic origin , history of recent fall , physical activity , and baseline 25(OH)D-was 0·99 ( 95 % CI 0·92 - 1·07 ; p=0·82 ) for vitamin D compared with placebo . Non-vertebral fractures were reported in 292 individuals , 156 ( 6 % ) of 2558 in the vitamin D group and 136 ( 5 % ) of 2550 in the placebo group . The adjusted HR for fractures was 1·19 ( 95 % CI 0·94 - 1·50 ; p=0·15 ) for vitamin D compared with placebo . 123 ( 2 % ) people died during the trial , 65 assigned vitamin D and 58 allocated placebo ; the difference between treatment groups was not significant . INTERPRETATION High-dose bolus vitamin D supplementation of 100 000 IU colecalciferol monthly over 2·5 - 4·2 years did not prevent falls or fractures in this healthy , ambulatory , adult population . Further research is needed to ascertain the effects of daily vitamin D dosing , with or without calcium . FUNDING Health Research Council of New Zeal and and Accident Compensation Corporation of New Zeal and"
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Major reported factors associated with the limited effectiveness of home telemonitoring interventions in chronic respiratory conditions include the lack of useful early predictors , poor patient compliance and the poor performance of conventional algorithms for detecting deteriorations . This article provides a systematic review of existing algorithms and the factors associated with their performance in detecting exacerbations and supporting clinical decisions in patients with chronic obstructive pulmonary disease ( COPD ) or asthma . An electronic literature search in Medline , Scopus , Web of Science and Cochrane library was conducted to identify relevant articles published between 2005 and July 2015 . A total of 20 studies ( 16 COPD , 4 asthma ) that included research about the use of algorithms in telemonitoring interventions in asthma and COPD were selected . Differences on the applied definition of exacerbation , telemonitoring duration , acquired physiological signals and symptoms , type of technology deployed and algorithms used were found . Predictive models with good clinical ly reliability have yet to be defined , and are an important goal for the future development of telehealth in chronic respiratory conditions . New predictive models incorporating both symptoms and physiological signals are being tested in telemonitoring interventions with positive outcomes . However , the underpinning algorithms behind these models need be vali date d in larger sample s of patients , for longer periods of time and with well-established protocol s. In addition , further research is needed to identify novel predictors that enable the early detection of deteriorations , especially in COPD . Only then will telemonitoring achieve the aim of preventing hospital admissions , contributing to the reduction of health re source utilization and improving the quality of life of patients | [
"Background Telehealth ( TH ) and telecare ( TC ) interventions are increasingly valued for supporting self-care in ageing population s ; however , evaluation studies often report high rates of non-participation that are not well understood . This paper reports from a qualitative study nested within a large r and omised controlled trial in the UK : the Whole System Demonstrator ( WSD ) project . It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial . Methods Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention ( n = 19 ) , or who withdrew from the intervention arm ( n = 3 ) . Participants were recruited from the four trial groups ( with diabetes , chronic obstructive pulmonary disease , heart failure , or social care needs ) ; and all came from the three trial areas ( Cornwall , Kent , east London ) . Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home . Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes . Results Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes : requirements for technical competence and operation of equipment ; threats to identity , independence and self-care ; expectations and experiences of disruption to services . Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderst and ings . Respondents ’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance , and views that interventions could undermine self-care and coping . Finally , participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued . Conclusions These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake . These insights have implication s for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction . It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation",
"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 Early treatment of COPD exacerbations has shown to be important . Despite a non-negligible negative impact on health related quality of life , a large proportion of these episodes is not reported ( no change in treatment ) . Little is known whether ( low burden ) strategies are able to capture these unreported exacerbations . Methods The Clinical COPD Question naire ( CCQ ) is a short question naire with great evaluative properties in measuring health status . The current explorative study evaluates the discriminative properties of weekly CCQ assessment in detecting exacerbations . Results In a multicentre prospect i ve cohort study , 121 patients , age 67.4 ± 10.5 years , FEV1 47.7 ± 18.5 % pred were followed for 6 weeks by daily diary card recording and weekly CCQ assessment . Weeks were retrospectively labeled as stable or exacerbation ( onset ) weeks using the Anthonisen symptom diary-card algorithm . Change in CCQ total scores are significantly higher in exacerbation-onset weeks , 0.35 ± 0.69 compared to -0.04 ± 0.37 in stable weeks ( p of the Δ CCQ total score discriminating between stable and exacerbation onset weeks was sufficient ( area under the ROC curve 0.75 ) . At a cut off point of 0.2 , sensitivity was 62.5 ( 50.3 - 73.4 ) , specificity 82.0 ( 79.3 - 84.4 ) , and a positive and negative predictive value of 43.5 ( 35.0 - 51.0 ) and 90.8 ( 87.8 - 93.5 ) , respectively . Using this cut off point , 22 ( out of 38 ) unreported exacerbations were detected while 39 stable patients would have been false positively ' contacted ' . Conclusions Weekly CCQ assessment is a promising , low burden method to detect unreported exacerbations . Further research is needed to vali date discriminative performance and practical implication s of the CCQ in detecting exacerbations in daily care",
"National Asthma Education and Prevention Program ( NAEPP ) suggests using asthma action plans for patient self-care . Recent studies reported that many asthma patients had difficulties in following action plans on a daily basis and had low compliance to medication regimens . The goal of our study was to design and evaluate the Home Asthma Telemonitoring ( HAT ) system aim ed to help asthma patients to follow their self-care plans according to the NAEPP recommendations . Our study result ed in the development of the system which provided patients with continuous individualized help in the daily routine of asthma self-care and notified heath care providers if certain clinical conditions occurred . This allowed early recognition of potentially dangerous situations and timely intervention . The evaluation of the HAT system underwent several stages . First we showed , that the HAT system provides reliable reciprocal exchange of all relevant information between a physician and asthma patient in home setting s. Further evaluation demonstrated that lung function test results collected during home asthma telemonitoring are comparable to those collected under the supervision of trained professionals , and Internet-based home asthma telemonitoring can be successfully implemented in a group of patients without previous computer experience . Preliminary results of an on-going HAT evaluation showed higher patient compliance to asthma action plans in comparison to the compliance reported for patients in st and ard care . The clinical impact of HAT on asthma outcomes is being currently evaluated in a r and omized clinical trial funded by NIH . HAT has a potential for improving clinical outcomes and quality of life in the studied patient population and may be a model for monitoring and self-management of patients with other chronic health conditions",
"Objective To assess the effect of second generation , home based telehealth on health related quality of life , anxiety , and depressive symptoms over 12 months in patients with long term conditions . Design A study of patient reported outcomes ( the Whole Systems Demonstrator telehealth question naire study ; baseline n=1573 ) was nested in a pragmatic , cluster r and omised trial of telehealth ( the Whole Systems Demonstrator telehealth trial , n=3230 ) . General practice was the unit of r and omisation , and telehealth was compared with usual care . Data were collected at baseline , four months ( short term ) , and 12 months ( long term ) . Primary intention to treat analyses tested treatment effectiveness ; multilevel models controlled for clustering by general practice and a range of covariates . Analyses were conducted for 759 participants who completed question naire measures at all three time points ( complete case cohort ) and 1201 who completed the baseline assessment plus at least one other assessment ( available case cohort ) . Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts , respectively . Setting Provision of primary and secondary care via general practice s , specialist nurses , and hospital clinics in three diverse regions of Engl and ( Cornwall , Kent , and Newham ) , with established integrated health and social care systems . Participants Patients with chronic obstructive pulmonary disease ( COPD ) , diabetes , or heart failure recruited between May 2008 and December 2009 . Main outcome measures Generic , health related quality of life ( assessed by physical and mental health component scores of the SF-12 , and the EQ-5D ) , anxiety ( assessed by the six item Brief State-Trait Anxiety Inventory ) , and depressive symptoms ( assessed by the 10 item Centre for Epidemiological Studies Depression Scale ) . Results In the intention to treat analyses , differences between treatment groups were small and non-significant for all outcomes in the complete case ( 0.480≤P≤0.904 ) or available case ( 0.181≤P≤0.905 ) cohorts . The magnitude of differences between trial arms did not reach the trial defined , minimal clinical ly important difference ( 0.3 st and ardised mean difference ) for any outcome in either cohort at four or 12 months . Per protocol analyses replicated the primary analyses ; the main effect of trial arm ( telehealth v usual care ) was non-significant for any outcome ( complete case cohort 0.273≤P≤0.761 ; available case cohort 0.145≤P≤0.696 ) . Conclusions Second generation , home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only . Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease , diabetes , or heart failure over 12 months . The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients . Trial Registration IS RCT N43002091",
"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",
"Aim This paper investigates the acceptance of in-home telehealth by frail older adults and carers of the Transition Care Program ( TCP ) , and evaluates telehealth acceptance as a predictor for usage compliance . Method A stratified r and om sample of participants was allocated to one of five groups : either a control group or to receive telehealth monitoring of their vital signs for a period of 12 or 24 weeks ; with or without a medical alarm pendant . Results Before being trained in and using telehealth , the majority of participants and carers demonstrated acceptance of the technology by reporting that they perceived it would be “ useful ” and “ easy to use . ” This acceptance was also reported post-TCP ( up to 12 weeks of usage ) . The “ perceived ease of use ” of the telehealth equipment increased significantly from pre-telehealth training and usage to post-TCP ( up to 12 weeks of usage ) ( P = 0.001 ) . There was no change , ( pre-training and usage to post-TCP ) in the “ perceived usefulness ” of the telehealth equipment . The telehealth acceptance constructs of “ ease of use ” and “ usefulness , ” at pre-telehealth training and usage , approached statistical significance as a predictor of future compliance ( P = 0.06 ) . “ Perceived ease of use , ” at pre-training and usage , had a positive relationship with future compliance ( P = 0.02 ) . Conclusion There is currently limited knowledge about the influences and determinants of home telehealth compliance in frail older people and their carers , potentially a significant user group for the technology into the future . This study ’s finding that frail older people and their carers perceive that home telehealth is useful and easy to use demonstrates their acceptance of home telehealth as a therapeutic tool . Further , perceived ease of use of home telehealth is a significant predictor of compliance with frail older people and their carers ’ use of home telehealth . Additional research is required in order to identify other influences and determinants of home telehealth compliance with this group . Knowledge about the influences and determinants of home telehealth compliance may assist the development of targeted interventions aim ed at encouraging high compliance with users who are recording lower reading rates",
"Some children with severe asthma develop frequent exacerbations despite intensive treatment . We sought to assess the outcome ( severe exacerbations and healthcare use , lung function , quality of life and maintenance treatment ) of a strategy based on daily home spirometry with teletransmission to an expert medical centre and whether it differs from that of a conventional strategy . 50 children with severe uncontrolled asthma were enrolled in a 12-month prospect i ve study and were r and omised into two groups : 1 ) treatment managed with daily home spirometry and medical feedback ( HM ) and 2 ) conventional treatment ( CT ) . The children ’s mean age was 10.9 yrs ( 95 % confidence interval 10.2–11.6 ) . 44 children completed the study ( 21 in the HM group and 23 in the CT group ) . The median number of severe exacerbations per patient was 2.0 ( interquartile range 1.0–4.0 ) in the HM group and 3.0 ( 1.0–4.0 ) in the CT group ( p=0.38 with adjustment for age ) . There were no significant differences between the two groups for unscheduled visits ( HM 5.0 ( 3.0–7.0 ) , CT 3.0 ( 2.0–7.0 ) ; p=0.30 ) , lung function ( pre-&bgr;2-agonist forced expiratory volume in 1 s ( FEV1 ) p=0.13 ) , Paediatric Asthma Quality of Life Question naire scores ( p=0.61 ) and median daily dose of inhaled corticosteroids ( p=0.86 ) . A treatment strategy based on daily FEV1 monitoring with medical feedback did not reduce severe asthma exacerbations",
"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",
"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 In asthma management guidelines the primary goal of treatment is asthma control . To date , asthma control , guided by symptoms and lung function , is not optimal in many children and adults . Direct monitoring of airway inflammation in exhaled breath may improve asthma control and reduce the number of exacerbations . Aim 1 ) To study the use of fractional exhaled nitric oxide ( FeNO ) and inflammatory markers in exhaled breath condensate ( EBC ) , in the prediction of asthma exacerbations in a pediatric population . 2 ) To study the predictive power of these exhaled inflammatory markers combined with clinical parameters . Methods 96 asthmatic children were included in this one-year prospect i ve observational study , with clinical visits every 2 months . Between visits , daily symptom scores and lung function were recorded using a home monitor . During clinical visits , asthma control and FeNO were assessed . Furthermore , lung function measurements were performed and EBC was collected . Statistical analysis was performed using a test data set and validation data set for 1 ) conditionally specified models , receiver operating characteristic-curves ( ROC-curves ) ; 2 ) k-nearest neighbors algorithm . Results Three conditionally specified predictive models were constructed . Model 1 included inflammatory markers in EBC alone , model 2 included FeNO plus clinical characteristics and the ACQ score , and model 3 included all the predictors used in model 1 and 2 . The area under the ROC-curves was estimated as 47 % , 54 % and 59 % for models 1 , 2 and 3 respectively . The k-nearest neighbors predictive algorithm , using the information of all the variables in model 3 , produced correct predictions for 52 % of the exacerbations in the validation data set . Conclusion The predictive power of FeNO and inflammatory markers in EBC for prediction of an asthma exacerbation was low , even when combined with clinical characteristics and symptoms . Qualitative improvement of the chemical analysis of EBC may lead to a better non-invasive prediction of asthma exacerbations",
"The effects of broad-spectrum antibiotic and placebo therapy in patients with chronic obstructive pulmonary disease in exacerbation were compared in a r and omized , double-blinded , crossover trial . Exacerbations were defined in terms of increased dyspnea , sputum production , and sputum purulence . Exacerbations were followed at 3-day intervals by home visits , and those that resolved in 21 days were design ated treatment successes . Treatment failures included exacerbations in which symptoms did not resolve but no intervention was necessary , and those in which the patient 's condition deteriorated so that intervention was necessary . Over 3.5 years in 173 patients , 362 exacerbations were treated , 180 with placebo and 182 with antibiotic . The success rate with placebo was 55 % and with antibiotic 68 % . The rate of failure with deterioration was 19 % with placebo and 10 % with antibiotic . There was a significant benefit associated with antibiotic . Peak flow recovered more rapidly with antibiotic treatment than with placebo . Side effects were uncommon and did not differ between antibiotic and placebo",
"RATIONALE Asthma exacerbations are unpredictable , disruptive , and frightening , and are therefore important to prevent . OBJECTIVES We investigated whether a policy of quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate reduces asthma exacerbations requiring treatment with oral corticosteroids . METHODS A total of 403 people with asthma were given a self-management plan and r and omized to take an active or placebo corticosteroid inhaler in addition to their usual asthma treatment when their PEF fell by 15 % on 2 consecutive days or by 30 % on 1 day . The study inhalers provided a quadrupling or no change in corticosteroid dose . MEASUREMENTS AND MAIN RESULTS Eighteen of 197 ( 9 % ) and 29 of 203 ( 14 % ) participants had an exacerbation of asthma requiring treatment with oral corticosteroids in the active and placebo groups , respectively , giving a risk ratio of 0.64 ( 95 % confidence interval , 0.37 - 1.11 , P = 0.11 ) . Of the 94 participants who started the study inhaler far fewer required treatment with oral corticosteroids in the active compared with the placebo group : 12 of 56 ( 21 % ) in the active group and 19 of 38 ( 50 % ) in the placebo group , giving a risk ratio of 0.43 ( 95 % confidence interval , 0.24 - 0.78 , P = 0.004 ) . CONCLUSIONS Although our primary outcome did not reach statistical significance , quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate appears to reduce acute exacerbations of asthma and deserves further investigation . Clinical trial registered with www.controlled-trials.com ( IS RCT N 46018181 )",
