Showing papers on "Randomized controlled trial published in 1981"
TL;DR: A reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.
1,364 citations
TL;DR: It is concluded that in healthy middle-aged men at high risk of CHD advice to change eating habits and to stop smoking significantly reduced the incidence of the first event of myocardial infarction and sudden death.
946 citations
TL;DR: Objective evidence is provided that a supportive group intervention for patients with metastatic cancer results in psychological benefit and mechanisms underlying the effectiveness of this group intervention are explored.
Abstract: • The effects of weekly supportive group meetings for women with metastatic carcinoma of the breast were systematically evaluated in a one-year, randomized, prospective outcome study. The groups focused on the problems of terminal illness, including improving relationships with family, friends, and physicians and living as fully as possible in the face of death. We hypothesized that this intervention would lead to improved mood, coping strategies, and self-esteem among those in the treatment group. Eighty-six patients were tested at four-month intervals. The treatment group had significantly lower mooddisturbance scores on the Profile of Mood States scale, had fewer maladaptive coping responses, and were less phobic than the control group. This study provides objective evidence that a supportive group intervention for patients with metastatic cancer results in psychological benefit. Mechanisms underlying the effectiveness of this group intervention are explored.
824 citations
TL;DR: It is concluded that folic acid supplementation might be a cheap, safe, and effective method of primary prevention of neural-tube defects but that this must be confirmed in a large, multicentre trial.
Abstract: A randomized controlled double-blind trial was undertaken in south Wales to prevent the recurrence of neural-tube defects in women who had had one child with a neural-tube defect. Sixty women were allocated before conception to take 4 mg of folic acid a day before and during early pregnancy and 44 complied with these instructions. Fifty-one women were allocated to placebo treatment. There were no recurrences among the compliant mothers but two among the non-compliers and four among the women in the placebo group. Thus there were no recurrences among those who received supplementation and six among those who did not; this difference is significant (p = 0.04). It is concluded that folic acid supplementation might be a cheap, safe, and effective method of primary prevention of neural-tube defects but that this must be confirmed in a large, multicentre trial.
612 citations
TL;DR: Since there was no statistically significant difference in efficacy and since tamoxifen was less toxic, tamoxIFen appears to be the preferred agent.
Abstract: Before the introduction of tamoxifen, diethylstilbestrol (DES) was widely considered to be the hormonal treatment of choice in postmenopausal women with advanced breast cancer. We performed a randomized clinical trial of these two agents to determine their relative efficacy and toxicity. The trial involved 143 evaluable patients, of whom 99 had received no prior systemic therapy and 44 had received previous chemotherapy. The regression rates (complete plus partial) were higher in patients receiving DES (41 per cent) than in those receiving tamoxifen (33 per cent), but not significantly so (P = 0.37). In patients who had had no prior systemic therapy, the rates were 44 per cent and 38 per cent, respectively (P = 0.55), and in those who had had previous chemotherapy, 32 per cent vs. 23 per cent (P = 0.50). Analysis of the time until treatment failure for the two treatment groups showed no significant difference (medians: DES, 142 days; tamoxifen, 171 days). Toxicity was greater in patients receiving DES; nine of 74 patients (12 per cent) discontinued therapy solely because of adverse reactions. Since there was no statistically significant difference in efficacy and since tamoxifen was less toxic, tamoxifen appears to be the preferred agent.
316 citations
TL;DR: While most patients were functioning reasonably well, there were some main effects of IPT on social functioning at the one-year follow-up and patients who received IPT with or without pharmacotherapy were doing significantly better on some measures of social functioning.
Abstract: • A one-year follow-up was conducted on ambulatory nonbipolar, nonpsychotic, acutely depressed patients who received amitriptyline hydrochloride and/or interpersonal psychotherapy (IPT), each alone and in combination, as part of a four-month clinical trial. There were no differential long-term effects of the initially randomized treatment on clinical symptoms one year later since most of the patients were asymptomatic. While most patients were functioning reasonably well, there were some main effects of IPT on social functioning at the one-year follow-up. Patients who received IPT with or without pharmacotherapy were doing significantly better on some measures of social functioning.
273 citations
TL;DR: Comparison of the two groups indicated that patients who received manipulative treatment were much more likely to report immediate relief after the first treatment, and at discharge, there was no significant difference between theTwo groups because both showed substantial improvement.
