Showing papers on "Randomized controlled trial published in 1999"
TL;DR: In this paper, 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 standard community care (treatments by community providers).
Abstract: 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 standard 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 random-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.
3,048 citations
TL;DR: Despite an increased frequency of early symptomatic intracranial hemorrhage, treatment with IA r-proUK within 6 hours of the onset of acute ischemic stroke caused by MCA occlusion significantly improved clinical outcome at 90 days.
Abstract: ContextIntravenous tissue-type plasminogen activator can be beneficial to some
patients when given within 3 hours of stroke onset, but many patients present
later after stroke onset and alternative treatments are needed.ObjectiveTo determine the clinical efficacy and safety of intra-arterial (IA)
recombinant prourokinase (r-proUK) in patients with acute stroke of less than
6 hours' duration caused by middle cerebral artery (MCA) occlusion.DesignPROACT II (Prolyse in Acute Cerebral Thromboembolism II), a randomized,
controlled, multicenter, open-label clinical trial with blinded follow-up
conducted between February 1996 and August 1998.SettingFifty-four centers in the United States and Canada.PatientsA total of 180 patients with acute ischemic stroke of less than 6 hours'
duration caused by angiographically proven occlusion of the MCA and without
hemorrhage or major early infarction signs on computed tomographic scan.InterventionPatients were randomized to receive 9 mg of IA r-proUK plus heparin
(n = 121) or heparin only (n = 59).Main Outcome MeasuresThe primary outcome, analyzed by intention-to-treat, was based on the
proportion of patients with slight or no neurological disability at 90 days
as defined by a modified Rankin score of 2 or less. Secondary outcomes included
MCA recanalization, the frequency of intracranial hemorrhage with neurological
deterioration, and mortality.ResultsFor the primary analysis, 40% of r-proUK patients and 25% of control
patients had a modified Rankin score of 2 or less (P
= .04). Mortality was 25% for the r-proUK group and 27% for the control group.
The recanalization rate was 66% for the r-proUK group and 18% for the control
group (P<.001). Intracranial hemorrhage with neurological
deterioration within 24 hours occurred in 10% of r-proUK patients and 2% of
control patients (P = .06).ConclusionDespite an increased frequency of early symptomatic intracranial hemorrhage,
treatment with IA r-proUK within 6 hours of the onset of acute ischemic stroke
caused by MCA occlusion significantly improved clinical outcome at 90 days.
3,014 citations
TL;DR: An intervention designed specifically to meet the needs of a heterogeneous group of chronic disease patients, including those with comorbid conditions, was feasible and beneficial beyond usual care in terms of improved health behaviors and health status.
Abstract: Objectives.This study evaluated the effectiveness (changes in health behaviors, health status, and health service utilization) of a self-management program for chronic disease designed for use with a heterogeneous group of chronic disease patients. It also explored the differential effectiveness of
2,249 citations
TL;DR: Captopril and conventional treatment did not differ in efficacy in preventing cardiovascular morbidity and mortality and the difference in stroke risk was probably due to the lower levels of blood pressure obtained initially in previously treated patients randomised to conventional therapy.
1,991 citations
01 Jan 1999
TL;DR: Among postmenopausal women with osteoporosis, the risk of invasive breast cancer was decreased by 76% during 3 years of treatment with raloxifene, mainly in the United States and Europe.
1,567 citations
TL;DR: An advanced practice nurse-centered discharge planning and home care intervention for at-risk hospitalized elders reduced readmissions, lengthened the time between discharge and readmission, and decreased the costs of providing health care.