"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",
"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",
"The objective of this study was to determine the effects of a homebased telemonitoring device , The Health Buddy ( HB ) , on health consumption and health-related quality of life ( HRQoL ) in patients with moderate to severe chronic obstructive pulmonary disease ( COPD ) . The HB provides daily symptom-surveillance by a case manager and education to enhance disease knowledge and self-management . A nonr and omized controlled multicenter study was established comparing the effectiveness of telemonitoring as an add-on to care as usual with a follow-up of 6 months . Four hospitals took part in the experimental group and 2 hospitals formed an equivalent control group with 59 and 56 patients , respectively . HRQoL was measured by the Clinical COPD Question naire . Healthcare consumption was assessed using medical records in the 6 months preceding study entry and during the study . Compared with the control group , the HB group showed a significant decrease in hospital admission rates ( HB -0.11 + /- 1.16 vs. control + 0.27 + /- 1.0 , p = 0.02 ) and in the total number of exacerbations ( HB -0.35 + /- 1.4 vs. control + 0.32 + /- 1.2 , p = 0.004 ) . There was a tendency toward decreased hospital days and outpatient visits . No significant changes in HRQoL were observed at follow-up between both study groups . Despite inherent limitations of the study , these findings suggest that adopting telemonitoring in everyday clinical practice is feasible and can substantially improve care and decrease healthcare utilization of patients with moderate to severe COPD",
"OBJECTIVE The present study seeks to conduct cost-utility analysis ( CUA ) of the Danish TELEKAT ( Telehomecare , Chronic Patients and the Integrated Healthcare System ) project . The TELEKAT project seeks to test and develop a preventive home monitoring concept across sectors for chronic obstructive pulmonary disease ( COPD ) patients . The concept of the TELEKAT project is to reduce admissions by enabling the COPD patients to conduct self-monitoring and maintain rehabilitation activities in their own home . COPD patients with severe and very severe COPD were included in the study . SUBJECTS AND METHODS This economic evaluation follows international guidelines for the conduction of a CUA alongside a clinical r and omized controlled trial . The analysis is based on a health sector perspective . RESULTS The mean incremental cost efficiency ratio , located in the southeast quadrant , shows that telerehabilitation is less costly and more effective than the rehabilitation given to the control group . The telerehabilitation program produces more value for money and generates savings on healthcare budgets . CONCLUSIONS The telerehabilitation program appears to be more cost-effective than the conventional rehabilitation program for COPD patients . Further studies of cost-effectiveness with a focus on large-scale studies are needed",
"BACKGROUND We have developed a winter forecasting service to predict when patients with COPD are at higher risk of an exacerbation and alert them via an automated telephone call . AIMS To assess the effect of the service and its ability to predict periods of increased risk . METHODS A 4-month prospect i ve r and omised controlled trial using clinical criteria and the EXACT PRO question naire to identify exacerbations . Patients were r and omly allocated to receive alert calls . All patients completed a diary including the EXACT PRO question naire on a BlackBerry Smartphone each day . They were contacted and assessed if they appeared to be exacerbating . RESULTS 79 patients participated , 40 received alert calls . The exacerbation frequency per patient per week was significantly greater during periods of predicted high risk ( 0.086 ± 0.010 v 0.055 ± 0.010 ) . The exacerbation frequency ( ± st and ard error of the mean , SEM ) in patients receiving alert calls was lower ( 0.95 ± 0.27 v 1.17 ± 0.29 ) but this was not statistically significant . Fewer patients receiving alert calls had one or more EXACT event compared to the controls ( 34 % v 53 % , p=0.11 ) , their duration was shorter ( 8.2 ± 2.0 v10.1 ± 1.9 days , p=0.481 ) and they were less severe ( AUC 65 ± 21 v 115 ± 22 , p=0.118 ) . There were no significant differences in the mean change ( ± SEM ) in SGRQ scores between the groups . CONCLUSIONS The ability of the forecast to predict high risk periods was confirmed unequivocally . Alert calls appeared to reduce the frequency and severity of exacerbations but these effects did not reach statistical significance , perhaps because of the number of participants , lower than expected exacerbation rates , and the fact that there was contact with patients in both groups whenever they appeared to be exacerbating"
] | 41166ec4-06ff-11f0-808a-c43d1ab1c353 |
Background : C and esartan is a relatively novel antihypertensive agent of the angiotensin receptor blocker ( ARB ) . Several clinical trials have compared c and esartan with losartan in the management of essential hypertension . However , systematic assessment of efficacy and safety between c and esartan and losartan is still lacking . Methods : We review ed r and omised controlled trials ( RCTs ) comparing c and esartan with losartan for net reduction in blood pressure from baseline , response and control rates , and incidences of common and serious adverse events . Weighted mean differences ( WMD ) , and relative risk ( RR ) with 95 % confidence intervals ( CI ) were calculated for continuous and dichotomous data , respectively . Results : A total of 12 RCTs with 3644 patients were included in this meta- analysis . When comparing the efficacy of c and esartan and losartan in reducing systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) at the end of the follow-up period , results with c and esartan were superior to losartan in the reduction SBP and DBP ( WMD , -2.97 ; 95 % CI , -4.18 — -1.77 ; p C and esartan had better response and control rates than losartan . ( RR , 1.12 ; 95 % CI , 1.06—1.18 ; p Reported common adverse events for the two agents were not significantly different ( RR , 0.98 ; 95 % CI , 0.86—1.12 ; p = 0.78 ) . The incidence of serious adverse events for c and esartan was lower than for losartan ( RR , 0.48 ; 95 % CI , 0.25—0.92 ; p = 0.03 ) . The net reduction of DBP showed negative correlation with baseline DBP in both c and esartan and losartan groups ( regression coefficient -1.81 , p = 0.03 and regression coefficient -1.56 , p = 0.02 , respectively ) . Conclusions : C and esartan is superior to losartan in reducing blood pressure . C and esartan also causes fewer serious adverse events than losartan | [
"The objectives of our study were to assess the reproducibility of the trough-to-peak ratio ( T/P ) and to see whether a high T/P is accompanied by more organ protection or vice versa . The study included 175 ( mean+/-SD age , 51+/-9 years ) subjects with mild-moderate essential hypertension who had echocardiographic evidence of left ventricular ( LV ) hypertrophy taken from the SAMPLE study ( Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation ) , an open-label multicenter study . The study included a 3-week washout pretreatment period , a 12-month treatment period with lisinopril ( n=84 ) or lisinopril plus hydrochlorothiazide ( n=91 ) once daily , and a 4-week placebo follow-up period . Results of 24-hour ambulatory blood pressure monitoring and echocardiographic determination of left ventricular mass index ( LVMI ) were obtained before and after 3 and 12 months of treatment . T/Ps were computed in each patient by dividing the systolic and diastolic blood pressure changes at trough ( changes in the last 2 hours of the monitoring period ) by those at peak ( average of the 2 adjacent hours with the maximal blood pressure reduction between the 2nd and 8th hour from drug intake ) after 3 and 12 months of treatment . Average 24-hour blood pressure was similarly reduced at 3 and 12 months . Trough blood pressure changes at 3 and 12 months were closely correlated , as were the corresponding peak blood pressure changes . However , the 3- and 12-month T/Ps correlated to a lesser degree ( r LVMI induced by treatment was similarly correlated with the treatment-induced reduction in 24-hour average , trough , and peak blood pressures but not with the T/Ps . This was also evident when the contribution to LV hypertrophy regression by 24-hour blood pressure changes and T/Ps was assessed in a multivariate regression analysis . In patients with a T/P > /=0.5 or peak and trough blood pressure changes are reproducible and predict the regression of LVMI induced by treatment as well as average 24-hour blood pressure . T/Ps are less reproducible , and their value does not predict regression of organ damage by antihypertensive treatment",
"An 8-week , multicenter , double-blind , r and omized , parallel-group , forced-titration study was conducted to evaluate the antihypertensive efficacy of c and esartan vs. losartan in 654 hypertensive patients with a diastolic blood pressure between 95 and 114 mm Hg from 72 sites throughout the U.S. Eligible patients were r and omized to c and esartan cilexetil 16 mg once daily , or losartan 50 mg once daily . Two weeks following r and omization , patients doubled the respective doses of their angiotensin receptor blockers for an additional 6 weeks . At week 8 , c and esartan cilexetil lowered trough systolic/diastolic blood pressure by a significantly greater amount than did losartan ( 13.3/10.9 mm Hg with c and esartan cilexetil vs. 9.8/8.7 mm Hg with losartan ; p less than 0.001 ) . At the same period , c and esartan cilexetil also lowered peak blood pressure by a significantly greater amount than did losartan ( 15.2 to 11.6 mm Hg with c and esartan cilexetil vs. 12.6 to 10.1 mm Hg with losartan ; p less than 0.05 ) . There were statistically significantly ( p less than 0.05 ) higher proportions of responders and controlled patients in the c and esartan cilexetil group ( 62.4 % and 56.0 % , respectively ) than in the losartan group ( 54.0 % and 46.9 % , respectively ) . Both treatment regimens were well tolerated ; 1.8 % in the c and esartan cilexetil group and 1.6 % in the losartan group withdrew because of adverse events . In conclusion , this forced-titration study confirms that c and esartan cilexetil is more effective than losartan in lowering blood pressure when both are administered once daily at maximum doses . Both drugs were well tolerated . (c)2001 by Le Jacq",
"An 8-week , multicentre ( 72 sites in the US ) , double-blind , r and omised , parallel group , forced titration study compared the antihypertensive efficacy of c and esartan cilexetil and losartan . A total of 611 patients with essential hypertension ( diastolic blood pressure 95 to 114 mm Hg ) were r and omised initially to c and esartan cilexetil 16 mg once daily or losartan 50 mg once daily . After 2 weeks of r and omised treatment , the doses of c and esartan cilexetil and losartan were doubled to 32 mg and 100 mg once daily and continued respectively for 6 weeks . At week 8 , c and esartan cilexetil lowered the blood pressure ( BP ) at 24 h ( trough ) , 6 h ( peak ) and 48 h post dose to a significantly greater extent ( P losartan : c and esartan cilexetil lowered trough BP by 13.4/10.5 mm Hg , peak BP by 15.5/12.9 mm Hg and 48-h BP by 10.5/9.9 mm Hg compared to a reduction of trough BP by 10.1/9.1 mm Hg , peak BP by 12.0/9.5 mm Hg , and 48-h BP by 5.9/7.0 mm Hg by losartan . The responder and control rates were numerically higher in the c and esartan cilexetil group , but the differences did not reach statistical significance ; the responder rates were 58.8 % for the c and esartan cilexetil group and 52.1 % for the losartan group and control rates were 49.0 % for the c and esartan cilexetil group and 44.6 % for the losartan group . Overall , both treatment regimens were well tolerated . A total of 15 of the 611 ( 2.5 % ) patients withdrew from the study due to an adverse event , including nine ( 2.9 % ) in the c and esartan cilexetil group and six ( 2.0 % ) in the losartan group . In conclusion , this forced titration study confirms that c and esartan cilexetil is more effective in lowering BP than losartan when compared at once daily maximum doses",
"This double-blind , r and omised , controlled study compared the efficacy of c and esartan cilexetil 8 mg ( n = 87 ) and losartan 50 mg ( n = 89 ) , once daily for 6 weeks , relative to placebo ( n = 80 ) in patients with mild-to-moderate essential hypertension ( diastolic blood pressure ( DBP ) : 95 - 115 mmHg ) . Ambulatory BP measurements were done every 15 min over 36 h. At the end of the 6-week treatment , the mean change in DBP between the baseline and the 0 - 24-h period after the last dose of study medication was greater in patients receiving c and esartan cilexetil 8 mg ( -7.3 mmHg + /- 6.9 mmHg ) compared with losartan 50 mg ( -5.1 mmHg + /- 4.9 mmHg ) ( p mean change in systolic BP ( SBP ) during this time was greater in patients receiving c and esartan cilexetil 8 mg ( -10.8 mmHg + /- 11.3 mmHg ) , or losartan 50 mg ( -8.8 mmHg + /- 8.9 mmHg ) than placebo ( 1.2 mmHg + /- 9.9 mmHg ) ( p C and esartan cilexetil 8 mg was associated with a greater reduction in DBP and SBP , relative to placebo , when compared with losartan 50 mg , during both daytime and night-time , and between 12 and 24 h after dosing ( p tolerated . In patients with mild-to-moderate essential hypertension , c and esartan cilexetil 8 mg therefore had greater , more consistent antihypertensive efficacy throughout the day and the night , and long-lasting efficacy after the last dose , compared with losartan 50 mg . This greater efficacy is maintained with an excellent tolerability associated with members of the angiotensin Il type 1-receptor blocker class",
"Objective To introduce a new method , the smoothness index , for assessing the homogeneity of 24 h blood pressure reduction by antihypertensive treatment and to compare it with the trough : peak ratio ; and to assess the ability of both indices to predict a reduction in the left ventricular mass index induced by treatment . Patients and methods In 174 patients with essential hypertension and left ventricular hypertrophy , enrolled in the Study on Ambulatory Monitoring of Pressure and Lisinopril Evaluation ( SAMPLE ) , aged 20–65 years , we measured clinic blood pressure , 24 h ambulatory blood pressure and the left ventricular mass index ( echocardiography ) before and after treatment with lisinopril at 20 mg with the addition of 12.5 or 25 mg hydrochlorothiazide as needed to reach a sufficient blood pressure reduction . The following parameters were computed for systolic and diastolic ambulatory blood pressure : ( 1 ) hourly and 24 h blood pressure averages ( ± SD ) at baseline and after 3 and 12 months of treatment ; ( 2 ) hourly blood pressure changes from baseline after 3 and 12 months of treatment , and their average ( ± SD ) over 24 h ; ( 3 ) the trough : peak ratio after 3 and 12 months of treatment ; and ( 4 ) the smoothness index after 3 and 12 months of treatment . Similar calculations were also performed at the end of a final study month during which active treatment was withdrawn and placebo was substituted ( n = 164 ) . Results The smoothness index for systolic and diastolic ambulatory blood pressure computed after 3 months of treatment was more closely related to its corresponding values after 12 months of treatment than the trough : peak ratio values computed after the same time periods were ( r = 0.68 versus 0.38 for systolic and 0.68 versus 0.42 for diastolic blood pressure , respectively ) . The smoothness index showed an inverse correlation with the 24 h st and ard deviation of systolic and diastolic blood pressure ( r = −0.25 and −0.16 , P the trough : peak ratio did not ( r = −0.01 to −0.12 , NS ) . A treatment-induced reduction in the left ventricular mass index was related to the smoothness index for systolic and diastolic blood pressure ( r = −0.35 and −0.32 , P trough : peak ratios . Conclusions The smoothness index identifies the occurrence of a balanced 24 h blood pressure reduction with treatment and correlates with the favourable effects of treatment on left ventricular hypertrophy better than the commonly used trough : peak ratio",
"The antihypertensive activity of losartan potassium ( losartan , Cozaar ) , an angiotensin II receptor antagonist , was evaluated in a parallel 12-week , double-blind , placebo-controlled trial in hypertensive patients with mild-to-moderate hypertension . After a 4-week , single-blind , placebo lead-in period , which included monitoring of baseline variables , 366 patients with a group mean sitting diastolic blood pressure of 101 + /- 5 ( s.d . ) mmHg were assigned r and omly to one of three treatment groups : placebo , losartan 50 mg , or losartan 50 mg with the option to titrate to 100 mg after the first 6 weeks if the target sitting diastolic blood pressure ( was not reached . To assess the potential blood pressure response associated with the act of titration , patients in the placebo and losartan 50 mg treatment groups with a sitting diastolic blood pressure of > or = 90 mmHg at week 6 were mock titrated ( changed to a new tablet containing the same study medication and dose ) . Sitting diastolic blood pressure was also evaluated at the end of the trial during a 1-week off-drug period to assess for rebound hypertension . At week 6 , patients in the active-drug-treatment arms experienced significantly greater peak ( 6 h post-dose ) and trough ( 24 h post-dose ) reduction in systolic and diastolic sitting blood pressures compared with placebo ( p trough blood pressures at week 12 , active drug ( both arms ) was more effective than placebo in lowering sitting diastolic blood pressure , with a very small additional benefit associated with increasing the dose of losartan to 100 mg in patients who did not reach the target blood pressure after the first 6 weeks on losartan 50 mg . There was no evidence of rebound hypertension during 1 week after withdrawal of losartan . The correlation between baseline plasma renin activity and reduction in peak and trough blood pressure at week 12 , although statistically significant , was generally poor in the active treatment groups . In this trial , losartan was efficacious and well tolerated , and was similar to placebo with regard to adverse-experience profile . Adverse experiences that could reasonably be related to excessive lowering of blood pressure were not common and there was no evidence of rebound hypertension",