Abstract: A randomized clinical trial of rotational manipulation was conducted on 95 patients with low back pain selected for (1) the absence of any contraindications for vertebral manipulation, (2) the absence of any psychosocial problems that might affect the outcome of treatment, (3) the absence of any previous experience with manipulative therapy, and (4) the presence of palpatory cues indicating that manipulation might be successful. Patients were randomly assigned to one of two groups: an experimental group receiving manipulation therapy and a control group receiving soft-tissue massage. Comparison of the two groups indicated that (1) patients who received manipulative treatment were much more likely to report immediate relief after the first treatment, and (2) at discharge, there was no significant difference between the two groups because both showed substantial improvement. ( JAMA 1981;245:1835-1838)
238 citations
TL;DR: Probably only a few stroke patients, mostly men, are suitable for intensive outpatient rehabilitation, but for those patients the treatment is effective and realistic.
Abstract: Of 1094 patients with a confirmed stroke admitted to Northwick Park, a district general hospital, 364 (33%) died while in hospital, 215 (20%) were fully recovered when discharged, and 329 (30%) were too frail or too ill from diseases other than stroke to be considered for active rehabilitation. Only 121 (11%) were suitable for intensive treatment. They and 12 patients referred direct to outpatients were allocated at random to one of three different courses of rehabilitation. Intensive was compared with conventional rehabilitation and with a third regimen which included no routine rehabilitation, but under which patients were encouraged to continue with exercises taught while in hospital and were regularly seen at home by a health visitor. Progress at three months and 12 months was measured by an index of activities of daily living. Improvement was greatest in those receiving intensive treatment, intermediate in those receiving conventional treatment, and least in those receiving no routine treatment. Decreasing intensity of treatment was associated with a significant increase in the proportions of patients who deteriorated and in the extent to which they deteriorated. Probably only a few stroke patients, mostly men, are suitable for intensive outpatient rehabilitation, but for those patients the treatment is effective and realistic.
225 citations
TL;DR: The study confirms the beneficial effects of exercise training in the chronically breathless and it suggests that the 12-minute walking distance is a useful index of changes in everyday exercise tolerance.
Abstract: A randomised controlled study of the effects of exercise training in 39 patients with chronic respiratory disability was performed Exercise training began with six weeks in a rehabilitation centre and was continued at home The original control group attended the rehabilitation centre after the controlled part of the study The treated group experienced subjective benefit from rehabilitation The 12-minute walking distance increased on average from 523 m to 643 m in the treatment group and from 564 m to 607 m in the control group The treatment effect of 77 m (SE 33 m) was significant at the 5% level Treadmill exercise performance changed little and resting lung function was unaltered after rehabilitation The treatment group maintained most of their improvement seven months later and the original control subjects improved after their rehabilitation The study confirms the beneficial effects of exercise training in the chronically breathless and it suggests that the 12-minute walking distance is a useful index of changes in everyday exercise tolerance
184 citations
TL;DR: The experience of the exercise group was more favorable than that of the control group in most of the comparisons made, and certain subgroups showed a greater benefit from exercise.
Abstract: This study enrolled 651 men with myocardial infarction in five participating centers in a randomized 3 year clinical trial of the effects of prescribed supervised exercise. The subjects, aged to 30 to 64 years, were screened for eligibility 2 to 36 months after their qualifying myocardial infarction. The men in the exercise group pursued intensive exercise in the laboratory for 8 weeks and then in a gymnasium for 34 months. The experience of the exercise group was more favorable than that of the control group in most of the comparisons made. The cumulative 3 year total mortality rate was 7.3 percent for the control group and 4.6 percent for the exercise group; the 3 year rate for recurrent myocardial infarction was 7.0 and 5.3 percent, respectively. Mortality rates in the two groups did not differ significantly, but the data were consistent with an assumption of substantial benefit from exercise. Adjustment for small differences in baseline variables by multivariate methods did not materially alter the estimate of effect of exercise. Certain subgroups showed a greater benefit from exercise.
175 citations
TL;DR: Life-table analysis shows a small increase in survival in the surgically treated group throughout the study, which is not statistically significant, and risk factors could not be identified that would improve the selection of patients for medical or surgical therapy.
TL;DR: In the short-term, active physiotherapy with several treatments appears to be of value in the outpatient management of patients with sciatic symptoms, but it does not seem to confer any longer-term benefit.
TL;DR: The data suggest that the effect of steroids may be different for different patient groups, and in order to identify these patients, a sensitive coma scale is needed; and a rational approach to steroid therapy in head-injured patients may be to start all patients on steroids, but to discontinue their use in patients identified as not benefiting from steroid therapy.
