Showing papers on "Randomized controlled trial published in 1990"

Treatment of Primary Pulmonary Hypertension with Continuous Intravenous Prostacyclin (Epoprostenol): Results of a Randomized Trial

Abstract: Study objective To determine the efficacy of continuous intravenous infusion of prostacyclin (epoprostenol) in primary pulmonary hypertension. Design Randomized trial with 8-week treatment periods and nonrandomized treatment for up to 18 months. Setting Four referral centers. Patients Sequential sample of 24 patients with primary pulmonary hypertension. Nineteen patients completed the study. Four patients died and one left the study because of adverse effects (pulmonary edema). Interventions Continuous intravenous prostacyclin administered by portable infusion pump at doses determined by acute responses during baseline catheterization in ten patients. Nine patients were treated with anticoagulants, oral vasodilators, and diuretics. Measurements and main results Starting with a baseline value for total pulmonary resistance of 21.6 units, there was a decrease of 7.9 units (95% CI, -13.1 to -2.2; P = 0.022) in the prostacyclin-treated group after 8 weeks; there was virtually no change in the conventional therapy group (from 20.6 to 20.4 units, not significant). Six of ten prostacyclin-treated patients who completed the 8-week study period had reductions in mean pulmonary artery pressure of greater than 10 mm Hg, whereas only one of nine in the conventional treatment group had a similar response (P = 0.057). Nine patients receiving prostacyclin for up to 18 months have persistent hemodynamic effects, although dose requirements have increased with time. Complications have been attributable to the drug delivery system. Conclusions Prostacyclin produces substantial and sustained hemodynamic and symptomatic responses in severe primary pulmonary hypertension and may be useful in the management of some patients with this disease.

Quality-of-life changes and hearing impairment. A randomized trial.

Abstract: Objective To assess whether hearing aids improve the quality of life of elderly persons with hearing loss. Setting Primary care clinics at a Bureau of Veterans Affairs hospital. Patients One hundred and ninety-four elderly veterans who were identified as being hearing impaired from a screening survey involving 771 consecutive clinic patients. Of the original 194, 188 (97%) completed the trial. Intervention Subjects were randomly assigned to either receive a hearing aid (n = 95) or join a waiting list (n = 99). MAIN ENDPOINTS: A comprehensive battery of disease-specific and generic quality-of-life measures were administered at baseline, 6 weeks, and 4 months. Measurements and main results Persons assigned to the two groups were similar in age, ethnicity, education, marital status, occupation, and comorbid diseases. At baseline, 82% of subjects reported adverse effects on quality of life due to hearing impairment, and 24% were depressed. At follow-up, a significant change in score improvements for social and emotional function (34.0; 95% CI, 27.3 to 40.8; P less than 0.0001), communication function (24.2; CI, 17.2 to 31.2; P less than 0.0001), cognitive function (0.28; CI, 0.08 to 0.48; P = 0.008), and depression (0.80; CI, 0.09 to 1.51; P = 0.03) was seen in subjects who received hearing aids compared with those assigned to the waiting list. Six drop-outs (three per group), no crossovers, and no significant changes in cointerventions were seen. Average, self-reported, daily aid use in the hearing aid group was 8 hours. Conclusion Hearing loss is associated with important adverse effects on the quality of life of elderly persons, effects which are reversible with hearing aids.

The treatment of medulloblastoma. Results of a prospective randomized trial of radiation therapy with and without CCNU, vincristine, and prednisone