"This report presents data on the safety and tolerability of losartan potassium ( losartan ) , a selective antagonist of the angiotensin II AT-1 receptor , in approximately 2,900 hypertensive patients treated in double-blind clinical trials . In these studies , headache ( 14.1 % ) , upper respiratory infection ( 6.5 % ) , dizziness ( 14.1 % ) , asthenia/fatigue ( 3.8 % ) , and cough ( 3.1 % ) were the clinical adverse experiences most often reported in patients treated with losartan . These adverse experiences were also frequently reported in patients receiving placebo : 17.2 % , 5.6 % , 2.4 % , 3.9 % , and 2.6 % , respectively . Dry cough as an adverse event was reported in 8.8 % of patients treated with angiotensin-converting enzyme inhibitors , and in 3.1 % and 2.6 % of patients treated with losartan or placebo , respectively . Only dizziness was considered \" drug-related \" more often in losartan-treated ( 2.4 % ) than placebo-treated ( 1.3 % ) patients . In controlled clinical trials , losartan was better tolerated than other antihypertensive agents as determined by the incidence of patients reporting any drug-related adverse experiences . Rates of discontinuation due to clinical adverse experiences in patients who received losartan monotherapy or losartan+hydrochlorothiazide were 2.3 % and 2.8 % , respectively , compared with placebo ( 3.7 % ) . No laboratory adverse experiences were unexpected or of clinical importance . First-dose hypotension rarely occurred with losartan or with losartan plus hydrochlorothiazide , and withdrawal effects such as rebound hypertension were not observed in clinical trials . There were no clinical ly important differences in the clinical or laboratory safety profiles in the demographic subgroups for age , gender , or race . In controlled clinical trials , losartan demonstrated an excellent tolerability profile",
"OBJECTIVE The goal of this multicenter , double-blind , r and omized , parallel-group study was to compare the effects of losartan potassium ( hereafter referred to as losartan ) , c and esartan cilexitil ( hereafter referred to as c and esartan ) , and losartan/hydrochlorothiazide ( HCTZ ) in patients with mild to moderate hypertension ( sitting diastolic blood pressure [ SiDBP ] 95 - 115 mm Hg ) . METHODS A total of 1161 patients were r and omized in a 2:2:1 ratio to 12 weeks of treatment with losartan 50 mg QD , possibly titrated to 100 mg QD ( n = 461 ) ; c and esartan 8 mg QD , possibly titrated to 16 mg QD ( n = 468 ) ; or losartan 50 mg QD , possibly titrated to losartan 50 mg plus HCTZ 12.5 mg QD ( n = 232 ) . At 6 weeks , the regimens of patients not reaching a goal SiDBP equivalence of the 2 monotherapy regimens , predefined as a maximum between-treatment difference in the mean change from baseline trough SiDBP of 2.5 mm Hg . RESULTS At 12 weeks , changes in SiDBP/sitting systolic blood pressure ( SiSBP ) of -12.4/-14.4 mm Hg with losartan 50 mg/100 mg and -13.1/-15.8 mm Hg with c and esartan 8 mg/16 mg demonstrated equivalence between the 2 monotherapy regimens ( 95 % CI for difference in SiDBP , -1.6 to 0.2 ) . At 12 weeks , the losartan 50 mg/50 mg plus HCTZ 12.5 mg regimen had reduced SiDBP/SiSBP significantly more ( -14.3/-18.0 mm Hg ) than either the c and esartan 8 mg/16 mg ( SiDBP , P = 0.045 ; SiSBP , P = 0.017 ) or losartan 50 mg/100 mg regimen ( SiDBP and SiSBP , P = 0.001 ) . During the last 6 weeks , patients whose regimen had been titrated to losartan 50 mg plus HCTZ 12.5 mg ( n = 114 ) showed a greater reduction in SiDBP/SiSBP ( -14.5/ -18.7 mm Hg ) than did those whose regimen had been titrated to either losartan 100 mg ( -10.5/-12.3 mm Hg ; n = 211 ) or c and esartan 16 mg ( -11.5/-13.2 mm Hg ; n = 206 ) , representing a clinical ly meaningful > or = 2.5-mm Hg ) difference . All 3 treatments were well tolerated , with few patients experiencing drug-related adverse events ( 6.9 % losartan 50 mg/100 mg , 7.5 % c and esartan 8 mg/16 mg , 3.0 % losartan 50 mg/ 50 mg plus HCTZ 12.5 mg ) . C and esartan 8 mg/16 mg increased serum uric acid levels ( 0.13 mg/dL ; 95 % CI , 0.04 to 0.23 ) , whereas losartan 50 mg/100 mg decreased them ( -0.14 mg/dL ; 95 % CI , -0.24 to -0.04 ) , and losartan 50 mg/50 mg plus HCTZ 12.5 mg left them unchanged ( 0.06 mg/dL ; 95 % CI , -0.07 to 0.20 ) . CONCLUSIONS Losartan 50 mg/100 mg and c and esartan 8 mg/16 mg were comparable treatments in terms of blood pressure reduction . After titration , losartan 50 mg plus HCTZ 12.5 mg was superior to either c and esartan 16 mg or losartan 100 mg in reducing hypertension . Losartan , but not c and esartan , lowered serum uric acid levels and attenuated the expected increase in uric acid levels with HCTZ 12.5 mg",
"OBJECTIVES To estimate the impact of small reductions in the population distribution of diastolic blood pressure ( DBP ) , such as those potentially achievable by population -wide lifestyle modification , on incidence of coronary heart disease ( CHD ) and stroke . DESIGN Published data from the Framingham Heart Study , a longitudinal cohort study , and from the National Health and Nutrition Examination Survey II , a national population survey , were used to examine the impact of a population -wide strategy aim ed at reducing DBP by an average of 2 mm Hg in a population including normotensive subjects . SETTING / PARTICIPANTS White men and women aged 35 to 64 years in the United States . MAIN OUTCOME MEASURES Incidence of CHD and stroke , including transient ischemic attacks ( TIAs ) . RESULTS Data from overviews of observational studies and r and omized trials suggest that a 2-mm Hg reduction in DBP would result in a 17 % decrease in the prevalence of hypertension as well as a 6 % reduction in the risk of CHD and a 15 % reduction in risk of stroke and TIAs . From an application of these results to US white men and women aged 35 to 64 years , it is estimated that a successful population intervention alone could reduce CHD incidence more than could medical treatment for all those with a DBP of 95 mm Hg or higher . It could prevent 84 % of the number prevented by medical treatment for all those with a DBP of 90 mm Hg or higher . For stroke ( including TIAs ) , a population -wide 2-mm Hg reduction could prevent 93 % of events prevented by medical treatment for those with a DBP of 95 mm Hg or higher and 69 % of events for treatment for those with a DBP of 90 mm Hg or higher . A combination strategy of both a population reduction in DBP and targeted medical intervention is most effective and could double or triple the impact of medical treatment alone . Adding a population -based intervention to existing levels of hypertension treatment could prevent an estimated additional 67,000 CHD events ( 6 % ) and 34,000 stroke and TIA events ( 13 % ) annually among all those aged 35 to 64 years in the United States . CONCLUSIONS A small reduction of 2 mm Hg in DBP in the mean of the population distribution , in addition to medical treatment , could have a great public health impact on the number of CHD and stroke events prevented . Whether such DBP reductions can be achieved in the population through lifestyle interventions , in particular through sodium reduction , depends on the results of ongoing primary prevention trials as well as the cooperation of the food industry , government agencies , and health education professionals",
"The antihypertensive efficacy and tolerability of the novel angiotensin-II ( A-II ) receptor blocker c and esartan cilexetil and the prototype A-II receptor blocker , losartan , were compared in an 8-week , multicenter , double-blind , r and omized , parallel-group , titration-to-effect study of 332 adults ( 42 % women , 12 % black ) with systemic hypertension ( sitting diastolic blood pressure [ DBP ] 95 - 114 mmHg , inclusive ) . In patients with a mean trough ( 24 + /- 3 hours after dose ) sitting DBP of 90 mmHg or higher after 4 weeks of once daily administration of c and esartan 16 mg or losartan 50 mg , dose was titrated up to c and esartan 32 mg or losartan 100 mg once daily . The c and esartan regimen was significantly more effective than the losartan regimen in reducing trough sitting DBP at week 8 ( 11.0 mmHg versus 8.9 mmHg ) . C and esartan also produced numerically greater reductions in secondary blood pressure parameters , including sitting systolic blood pressure ( SBP ) , trough st and ing DBP and SBP , and peak ( 6 + /- 2.5 hours after dose ) sitting and st and ing DBP and SBP . Responder rates ( sitting DBP or = 10 mmHg ) and control rates ( sitting DBP c and esartan ( 64 % versus 54 % and 54 % versus 43 % , respectively ) . A total of 1.9 % of the patients taking c and esartan and 6.5 % of those taking losartan discontinued prematurely because of adverse events or lack of efficacy",
"The purpose of this double-blind , forced titration study was to compare the antihypertensive effect duration of c and esartan cilexetil , which has a longlasting binding to the human AT1-receptor , to that of losartan on ambulatory BP ( ABP ) not only during the 24-h dosing interval but also during the day of a missed dose intake . After a 4-week placebo lead-in period , 268 patients with sitting diastolic BP 95 to 110 mm Hg and mean awake ambulatory DBP > or = 85 mm Hg were r and omized to receive either 8 mg of c and esartan , 50 mg of losartan , or placebo for a 4-week period . Thereafter , the doses were doubled in all patients for an additional 4-week period . Ambulatory BP monitoring was performed for 36 h after dosing and clinic BP measured 48 h after dosing . C and esartan cilexetil ( 16 mg ) reduced ABP to a significantly greater extent than 100 mg of losartan , particularly for systolic ABP during daytime ( P systolic ( P diastolic ( P ABP between 0 and 36 h , and both systolic ( P diastolic ( P ABP during the day of a missed dose . Clinic BP at 48 h after dosing was significantly reduced exclusively with 16 mg of c and esartan . The differences in BP reduction between 8 mg of c and esartan and 50 mg of losartan were statistically significant for systolic ABP during daytime ( P losartan did not significantly reduce ambulatory BP in a dose-related manner , ambulatory systolic and diastolic BP reductions with 16 mg of c and esartan were significantly greater ( P c and esartan during every period at the ABP supporting a dose-response relationship . In conclusion , this forced titration study in ambulatory hypertensive patients demonstrates that c and esartan cilexetil provides significant dose-dependent reduction in both clinic and ambulatory BP in doses ranging from 8 to 16 mg once daily . Furthermore , c and esartan cilexetil is superior to losartan in reducing systolic ABP and in controlling both systolic and diastolic ABP on the day of a missed dose . The differences observed between both agents are most likely attributable to a tighter binding to , and a slower dissociation from , the receptor binding site with c and esartan cilexetil",
"This multicentre study compared the antihypertensive effect and tolerability of the novel angiotensin II antagonist c and esartan cilexetil with those of losartan and placebo . Men and women aged 20 - 80 years , with primary hypertension and sitting diastolic blood pressure ( DBP ) 95 - 114 mm Hg after a 4-week placebo run-in period , were r and omized to once daily double-blind treatment with c and esartan cilexetil 8 mg ( n=82 ) , c and esartan cilexetil 16 mg ( n=84 ) , losartan 50 mg ( n=83 ) or placebo ( n=85 ) for 8 weeks . Blood pressure was measured 6 and 24 h after dose , i.e. at peak and trough . Differences between treatments were analysed by analysis of covariance , and the primary effect variable was reduction in trough sitting DBP . Compared with placebo treatment , trough DBP was significantly reduced by a mean ( 95 % CI ) of 8.9 ( 6.0 ; 11.8 ) mm Hg with 8 mg and 10.3 ( 7.4 ; 13.2 ) mm Hg with 16 mg c and esartan cilexetil . The 8 mg dose was as effective as losartan 50 mg , while 16 mg c and esartan cilexetil was significantly more effective , with a difference between treatments of 3.7 ( 0.8 ; 6.7 ) mm Hg ( p=0.013 ) . The placebo corrected trough/peak ratio was 0.9 - 1.1 with c and esartan cilexetil and 0.7 with losartan . C and esartan cilexetil was similarly well tolerated as placebo . In conclusion , c and esartan cilexetil 8 mg or 16 mg once daily is an effective and well tolerated antihypertensive treatment . C and esartan cilexetil 16 mg is significantly more effective than losartan 50 mg once daily",
"This r and omized , double-blind study compared the antihypertensive effect , safety and tolerability of a c and esartan cilexetil/hydrochlorothiazide ( c and esartan/HCT ; 16/12.5 mg ) combination tablet with that of a losartan/HCT ( 50/12.5 mg ) combination tablet in patients with mild-to-moderate primary hypertension insufficiently controlled on previous monotherapy . Men and women , aged 20 - 80 years , with a sitting diastolic blood pressure ( DBP ) > or = 90 and c and esartan/HCT or losartan/HCT once daily for 12 weeks . All BP measurements were performed 24 h after previous dose . Mean values and st and ard deviations ( SD ) or confidence intervals ( CI ) are given . A total of 340 patients were enrolled , of whom 299 ( 144 women and 155 men , mean age 59.5 [ 10.5 ] years ) were r and omized to c and esartan/HCT ( n = 151 ) or losartan/HCT ( n = 148 ) . BPs at r and omization were 159.5 (15.4)/98.4 (5.8)mmHg and 160.5 (16.1)/98.5 (5.4)mmHg , respectively . There was a greater reduction in BP with c and esartan/HCT than with losartan/HCT : DBP -10.4 ( -11.8 ; -8.9 ) vs -7.8 ( -9.3 ; -6.3 ) mmHg , difference between treatments -2.6 ( -4.7 ; -0.5 ) mmHg ( p = 0.016 ) ; SBP -19.4 ( -22.1 ; -16.7 ) vs - 13.7 ( -16.5 ; - 10.9 ) mmHg , difference between treatments -5.7 ( -9.6 ; -1.8 ) mmHg ( p = 0.004 ) . The proportion of patients achieving a DBP was greater in the c and esartan/HCT group : 60.9 ( 53.1 ; 68.7 ) vs 49.3 ( 41.3 ; 57.4)% ( p = 0.044 ) . There were 12 withdrawals in the c and esartan/HCT group , of which 8 were due to adverse events , and 17 and 12 , respectively in the losartan/HCT group . We conclude that the combination of c and esartan and HCT reduces BP effectively and is well tolerated . BP was normalized in 61 % of these patients who had insufficient response to previous monotherapy . The reduction in BP and the proportion of patients with normalized BP were greater with the c and esartan/HCT 16/12.5 mg combination than with the losartan/ HCT 50/12.5 mg combination"
] | 41166f00-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND For the past decade , electric pulmonary vein isolation ( PVI ) has become a procedure implemented worldwide for the treatment of atrial fibrillation . Currently , 2 main approaches are used for PVI : ostial isolation of the PVs and wide antral PVI . The aims of this systematic review are to evaluate the relative merits of each technique with a pooled comparative analysis of efficacy and complications . METHODS AND RESULTS Studies were identified by search ing electronic data bases for studies on ostial versus antral PVI . Information was extracted from each included trial . Odds ratio was the primary measure of treatment effect or side effects . The proportion of patients with recurrences of atrial fibrillation or other atrial tachyarrhythmias was evaluated at the end of the follow-up periods in 12 trials , including 1183 patients . The recurrence rate of total supraventricular arrhythmias was significantly lower in wide antral than in segmental PVI group ( odds ratio , 0.42 ; 95 % confidence interval , 0.32 - 0.56 ; P Atrial fibrillation recurrence was significantly lower in the wide antral group ( odds ratio , 0.33 ; 95 % confidence interval , 0.24 - 0.46 ; P incidence of left atrial tachycardia occurrence in the wide antral circumferential ablation group was detected , which did not reach statistical significance ( odds ratio , 1.53 ; 95 % confidence interval , 0.88 - 2.69 ; P=0.13 ) . CONCLUSIONS Our primary finding is that PVI performed with a wide antral approach is more effective than ostial PVI in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up | [
"Background —Circumferential radiofrequency ablation around pulmonary vein ( PV ) ostia has recently been described as a new anatomic approach for atrial fibrillation ( AF ) . Methods and Results —We treated 251 consecutive patients with paroxysmal ( n=179 ) or permanent ( n=72 ) AF . Circular PV lesions were deployed transseptally during sinus rhythm ( n=124 ) or AF ( n=127 ) using 3D electroanatomic guidance . Procedures lasted 148±26 minutes . Among 980 lesions surrounding individual PVs ( n=956 ) or 2 ipsilateral veins with close openings or common ostium ( n=24 ) , 75 % were defined as complete by a bipolar electrogram amplitude 30 ms across the line . The amount of low-voltage encircled area was 3594±449 mm2 , which accounted for 23±9 % of the total left atrial ( LA ) map surface . Major complications ( cardiac tamponade ) occurred in 2 patients ( 0.8 % ) . No PV stenoses were detected by transesophageal echocardiography . After 10.4±4.5 months , 152 patients with paroxysmal AF ( 85 % ) and 49 with permanent AF ( 68 % ) were AF-free . Patients with and without AF recurrence did not differ in age , AF duration , prevalence of heart disease , or ejection fraction , but the LA diameter was significantly higher ( P The proportion of PVs with complete lesions was similar between patients with and without recurrence , but the latter had larger low-voltage encircled areas after radiofrequency ( expressed as percent of LA surface area;P PV ablation is a safe and effective treatment for AF . Its success is likely due to both PV trigger isolation and electroanatomic remodeling of the area encompassing the PV ostia",
"AIMS This study examined the difference in autonomic modification ( AM ) and its effect on paroxysmal atrial fibrillation ( PAF ) recurrence between segmental pulmonary vein isolation ( S-PVI ) and circumferential PVI ( C-PVI ) . METHODS AND RESULTS Successful S-PVI or C-PVI with a basket catheter was achieved in 120 consecutive PAF patients . Serial 24 Holter-recordings were obtained before , immediately , and 1 , 3 , 6 , 12 months after the PVI to analyse the heart rate variability ( HRV ) . Nineteen patients were excluded from analysis because of additional ablation for recurrent PAF after successful PVI . Among the residual 101 patients , 33 had PAF recurrences ( S-PVI = 44.0 % , C-PVI = 21.6 % ) at 1 year of follow-up . The root mean square of successive differences and high-frequency power reflecting parasympathetic nervous activity were significantly lower in patients with and without PAF recurrences after C-PVI and patients without PAF recurrences after S-PVI than patients with PAF recurrences after S-PVI ( P HRV parameters in the immediate aftermath of PVI among the patients without PAF recurrences after S-PVI and those with and without PAF recurrences after C-PVI . CONCLUSION Although additional radiofrequency ablation for AM may be recommended after S-PVI to reduce PAF recurrences , it should be carefully determined after C-PVI",