Abstract: This is a prospective randomized study of the efficacy of steroid therapy in patients with severe head injury. One hundred patients were randomized into two equal groups: the steroid group received 5 mg/kg/day of methylprednisolone, and the nonsteroid group received no drug. The groups were similar in their clinical features. All patients received a standardized therapeutic regimen. The patients were also classified as early responders or nonresponders to the overall treatment protocol without regard to steroid administration, on the basis of change in Glasgow Coma Scale score during the first 3 days of admission. There was no statistically significant difference in the outcome of the steroid and nonsteroid group at 6 months. Of the responders who were on steroids, 74% had good outcomes or were disabled, compared with 56% of the responders who did not receive steroids. In the nonresponder group, the patients on steroids were actually associated with a worse outcome than those who did not receive steroids: 75% of the nonresponders who received steroids were dead or vegetative, compared to 56% of those who were not receiving steroids. The data suggest that: 1) the effect of steroids may be different for different patient groups; 2) in order to identify these patients, a sensitive coma scale is needed; and 3) a rational approach to steroid therapy in head-injured patients may be to start all patients on steroids, but to discontinue their use in patients identified as not benefiting from steroid therapy.
Journal Article•
TL;DR: First-admission schizophrenic patients were randomly assigned to the following five treatments: psychotherapy alone, drug alone, psychotherapy plus drug, electroconvulsive therapy (ECT, and milieu), and a five-year follow-up examined their course after release from the hospital.
Abstract: Two hundred twenty-eight first-admission schizophrenic patients were randomly assigned to the following five treatments: psychotherapy alone, drug alone, psychotherapy plus drug, electroconvulsive therapy (ECT, and milieu. A there- to five-year follow-up examined their course after release from the hospital. The drug alone and ECT groups tended to have the best outcome and the psychotherapy alone group the worst. The positive effect from prior drug treatment began to dissipate after three years postadmission. For the in-hospital treatment successes, the advantage from drug treatment and the disadvantage from psychotherapy were less apparent. Overall, the follow-up outcome is far from reassuring, whatever the type of treatment. Even though a few patients may do well, much remains to be done in and out of the hospital.
TL;DR: It is recommended that reported study results should include outcome data from all subjects randomized in the group to which they were originally assigned.
Abstract: The realization that bias in patient selection may influence the results of clinical studies has helped to establish the randomized controlled clinical trial in medical research. However, bias can be equally important at other stages of a trial, especially at the time of analysis. Withdrawing patients from consideration in the analysis because of ineligibility on account of study entry criteria, lack of compliance to the protocol, or data of poor quality may be a source of systematic error. Examples to illustrate the possible consequences are taken from trials in the cardiovascular field. We recommended that reported study results should include outcome data from all subjects randomized in the group to which they were originally assigned.
TL;DR: Patients receiving the gastric partitioning procedure showed significantly poorer weight loss as early as three months postoperatively than did those receiving gastric bypass, which persisted throughout the study period.
Abstract: A prospective randomized clinical trial was undertaken to compare the effects of gastric bypass with Roux-en-Y gastrojejunostomy and a gastric partitioning procedure. Operative groups were comparable, with regard to preoperative weight, age, sex, historic findings and operative complications. Post-operative weight loss was followed for one year. Patients receiving the gastric partitioning procedure showed significantly poorer weight loss as early as three months postoperatively than did those receiving gastric bypass. This poorer performance persisted throughout the study period.
TL;DR: Fifty women with urinary incontinence due to derisory instability entered a controlled clinical trial to compare in-patient bladder drill with out-patient drug therapy, and following bladder drill, 84% of patients were continent.
Abstract: Summary— Fifty women with urinary incontinence due to derisory instability entered a controlled clinical trial to compare in-patient bladder drill with out-patient drug therapy. Following bladder drill, 84% of patients were continent, whereas following treatment with flavoxate hydrochloride and imipramine, 56% 01 patients were continent. Side effects due to drug therapy were significant.
TL;DR: The results suggest that in the absence of disabling angina or left main coronary artery stenosis, coronary artery surgery need not be advised for survivors of recurrent infarctions who have severe coronary artery disease.