Abstract: ContextComprehensive discharge planning by advanced practice
nurses has demonstrated short-term reductions in readmissions of
elderly patients, but the benefits of more intensive follow-up of
hospitalized elders at risk for poor outcomes after discharge has not
been studied.ObjectiveTo examine the effectiveness of an advanced
practice nurse–centered discharge planning and home follow-up
intervention for elders at risk for hospital readmissions.DesignRandomized clinical trial with follow-up at 2, 6, 12, and
24 weeks after index hospital discharge.SettingTwo urban, academically affiliated hospitals in
Philadelphia, Pa.ParticipantsEligible patients were 65 years or older,
hospitalized between August 1992 and March 1996, and had 1 of several
medical and surgical reasons for admission.InterventionIntervention group patients received a comprehensive
discharge planning and home follow-up protocol designed specifically
for elders at risk for poor outcomes after discharge and implemented by
advanced practice nurses.Main Outcome MeasuresReadmissions, time to first readmission,
acute care visits after discharge, costs, functional status,
depression, and patient satisfaction.ResultsA total of 363 patients (186 in the control group and 177
in the intervention group) were enrolled in the study; 70% of
intervention and 74% of control subjects completed the trial. Mean age
of sample was 75 years; 50% were men and 45% were black. By week 24
after the index hospital discharge, control group patients were more
likely than intervention group patients to be readmitted at least once
(37.1% vs 20.3%; P<.001). Fewer intervention group
patients had multiple readmissions (6.2% vs 14.5%;P = .01) and the intervention group had fewer hospital days per
patient (1.53 vs 4.09 days; P<.001). Time to first
readmission was increased in the intervention group
(P<.001). At 24 weeks after discharge, total Medicare
reimbursements for health services were about $1.2 million in the
control group vs about $0.6 million in the intervention group
(P<.001). There were no significant group differences in
postdischarge acute care visits, functional status, depression, or
patient satisfaction.ConclusionsAn advanced practice nurse–centered discharge
planning and home care intervention for at-risk hospitalized elders
reduced readmissions, lengthened the time between discharge and
readmission, and decreased the costs of providing health care. Thus,
the intervention demonstrated great potential in promoting positive
outcomes for hospitalized elders at high risk for rehospitalization
while reducing costs.
1,562 citations
TL;DR: Cognitive-behavioural treatments based on the principle of cognitive behavioural therapy are effective and are associated with significant effect sizes on all domains of measurement.
Abstract: A computer and a hand search of the literature recovered 33 papers from which 25 trials suitable for meta-analysis were identified. We compared the effectiveness of cognitive-behavioural treatments with the waiting list control and alternative treatment control conditions. There was a great diversity of measurements which we grouped into domains representing major facets of pain. Effect sizes, corrected for measurement unreliability, were estimated for each domain. When compared with the waiting list control conditions cognitive-behavioural treatments were associated with significant effect sizes on all domains of measurement (median effect size across domains=0.5). Comparison with alternative active treatments revealed that cognitive-behavioural treatments produced significantly greater changes for the domains of pain experience, cognitive coping and appraisal (positive coping measures), and reduced behavioural expression of pain. Differences on the following domains were not significant; mood/affect (depression and other, non-depression, measures), cognitive coping and appraisal (negative, e.g. catastrophization), and social role functioning. We conclude that active psychological treatments based on the principle of cognitive behavioural therapy are effective. We discuss the results with reference to the complexity and quality of the trials.
1,544 citations
TL;DR: The results in Dutch patients do not support the routine use of D2 lymph-node dissection in patients with gastric cancer, as recommended by the Japanese medical community.
Abstract: Background Curative resection is the treatment of choice for gastric cancer, but it is unclear whether this operation should include an extended (D2) lymph-node dissection, as recommended by the Japanese medical community, or a limited (D1) dissection. We conducted a randomized trial in 80 Dutch hospitals in which we compared D1 with D2 lymph-node dissection for gastric cancer in terms of morbidity, postoperative mortality, long-term survival, and cumulative risk of relapse after surgery. Methods Between August 1989 and July 1993, a total of 996 patients entered the study. Of these patients, 711 (380 in the D1 group and 331 in the D2 group) underwent the randomly assigned treatment with curative intent, and 285 received palliative treatment. The procedures for quality control included instruction and supervision in the operating room and monitoring of the pathological results. Results Patients in the D2 group had a significantly higher rate of complications than did those in the D1 group (43 percent vs. 2...
1,421 citations
TL;DR: β Blockers are effective in long term secondary prevention after myocardial infarction, but they are underused in such cases and lead to avoidable mortality and morbidity.