"Background — Pulmonary vein ( PV ) isolation is a promising new treatment for atrial fibrillation ( AF ) . We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV . Methods and Results — A total of 110 patients , 67 with paroxysmal AF and 43 with persistent AF , were r and omly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs . The isolation of each individual PV was an electrophysiologically guided , ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter ( group I ) . Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block ( group II ) . In both groups , an irrigated-tip ablation catheter ( 25 to 35 W ) was used to achieve complete isolation . Procedure and ablation times were longer in group II , whereas fluoroscopic time was significantly shorter ( P≤0.001 ) . After a follow-up period of 15±4 months , 27 patients in group I ( 49 % ) and 37 patients in group II ( 67 % ) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure ( P≤0.05 ) . Conclusions — The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation",
"Background —The pulmonary veins ( PVs ) and surrounding ostial areas frequently house focal triggers or reentrant circuits critical to the genesis of atrial fibrillation ( AF ) . We developed an anatomic approach aim ed at isolating each PV from the left atrium ( LA ) by circumferential radiofrequency ( RF ) lesions around their ostia . Methods and Results —We selected 26 patients with resistant AF , either paroxysmal ( n=14 ) or permanent ( n=12 ) . A nonfluoroscopic mapping system was used to generate 3D electroanatomic LA maps and deliver RF energy . Two maps were acquired during coronary sinus and right atrial pacing to vali date the lateral and septal PV lesions , respectively . Patients were followed up closely for ≥6 months . Procedures lasted 290±58 minutes , including 80±22 minutes for acquisition of all maps , and 118±16 RF pulses were deployed . Among 14 patients in AF at the beginning of the procedure , 64 % had sinus rhythm restoration during ablation . PV isolation was demonstrated in 76 % of 104 PVs treated by low peak-to-peak electrogram amplitude ( 0.08±0.02 mV ) inside the circular line and by disparity in activation times ( 58±11 ms ) across the lesion . After 9±3 months , 22 patients ( 85 % ) were AF-free , including 62 % not taking and 23 % taking antiarrhythmic drugs , with no difference ( P = NS ) between paroxysmal and permanent AF . No thromboembolic events or PV stenoses were observed by transesophageal echocardiography . Conclusions —Radiofrequency PV isolation with electroanatomic guidance is safe and effective in either paroxysmal or permanent AF",
"Background —Atrial fibrillation ( AF ) is frequently initiated from pulmonary veins ( PVs ) , but little is known of the electrophysiological properties of PVs . Methods and Results —Two groups were studied : 28 patients ( 49±13 years old ) with paroxysmal AF and 20 control patients ( 49±14 years old ) without AF . Effective and functional refractory period and conduction time from PV to left atrium ( LA ) were compared in the 2 groups by use of programmed stimulation with a single extrastimulus in the PVs and LA . In the AF group , the venous effective refractory periods ( ERPs ) were shorter than that of the LA : 185±71 versus 253±21 ms , P The venous ERPs and functional refractory periods in patients with AF were also shorter than that observed in control subjects ( 185±71 versus 282±45 ms and 210±77 versus 315±43 ms , respectively , P LA ERPs were not significantly different . Decremental conduction in PVs was more frequent ( 93 % versus 56 % , P = 0.01 ) and had a greater increment ( 102±65 versus 42±40 ms , P AF was more frequently induced when pacing was performed in PVs ( 22 of 90 ) versus LA ( 1 of 81 ) in patients with AF ( P < 0.001 ) . Conclusions —The PVs of patients with AF exhibited distinctive electrophysiological properties , which were strikingly different from those of patients devoid of AF , potentially explaining their arrhythmogenicity",
"Background —Segmental ostial catheter ablation ( SOCA ) to isolate the pulmonary veins ( PVs ) and left atrial catheter ablation ( LACA ) to encircle the PVs both may eliminate paroxysmal atrial fibrillation ( PAF ) . The relative efficacy of these 2 techniques has not been directly compared . Methods and Results —Of 80 consecutive patients with symptomatic PAF ( age , 52±10 years ) , 40 patients underwent PV isolation by SOCA and 40 patients underwent LACA to encircle the PVs . During SOCA , ostial PV potentials recorded with a ring catheter were targeted . LACA was performed by encircling the left- and right-sided PVs 1 to 2 cm from the ostia and was guided by an electroanatomic mapping system ; ablation lines also were created in the mitral isthmus and posterior left atrium . The mean procedure and fluoroscopy times were 156±45 and 50±17 minutes for SOCA and 149±33 and 39±12 minutes for LACA , respectively . At 6 months , 67 % of patients who underwent SOCA and 88 % of patients who underwent LACA were free of symptomatic PAF when not taking antiarrhythmic drug therapy ( P = 0.02 ) . Among the variables of age , sex , duration and frequency of PAF , ejection fraction , left atrial size , structural heart disease , and the ablation technique , only an increased left atrial size and the SOCA technique were independent predictors of recurrent PAF . The only complication was left atrial flutter in a patient who underwent LACA . Conclusions —In patients undergoing catheter ablation for PAF , LACA to encircle the PVs is more effective than SOCA",
"BACKGROUND Stepwise segmental pulmonary vein isolation ( SPVI ) and circumferential pulmonary vein isolation ( CPVI ) have been developed to treat patients with atrial fibrillation ( AF ) , but the preferable approach for paroxysmal AF ( PAF ) has not been established . METHODS AND RESULTS One hundred and ten patients with symptomatic PAF were r and omized into a stepwise SPVI group ( n=55 ) or CPVI group ( n=55 ) . Systemic SPVI combined with left atrial linear ablation tailored by inducibility of AF was performed in the stepwise SPVI group . Circumferential linear ablation around the left and right-sided pulmonary veins ( PVs ) guided by 3-dimensional electroanatomic mapping was performed in the CPVI group . The endpoints of ablation are non-induciblity of AF in the stepwise SPVI group and continuity of circular lesions combined with PV isolation in the CPVI group . After the initial procedures , atrial tachyarrhythmis ( ATa ) recurred within the first 3 months in 23 of the 55 patients ( 41.8 % ) who underwent stepwise SPVI and in 20 of the 55 patients ( 36.4 % ) who had CPVI ( p=0.69 ) . Repeat procedures were performed in 7 patients from the stepwise SPVI group and 5 from the CPVI group ( p=0.76 ) . During the 3 - 9 months after the last procedure , 46 patients ( 83.6 % ) from the CPVI group and 43 ( 78.2 % ) from the stepwise SPVI group did not have symptomatic ATa while not taking anti-arrhythmic drugs ( p=0.63 ) . Severe subcutaneous hematoma or PV stenosis occurred in 3 patients . CONCLUSIONS The efficacy of stepwise SPVI is comparable to that of CPVI for patients with PAF",
"Aims Previous studies have analyzed the efficacy of atrial fibrillation ( AF ) ablation in series of consecutive patients or comparing methods in a r and omized way , without taking account individual patient characteristics . The purpose of this study was to evaluate the results of a strategy based on selecting the ablation method according to patient clinical features in drug-refractory paroxysmal or persistent AF . Methods and results Patients with left atrial diameter ≤40 mm and runs of atrial tachycardia of more than ten beats during Holter recording were selected for selective segmental ostial ablation ( SSOA ) in order to disconnect only those pulmonary veins with electrical potentials . The remaining patients underwent circumferential pulmonary veins ablation ( CPVA ) to modify left atrial substrate by extensive linear lesions . A group of 131 consecutive patients were included . Mean follow-up was 21.5 ± 15.2 months . In paroxysmal AF , 44 and 55 patients were selected for SSOA and CPVA , respectively , and the efficacy of the procedure was similar in the two groups ( 77 vs 74 % ; log-rank test p = NS ) . In persistent AF , 6 and 26 patients underwent SSOA and CPVA , respectively , and greater efficacy was observed in the second group ( 17 vs 65 % ; log-rank test p = 0.004 ) . Conclusions Selecting the ablation method according to patient characteristics achieved good results and reduced the overall amount of ablated atrial tissue in patients with paroxysmal AF . However , in persistent AF the SSOA technique showed very limited efficacy despite the previous patient selection and a CPVA-like procedure may be the appropriate choice in all cases",
"BACKGROUND The activation patterns that underlie the irregular electrical activity during atrial fibrillation ( AF ) have traditionally been described as disorganized or r and om . Recent studies , based predominantly on statistical methods , have provided evidence that AF is spatially organized . The objective of this study was to demonstrate the presence of spatial and temporal periodicity during AF . METHODS AND RESULTS We used a combination of high-resolution video imaging , ECG recordings , and spectral analysis to identify sequential wave fronts with temporal periodicity and similar spatial patterns of propagation during 20 episodes of AF in 6 Langendorff-perfused sheep hearts . Spectral analysis of AF demonstrated multiple narrow-b and peaks with a single dominant peak in all cases ( mean , 9.4+/-2.6 Hz ; cycle length , 112+/-26 ms ) . Evidence of spatiotemporal periodicity was found in 12 of 20 optical recordings of the right atrium ( RA ) and in all ( n=19 ) recordings of the left atrium ( LA ) . The cycle length of spatiotemporal periodic waves correlated with the dominant frequency of their respective optical pseudo-ECGs ( LA : R2=0.99 , slope=0.94 [ 95 % CI , 0.88 to 0.99 ] ; RA : R2=0.97 , slope=0.92 [ 95 % CI , 0.80 to 1.03 ] ) . The dominant frequency of the LA pseudo-ECG alone correlated with the global bipolar atrial EG ( R2=0.76 , slope=0.75 [ 95 % CI , 0.52 to 0.99 ] ) . In specific examples , sources of periodic activity were seen as rotors in the epicardial sheet or as periodic breakthroughs that most likely represented transmural pectinate muscle reentry . However , in the majority of cases , periodic waves were seen to enter the mapping area from the edge of the field of view . CONCLUSIONS Reentry in anatomically or functionally determined circuits forms the basis of spatiotemporal periodic activity during AF . The cycle length of sources in the LA determines the dominant peak in the frequency spectra in this experimental model of AF",
"Background —There has been growing concern that linear ablation is associated with an increased risk of iatrogenic arrhythmias in patients undergoing ablation for atrial fibrillation ( AF ) . Therefore , we compared circumferential pulmonary vein ablation plus left atrial linear ablation ( CPVA+LALA ) with segmental pulmonary vein isolation (PVI)in patients with paroxysmal AF . Methods and Results —Sixty-six consecutive patients with paroxysmal AF were prospect ively r and omly assigned to receive PVI versus CPVA+LALA ( consisting of encircling lesions around the pulmonary veins ) , a roof line , and a mitral isthmus line with documentation of bidirectional mitral isthmus block . All patients were seen at 1 , 3 , 6 , and every 12 months after ablation , with 14-day continuous ECG monitoring every 6 months . At 16.4±6.3 months after 1 ablation procedure , 19 patients ( 58 % ) remained free of atrial arrhythmias after PVI versus 17 patients ( 51 % ) after CPVA+LALA ( P=0.62 ) . After PVI , 14 patients had recurrent paroxysmal AF , whereas after CPVA+LALA , 8 patients had recurrent AF , 6 had atypical left atrial flutter ( LAFL ) , and 2 had both AF and LAFL ( P=0.32 between PVI versus CPVA+LALA for AF but P=0.002 for LAFL ) . Twenty-eight patients ( 85 % ) remained arrhythmia-free after 1.3±0.5 PVI procedures versus 28 patients ( 85 % ) after 1.4±0.6 CPVA+LALA procedures ( P = NS ) . Fluoroscopy time was longer after CPVA+LALA versus PVI ( 91 versus 73 minutes , P=0.04 ) . Conclusions —As an initial ablation approach in patients with paroxysmal AF , more LAFL occurred after CPVA+LALA and fluoroscopy times were longer compared with segmental PVI",
"Background — Data on the comparative value of the circumferential pulmonary vein and the segmental pulmonary vein ablation for interventional treatment of atrial fibrillation are limited . We hypothesized that the circumferential pulmonary vein ablation approach was superior to the segmental pulmonary vein ablation approach . Methods and Results —One hundred patients with highly symptomatic atrial fibrillation were r and omly assigned to undergo either circumferential ( n=50 ) or segmental pulmonary vein ablation ( n=50 ) . Freedom from atrial tachyarrhythmias in a 7-day Holter monitoring at 6 months was the primary end point . Secondary end points were freedom of arrhythmia-related symptoms and a composite of pericardial tamponade , thromboembolic complications , and pulmonary vein stenosis ( safety end point ) . On the basis of the results of the 7-day Holter monitoring at 6 months , 21 patients ( 42 % ) after circumferential pulmonary vein ablation and 33 patients ( 66 % ) after segmental pulmonary vein ablation ( P=0.02 ) were free of atrial tachyarrhythmia episodes . During the 6-month follow-up period , 27 patients ( 54 % ) after circumferential pulmonary vein ablation and 41 patients ( 82 % ) after segmental pulmonary vein ablation remained free of arrhythmia-related symptoms ( P safety end point ( 6 versus 7 events ; P=0.77 ) in the circumferential versus segmental pulmonary vein ablation group , respectively . Conclusions —This study demonstrates no superiority of the circumferential pulmonary vein ablation over segmental pulmonary vein ablation for treatment of atrial fibrillation in terms of efficacy and safety",
"BACKGROUND The limited efficacy and complications of segmental ostial pulmonary vein isolation ( PVI ) for treating atrial fibrillation ( AF ) have been discussed so , in the present study the feasibility and efficiency of performing segmental pulmonary vein ( PV ) antrum isolation to treat AF were assessed . METHODS AND RESULTS A total of 187 patients with drug-refractory AF ( paroxysmal 120 , persistent 67 ) underwent segmental PVI guided by circumferential 20-electrode catheters ( Lasso ) . Radiofrequency ( RF ) current was delivered either at the ostium using a regular Lasso ( 15 - 20 mm in diameter , 70 patients : Group 1 ) or at the antrum using a larger Lasso ( 25 - 30 mm in diameter , 117 patients : Group 2 ) . A significantly wider region had to be ablated , with a longer RF application time , to isolate all 4 PVs in Group 2 patients than in Group 1 patients . Although the rate of recurrence of AF after the initial session was equal in both groups , a significantly greater number of patients were free from AF after a mean of 1.4 procedures in Group 2 than in Group 1 ( 93 % vs 76 % for paroxysmal AF , 78 % vs 48 % for persistent AF ) . CONCLUSIONS Segmental antral PVI using large-sized Lasso catheters was found to be more effective and safer than ostial PVI for the treatment of AF",
"BACKGROUND Catheter ablation ( CA ) by wide encirclement of pulmonary veins ( WEPV ) restores sinus rhythm in up to 95 % . Complex PV-left atrial ( LA ) connections make achieving electrical isolation ( EI ) challenging . We examined anatomical and technical features associated with resistance to EI during WEPV in a prospect i ve study . METHODS One hundred one consecutive patients with symptomatic AF underwent first-time CA guided by electroanatomic mapping and CT integration ( Cartomerg ) . Following double-transseptal access , WEPV was performed . After completion of PV encirclement , the line was mapped and where no signal could be obtained , CA was performed inside the WE line at the site of earliest PV breakthrough on the circular mapping catheter . Sites of EI were tagged . Anatomic studies of corresponding regions of the venoatrial junction in 24 adult hearts were performed . RESULTS Sites resistant to EI were located at the inferior quadrant ( P EI was significantly less frequent at the posterior quadrant ( P EI , CA was necessary inside the WE on the intervenous ridge on the right in 51 % and on the left in 41 % . The LPV/LAA ridge was investigated by anatomic studies that demonstrated considerable variation in the narrowest width ( 3 - 23.7 mm ) and transmural thickness ( 1 - 5 mm ) . CONCLUSION Sites of EI after WEPV have a preferential distribution determined by anatomic features . CA on the intervenous ridge is required in a significant proportion of patients to achieve EI . Atrial folds and ridges increase myocardial thickness creating technical and anatomic challenges for achieving transmural lesions",
"BACKGROUND Electrical isolation of pulmonary veins ( PVs ) is an effective therapy for atrial fibrillation ( AF ) . Both segmental ostial PV ablation and circumferential ablation with PV-left atrial ( LA ) block have been implicated to eliminate AF . However , the mechanism of the recurrent AF after undergoing either strategy remains unclear . METHODS AND RESULTS Of the 73 consecutive patients with symptomatic AF that underwent PV isolation and had recurrences of AF , Group 1 consisted of 46 patients ( age 56 + /- 13 years old , 35 males ) who underwent PV isolation by segmental ostial PV ablation and Group 2 consisted of 27 patients ( age 51 + /- 11 years old , 24 males ) who underwent circumferential ablation with PV-LA block . In Group 1 , the earliest ectopic beat or ostial PV potentials were targeted . In Group 2 , circumferential ablation with PV-LA block was performed by encircling the extraostial regions around the left and right PVs . During the first procedure , all patients had PV-AF . There was no difference in the non-PV ectopy between Group 1 and Group 2 . During the second procedure , the incidence of an LA posterior wall ectopy initiating AF was significantly lower ( 20 % vs. 0 % , P = 0.01 ) in Group 2 . There was no difference in the PV ectopy initiating AF during the second procedure . CONCLUSION Circumferential ablation of AF with PV-LA block may eliminate the LA posterior wall ectopy and decrease the incidence of LA posterior wall ectopy initiating AF during the second procedure",
"Background —Ablation of the pulmonary veins ( PVs ) for atrial fibrillation treatment is often combined with linear radiofrequency lesions along the left atrium ( LA ) to improve the success rate . The study was design ed to assess the contribution of LA posterior wall isolation to the outcome of circumferential pulmonary vein ablation ( CPVA ) . Methods and Results —CPVA consisted of continuous radiofrequency lesions encircling both ipsilateral PVs plus an ablation line along the mitral isthmus . Patients were then r and omized into 2 groups . In the first group , superior PVs were connected by linear lesions along the LA roof ( CPVA-1 group ) . In the second group , the LA posterior wall was isolated by adding a second line connecting the inferior aspect of the 2 inferior PVs ( CPVA-2 group ) . The study included 120 patients ( 53±11 years , 77 % male , 60 % paroxysmal atrial fibrillation , LA of 41.3±5.4 mm , 46 % with hypertension , and 22 % with structural heart disease ) . After a single ablation procedure and a mean follow-up of 10±4 months , 24 ( 40 % ) patients of the CPVA-1 group had atrial fibrillation recurrences and 3 ( 5 % ) had new-onset LA flutter . In the CPVA-2 group , recurrences were due to atrial fibrillation episodes in 23 patients ( 38 % ) and LA flutter in 4 ( 7 % ) . Freedom from arrhythmia recurrences was not statistically different in the CPVA-1 group as compared with the CPVA-2 group ( log rank P=0.943 ) . Conclusion —Isolation of the LA posterior wall did not increase the success rate of CPVA ",