Abstract: In a prospective randomized trial designed to study the effectiveness of adjuvant chemotherapy following standard surgical treatment and radiation therapy, 233 eligible patients with medulloblastoma were treated by members of the Children's Cancer Study Group and the Radiation Therapy Oncology Group. Eligible patients were randomly assigned to receive radiation therapy with or without adjuvant chemotherapy consisting of 1-(2-chloroethyl)-3-cyclohexyl-nitrosourea (CCNU), vincristine, and prednisone. The estimated 5-year event-free survival probability was 59% for patients treated with radiation therapy and chemotherapy and 50% for patients treated with radiation therapy alone, a difference which is not statistically significant. The 5-year survival probability was 65% for both groups. Although the treatment difference was not statistically significant when all patients were combined, in the small number of patients with more extensive tumors, event-free survival was better in the group receiving chemotherapy (48% vs. 0%, p = 0.006). In these latter patients the survival time is also significantly prolonged. Extent of disease (as measured by the M staging criteria described by Chang) and age at diagnosis were significantly associated with outcome; advanced disease and young age had a worse prognosis. The extent of tumor resection was not an independent prognostic factor. It is concluded that chemotherapy does not benefit patients with low-stage medulloblastoma, but may benefit those with more advanced stages of disease.

A Randomized, Controlled Trial of a Geriatric Assessment Unit in a Community Rehabilitation Hospital

Abstract: We conducted a randomized trial in a community rehabilitation hospital to determine the effect of treatment in a geriatric assessment unit on the physical function, institutionalization rate, and mortality of elderly patients. Functionally impaired elderly patients (mean age, 78.8 years) who were recovering from acute medical or surgical illnesses and were considered at risk for nursing home placement were randomly assigned either to the geriatric assessment unit (n = 78) or to a control group that received usual care (n = 77). The two groups were similar at entry and were stratified according to the perceived risk of an immediate nursing home placement. After six months, the patients treated in the geriatric assessment unit had significantly more functional improvement in three of eight basic self-care activities (P less than 0.05). Those in the lower-risk stratum had significantly more improvement in seven of eight self-care activities. Both six weeks and six months after randomization, significantly more patients treated in the geriatric assessment unit than controls (79 vs. 61 percent after six months) were residing in the community. During the year of follow-up, the control patients had more nursing home stays of six months or longer (10 vs. 3; P less than 0.05). However, there was no difference between the groups in the mean number of days spent in health care facilities (acute care hospital, nursing home, or rehabilitation hospital). Survival analysis showed a trend toward fewer deaths among the patients treated in the geriatric assessment unit, and mortality was significantly reduced in the patients considered to be at lower risk of immediate nursing home placement (P less than 0.05). We conclude that the treatment of selected elderly patients in a specialized geriatric rehabilitation unit improves function, decreases the risk of nursing home placement, and may reduce mortality. The beneficial effects on mortality and function appear greatest for patients at a moderate rather than high risk of nursing home placement.

Corticosteroids as adjunctive therapy for severe Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. A double-blind, placebo-controlled trial.

Abstract: Background. Preliminary reports suggest that patients with the acquired immunodeficiency syndrome (AIDS) and Pneumocystis carinii pneumonia may benefit from the addition of corticosteroid treatment to antibiotic therapy. Methods. We conducted a double-blind, placebo-controlled trial to assess the efficacy of adjunctive corticosteroids in patients with AIDS and severe P. carinii pneumonia. Patients with marked abnormalities in gas exchange who had been treated with antibiotics for less than 72 hours were randomly assigned to receive either methylprednisolone (40 mg) or placebo every 6 hours for 7 days, in addition to treatment for 21 days with trimethoprim–sulfamethoxazole. The primary outcome measures were survival until hospital discharge and the development of respiratory failure. Results. Twenty-three patients were enrolled in the study; there were no significant differences in base-line clinical or laboratory measures between the two treatment groups. Of 12 patients treated with corticosteroi...

The value of assessing falls in an elderly population. A randomized clinical trial.