Abstract: Objectives: To assess the effectiveness of β blockers in short term treatment for acute myocardial infarction and in longer term secondary prevention; to examine predictive factors that may influence outcome and therefore choice of drug; and to examine the clinical importance of the results in the light of current treatment. Design:Systematic review of randomised controlled trials. Setting: Randomised controlled trials. Subjects: Patients with acute or past myocardial infarction. Intervention: βBlockers compared with control. Main:outcome measures All cause mortality and non-fatal reinfarction. Results: Overall, 5477 of 54 234 patients (10.1%) randomised to β blockers or control died. We identified a 23% reduction in the odds of death in long term trials (95% confidence interval 15% to 31%), but only a 4% reduction in the odds of death in short term trials (−8% to 15%). Meta regression in long term trials did not identify a significant reduction in effectiveness in drugs with cardioselectivity but did identify a near significant trend towards decreased benefit in drugs with intrinsic sympathomimetic activity. Most evidence is available for propranolol, timolol, and metoprolol. In long term trials, the number needed to treat for 2 years to avoid a death is 42, which compares favourably with other treatments for patients with acute or past myocardial infarction. Conclusions: β Blockers are effective in long term secondary prevention after myocardial infarction, but they are underused in such cases and lead to avoidable mortality and morbidity.
1,272 citations
TL;DR: Results suggest that partial hospitalization may offer an alternative to inpatient treatment for patients with borderline personality disorder and that replication is needed with larger groups.
Abstract: OBJECTIVE: This study compared the effectiveness of psychoanalytically oriented partial hospitalization with standard psychiatric care for patients with borderline personality disorder. METHOD: Thirty-eight patients with borderline personality disorder, diagnosed according to standardized criteria, were allocated either to a partially hospitalized group or to a standard psychiatric care (control) group in a randomized controlled design. Treatment, which included individual and group psychoanalytic psychotherapy, was for a maximum of 18 months. Outcome measures included the frequency of suicide attempts and acts of self-harm, the number and duration of inpatient admissions, the use of psychotropic medication, and self-report measures of depression, anxiety, general symptom distress, interpersonal function, and social adjustment. Data analysis used repeated measures analysis of covariance and nonparametric tests of trend. RESULTS: Patients who were partially hospitalized showed a statistically significant d...
1,187 citations
TL;DR: After 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD, and an exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons.
Abstract: Background Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression. However, the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder (MDD) has not been systematically evaluated. Objective To assess the effectiveness of an aerobic exercise program compared with standard medication (ie, antidepressants) for treatment of MDD in older patients, we conducted a 16-week randomized controlled trial. Methods One hundred fifty-six men and women with MDD (age, > or = 50 years) were assigned randomly to a program of aerobic exercise, antidepressants (sertraline hydrochloride), or combined exercise and medication. Subjects underwent comprehensive evaluations of depression, including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and Hamilton Rating Scale for Depression (HAM-D) and Beck Depression Inventory (BDI) scores before and after treatment. Secondary outcome measures included aerobic capacity, life satisfaction, self-esteem, anxiety, and dysfunctional cognitions. Results After 16 weeks of treatment, the groups did not differ statistically on HAM-D or BDI scores (P = .67); adjustment for baseline levels of depression yielded an essentially identical result. Growth curve models revealed that all groups exhibited statistically and clinically significant reductions on HAM-D and BDI scores. However, patients receiving medication alone exhibited the fastest initial response; among patients receiving combination therapy, those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms. Conclusions An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons. Although antidepressants may facilitate a more rapid initial therapeutic response than exercise, after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD.
TL;DR: To evaluate critically the evidence linking psychotropic drugs with falls in older people, a large number of studies have found no link between these drugs and falls in adults over the age of 65.
Abstract: OBJECTIVES: To evaluate critically the evidence linking psychotropic drugs with falls in older people.
DESIGN: Fixed-effects meta-analysis.
DATA SOURCES: English-language articles in MEDLINE (1966 – March 1996) indexed under accidents or accidental falls and aged or age factors; bibliographies of retrieved papers.
STUDY SELECTION: Systematic evaluation of sedative/hypnotic, antidepressant, or neuroleptic use with falling in people aged 60 and older.
DATA EXTRACTION: Study design, inclusion and exclusion criteria, setting, sample size, response rate, mean age, method of medication verification and fall assessment, fall definition, and the number of fallers and non-fallers taking specific classes of psychotropic drugs.