"Background : The wide area circumferential ablation ( WACA ) approach to atrial fibrillation is thought to result in ‘ substrate modification ’ perhaps related to autonomic denervation . We examined this prospect ively by comparing WACA and segmental pulmonary vein isolation ( PVI ) using noninvasive surrogate markers",
"INTRODUCTION Circumferential pulmonary vein ablation ( CPVA ) with the endpoint of pulmonary vein ( PV ) isolation has been developed as an effective therapy for atrial fibrillation ( AF ) . This endpoint can be achieved either by closing gaps along circular lines or by segmental PV isolation inside the circular lines after creation of initial CPVA lesions . We investigated whether the clinical outcome depends on the PV isolation approach used during the first-time CPVA procedure . METHODS AND RESULTS One hundred consecutive patients ( 69 male ; age , 56.7 + /- 11.6 years ) who underwent first-time CPVA for treatment of symptomatic AF were enrolled . PV isolation was r and omly achieved either by CPVA alone ( aggressive CPVA [ A-CPVA ] group , n = 50 ) or by a combination of CPVA with segmental PV ostia ablation ( modified CPVA [ M-CPVA ] group , n = 50 ) . Recurrence of atrial tachyarrhythmias ( ATa ) within 3 months after the initial procedure occurred in 30 patients ( 60 % ) in the M-CPVA group and in only 15 patients ( 30 % ) in the A-CPVA group ( P ATa relapse after the first 3 months was detected in 21 patients ( 42 % ) in the M-CPVA group , compared with 9 patients ( 18 % ) in the A-CPVA group ( P = 0.01 ) . At 13 + /- 4 months , patients treated by the A-CPVA approach had greater freedom from ATa recurrence than patients who underwent M-CPVA ( P = 0.01 ) . The M-CPVA approach was the only independent predictor associated with procedural failure ( RR 0.318 ; 95 % CI 0.123 - 0.821 ; P = 0.02 ) . CONCLUSIONS When PV isolation is the endpoint of CPVA , the efficacy of the A-CPVA approach is better than that of M-CPVA",
"Background —Electric isolation of the pulmonary veins and posterior left atrium with a single ring of radiofrequency lesions ( single-ring isolation [ SRI ] ) may result in fewer atrial fibrillation ( AF ) recurrences than wide antral pulmonary vein isolation ( wide antral isolation [ WAI ] ) by abolishing extravenous AF triggers . The effect of mitral isthmus line ( MIL ) ablation on outcomes after SRI has not previously been assessed . Methods and Results —We r and omly assigned 220 consecutive patients ( 58±10 years old ; 82 % men ) with highly symptomatic AF ( 61 % paroxysmal , 39 % persistent/longst and ing persistent ) to undergo either SRI or WAI . Half of each cohort was also r and omly allocated to have left lateral MIL ablation ( 2 × 2 factorial study design ) . Patients were followed clinical ly and with 7-day Holter studies for arrhythmia recurrences . The primary end points were recurrence of AF and organized atrial tachyarrhythmias . AF-free survival at 2 years was better after SRI ( 74 % [ 95 % CI , 65%–82 % ] ) than WAI ( 61 % [ 51%–70 % ] ; P=0.031 ) . Organized atrial tachyarrhythmia – free survival was similar after SRI and WAI ( 67 % [ 57%–75 % ] ersus 64 % [ 54%–72 % ] , respectively , at 2 years ; P=0.988 ) . MIL ablation result ed in better 2-year organized atrial tachyarrhythmia – free survival ( 71 % [ 62%–79 % ] versus 60 % [ 50%–69 % ] ; P=0.07 ) , which approached statistical significance . Survival free of any atrial arrhythmia after one procedure was not significantly affected by isolation technique or MIL ablation . Conclusions —SRI result ed in fewer AF recurrences compared with WAI on long-term follow-up but did not reduce the recurrence of all atrial arrhythmias . MIL ablation may reduce organized atrial tachyarrhythmia recurrences . Clinical Trial Registration —http://www.anzctr.org.au ; ACTRN12606000467538",
"AIMS Early recurrences of atrial arrhythmia after wide electrically isolating ablation for atrial fibrillation ( AF ) are well described , but the long-term risk of recurrence for patients with persistent and permanent AF has not been studied in detail . METHODS AND RESULTS Fifty-six consecutive patients [ 45 men ( 80.4 % ) , age 55.9 + /- 8.7 years ] with persistent [ 39(69.6 % ) ] or permanent [ 17(30.4 % ) ] AF were followed for 21.6 + /- 8.8 months after ablation . Atrial fibrillation duration prior to ablation was 6.4 + /- 5.6 years . Electrically isolating lesions encircling the left and right pulmonary veins ( PVs ) in pairs were created . After 1.5 + /- 0.7 procedures , 48 ( 85.7 % ) had sinus rhythm ( SR ) at 21.6 + /- 8.8 months of follow-up : achieved with 1 procedure in 27 ( 56.3 % ) and without anti-arrhythmics in 30 ( 62.5 % ) . Atrial fibrillation recurrence was observed in 69.6 % after the first and 46.4 % after the last procedure . Of those with late recurrences ( > 90 days ) following the last procedure , most [ 18 ( 69.2 % ) ] did not have early recurrences . Pre-procedural AF duration ( P = 0.007 ) and female gender ( P = 0.005 ) were independent predictors of recurrence following the last procedure . CONCLUSION Circumferential PV isolation is effective in most patients with persistent or permanent AF . However , repeat procedures are frequently required . Late recurrences are common and not precluded by the absence of early post-procedural arrhythmias",
"BACKGROUND Both segmental ostial and circumferential extraostial pulmonary vein ( PV ) isolation have been proven effective in the treatment of atrial fibrillation ( AF ) . However , the recurrence of AF and PV conduction after the 2 ablation strategies has never been compared in a r and omized study . METHODS A total of 100 consecutive patients ( age 56 + /- 10 ; 71 men ) with symptomatic AF ( paroxysmal , 51 ; persistent , 49 ) were r and omized to segmental ostial ( n = 54 ) or circumferential extraostial ( n = 46 ) PV isolation . A circular catheter positioned at the ostium of each target PV guided the ostial PV isolation . Extraostial PV isolation was performed by encircling the paired left and right PVs , respectively , guided by an electroanatomic mapping system . RESULTS A total of 84 % of the patients had recurrent AF after the first PV isolation procedure , showing 72 % with AF and 12 % with organized left atrial tachycardia . In patients undergoing reablation , all but 2 patients had recurrence of left atrium PV conduction ( > 95 % ) . During a mean follow-up of 12 months without antiarrhythmic medication , 57 % of patients who underwent extraostial PV isolation were free of arrhythmia symptoms compared with 31 % of patients who underwent ostial PV isolation ( P success rate between the 2 ablation strategies was mainly seen in patients known with persistent AF ( 52 % and 15 % , respectively ; P = .02 ) as opposed to patients with paroxysmal AF ( 65 % and 46 % , respectively ; P = .26 ) . CONCLUSIONS Overall , the more proximal , extraostial PV isolation was found to be superior to ostial PV isolation , especially in patients known with persistent AF . A high recurrence rate of 84 % after a single complete PV isolation procedure was seen . At reablation , more than 95 % had recurrence of left atrium PV conduction regardless of the procedure used , supporting the idea that complete PV isolation seems essential to prevent arrhythmia recurrences",
"INTRODUCTION Pulmonary vein ( PV ) isolation for atrial fibrillation ( AF ) can be performed using a segmental ostial or a circumferential extra-ostial approach . The relative merits and potential limitations of each approach are currently debated . Here we report our early experience with each of these approaches , including their relative efficacy and safety . METHODS AND RESULTS Forty patients with drug-refractory AF underwent segmental ostial PV isolation and were compared to 40 consecutive patients who underwent PV isolation using a circumferential extra-ostial approach . The latter approach described here is novel in two aspects : ( 1 ) the endpoint for ablation was PV isolation and not only delay in left atrial to PV conduction time , and ( 2 ) isolation of the right and left PVs was achieved by a single encirclement of ipsilateral veins . At follow-up , 60 % of the patients in the segmental group were free of AF compared to 75 % of the patients in the circumferential group . There was one thromboembolic cerebrovascular complication during the ablation procedure in each group . CONCLUSION PV isolation using a circumferential extra-ostial approach , where the ipsilateral PVs are isolated together by one encircling line of block using electroanatomic mapping , is a technically feasible procedure . This approach is at least as effective and safe as the more established segmental ostial approach for AF ablation"
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The aim of this study was to examine the use of pedometers as a tool to promote daily physical activity levels in patients with COPD .A systematic review meta- analysis of pedometer physical activity promotion in patients with COPD was conducted . Medline / PubMed , Cochrane Library , Web of Science and CINAHL were search ed from inception to January 2019 . The search strategy included the following keywords : physical activity promotion , pulmonary rehabilitation and daily physical activity . The eligibility criteria for selecting studies were r and omised controlled trials reporting pedometer physical activity promotion in patients with COPD .Improvements in steps per day were found with pedometer physical activity promotion either st and alone ( n=12 , mean 0.53 ( 95 % CI 0.29 - 0.77 ) ; p=0.00001 ) or alongside pulmonary rehabilitation ( n=7 , 0.51 ( 0.13 - 0.88 ) ; p=0.006 ) . A subgroup analysis reported significant differences in the promotion of physical activity based on baseline physical activity levels and the type of instrument used to assess levels of physical activity . Future trials should consider the way in which pedometers are used to promote physical activity to inform clinical practice in the setting of pulmonary rehabilitation | [
"Rationale : Increasing physical activity is a key therapeutic aim in chronic obstructive pulmonary disease ( COPD ) . Pulmonary rehabilitation ( PR ) improves exercise capacity , but there is conflicting evidence regarding its ability to improve physical activity levels . Objectives : To determine whether using pedometers as an adjunct to PR can enhance time spent in at least moderate‐intensity physical activity ( time expending ≥3 metabolic equivalents [ METs ] ) by people with COPD . Methods : In this single‐blind r and omized controlled trial , participants were assigned 1:1 to receive a control intervention ( PR comprising 8 wk , two supervised sessions per week ) or the trial intervention ( PR plus pedometer‐directed step targets , review ed weekly for 8 wk ) . In the r and omization process , we used minimization to balance groups for age , sex , FEV1 percent predicted , and baseline exercise capacity and physical activity levels . Outcome assessors and PR therapists were blinded to group allocation . The primary analysis was based on the intention‐to‐treat principle . Measurements and Main Results : The primary outcome was change from baseline to 8 weeks in accelerometer‐measured daily time expending at least 3 METs . A total of 152 participants ( 72 % male ; mean [ SD ] FEV1 percent predicted , 50.5 % [ 21.2 ] ; median [ first quartile , third quartile ] time expending ≥3 METs , 46 [ 21 , 92 ] min ) were enrolled and assigned to the intervention ( n = 76 ) or control ( n = 76 ) arm . There was no significant difference in change in time expending at least 3 METs between the intervention and control groups at 8 weeks ( median [ first quartile , third quartile ] difference , 0.5 [ −1.0 , 31.0 ] min ; P = 0.87 ) or at the 6‐month follow‐up ( 7.0 [ −9 , 27 ] min ; P = 0.16 ) . Conclusions : Pedometer‐directed step‐count targets during an outpatient PR program did not enhance moderate‐intensity physical activity levels in people with COPD . Clinical trial registered with www . clinical trials.gov ( NCT01719822 )",
"Background In some patients with COPD , the disease is characterized by exacerbations . Severe exacerbations warrant a hospitalization , with prolonged detrimental effects on physical activity . Interventions after an exacerbation may improve physical activity , with longst and ing health benefits . Physical activity counseling and real-time feedback were effective in stable COPD . No evidence is available on the use of this therapeutic modality in patients after a COPD exacerbation . Methods Thirty patients were r and omly assigned to usual care or physical activity counseling , by telephone contacts at a frequency of 3 times a week and real-time feedback . Lung function , peripheral muscle strength , functional exercise capacity , symptom experience and COPD -related health status were assessed during hospital stay and 1 month later . Results Both groups significantly recovered in physical activity ( PAsteps : control group : 1013 ± 1275 steps vs intervention group : 984 ± 1208 steps ( p = 0.0005 ) ; PAwalk : control group : 13 ± 14 min vs intervention group : 13 ± 16 min ( p = 0.0002 ) ) , functional exercise capacity ( control group : 64 ± 59 m ( p = 0.002 ) vs intervention group : 67 ± 84 m ( p = 0.02 ) ) and COPD -related health status ( CAT : control group : −5 [ −7 to 1 ] ( p = 0.02 ) vs intervention group : −3 [ −10 to 1 ] points ( p = 0.03 ) ) . No differences between groups were observed . Conclusion From our pilot study , we concluded that telephone based physical activity counseling with pedometer feedback after an exacerbation did not result in better improvements in physical activity and clinical outcomes compared to usual care . Because of the difficult recruitment and the negative intermediate analyses , this study was not continued . Trial registration Clinical trials.gov NCT02223962 . Registered 4 September 2013",
"Reduced physical activity is an important feature of Chronic Obstructive Pulmonary Disease ( COPD ) . Various activity monitors are available but their validity is poorly established . The aim was to evaluate the validity of six monitors in patients with COPD . We hypothesized triaxial monitors to be more valid compared to uniaxial monitors . Thirty-nine patients ( age 68±7years , FEV1 54±18%predicted ) performed a one-hour st and ardized activity protocol . Patients wore 6 monitors ( Kenz Lifecorder ( Kenz ) , Actiwatch , RT3 , Actigraph GT3X ( Actigraph ) , Dynaport MiniMod ( MiniMod ) , and SenseWear Armb and ( SenseWear ) ) as well as a portable metabolic system ( Oxycon Mobile ) . Validity was evaluated by correlation analysis between indirect calorimetry ( VO2 ) and the monitor outputs : Metabolic Equivalent of Task [ METs ] ( SenseWear , MiniMod ) , activity counts ( Actiwatch ) , vector magnitude units ( Actigraph , RT3 ) and arbitrary units ( Kenz ) over the whole protocol and slow versus fast walking . Minute-by-minute correlations were highest for the MiniMod ( r = 0.82 ) , Actigraph ( r = 0.79 ) , SenseWear ( r = 0.73 ) and RT3 ( r = 0.73 ) . Over the whole protocol , the mean correlations were best for the SenseWear ( r = 0.76 ) , Kenz ( r = 0.52 ) , Actigraph ( r = 0.49 ) and MiniMod ( r = 0.45 ) . The MiniMod ( r = 0.94 ) and Actigraph ( r = 0.88 ) performed better in detecting different walking speeds . The Dynaport MiniMod , Actigraph GT3X and SenseWear Armb and ( all triaxial monitors ) are the most valid monitors during st and ardized physical activities . The Dynaport MiniMod and Actigraph GT3X discriminate best between different walking speeds ",
"RATIONALE Low physical activity is highly prevalent among COPD patients and is associated with increased healthcare utilization and mortality and reduced HRQL . The addition of a website to pedometer use is effective at increasing physical activity ; however , the timeline of change and impact of environmental factors on efficacy is unknown . METHODS U.S. Veterans with COPD were r and omized ( 1:1 ) to receive either ( 1 ) a pedometer and website which provided goal - setting , feedback , disease-specific education , and an online community forum or ( 2 ) pedometer alone for 3 months . Primary outcome was change in daily step count . Secondary outcomes included 6MWT distance , HRQL , dyspnea , depression , COPD knowledge , exercise self-efficacy , social support , motivation , and confidence to exercise . Generalized linear mixed-effects models evaluated the effect of the pedometer plus website compared to pedometer alone . RESULTS Data from 109 subjects ( 98.5 % male , mean age 68.6 ± 8.3 years ) were analyzed . At 13 weeks , subjects in the pedometer plus website group had significant increases daily step count from baseline relative to the pedometer alone group ( 804 ± 356.5 steps per day , p = 0.02 ) . The pedometer plus website group had significant improvements in daily step count from baseline beginning in week 3 which were sustained until week 13 . In subgroup analyses , the pedometer plus website attenuated declines in daily step count during the transition from summer to fall . No significant differences in secondary outcomes were noted between groups . CONCLUSIONS A website added to pedometer use improves daily step counts , sustains walking over 3 months , and attenuates declines in physical activity due to season",
"Rationale Reduced physical activity ( PA ) in patients with COPD is associated with a poor prognosis . Increasing PA is a key therapeutic target , but thus far few strategies have been found effective in this patient group . Objectives To investigate the effectiveness of a 12-week semiautomated telecoaching intervention on PA in patients with COPD in a multicentre European r and omised controlled trial . Methods 343 patients from six centres , encompassing a wide spectrum of disease severity , were r and omly allocated to either a usual care group ( UCG ) or a telecoaching intervention group ( IG ) between June and December 2014 . This 12-week intervention included an exercise booklet and a step counter providing feedback both directly and via a dedicated smartphone application . The latter provided an individualised daily activity goal ( steps ) revised weekly and text messages as well as allowing occasional telephone contacts with investigators . PA was measured using accelerometry during 1 week preceding r and omisation and during week 12 . Secondary outcomes included exercise capacity and health status . Analyses were based on modified intention to treat . Main results Both groups were comparable at baseline in terms of factors influencing PA . At 12 weeks , the intervention yielded a between-group difference of mean , 95 % CI ( lower limit – upper limit ; ll-ul ) + 1469 , 95 % CI ( 971 to 1965 ) steps/day and + 10.4 , 95 % CI ( 6.1 to 14.7 ) min/day moderate PA ; favouring the IG ( all p≤0.001 ) . The change in 6-min walk distance was significantly different ( 13.4 , 95 % CI ( 3.40 to 23.5 ) m , p the functional state domain of the clinical COPD question naire ( p=0.03 ) compared with UCG . Other health status outcomes did not differ . Conclusions The amount and intensity of PA can be significantly increased in patients with COPD using a 12-week semiautomated telecoaching intervention including a step counter and an application installed on a smartphone . Trial registration number : NCT02158065",