Abstract: OBJECTIVE: To measure the effects of a specialized postfall assessment intended to detect causes and underlying risk factors for falls, and to recommend preventive and therapeutic interventions. DESIGN: Randomized, controlled trial. SETTING: A long-term residential care facility for elderly persons. SUBJECTS: Within 7 days of a fall, 160 ambulatory subjects (mean age, 87 years) were randomly assigned to receive either a comprehensive postfall assessment (intervention group, n = 79) or usual care (control group, n = 81). INTERVENTION: The postfall assessment included a detailed physical examination and environmental assessment by a nurse practitioner; laboratory tests; electrocardiogram; and 24-hour Holter monitoring. Probable cause or causes for the fall, identified risk factors, and therapeutic recommendations were given to the patient's primary physician. MEASUREMENTS AND MAIN RESULTS: Through use of the assessment, many remediable problems (for example, weakness, environmental hazards, orthostatic hypotension, drug side effects, gait dysfunction) were detected. At the end of the 2-year follow-up period, the intervention group had 26% fewer hospitalizations (P less than 0.05) and a 52% reduction in hospital days (P less than 0.01) compared with controls. Patients in the intervention group had 9% fewer falls and 17% fewer deaths than controls by 2 years, but these trends were not statistically significant. CONCLUSIONS: Our study suggests that falls are a marker of underlying disorders easily identifiable by a careful postfall assessment, which in turn can reduce disability and costs. Language: en

Cognitive-behavioural problem solving in the treatment of patients who repeatedly attempt suicide : a controlled trial

Abstract: In a controlled trial, 20 patients at high risk of repeated suicide attempts were randomly allocated to either cognitive-behavioural problem solving or a 'treatment-as-usual' control condition. The group practising problem solving improved significantly more than controls on ratings of depression, hopelessness, suicidal ideation and target problems at the end of treatment and at follow-up of up to one year, and there was evidence of an effect on the rates of repetition over the six months after treatment.

A longitudinal study of two early intervention strategies: Project CARE.

Abstract: 65 families with children at risk for cognitive difficulties were randomly assigned at the time of the child's birth to 1 of 3 groups, 2 intervention and 1 control. For the most intensive intervention group, family education was combined with a center-based educational day-care program; the less intensive intervention group received the home-based family education program only. To assess the cognitive performance of children, The Bayley Scales of Infant Development were administered at 6, 12, and 18 months; the Stanford-Binet Intelligence Test at 24, 36, and 48 months; and the McCarthy Scales of Children's Abilities at 30, 42, and 54 months. On each test after the 6-month assessment, scores of children in the educational day-care plus family support group were greater than those in the other 2 groups. No cognitive intervention effects were obtained for the family education group. Group effects were not obtained for measures of either the quality of the home environment or parent attention.

A randomized trial to improve self-management practices of adults with asthma.

Abstract: The prevalence and impact of adult asthma are substantial, and poor self-management practices, especially failures to adhere to treatment regimens, appear to be a significant problem. Desirable characteristics of an intervention program to improve self-management were identified through needs assessment and review of existing patient education resources. A comprehensive program was developed that integrated a workbook with one-to-one counseling and adherence-enhancing strategies. A longitudinal 1-year study compared patients receiving this self-management program with "usual care" patients receiving standard asthma pamphlets. Patients were randomly assigned to conditions. Baseline score and asthma severity were statistically controlled. Self-management patients had substantially better adherence than usual care patients, as well as improved functional status, at follow-up. Hospital and emergency department visits decreased in both groups but did not differ between groups.

Failure of Surgery to Improve Outcome in Hypertensive Putaminal Hemorrhage: A Prospective Randomized Trial

Abstract: • Hypertensive putaminal hemorrhage remains a major cause of hemorrhagic stroke carrying extremely high morbidity. Considerable controversy remains regarding the optimal form of therapy. Between 1983 and 1989 we conducted a prospective randomized trial with three treatment strategies: best medical management, best medical management plus intracranial pressure monitoring, and surgical evacuation. Only patients with significant deficit harboring a putaminal hematoma at least 3.0cm in diameter were entered. The study was interrupted after 21 patients had been studied (9, best medical management; 4, intracranial pressure monitoring; and 8, surgical evacuation). No differences were found among groups for age, admission blood pressure, and time interval between onset of symptoms and arrival at hospital. None of the subjects were capable of returning to prestroke activity. Fifteen (71%) died or remained vegetative at 6 months, and only 4 (19%) were capable of independent life at home. Of the 9 patients in the best medical management arm, 7 were dead or vegetative. In the surgical group, 4 patients died and only 2 were capable of independent life. These results suggest that current medical and neurosurgical therapies remain ineffective in preventing the devastating neurologic consequences of hypertensive putaminal hemorrhage.