RESULTS: Forty studies, none randomized controlled trials, met eligibility criteria. For one or more falls, the pooled odds ratio (95% confidence interval) was 1.73 (95%CI, 1.52-1.97) for any psychotropic use; 1.50 (95%CI, 1.25-1.79) for neuroleptic use; 1.54 (95%CI, 1.40-1.70) for sedative/hypnotic use; 1.66 (95%CI, 1.4-1.95) for any antidepressant use (mainly TCAs); 1.51 (95%CI, 1.14-2.00) for only TCA use; and 1.48 (95%CI, 1.23-1.77) for benzodiazepine use, with no difference between short and long acting benzodiazepines. For neuroleptics in psychiatric inpatients, the pooled OR was 0.41 (95%CI, 0.21-.82); for all other patients, the pooled OR was 1.66 (95%CI, 1.38-2.00). Comparing ≥1 with ≥ 2 falls, mean subject age >75 versus ≥ 75 years old, communities with >35% versus ≥35% fallers, or subject place of residence did not affect the pooled OR. Increased falls occurred in patients taking more than one psychotropic drug.
CONCLUSION: There is a small, but consistent, association between the use of most classes of psychotropic drugs and falls. The evidence to date, however, is based solely on observational data, with minimal adjustment for confounders, dosage, or duration of therapy. The incidence of falls and their consequences in this population necessitate that future large randomized controlled trials of any medication in older persons should measure falls prospectively as an adverse outcome event.
TL;DR: The results suggest that treatment with a non-pathogenic E. coli has an equivalent effect to mesalazine in maintaining remission of ulcerative colitis.
TL;DR: In this article, the authors investigated whether long-term moderate ET improves functional capacity and quality of life in patients with chronic heart failure and whether these effects translate into a favorable outcome.
Abstract: Background—It is still a matter of debate whether exercise training (ET) is a beneficial treatment in chronic heart failure (CHF) Methods and Results—To determine whether long-term moderate ET improves functional capacity and quality of life in patients with CHF and whether these effects translate into a favorable outcome, 110 patients with stable CHF were initially recruited, and 99 (59±14 years of age; 88 men and 11 women) were randomized into 2 groups One group (group T, n=50) underwent ET at 60% of peak Vo2, initially 3 times a week for 8 weeks, then twice a week for 1 year Another group (group NT, n=49) did not exercise At baseline and at months 2 and 14, all patients underwent a cardiopulmonary exercise test, while 74 patients (37 in group T and 37 in group NT) with ischemic heart disease underwent myocardial scintigraphy Quality of life was assessed by questionnaire Ninety-four patients completed the protocol (48 in group T and 46 in group NT) Changes were observed only in patients in group
Journal Article•
TL;DR: Preliminary clinical evidence is presented of the beneficial effect of the use of plasma rich in growth factors of autologous origin, which can introduce several advantages, including the enhancement and acceleration of bone regeneration and more rapid and predictable soft tissue healing.
Abstract: This article presents preliminary clinical evidence of the beneficial effect of the use of plasma rich in growth factors of autologous origin. The plasma is obtained from the individual patient by plasmapheresis. The macroscopic and microscopic results obtained with bone regeneration using this technique, which uses no membrane or barrier, can be observed. The incorporation of these concepts can introduce several advantages, including the enhancement and acceleration of bone regeneration and more rapid and predictable soft tissue healing.
TL;DR: The study shows that an interdisciplinary approach to this high-risk population can significantly decrease the risk of further falls and limit functional impairment.
TL;DR: A multicenter study to compare primary angioplasty with angiopLasty accompanied by implantation of a heparin-coated Palmaz–Schatz stent with primary angiovlasty alone found that patients with acute myocardial infarction undergoing emergency catheterization after stent implantation had fewer patients in the stent group after six months.
Abstract: Background Coronary-stent implantation is frequently performed for treatment of acute myocardial infarction. However, few studies have compared stent implantation with primary angioplasty alone. Methods We designed a multicenter study to compare primary angioplasty with angioplasty accompanied by implantation of a heparin-coated Palmaz–Schatz stent. Patients with acute myocardial infarction underwent emergency catheterization and angioplasty. Those with vessels suitable for stenting were randomly assigned to undergo angioplasty with stenting (452 patients) or angioplasty alone (448 patients). Results The mean (±SD) minimal luminal diameter was larger after stenting than after angioplasty alone (2.56±0.44 mm vs. 2.12±0.45 mm, P<0.001), although fewer patients assigned to stenting had grade 3 blood flow (according to the classification of the Thrombolysis in Myocardial Infarction trial) (89.4 percent, vs. 92.7 percent in the angioplasty group; P=0.10). After six months, fewer patients in the stent group tha...