"Physical inactivity is a cardinal feature of chronic obstructive pulmonary disease ( COPD ) , and is associated with increased morbidity and mortality . Pedometers , which have been used in healthy population s , might also increase physical activity in patients with COPD . COPD patients taking part in a 3-month individualised programme to promote an increase in their daily physical activity were r and omised to either a st and ard programme of physical activity encouragement alone , or a pedometer-based programme . Assessment s were performed by investigators blinded to treatment allocation . Change in average 1-week daily step count , 6-min walking distance ( 6MWD ) , modified Medical Research Council scale , St George ’s respiratory question naire ( SGRQ ) and COPD assessment test ( CAT ) were compared between groups . 102 patients were recruited , of whom 97 completed the programme ( pedometer group : n=50 ; control group : n=47 ) ; 60.8 % were male with a mean±sd age of 68.7±8.5 years , and forced expiratory volume in 1 s ( FEV1 ) 66.1±19.4 % and FEV1/forced vital capacity 55.2±9.5 % . Both groups had comparable characteristics at baseline . The pedometer group had significantly greater improvements in : physical activity 3080±3254 steps·day−1 versus 138.3±1950 steps·day−1 ( p ) ; SGRQ −8.8±12.2 versus −3.8±10.9 ( p=0.01 ) ; CAT score −3.5±5.5 versus −0.6±6.6 ( p=0.001 ) ; and 6MWD 12.4±34.6 versus −0.7±24.4 m ( p=0.02 ) than patients receiving activity encouragement only . A simple physical activity enhancement programme using pedometers can effectively improve physical activity level and quality of life in COPD patients . Pedometer-based programme produced clinical ly important improvements in physical activity and health status in COPD",
"PURPOSE We evaluated the effects of low-intensity and home-based pulmonary rehabilitation ( PR ) on physical activity ( PA ) and the feedback provided by a pedometer in stable elderly patients with chronic obstructive pulmonary disease ( COPD ) . METHODS We assessed PA using a newly developed triaxial accelerometer ( A-MES ™ , Kumamoto , Japan ) , which measures the time spent walking , st and ing , sitting and lying down . Twenty-seven elderly patients with COPD ( age 74 ± 8 yrs ; % FEV1 56.6 ± 18.7 % ) participated . They were r and omly selected to undergo PR ( pulmonary rehabilitation only ) or PR + P ( PR plus the feedback from using a pedometer ) . Their PA and pulmonary function , exercise capacity ( 6-min walking distance ; 6MWD ) , quadriceps femoris muscle force ( QF ) were evaluated before the PR began ( baseline ) and at 1 year later . We compared the patients ' changes in PA and other factors between the baseline values and those obtained 1 year later and analyzed the relationships between the changes in PA and other factors in the both groups . RESULTS The increase in the time spent walking in the PR + P group ( 51.3 ± 63.7 min/day ) was significantly greater than that of PR group ( 12.3 ± 25.5 min/day ) after the PR . The improvement rate of daily walking time after PR was significantly correlated with that of the 6MWD and QF in all subjects . CONCLUSIONS These data suggest that low-intensity and home-based PR with the feedback from using pedometer was effective in improving PA , and the improvements of physiological factors were correlated with increased walking time in stable elderly patients with COPD",
"Physical inactivity in patients with chronic obstructive pulmonary disease ( COPD ) is associated with poor health status and increased disease burden . The present study aims to test the efficacy of a previously developed mobile (m)Health intervention to improve or maintain physical activity in patients with COPD after pulmonary rehabilitation . A r and omised controlled trial was performed in 32 physiotherapy practice s in the Netherl and s. COPD patients were r and omised into intervention or usual care groups . The intervention consisted of a smartphone application for the patients and a monitoring website for the physiotherapists . Measurements were performed at 0 , 3 , 6 and 12 months . Physical activity , functional exercise capacity , lung function , health-related quality of life and body mass index were assessed . 157 patients started the study and 121 completed it . There were no significant positive effects of the intervention on physical activity ( at 0 months : intervention 5824±3418 steps per weekday , usual care 5717±2870 steps per weekday ; at 12 months : intervention 4819±2526 steps per weekday , usual care 4950±2634 steps per weekday ; p=0.811 ) or on the secondary end-points . There was a significant decrease over time in physical activity ( p ) , lung function ( p and mastery ( p=0.017 ) , but not in functional exercise capacity ( p=0.585 ) . Although functional exercise capacity did not deteriorate , our mHealth intervention did not improve or maintain physical activity in patients with COPD after a period of pulmonary rehabilitation . mHealth intervention does not improve or maintain physical activity in COPD patients after pulmonary rehabilitation",
"Background Pulmonary rehabilitation is a cornerstone of care for COPD but uptake of traditional centre-based programmes is poor . We assessed whether home-based pulmonary rehabilitation , delivered using minimal re sources , had equivalent outcomes to centre-based pulmonary rehabilitation . Methods A r and omised controlled equivalence trial with 12 months follow-up . Participants with stable COPD were r and omly assigned to receive 8 weeks of pulmonary rehabilitation by either the st and ard outpatient centre-based model , or a new home-based model including one home visit and seven once-weekly telephone calls from a physiotherapist . The primary outcome was change in 6 min walk distance ( 6MWD ) . Results We enrolled 166 participants to receive centre-based rehabilitation ( n=86 ) or home-based rehabilitation ( n=80 ) . Intention-to-treat analysis confirmed non-inferiority of home-based rehabilitation for 6MWD at end-rehabilitation and the confidence interval ( CI ) did not rule out superiority ( mean difference favouring home group 18.6 m , 95 % CI −3.3 to 40.7 ) . At 12 months the CI did not exclude inferiority ( −5.1 m , −29.2 to 18.9 ) . Between-group differences for dyspnoea-related quality of life did not rule out superiority of home-based rehabilitation at programme completion ( 1.6 points , −0.3 to 3.5 ) and groups were equivalent at 12 months ( 0.05 points , −2.0 to 2.1 ) . The per- protocol analysis showed the same pattern of findings . Neither group maintained postrehabilitation gains at 12 months . Conclusions This home-based pulmonary rehabilitation model , delivered with minimal re sources , produced short-term clinical outcomes that were equivalent to centre-based pulmonary rehabilitation . Neither model was effective in maintaining gains at 12 months . Home-based pulmonary rehabilitation could be considered for people with COPD who can not access centre-based pulmonary rehabilitation . Trial registration number NCT01423227 , clinical trials.gov",
"OBJECTIVE To study the effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation . METHODS Twenty-one chronic obstructive pulmonary disease ( COPD ) patients were r and omized to an experimental group that followed a regular rehabilitation program plus the counseling intervention or to a control group that only followed rehabilitation . The primary outcome was daily physical activity assessed by pedometers . Secondary outcomes were physical fitness , health-related quality of life , activities of daily living , depression and self-efficacy . RESULTS The experimental group showed an increase of 1,430 steps/day ( + 69 % from baseline ) , whereas the control group showed an increase of 455 steps/day ( + 19 % ) ( p = 0.11 for group x time interaction ) . The secondary outcomes showed no differences . CONCLUSION AND PRACTICE IMPLICATION S This study showed that the use of the pedometer , in combination with exercise counseling and the stimulation of lifestyle physical activity , is a feasible addition to pulmonary rehabilitation which may improve outcome and maintenance of rehabilitation results",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"BACKGROUND Low levels of physical activity ( PA ) are associated with poor outcomes in people with COPD . Interventions to increase PA could improve outcomes . METHODS We tested the efficacy of a novel Internet-mediated , pedometer-based exercise intervention . Veterans with COPD ( N = 239 ) were r and omized in a 2:1 ratio to the ( 1 ) intervention group ( Omron HJ-720 ITC pedometer and Internet-mediated program ) or ( 2 ) wait-list control group ( pedometer ) . The primary outcome was health-related quality of life ( HRQL ) , assessed by the St. George 's Respiratory Question naire ( SGRQ ) , at 4 months . We examined the SGRQ total score ( SGRQ-TS ) and three domain scores : Symptoms , Activities , and Impact . The secondary outcome was daily step counts . Linear regression models assessed the effect of intervention on outcomes . RESULTS Participants had a mean age of 67 ± 9 years , and 94 % were men . There was no significant between-group difference in mean 4-month SGRQ-TS ( 2.3 units , P = .14 ) . Nevertheless , a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS , the minimum clinical ly important difference ( 53 % vs 39 % , respectively , P = .05 ) . For domain scores , the intervention group had a lower ( reflecting better HRQL ) mean than the control group by 4.6 units for Symptoms ( P = .046 ) and by 3.3 units for Impact ( P = .049 ) . There was no significant difference in Activities score between the two groups . Compared with the control subjects , intervention participants walked 779 more steps per day at 4 months ( P = .005 ) . CONCLUSIONS An Internet-mediated , pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD . TRIAL REGISTRY Clinical Trials.gov ; No. : NCT01102777 ; URL : www . clinical trials.gov",
"Background : Pulmonary rehabilitation programs improve dyspnea and health status associated with chronic obstructive pulmonary disease ( COPD ) , but benefits wane when patients return to a sedentary lifestyle . This study tested a simple , low-re source , low-cost home walking program . Methods : In this single center , 3-month study , 115 COPD patients were r and omized to a control cohort or a goal setting cohort . Each patient met with study staff and received 5 telephone calls at 2-week intervals . During these contacts , the Goal group was assisted by a wellness coach who helped them set personal activity goals . All patients wore a pedometer to record daily steps , the primary study outcome . Results : Over the 12-week interval , the average step-per-days was 36 % higher for the Goal cohort patients ( Week 12 mean = 4390 ) than for Control patients ( mean = 3790 ) . No group differences emerged on the modified Medical Research Council ( mMRC ) dyspnea scale , the COPD Assessment Test , or the St. George 's Respiratory Question naire . Secondary analyses indicated that even patients with greater disease severity , including those with an mMRC score > 2 or forced expiratory volume in 1 second ( FEV1 ) % predicted below 50 % , increased their walking relative to Control patients . Almost half ( 48 % ) of Goal patients successfully reached at least one personal goal such as increasing stamina and activity , or decreasing shortness of breath or weight . Conclusions : A relatively low-re source wellness coaching , goal - setting intervention result ed in a small improvement in the activity level of COPD patients over a 12-week period including those with marked pulmonary impairment . Further investigation should be directed at underst and ing the optimal blend of in person and remote coaching needed to produce the greatest cost-to-benefit ratio",
"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",
"The aim of this study was to investigate the impact of a physical activity (PA)-focused behavioural intervention during and after pulmonary rehabilitation ( PR ) on PA levels ( primary aim ) , health-related outcomes and self-efficacy ( secondary aims ) of patients with COPD . Thirty-two patients were r and omly assigned to an experimental group ( EG ) or control group ( CG ) . The EG received a PA-focused behavioural intervention during PR ( 3 months ) and follow-up support ( 3 months ) . The CG received PR ( 3 months ) . Daily PA was collected : number of steps ; time spent in moderate-to-vigorous PA ( MVPA ) , total PA and sedentary activities ( SA ) . Secondary outcomes comprised exercise capacity , muscle strength , health-related quality of life ( HRQOL ) and self-efficacy . Measures were collected at baseline , 3 and 6 months . Compared with the CG , the EG improved the number of steps ( p = 0.006 ) and time spent in MVPA ( p = 0.007 ) , total PA ( p = 0.014 ) and SA ( p = 0.018 ) at 3 months . Differences were maintained after follow-up support ( 0.025 ≤ p ≤ 0.040 ) , except for SA ( p = 0.781 ) . Exercise capacity , muscle strength and HRQOL were increased at 3 and 6 months ( p ≤ 0.002 ) with no between-group differences ( 0.148 ≤ p ≤ 0.987 ) . No changes were observed in self-efficacy ( p = 0.899 ) . A PA-focused behavioural intervention during and after PR may improve patients ' PA levels . Further research is warranted to assess the sustainability of the findings",
"There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease ( COPD ) . We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients . This r and omised controlled trial ( NCT01897298 ) allocated 407 COPD patients from primary and hospital setting s 1:1 to usual care ( n=205 ) or Urban Training ( n=202 ) . Urban Training consisted of a baseline motivational interview , advice to walk on urban trails design ed for COPD patients in outdoor public spaces and other optional components for feedback , motivation , information and support ( pedometer , calendar , physical activity brochure , website , phone text messages , walking groups and a phone number ) . The primary outcome was 12-month change in steps·day−1 measured by accelerometer . Efficacy analysis ( with per- protocol analysis set , n=233 classified as adherent to the assigned intervention ) showed adjusted ( 95 % CI ) 12-month difference + 957 ( 184–1731 ) steps·day−1 between Urban Training and usual care . Effectiveness analysis ( with intention-to-treat analysis set , n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients ) showed no differences between groups . Leg muscle pain during walks was more frequently reported in Urban Training than usual care , without differences in any of the other adverse events . Urban Training , combining behavioural strategies with unsupervised outdoor walking , was efficacious in increasing physical activity after 12 months in COPD patients , with few safety concerns . However , it was ineffective in the full population including unwilling and self-reported non-adherent patients . Urban Training in COPD increased physical activity after 12 months but not in self-reported non-adherent patients",
"Purpose Pulmonary rehabilitation ( PR ) enhances exercise tolerance in patients with COPD ; however , improvements in physical activity ( PA ) are not guaranteed . This study explored the relationship between baseline exercise tolerance and changes in PA after PR . Material s and methods Patient data from prospect i ve clinical trials in the PR setting s of Athens and Leuven ( 2008–2016 ) were analyzed . Vali date d PA monitors were worn for 1 week before and after a 12-week program . The proportion of patients who improved PA levels ≥1,000 steps/day ( “ PA responders ” ) after PR was compared between those with initial 6-minute walk distance [ 6MWDi ] Two hundred thirty-six patients with COPD ( median [ IQR ] FEV1 44 [ 33–59 ] % predicted , age 65±8 years , 6MWDi 416 [ 332–486 ] m ) were included . The proportion of “ PA responders ” after PR was significantly greater in those with higher vs lower 6MWDi ( 37.9 % vs 16.4 % , respectively ; P predictor of PA improvement ( univariate OR 3.10 , 95 % CI 1.51–6.36 ) . Conclusion The likelihood of improving PA after PR is increased with greater 6MWDi . Baseline exercise tolerance appears as an important stratification metric for future research in this field",
"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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INTRODUCTION Stroke is a leading health problem worldwide and an important cause of disability . Stroke survivors show low levels of physical activity , and increases in physical activity levels may improve function and health status . Therefore , the aims are to identify which interventions that have been employed to increase physical activity levels with stroke survivors , to verify their efficacy and to identify the gaps in the literature . METHODS AND ANALYSIS A systematic review of r and omised controlled trials that investigated the efficacy of interventions aim ing at increasing physical activity levels of stroke survivors will be conducted . Electronic search es will be performed in the MEDLINE , Physiotherapy Evidence Data base ( PEDro ) , Excerpta Medica ( EMBASE ) , Literatura Latino-Americana e do Caribe em Ciências da Saúde ( LILACS ) and Scientific Electronic Library Online ( SCIELO ) data bases . H and search es of the reference lists of the included studies or relevant review s will also be employed . Two independent review ers will screen all the retrieved titles , abstract s and full texts . A third review er will be referred to solve any disagreements . The quality of the included studies will be assessed by the PEDro Rating Scale . This systematic review will also include a qualitative synthesis . Meta-analyses will be performed , if the studies are sufficiently homogeneous . This review will follow the Preferred Reporting Items for Systematic Review and Meta- Analysis ( PRISMA ) statement . The quality of the evidence regarding physical activity will be assessed , according to the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) . DISCUSSION This systematic review will provide information on which interventions are effective for increasing physical activity levels of stroke survivors . This evidence may be important for clinical decision-making and will allow the identification of gaps in the literature that may be useful for the definition of future research goals and the planning of new trials . TRIAL REGISTRATION NUMBER CRD42016037750 | [