Abstract: A randomized trial of surgical vs nonsurgical management was carried out in men 60 years of age or younger who had recovered from a recurrent myocardial infarction. Of 205 patients considered, 100 had few or no symptoms and had coronary vessels favorable for bypass grafting; these patients fulfilled the trial conditions and were randomized (50 surgical and 50 nonsurgical). In 41 patients (elective nonsurgical group), randomization was not considered justifiable because of relatively unfavorable coronary anatomy or severe left ventricular dysfunction. Nineteen patients had elective surgery because of disabling angina despite full medical treatment or because of significant left main coronary stenosis. In 45 patients, coronary angiography was not undertaken because of medical contraindications or reluctance of the patient to enter the study. Actuarial survival curves (mean follow-up 4.5 years) show an annual mortality rate of 3-4% per year for all investigated patients, and no advantage for the randomized surgical over the randomized nonsurgical group. The results suggest that in the absence of disabling angina or left main coronary artery stenosis, coronary artery surgery need not be advised for survivors of recurrent infarctions who have severe coronary artery disease. Moreover, the prognosis for the group of patients not treated surgically appears to be better than has been previously described.
TL;DR: It is concluded that folic acid supplementation might be a cheap, safe, and effective method of primary prevention of neural-tube defects but that this must be confirmed in a large, multicentre trial.
Abstract: A randomized controlled double-blind trial was undertaken in south Wales to prevent the recurrence of neural-tube defects in women who had had one child with a neural-tube defect. Sixty women were allocated before conception to take 4 mg of folic acid a day before and during early pregnancy and 44 complied with these instructions. Fifty-one women were allocated to placebo treatment. There were no recurrences among the compliant mothers but two among the non-compliers and four among the women in the placebo group. Thus there were no recurrences among those who received supplementation and six among those who did not; this difference is significant (p = 0.04). It is concluded that folic acid supplementation might be a cheap, safe, and effective method of primary prevention of neural-tube defects but that this must be confirmed in a large, multicentre trial.
TL;DR: In a Central Oncology Group trial in 319 evaluable patients the addition of 5-FU to the surgical treatment of colorectal carcinoma provided a small but significant benefit in those with colotectal cancer in certain unfavorable situations, namely Dukes C tumors and rectal carcinomas.
Journal Article•
TL;DR: A randomized clinical trial was conducted to evaluate the efficacy of 3 physical therapy approaches--lumbar flexion exercise, manual therapy, and home care--in the treatment of lumbar disc disease, showing no statistically significant differences.
TL;DR: There was no cumulative impact of the interventions and different aspects of regimens were not signiticantly related to one another.
Abstract: Low rates of adherence to hypertensive therapy limit patients' securing the full benefits of treatment. While some factors related to adherence have been identified research on the effectiveness of interventions to increase adherence levels is sparse. The present study was designed to assess the impact of a series of different interventions on a group of some 400 patients, all under the care of private physicians in a small community. A factorial design was employed to deliver four, sequential educational interventions, about four months apart, to randomly selected sub-groups. Interviews before and after each intervention provided information concerning self-reported adherence, health status, health beliefs, and personal characteristics. Pertinent medical records and pharmacy data were also obtained. The first intervention - printed material - did not significantly affect adherence. The second and fourth interventions - nurse telephone calls and social support - each increased medication taking and the third intervention - self-monitoring - led to better weight control. There was no cumulative impact of the interventions and different aspects of regimens were not significantly related to one another.
TL;DR: A preliminary analysis is presented of a clinical trial to determine whether adjuvant immunotherapy or chemotherapy can prolong the disease-free interval and survival of patients with poor prognosis Stage I malignant melanoma or Stage II melanoma.
TL;DR: It was concluded that betamethasone therapy, under the conditions of the original trial, was not hazardous to cognitive development as measured in this study.
Abstract: The present study was part of a larger study investigating the long-term development of children of mothers included in a controlled trial of betamethasone therapy in preterm labor, the purpose was to determine whether there are any benefits or hazards of treatment detectable up to the seventh year of life The first 318 children of mothers included in the trial because of spontaneous premature labor were selected for study Of 305 survivors, 258 (846%) were included in this phase of the study Detailed tests of psychological development, together with assessments of psychosocial background, were made during the fifth year Of the 258 children 144 were in the betamethasone group and 114 were control patients Despite a heavy weighting of the betamethasone group with more prematurely delivered infants and more boys (resulting from improved perinatal survival of these children associated with betamethasone therapy), no significant differences emerged between the groups in measures of outcome It was concluded that betamethasone therapy, under the conditions of the original trial, was not hazardous to cognitive development as measured in this study
Journal Article•
TL;DR: Specific screening problems addressed within this context include the uses of various definitions of age, the age at which screening is effective, and the marginal contribution of a single screening modality.