TL;DR: No data is found to suggest that tube feeding improves any of these clinically important outcomes and some data suggest that it does not, and the widespread practice of tube feeding should be carefully reconsidered.
Abstract: Patients with advanced dementia frequently develop eating difficulties and weight loss. Enteral feeding tubes are often used in this situation, yet benefits and risks of this therapy are unclear. We searched MEDLINE, 1966 through March 1999, to identify data about whether tube feeding in patients with advanced dementia can prevent aspiration pneumonia, prolong survival, reduce the risk of pressure sores or infections, improve function, or provide palliation. We found no published randomized trials that compare tube feeding with oral feeding. We found no data to suggest that tube feeding improves any of these clinically important outcomes and some data to suggest that it does not. Further, risks are substantial. The widespread practice of tube feeding should be carefully reconsidered, and we believe that for severely demented patients the practice should be discouraged on clinical grounds.
TL;DR: The combination of candesartan and enalapril was more beneficial for preventing left ventricular remodeling than either candeartan or en alapril alone and was as effective, safe, and tolerable as enalAPril.
Abstract: Background—We investigated the effects of candesartan (an angiotensin II antagonist) alone, enalapril alone, and their combination on exercise tolerance, ventricular function, quality of life (QOL)...
TL;DR: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible.
TL;DR: In this paper, the effects of rivastigmine on the core domains of Alzheimer9s disease were assessed in a 6-month trial with 725 patients with mild to moderately severe probable Alzheimer 9s disease diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition.
Abstract: Objectives: To assess the effects of rivastigmine on the core domains of Alzheimer9s disease. Design: Prospective, randomised, multicentre, double blind, placebo controlled, parallel group trial. Patients received either placebo, 1-4 mg/day (lower dose) rivastigmine, or 6-12 mg/day (higher dose) rivastigmine. Doses were increased in one of two fixed dose ranges (1-4 mg/day or 6-12 mg/day) over the first 12 weeks with a subsequent assessment period of 14 weeks. Setting: 45 centres in Europe and North America. Participants: 725 patients with mild to moderately severe probable Alzheimer9s disease diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders , fourth edition, and the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer9s Disease and Related Disorders Association. Outcome measures: Cognitive subscale of the Alzheimer9s disease assessment scale, rating on the clinician interview based impression of change incorporating caregiver information scale, and the progressive deterioration scale. Results: At the end of the study cognitive function had deteriorated among those in the placebo group. Scores on the Alzheimer9s disease assessment scale improved in patients in the higher dose group when compared with patients taking placebo (P v 16% (39/238)). Global function as rated by the clinician interview scale had significantly improved among those in the higher dose group compared with those taking placebo (P v 20% (46/230)). Mean scores on the progressive deterioration scale improved from baseline in patients in the higher dose group but fell in the placebo group. Adverse events were predominantly gastrointestinal, of mild to moderate severity, transient, and occurred mainly during escalation of the dose. 23% (55/242) of those in the higher dose group, 7% (18/242) of those in the lower dose group, and 7% (16/239) of those in the placebo group discontinued treatment because of adverse events. Conclusions: Rivastigmine is well tolerated and effective. It improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer9s disease. This is the first treatment to show compelling evidence of efficacy in a predominantly European population. Key messages In a 6 month trial rivastigmine was effective in treating the core cognitive and functional symptoms of patients with mild to moderate Alzheimer9s disease Rivastigmine at doses of 6-12 mg/day produces clinically relevant and statistically significant improvements in cognitive and global assessments, and in activities of daily living The effects of rivastigmine are dose dependent Rivastigmine was well tolerated in this population of elderly patients
TL;DR: Treatment with systemic glucocorticoids results in moderate improvement in clinical outcomes among patients hospitalized for exacerbations of COPD, and the maximal benefit is obtained during the first two weeks of therapy.