"Objective This study aim ed to demonstrate that maximal strength training improves muscle strength and to assess the effect of training on function , aerobic status , and quality -of-life among chronic stroke survivors . Design Ten patients acted as their own controls for 4 wks , before an 8-week training intervention . Patients trained 3 days/wk , with four sets of four repetitions at 85%–95 % one repetition maximum in unilateral leg press and plantarflexion with an emphasis on maximal mobilization of force in the concentric phase . Results After training , leg press strength improved by 30.6 kg ( 75 % ) and 17.8 kg ( 86 % ) ; plantarflexion strength improved by 35.5 kg ( 89 % ) and 28.5 kg ( 223 % ) for the unaffected and affected limbs , respectively , significantly different from the control period ( all P The 6-min walk test improved by 13.9 m ( within training period ; P = 0.01 ) , and the Timed Up and Go test time improved by 0.6 secs ( within training period ; P in walking economy , peak aerobic capacity , Four-Square Step Test , or health-related quality -of-life after training . Conclusions Maximal strength training improved muscle strength in the most affected as well as in the nonaffected leg and improved Timed-Up- And -Go time and 6-min walk distance but did not alter Four-Step Square Test time , aerobic status , or quality -of-life among chronic stroke survivors",
"Background Many bibliographic data bases index research studies evaluating the effects of health care interventions . One study has concluded that the Physiotherapy Evidence Data base ( PEDro ) has the most complete indexing of reports of r and omized controlled trials of physical therapy interventions , but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro . Objective The purpose of this study was to compare the completeness of indexing of reports of r and omized controlled trials of physical therapy interventions by 8 bibliographic data bases . Design This study was an audit of bibliographic data bases . Methods Prespecified criteria were used to identify 400 reports of r and omized controlled trials from the reference lists of systematic review s published in 2008 that evaluated physical therapy interventions . Eight data bases ( AMED , CENTRAL , CINAHL , EMBASE , Hooked on Evidence , PEDro , PsycINFO , and PubMed ) were search ed for each trial report . The proportion of the 400 trial reports indexed by each data base was calculated . Results The proportions of the 400 trial reports indexed by the data bases were as follows : CENTRAL , 95 % ; PEDro , 92 % ; PubMed , 89 % ; EMBASE , 88 % ; CINAHL , 53 % ; AMED , 50 % ; Hooked on Evidence , 45 % ; and PsycINFO , 6 % . Almost all of the trial reports ( 99 % ) were found in at least 1 data base , and 88 % were indexed by 4 or more data bases . Four trial reports were uniquely indexed by a single data base only ( 2 in CENTRAL and 1 each in PEDro and PubMed ) . Limitations The results are only applicable to search ing for English- language published reports of r and omized controlled trials evaluating physical therapy interventions . Conclusions The 4 most comprehensive data bases of trial reports evaluating physical therapy interventions were CENTRAL , PEDro , PubMed , and EMBASE . Clinicians seeking quick answers to clinical questions could search any of these data bases knowing that all are reasonably comprehensive . PEDro , unlike the other 3 most complete data bases , is specific to physical therapy , so studies not relevant to physical therapy are less likely to be retrieved . Research ers could use CENTRAL , PEDro , PubMed , and EMBASE in combination to conduct exhaustive search es for r and omized trials in physical therapy "
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OBJECTIVES Keeping physically active has been shown to bring positive outcomes for patients diagnosed with heart failure ( HF ) . However , a number of individuals with this health problem do not undertake regular exercise . A review of extant qualitative research was conducted to explore what it can tell us about barriers and enablers to physical activity among people with HF . METHODS A systematic search , involving electronic data bases and endeavors to locate gray literature , was carried out to identify relevant qualitative studies published from 1980 onward . Data from retrieved papers were combined using framework analysis . Papers read in full numbered 32 , and 20 were included in the review . RESULTS Synthesis of results from the 20 studies result ed in 4 main themes : Changing soma , negative emotional response , adjusting to altered status , and interpersonal influences . How individuals responded to their diagnosis and their altered physical status related to their activity levels , as did the degree of encouragement to exercise coming from family , friends , and professionals . These findings can be connected to the theory of behavioral change developed by B and ura , known as social cognitive theory ( SCT ) . CONCLUSIONS SCT may be a useful framework for developing interventions to support patients with HF in undertaking and maintaining regular exercise patterns . Specific components of SCT that practitioners may wish to consider include self-efficacy and outcome expectancies . These were issues referred to in papers for the systematic review that appear to be particularly related to exercise adherence | [
"CONTEXT Guidelines recommend that exercise training be considered for medically stable out patients with heart failure . Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes . OBJECTIVE To test the efficacy and safety of exercise training among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial of 2331 medically stable out patients with heart failure and reduced ejection fraction . Participants in Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) were r and omized from April 2003 through February 2007 at 82 centers within the United States , Canada , and France ; median follow-up was 30 months . INTERVENTIONS Usual care plus aerobic exercise training , consisting of 36 supervised sessions followed by home-based training , or usual care alone . MAIN OUTCOME MEASURES Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality , cardiovascular mortality or cardiovascular hospitalization , and cardiovascular mortality or heart failure hospitalization . RESULTS The median age was 59 years , 28 % were women , and 37 % had New York Heart Association class III or IV symptoms . Heart failure etiology was ischemic in 51 % , and median left ventricular ejection fraction was 25 % . Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12 . A total of 759 patients ( 65 % ) in the exercise training group died or were hospitalized compared with 796 patients ( 68 % ) in the usual care group ( hazard ratio [ HR ] , 0.93 [ 95 % confidence interval { CI } , 0.84 - 1.02 ] ; P = .13 ) . There were nonsignificant reductions in the exercise training group for mortality ( 189 patients [ 16 % ] in the exercise training group vs 198 patients [ 17 % ] in the usual care group ; HR , 0.96 [ 95 % CI , 0.79 - 1.17 ] ; P = .70 ) , cardiovascular mortality or cardiovascular hospitalization ( 632 [ 55 % ] in the exercise training group vs 677 [ 58 % ] in the usual care group ; HR , 0.92 [ 95 % CI , 0.83 - 1.03 ] ; P = .14 ) , and cardiovascular mortality or heart failure hospitalization ( 344 [ 30 % ] in the exercise training group vs 393 [ 34 % ] in the usual care group ; HR , 0.87 [ 95 % CI , 0.75 - 1.00 ] ; P = .06 ) . In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics , the HRs were 0.89 ( 95 % CI , 0.81 - 0.99 ; P = .03 ) for all-cause mortality or hospitalization , 0.91 ( 95 % CI , 0.82 - 1.01 ; P = .09 ) for cardiovascular mortality or cardiovascular hospitalization , and 0.85 ( 95 % CI , 0.74 - 0.99 ; P = .03 ) for cardiovascular mortality or heart failure hospitalization . Other adverse events were similar between the groups . CONCLUSIONS In the protocol -specified primary analysis , exercise training result ed in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points . After adjustment for highly prognostic predictors of the primary end point , exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437",
"OBJECTIVE The purpose of this study is to determine the impact of a home communication intervention ( HCI ) for ischemic heart failure Coronary Artery Bypass Graft ( CABG ) patients > /= 65 years of age on self-efficacy , coronary artery disease risk factor modification and functioning posthospitalization . DESIGN A r and omized clinical trial with repeated measures was used . SAMPLE A sub sample of ischemic heart failure CABG surgery patients ( n = 35 ) was drawn from the parent study of 180 CABG patients . RESULTS HCI participants ( n = 18 ) had significantly higher adjusted mean self-efficacy scores [ F(1 , 29 ) = 6.40 , P adjusted mean levels of functioning ( physical , general health , mental , and vitality functioning ) compared with the routine care group ( n = 17 ) , using repeated measures analysis of covariance with baseline scores as covariates . There were also significant effects of time on bodily pain and role emotional functioning . Significantly higher exercise adherence ( t = 3.09 , P reported stress ( t = 3.77 , P HCI intervention with more tailored strategies for vulnerable subgroups of CABG patients"
] | 41166ff0-06ff-11f0-808a-c43d1ab1c353 |
Aims This study evaluated clinical effectiveness of telemonitoring on the management of patients with type 2 diabetes . Methods We search ed Ovid- Medline , Ovid- EMBASE , and the Cochrane Library to identify r and omized controlled trials that compared telemonitoring and usual care in patients with type 2 diabetes . Results Thirty-eight studies ( 6855 patients ) were included . Telemonitoring was associated with a significant decrease in glycated haemoglobin levels compared to usual care ( weighted mean difference –0.42 % , 95 % confidence interval –0.56 to –0.27 ) but there was evidence of heterogeneity ( I2 = 96.9 % ) . Telemonitoring was associated with a significant glycated haemoglobin reduction when biological data were transmitted through a web-based device weekly , when voice feedback was performed daily or immediately and when patients were provided with counselling . Telemonitoring also reduced glycated haemoglobin level in studies that monitored patients ’ medication adherence , provided counselling , education and alarm message . The rate of achieving glycated haemoglobin levels of care group ( risk ratio 1.83 , 95 % confidence interval 1.35 to 2.47 , I2 = 0 % ) . There was also significant reduction in systolic blood pressure ( weighted mean difference –1.33 mm Hg ) and body mass index ( weighted mean difference –0.25 kg/m2 ) , but the clinical relevance of these results can be question ed . The data available on patient satisfaction , quality of life , medication adherence , prescription changes , stress and depression were limited . Conclusions Telemonitoring interventions may be a better option than usual care in improving glycated haemoglobin control of patients with type 2 diabetes . Further studies should assess clinical benefit according to specific delivery modes of the intervention and patient-reported outcomes | [
"OBJECTIVE To assess the effectiveness of structured blood glucose testing in poorly controlled , noninsulin-treated type 2 diabetes . RESEARCH DESIGN AND METHODS This 12-month , prospect i ve , cluster-r and omized , multicenter study recruited 483 poorly controlled ( A1C ≥7.5 % ) , insulin-naïve type 2 diabetic subjects from 34 primary care practice s in the U.S. Practice s were r and omized to an active control group ( ACG ) with enhanced usual care or a structured testing group ( STG ) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose ( SMBG ) . STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days . The primary end point was A1C level measured at 12 months . RESULTS The 12-month intent-to-treat analysis ( ACG , n = 227 ; STG , n = 256 ) showed significantly greater reductions in mean ( SE ) A1C in the STG compared with the ACG : −1.2 % ( 0.09 ) vs. −0.9 % ( 0.10 ) ; Δ = −0.3 % ; P = 0.04 . Per protocol analysis ( ACG , n = 161 ; STG , n = 130 ) showed even greater mean ( SE ) A1C reductions in the STG compared with the ACG : −1.3 % ( 0.11 ) vs. −0.8 % ( 0.11 ) ; Δ = −0.5 % ; P ’s initial baseline A1C level : 179 ( 75.5 % ) vs. 61 ( 28.0 % ) ; Both STG and ACG patients displayed significant ( P 0.0001 ) improvements in general well-being ( GWB ) . CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB",
"OBJECTIVE This study was design ed to evaluate the impact of a teleassistance system on the metabolic control of type 2 diabetes patients . RESEARCH DESIGN AND METHODS We conducted a 1-year controlled parallel-group trial comparing patients r and omized ( 1 ) to an intervention group , assigned to a teleassistance system using real-time transmission of blood glucose results , with immediate reply when necessary , and telephone consultations , or ( 2 ) to a control group , being regularly followed-up at their healthcare center . Study subjects were type 2 diabetes patients > 30 years of age followed in the primary care setting . RESULTS A total of 328 type 2 diabetes patients were recruited from 35 family practice s in the province of Málaga , Spain . There was a reduction in hemoglobin A1c after 12 months from 7.62 + /- 1.60 % to 7.40 + /- 1.43 % ( P = 0.027 ) in the intervention group and from 7.44 + /- 1.31 % to 7.35 + /- 1.38 % ( P = 0.303 ) in the control group . The difference in the change between groups was not statistically significant . There was also a significant decrease in systolic and diastolic blood pressure , total cholesterol , low-density lipoprotein cholesterol , and body mass index in the intervention group . In the control group , the only significant decline was in low-density lipoprotein cholesterol . CONCLUSIONS A teleassistance system using real-time transmission of blood glucose results with an option to make telephone consultations is feasible in the primary care setting as a support tool for family physicians in their follow-up of type 2 diabetes patients",
"BACKGROUND 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 )",
"BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness . METHODS The authors conducted a r and omized , controlled trial comparing telemedicine case management to usual care , with blinding of those obtaining outcome data , in 1,665 Medicare recipients with diabetes , aged 55 years or greater , and living in federally design ated medically underserved areas of New York State . The primary endpoints were HgbA1c , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels . RESULTS In the intervention group ( n = 844 ) , mean HgbA1c improved over one year from 7.35 % to 6.97 % and from 8.35 % to 7.42 % in the subgroup with baseline HgbA1c > or = 7 % ( n = 353 ) . In the usual care group ( n = 821 ) mean HgbA1c improved over one year from 7.42 % to 7.17 % . Adjusted net reductions ( one-year minus baseline mean values in each group , compared between groups ) favoring the intervention were as follows : HgbA1c , 0.18 % ( p = 0.006 ) , systolic and diastolic blood pressure , 3.4 ( p = 0.001 ) and 1.9 mm Hg ( p LDL cholesterol , 9.5 mg/dL ( p HgbA1c > or = 7 % , net adjusted reduction in HgbA1c favoring the intervention group was 0.32 % ( p = 0.002 ) . Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York . CONCLUSION Telemedicine case management improved glycemic control , blood pressure levels , and total and LDL cholesterol levels at one year of follow-up",
"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 is to test the efficacy of a culturally tailored comprehensive type 2 diabetes management intervention for Korean American immigrants ( KAIs ) with type 2 diabetes . Methods A r and omized controlled pilot trial with 2 parallel arms ( intervention vs control ) with a delayed intervention design was used . A total of 79 KAIs , recruited from the Baltimore-Washington area , completed baseline , 18-week , and 30-week follow-ups ( intervention , n = 40 ; control , n = 39 ) . All participants had uncontrolled type 2 diabetes ( hemoglobin A1C ≥7.5 % ) at baseline . The authors ’ comprehensive , self-help intervention program for type 2 diabetes management ( SHIP-DM ) consisted of a 6-week structured psychobehavioral education , home glucose monitoring with teletransmission , and bilingual nurse telephone counseling for 24 weeks . The primary outcome of the study was A1C level , and secondary outcomes included an array of psychobehavioral variables . Results Using analysis of covariance , the findings support that the proposed intervention was effective in significantly lowering A1C and fasting glucose and also in improving psychosocial outcomes in the sample . Specifically , the amount of reduction in A1C among intervention group participants was 1.19 % at 18 weeks and 1.31 % at 30 weeks , with 10 % and 15.5 % of the participants achieving the suggested goal of A1C efficacy of the SHIP-DM intervention composed of a 6-week education program , self-monitoring , and follow-up counseling , in terms of maintaining the improved intervention effects obtained and in terms of glucose control",
"Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control . We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes . Methods and Findings We performed a r and omized , parallel , investigator-blind controlled trial with central ized r and omization in family practice s in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin ( HbA1c ) > 58 mmol/mol . The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group . The control group received usual care , with at least annual review and more frequent review s for people with poor glycemic or blood pressure control . HbA1c assessed at 9 mo was the primary outcome . Intention-to-treat analyses were performed . 160 people were r and omized to the intervention group and 161 to the usual care group between June 6 , 2011 , and July 19 , 2013 . HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group . The mean ( SD ) HbA1c at follow-up was 63.0 ( 15.5 ) mmol/mol in the intervention group and 67.8 ( 14.7 ) mmol/mol in the usual care group . For primary analysis , adjusted mean HbA1c was 5.60 mmol/mol / 0.51 % lower ( 95 % CI 2.38 to 8.81 mmol/mol/ 95 % CI 0.22 % to 0.81 % , p = 0·0007 ) . For secondary analyses , adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower ( 95 % CI 0.56–5.56 mmHg , p = 0.017 ) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower ( 95 % CI 0.62–3.72 , p = 0.006 ) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata . No significant differences were identified between groups in weight , treatment pattern , adherence to medication , or quality of life in secondary analyses . There were few adverse events and these were equally distributed between the intervention and control groups . In secondary analysis , there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group ( rate ratio 7.50 ( 95 % CI 4.45–12.65 , p Supported telemonitoring result ed in clinical ly important improvements in control of glycaemia in patients with type 2 diabetes in family practice . Current Controlled Trials , registration number IS RCT N71674628 . Trial Registration Current Controlled Trials IS RCT N",