The n-of-1 Randomized Controlled Trial: Clinical Usefulness: Our Three-Year Experience

Abstract: OBJECTIVE To review the feasibility and effectiveness of n-of-1 randomized controlled trials (n-of-1 trials) in clinical practice. DESIGN Individual trials were double-blind, randomized, multiple crossover trials. The impact of n-of-1 trials was determined by eliciting physicians' plans of management and confidence in those plans before and after each trial. SETTING Referral service doing n-of-1 trials at the requests of community and academic physicians. OBJECT of ANALYSIS All trials were planned, started, and completed by the n-of-1 service. MEASURES OF OUTCOME The proportion of planned n-of-1 trials that were completed and the proportion that provided a definite clinical or statistical answer. A definite clinical answer was achieved if an n-of-1 trial resulted in a high level of physician's confidence in the management plan. Specific criteria were developed for classifying an n-of-1 trial as providing a definite statistical answer. MAIN RESULTS Seventy-three n-of-1 trials were planned in various clinical situations. Of 70 n-of-1 trials begun, 57 were completed. The reasons for not completing n-of-1 trials were patients' or physicians' noncompliance or patients' concurrent illness. Of 57 n-of-1 trials completed, 50 provided a definite clinical or statistical answer. In 15 trials (39% of trials in which appropriate data were available), the results prompted physicians to change their "prior to the trial" plan of management (in 11 trials, the physicians stopped the drug therapy that they had planned to continue indefinitely). CONCLUSION We interpret the results as supporting the feasibility and usefulness of n-of-1 trials in clinical practice.

A Comparison Study of Antidepressants and Structured Intensive Group Psychotherapy in the Treatment of Bulimia Nervosa

Abstract: Previous research on the treatment of outpatients with bulimia nervosa has focused on two treatment strategies: (1) drug therapy, primarily using tricyclic antidepressants, and (2) psychotherapy, often employing behavioral and cognitive behavioral techniques. We report here the short-term treatment outcome of a 12-week comparison trial of bulimic outpatients who were randomly assigned to one of four treatment cells: (1) imipramine hydrochloride treatment, (2) placebo treatment, (3) imipramine treatment combined with intensive group psychotherapy, and (4) placebo treatment combined with intensive group psychotherapy. All three active treatment cells resulted in significant reductions in target-eating behaviors and in a significant improvement in mood relative to placebo treatment. However, the results also suggested that the amount of improvement obtained with the intensive group psychotherapy component was superior to that obtained with antidepressant treatment alone. The addition of antidepressant treatment to the intensive group psychotherapy component did not significantly improve outcome over intensive group psychotherapy combined with placebo treatment in terms of eating behavior, but did result in more improvement in the symptoms of depression and anxiety.

Lack of benefit from semi-annual screening for cancer of the lung : follow-up report of a randomized controlled trial on a population of high-risk males in Czechoslovakia

Abstract: Cigarette-smoking males (6,364), aged 40-64, were randomized into an intervention group which received 6-monthly screening by chest X-ray and sputum cytology, and a control group which received no asymptomatic investigation. After 3 years, both groups entered a follow-up period during which they received annual chest X-rays. Lung cancer cases detected by screening were identified at an earlier stage, more often resectable, and had a significantly better survival than "interval" cases diagnosed mainly because of symptoms. Comparison of the 2 groups showed a higher incidence of lung cancer in the intervention group, despite the follow-up period when both groups received annual examinations. There was no significant difference in mortality between the 2 groups.