Abstract: Background and Methods Although their clinical efficacy is unclear and they may cause serious adverse effects, systemic glucocorticoids are a standard treatment for patients hospitalized with exacerbations of chronic obstructive pulmonary disease (COPD). We conducted a double-blind, randomized trial of systemic glucocorticoids (given for two or eight weeks) or placebo, in addition to other therapies, for exacerbations of COPD. Most other care was standardized over the six-month period of follow-up. The primary end point was treatment failure, defined as death from any cause or the need for intubation and mechanical ventilation, readmission to the hospital for COPD, or intensification of drug therapy. Results Of 1840 potential study participants at 25 Veterans Affairs medical centers, 271 were eligible for participation and were enrolled; 80 received an eight-week course of glucocorticoid therapy, 80 received a two-week course, and 111 received placebo. About half the potential participants were ineligible...
TL;DR: A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half.
TL;DR: The prevalence of chronic heart failure rises with increasing age, from <1% in those below 65 years of age to > 5% in the elderly in general and is a major cause of morbidity and mortality in older people.
Abstract: Background: The prevalence of chronic heart failure (CHF) rises with increasing age, from 5% in those over 65 years of age and is a major cause of morbidity and mortality in older people. Recent European guidelines point to a major deficiency in our knowledge of how to treat diastolic chronic heart failure, and a lack of information on treatment for heart failure in the elderly in general. Aims: The aims of this trial are to assess the potential benefits of the ACE inhibitor perindopril to treat chronic heart failure in elderly people, in the absence of any major left ventricular systolic dysfunction. Subjects: One thousand people over the age of 70 years will be recruited into this study. Evidence of chronic heart failure will be confirmed by clinical criteria and echocardiography. Methods: Once a diagnosis of chronic heart failure has been confirmed, the patient will receive either perindopril or placebo in addition to their usual treatment. Death, and unplanned heart failure related hospitalisations, are the primary outcomes. Quality of life, as measured by the Guyatt questionnaire will be assessed at the beginning of the study and at 1 year. Sub-studies of this trial include a 6-min walking test and more detailed evaluation of ventricular function (as assessed by echocardiography). Both parameters will be measured at 8 weeks and 1 year, and analysed against baseline data. Cognitive function in this group of patients will also be evaluated at baseline and 1 year. This trial is due to report in the year 2001. (C) 1999 European Society of Cardiology. All rights reserved.
TL;DR: Replacement of some dietary carbohydrate by protein in an ad libitum fat-reduced diet, improves weight loss and increases the proportion of subjects achieving a clinically relevant weight loss.
Abstract: OBJECTIVE: To study the effect on weight loss in obese subjects by replacement of carbohydrate by protein in ad libitum consumed fat-reduced diets. DESIGN: Randomized dietary intervention study over six months comparing two ad libitum fat reduced diets (30% of total energy) strictly controlled in composition: High-carbohydrate (HC, protein 12% of total energy) or high-protein (HP, protein 25% of total energy). SETTING AND PARTICIPANTS: Subjects were 65 healthy, overweight and obese subjects (50 women, 15 men, aged 18–55 y) randomly assigned to HC (n=25), HP (n=25) or a control group (C, n=15). All food was provided by self-selection in a shop at the department, and compliance to the diet composition was evaluated by urinary nitrogen excretion. MAIN OUTCOME MEASURE: Change in body weight, body composition and blood lipids. RESULTS: More than 90% completed the trial. Weight loss after six months was 5.1 kg in the HC group and 8.9 kg in the HP group (difference 3.7 kg, 95% confidence interval (CI)(1.3–6.2 kg) P 10 kg in the HP group (35 %) than in the HC group (9 %). The HP diet only decreased fasting plasma triglycerides and free fatty acids significantly. CONCLUSIONS: Replacement of some dietary carbohydrate by protein in an ad libitum fat-reduced diet, improves weight loss and increases the proportion of subjects achieving a clinically relevant weight loss. More freedom to choose between protein-rich and complex carbohydrate-rich foods may allow obese subjects to choose more lean meat and dairy products, and hence improve adherence to low-fat diets in weight reduction programs.
TL;DR: A small but lasting effect of forced use therapy on the dexterity of the affected arm (ARA) and a temporary clinically relevant effect on the amount of use of theaffected arm during activities of daily living (MAL amount ofUse) are shown.