"BACKGROUND Home telehealth programs often focus on a single disease , yet many patients who need monitoring have multiple conditions . This study evaluated secondary outcomes from a clinical trial evaluating the efficacy of home telehealth to improve outcomes of patients with co-morbid diabetes and hypertension . SUBJECTS AND METHODS A single-center r and omized controlled clinical trial compared two remote monitoring intensity levels ( low and high ) and usual care in patients with type 2 diabetes and hypertension being treated in primary care . Secondary outcomes assessed were knowledge ( diabetes , hypertension , medications ) , self-efficacy , adherence ( diabetes , medications ) , and patient perceptions of the intervention mode . RESULTS Knowledge scores improved in the high-intensity intervention group participants , but upon further analysis , we found the intervention effect was not mediated by gain in knowledge . No significant differences were found across the groups in self-efficacy , adherence , or patient perceptions of the intervention mode . CONCLUSIONS Home telehealth can enhance detection of key clinical symptoms that occur between regular physician visits . While our intervention improved glycemic and blood pressure control , the mechanism of the effect for this improvement was not clear",
"Background 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",
"We have demonstrated previously that an individualized health management system using advanced medical information technology , named ubiquitous (u)-healthcare , was helpful in achieving better glycemic control than routine care . Recently , we generated a new u-healthcare system using a voice inception technique for elderly diabetic patients to communicate information about their glucose control , physical activity , and diet more easily . In a r and omized clinical trial , 70 diabetic patients aged 60–85 years were assigned r and omly to a st and ard care group or u-healthcare group for 6 months . The primary end points were the changes in glycated hemoglobin ( HbA1c ) and glucose fluctuation assessed by the mean amplitude glycemic excursion ( MAGE ) . Changes in body weight , lifestyle , and knowledge about diabetes were also investigated . After 6 months , the HbA1c levels decreased significantly in the u-healthcare group ( from 8.6 ± 1.0 % to 7.5 ± 0.6 % ) compared with the st and ard care group ( from 8.7 ± 0.9 % to 8.2 ± 1.1 % , P The MAGE decreased more in the u-healthcare group than in the st and ard care group . Systolic blood pressure and body weight decreased and liver functions improved in the u-healthcare group , but not in the st and ard care group . The u-healthcare system with voice inception technique was effective in achieving glycemic control without hypoglycemia in elderly diabetic patients ( Clinical trials.gov : NCT01891474 )",
"Objective To explore a model of Internet‐based integrated management of diabetes , we established a remote diabetes medical service platform ( U‐Healthcare ) and evaluated its effectiveness and practicality . Material s and Methods In total , 212 patients with type 2 diabetes mellitus were r and omly assigned to 2 groups . Data from the intervention group were automatically transmitted through a glucometer ; furthermore , this group received information regarding medicines , diet , exercise and other management through U‐Healthcare . The control group received conventional medical treatment without any additional intervention . All patients were regularly followed up every 3 months for half a year . Results At the 3‐month follow‐up , fasting plasma glucose levels of the intervention group were significantly lower than those at the baseline as well as those of the control group . Triglyceride levels of the intervention group were much lower than those at the baseline . At the 6‐month follow‐up , 2‐hour postpr and ial plasma glucose levels of the intervention group significantly improved compared with those of the control group . HbA1c levels gradually decreased every 3 months in the intervention group , and the mean change in the levels was significantly greater in this group than in the control group ( from 1.27‐0.68 % ) . At the end of the study , more than 80 % of the patients in the intervention group adhered to blood glucose monitoring 2‐3 days per week , and their compliance degree was 72 % . Conclusions The Internet‐based U‐Healthcare system of integrated management in diabetes not only achieved better glycemic control , effectively improved HbA1c levels and decreased triglyceride levels but also enhanced patients ’ adherence to the medical team 's instructions",
"OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes",
"Numerous diabetes-management systems and programs for improving glycemic control to meet guideline targets have been proposed , using IT technology . But all of them allow only limited-or no-real-time interaction between patients and the system in terms of system response to patient input ; few studies have effectively assessed the systems ' usability and feasibility to determine how well patients underst and and can adopt the technology involved . DialBetics is composed of 4 modules : ( 1 ) data transmission module , ( 2 ) evaluation module , ( 3 ) communication module , and ( 4 ) dietary evaluation module . A 3-month r and omized study was design ed to assess the safety and usability of a remote health- data monitoring system , and especially its impact on modifying patient lifestyles to improve diabetes self-management and , thus , clinical outcomes . Fifty-four type 2 diabetes patients were r and omly divided into 2 groups , 27 in the DialBetics group and 27 in the non-DialBetics control group . HbA1c and fasting blood sugar ( FBS ) values declined significantly in the DialBetics group : HbA1c decreased an average of 0.4 % ( from 7.1 ± 1.0 % to 6.7 ± 0.7 % ) compared with an average increase of 0.1 % in the non-DialBetics group ( from 7.0 ± 0.9 % to 7.1 ± 1.1 % ) ( P = .015 ) ; The DialBetics group FBS decreased an average of 5.5 mg/dl compared with a non-DialBetics group average increase of 16.9 mg/dl ( P = .019 ) . BMI improvement-although not statistically significant because of the small sample size-was greater in the DialBetics group . DialBetics was shown to be a feasible and an effective tool for improving HbA1c by providing patients with real-time support based on their measurements and inputs",
"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",
"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",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE The use of a real time continuous glucose monitoring system ( RT-CGM ) was studied as a behavior modification tool and the effectiveness of a RT-CGM in glucose control for patients with type 2 diabetes was determined . METHODS We conducted a prospect i ve , open-label , r and omized , controlled clinical trial in 65 patients with poorly controlled type 2 diabetes ( 8.0 The intervention group was monitored monthly with a RT-CGM ( three days at a time for 3 months ) and the control group continued self-monitoring blood glucose ( SMBG ) at least four times a week for 3 months . RESULTS The HbA1c of the RT-CGM group was significantly reduced after 12 weeks compared with the SMBG group ( 9.1+/-1.0 % to 8.0+/-1.2 % vs. 8.7+/-0.7 % to 8.3+/-1.1 % , respectively ; P=0.004 ) . In the RT-CGM group , there was a significant reduction in total daily calorie intake , weight , body mass index ( BMI ) , and postpr and ial glucose level , and a significant increase in total exercise time per week after 3 months . CONCLUSIONS We demonstrated that the RT-CGM was useful in modifying a patient 's diet and exercise habits and could induce better glycemic control than SMBG for patients with type 2 diabetes",
"OBJECTIVE To determine whether short-time , real-time continuous glucose monitoring ( RT-CGM ) has long-term salutary glycemic effects in patients with type 2 diabetes who are not on pr and ial insulin . RESEARCH DESIGN AND METHODS This was a r and omized controlled trial of 100 adults with type 2 diabetes who were not on pr and ial insulin . This study compared the effects of 12 weeks of intermittent RT-CGM with self-monitoring of blood glucose ( SMBG ) on glycemic control over a 40-week follow-up period . Subjects received diabetes care from their regular provider without therapeutic intervention from the study team . RESULTS There was a significant difference in A1C at the end of the 3-month active intervention that was sustained during the follow-up period . The mean , unadjusted A1C decreased by 1.0 , 1.2 , 0.8 , and 0.8 % in the RT-CGM group vs. 0.5 , 0.5 , 0.5 , and 0.2 % in the SMBG group at 12 , 24 , 38 , and 52 weeks , respectively ( P = 0.04 ) . There was a significantly greater decline in A1C over the course of the study for the RT-CGM group than for the SMBG group , after adjusting for covariates ( P used RT-CGM per protocol ( ≥48 days ) improved the most ( P the RT-CGM group occurred without a greater intensification of medication compared with those in the SMBG group . CONCLUSIONS Subjects with type 2 diabetes not on pr and ial insulin who used RT-CGM intermittently for 12 weeks significantly improved glycemic control at 12 weeks and sustained the improvement without RT-CGM during the 40-week follow-up period , compared with those who used only SMBG",
"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 The Internet is used worldwide as a communication tool . To improve the quality of diabetes control , we investigated the effectiveness of an Internet-based blood glucose monitoring system ( IBGMS ) on controlling the changes in HbA(1c ) levels . RESEARCH DESIGN AND METHODS We conducted a r and omized clinical trial involving 110 patients who visited the outpatient clinic at the Kangnam St. Mary 's Hospital for 3 months . The study subjects were treated with IBGMS for 12 weeks , and the control group received the usual outpatient management over the same period . HbA(1c ) and other laboratory tests were performed twice , once at the beginning of the study and again at the end of the study . RESULTS The test results from the beginning of the study established that there were no significant differences between the two groups with respect to age , sex , diabetes duration , BMI , blood pressure , HbA(1c ) , and other laboratory data . On follow-up examination 12 weeks later , HbA(1c ) levels were significantly decreased from 7.59 to 6.94 % within the intervention group ( P HbA(1c ) levels in the intervention group were significantly lower than in the control group after adjusting the baseline HbA(1c ) ( 6.94 vs. 7.62 % ; P HbA(1c ) lower HbA(1c ) than those in the control group ( 6.38 vs. 6.99 % ; P HbA(1c ) > or = 7.0 % , the difference between the two groups appeared more obvious : HbA(1c ) levels at the end of the study were 8.12 % . CONCLUSIONS This new IBGMS result ed in a significant reduction of HbA(1c ) during the study period . We propose that this IBGMS be used as a method for improving diabetes control",
"OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C ≥7.5 % . RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005 , who were taking oral hypoglycemic agents and /or insulin for ≥1 year , and who had A1C ≥7.5 % at enrollment were r and omly assigned to either active care management with home telemonitoring ( ACM+HT group , n = 73 ) or a monthly care coordination telephone call ( CC group , n = 77 ) . Both groups received monthly calls for diabetes education and self-management review . ACM+HT group participants transmitted blood glucose , blood pressure , and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor ; the nurse practitioner adjusted medications for glucose , blood pressure , and lipid control based on established American Diabetes Association targets . Measures were obtained at baseline , 3-month , and 6-month visits . RESULTS Baseline characteristics were similar in both groups , with mean A1C of 9.4 % ( CC group ) and 9.6 % ( ACM+HT group ) . Compared with the CC group , the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months ( 1.7 vs. 0.7 % ) and 6 months ( 1.7 vs. 0.8 % ; P ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months . However , both interventions improved glycemic control in primary care patients with previously inadequate control",
" 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",
"OBJECTIVE We aim ed to evaluate the added value of intensive self-monitoring of blood glucose ( SMBG ) , structured in timing and frequency , in noninsulin-treated patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The 12-month , r and omized , clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes ( median baseline HbA1c , 7.3 % [ IQR , 6.9–7.8 % ] ) at 39 diabetes clinics in Italy . After st and ardized education , 501 patients were r and omized to intensive structured monitoring ( ISM ) with 4-point glycemic profiles ( fasting , prepr and ial , 2-h postpr and ial , and postabsorptive measurements ) performed 3 days/week ; 523 patients were r and omized to active control ( AC ) with 4-point glycemic profiles performed at baseline and at 6 and 12 months . Two primary end points were tested in hierarchical order : HbA1c change at 12 months and percentage of patients at risk target for low and high blood glucose index . RESULTS Intent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM ( −0.39 % ) than in AC patients ( −0.27 % ) , with a between-group difference of −0.12 % ( 95 % CI , −0.210 to −0.024 ; P = 0.013 ) . In the per- protocol analysis , the between-group difference was −0.21 % ( −0.331 to −0.089 ; P = 0.0007 ) . More ISM than AC patients achieved clinical ly meaningful reductions in HbA1c ( > 0.3 , > 0.4 , or > 0.5 % ) at study end ( P The proportion of patients reaching/maintaining the risk target at month 12 was similar in ISM ( 74.6 % ) and AC ( 70.1 % ) patients ( P = 0.131 ) . At visits 2 , 3 , and 4 , diabetes medications were changed more often in ISM than in AC patients ( P glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated type 2 diabetes",
"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",
"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 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",
"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",
"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",
"Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety . Methods We conducted a large-scale , multi-centre , r and omized clinical trial involving 484 patients . Patients in the intervention group ( n = 244 ) were treated with the Internet-based system for six months , while the control group ( n = 240 ) received the usual outpatient management over the same period . HbA1c , blood chemistries , anthropometric parameters , and adverse events were assessed at the beginning of the study , after three months , and the end of the study . Results There were no initial significant differences between the groups with respect to demographics and clinical parameters . Upon six-month follow-up , HbA1c levels were significantly decreased from 7.86 ± 0.69 % to 7.55 ± 0.86 % within the intervention group ( p control group . Postpr and ial glucose reduction was predominant . A subgroup with baseline HbA1c higher than 8 % and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05 % . Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age . There were no adverse events associated with the intervention . Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial . This system may be effective in improving diabetes control in the general population",
"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",
"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",
"BACKGROUND The Structured Testing Program ( STeP ) study , a cluster-r and omized , controlled trial , showed that a structured self-monitoring of blood glucose (SMBG)-based intervention improves clinical outcomes . It is important to determine whether this intervention can be adapted for use in general medical practice . This study examined the feasibility and effects of a modified version of the STeP intervention on clinical and attitudinal outcomes in real world clinical setting s. METHODS In this 3-month , observational , multinational study , 375 type 1 and type 2 diabetes patients in 11 countries were asked to generate a blood glucose ( bG ) profile once per month for 3 consecutive months , using a paper-based bG analysis tool ( Accu-Chek ® 360 ° View ® bG analysis system , Roche Diagnostics , Mannheim , Germany ) . Measurements were to be performed before and 2 h after main meals and before bedtime on 3 consecutive days . End points included change from baseline in glycated hemoglobin ( HbA1c ) and other parameters of diabetes complications . Patient and physician attitudes toward use of the structured testing form were also assessed . RESULTS Reductions in mean ( SD ) HbA1c from baseline were significant , from 9.2 % ( 1.6 % ) to 8.0 % ( 1.4 % ) ( Δ -1.2 % [ 1.6 % ] , P ) . Reductions in mean ( SD ) average bG from baseline were significant , from 189.5 mg/dL ( 55.5 mg/dL ) to 153 mg/dL ( 39.6 mg/dL ) ( Δ-36.4 mg/dL [ 52.5 mg/dL ] , P ) improvements in body mass index , lipids , and blood pressure were also observed . Patients and physicians were generally positive about the utility of the structured testing form . CONCLUSIONS Use of the structured SMBG intervention is practical in real world clinical setting s and is associated with improved diabetes management",
"Background : Of adults with type 2 diabetes , 84 % take antihyperglycemic medication . Successful treatment requires active monitoring and medication dose adjustment by health providers . The objective of this study was to determine how a mobile-phone-based coaching system for diabetes management influences physician prescribing behavior . Method : This secondary data analysis is based on a cluster r and omized clinical trial that reported patients provided with mobile self-management had reduction in glycated hemoglobin ( HbA1c ) of 1.9 % over 1 year , compared to 0.7 % in control patients ( P Participants were primary care patients with type 2 diabetes r and omized at physician practice level into a control group ( n = 55 ) and intervention group ( n = 62 ) . Main study measures were patients ’ medication records ( medication , dose , frequency , start and end date ) abstract ed at baseline and study end . Antihyperglycemic medications , including sulfonylureas or thiazolidinediones , and antihypertensive and antilipemic medications were analyzed . Results : A higher percentage of patients in the intervention group had modification and intensification of incretin mimetics during the 1-year study period ( 9.7 % vs 0.0 % and 8.1 % vs 0.0 % , both P = .008 ) . A higher percentage of patients in the intervention group had modification and intensification of metformin ( 24.2 % vs 7.3 % , P = .033 ) . The overall difference in physician prescribing of oral antihyperglycemic medications was not statistically significant . Conclusions : Our results suggest mobile diabetes interventions can encourage physicians to modify and intensify antihyperglycemic medications in patients with type 2 diabetes . Differences in physician prescribing behavior were modest , and do not appear to be large enough to explain a 1.2 % decrease in HbA1c"
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