Abstract: Background and Purpose—Of all stroke survivors, 30% to 66% are unable to use their affected arm in performing activities of daily living. Although forced use therapy appears to improve arm function in chronic stroke patients, there is no conclusive evidence. This study evaluates the effectiveness of forced use therapy. Methods—In an observer-blinded randomized clinical trial, 66 chronic stroke patients were allocated to either forced use therapy (immobilization of the unaffected arm combined with intensive training) or a reference therapy of equally intensive bimanual training, based on Neuro-Developmental Treatment, for a period of 2 weeks. Outcomes were evaluated on the basis of the Rehabilitation Activities Profile (activities), the Action Research Arm (ARA) test (dexterity), the upper extremity section of the Fugl-Meyer Assessment scale, the Motor Activity Log (MAL), and a Problem Score. The minimal clinically important difference (MCID) was determined at the onset of the study. Results—One week after...
TL;DR: Genotypic-resistance testing is found to have a significant benefit on the virological response when choosing a therapeutic alternative for HIV-1-infected patients in whom combination therapy was not successful.
TL;DR: Alcohol interventions are associated with a reduction in alcohol intake and a reduced risk of trauma recidivism and screening, intervention, and counseling for alcohol problems should be routine.
Abstract: Regional trauma centers were developed 25 years ago in response to studies showing that 40% of deaths from injuries in the United States could have been prevented if the patient had been treated in a facility with special expertise in treating injuries. 1 With the advent of regional trauma systems, the preventable death rate has now been reduced to <2% to 3%; therefore, future decreases in the trauma death rate are not likely to occur as a result of improvements in the delivery of care. 2 Nearly half of all trauma deaths occur at the scene; these also are not responsive to improvements in care. 3,4 Future significant decreases in the death rate for injuries, therefore, depend primarily on progress in injury prevention.
By far the most common underlying causes of injuries in the United States are alcohol abuse and dependence. 5,6 Studies repeatedly demonstrate that approximately 50% of patients admitted to a trauma center are under the influence of alcohol, and the mean blood alcohol concentration of such patients is 187 mg/dl, nearly twice the legal level for driving in most states. 7,8 When questionnaires such as the Short Michigan Alcohol Screening Test (SMAST) are administered to trauma patients, as many as 44% test positive for chronic alcohol abuse. 9,10 Alcoholism plays such a significant role in trauma that efforts to reduce the risk of injuries or their recurrence are unlikely to be successful if it remains untreated.
In the past several years, there has been increasing interest in the use of brief, motivational interventions designed to assist patients with alcohol abuse or mild symptoms of alcohol dependency to reduce or eliminate their alcohol consumption. A series of randomized trials conducted in a variety of health care settings have demonstrated a significant reduction in alcohol consumption with the use of brief interventions in appropriately targeted populations. 11–13
Addressing alcohol problems in trauma centers is currently not routine. Only 19% of trauma centers routinely measure blood alcohol concentrations on injured patients, and <15% formally assess patients for an alcohol use disorder using screening questionnaires; the provision of alcohol counseling as a routine component of trauma care is even rarer. 14 Preliminary data suggest that a recent life-threatening injury increases the receptivity of patients toward alcohol counseling. 15–19 We hypothesized that alcohol interventions, coupled with trauma center admission, would significantly reduce alcohol consumption and decrease the risk of reinjury. We report the first prospective, randomized, controlled trial on the use of alcohol interventions in a level 1 trauma center as a means of injury prevention.
TL;DR: Leflunomide was more effective than placebo in treatment of rheumatoid arthritis and showed similar efficacy to sulphasalazine and may be a useful option as a diseasemodifying antirheumatic drug.
TL;DR: In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing and complete fistula Healing was sustained for up to 2 years by most patients in an open-label extension trial.
Abstract: Objective: To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn9s disease (CD). Design: A Phase III, multicentre, randomised, double-blind, placebo-controlled study with an open-label extension. Setting: 92 sites. Patients: A subgroup of adults with moderate to severely active CD (CD Activity Index [CDAI] 220-450) for ≥4 months who had draining fistulas at baseline. Interventions: All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at Week 0/2). At Week 4, all patients were randomised to receive double-blind placebo or adalimumab 40 mg every other week or weekly through Week 56 (irrespective of fistula status). Patients completing Week 56 of therapy were then eligible to enroll in an open-label extension. Main outcome measures: Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression. Results: Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomised to adalimumab and 47 randomised to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at Week 56 (both adalimumab and placebo groups), 90% (28 of 31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis). Conclusions: In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.