Do corticosteroids reduce mortality from alcoholic hepatitis? A meta-analysis of the randomized trials

Abstract: Purpose To determine whether corticosteroids affect short-term mortality from alcoholic hepatitis. Data identification Studies published from 1966 to 1989 were identified through a MEDLINE computer search and an extensive manual search of the bibliographies of identified articles. Study selection We found 11 randomized studies (10 of which were placebo controlled) that assessed mortality in hospitalized patients diagnosed with acute alcoholic hepatitis and treated with corticosteroids. Data extraction Two critical appraisers independently evaluated trial quality and abstracted quantitative data on clinical characteristics of the populations, interventions, and all-cause mortality. Results of data synthesis Overall, the protective efficacy (or percent reduction in mortality) of corticosteroids was 37% (95% CI, 20% to 50%). Protective efficacy was higher among trials with higher quality scores and trials that excluded subjects with active gastrointestinal bleeding. In subjects with hepatic encephalopathy, protective efficacy was 34% overall (CI, 15% to 48%). It was also higher among trials with higher quality scores and trials excluding subjects with acute gastrointestinal bleeding, but was not present among trials with lower quality scores or trials that did not exclude subjects with acute gastrointestinal bleeding. In subjects without hepatic encephalopathy, corticosteroids had no protective effect, and this lack of efficacy was consistent across all trial subgroups. Conclusions These results suggest that corticosteroids reduce short-term mortality in patients with acute alcoholic hepatitis who have hepatic encephalopathy, that the protective effect depends on the exclusion criterion of acute gastrointestinal bleeding and is influenced by trial quality, and that corticosteroids are of no benefit in patients without hepatic encephalopathy.

Randomized consent designs for clinical trials: an update.

Abstract: Randomized consent designs were introduced to make it easier for physicians to enter patients in randomized clinical trials. Physician reluctance to participate in randomized clinical trials is often a reflection that the physician-patient relationship could be compromised if the physician makes known to the patient his/her inability to select a preferred therapy. Clinical trials having a no-treatment control or placebo amplify this concern. This paper reviews the main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis, and presents some recent experiences.

Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement : results of parallel randomized and nonrandomized trials

Abstract: We studied the efficacy of adenoidectomy in 213 children who had received tympanostomy-tube placement because of persistent and/or recurrent otitis media and had again developed otitis media after tubal extrusion. Ninety-nine of the children were assigned randomly to either an adenoidectomy group or a control group; in a separate trial, 114 children whose parents withheld consent for randomization were assigned according to parental preference. In both trials, control group outcomes appeared to have been biased favorably by the withdrawal of certain severely affected subjects from control status to receive adenoidectomy. Nonetheless, in both trials, adenoidectomy group outcomes were more favorable than control group outcomes during the first 2 follow-up years. Statistically significant differences were found mainly in the randomized trial, where during the first and second years, respectively, adenoidectomy subjects had 47% and 37% less time with otitis media than control subjects and 28% and 35% fewer suppurative (acute) episodes than control subjects. We conclude that adenoidectomy is warranted on an individualized basis for children who develop recurrent otitis media after extrusion of tympanostomy tubes. (JAMA. 1990;263:2066-2073)

A Patient Education Program to Improve Adherence Rates with Antituberculosis Drug Regimens

Abstract: The design, logic, and results of a two-year health education study directed at im proving rates of patient adherence to antituberculosis medical regimens are presented. An incentive scheme to reward positive health behaviors plus targeted educational coun seling sessions was implemented in a randomized clinical controlled trial. The 205 subjects who participated in the study are categorized according to patients with active tuberculosis (n = 88) or preventive patients with no evidence of active disease (n = 117). Patients in each of these groups were randomly assigned to a special intervention (SI) group or a usual care (UC) control group and were followed monthly throughout their treatment program. While SI patients with active tuberculosis demonstrated higher levels of ap pointment-keeping behavior and mean percent of medication taken compared to UC patients, no statistically significant differences between the two groups were found. Pre ventive therapy patients assigned to the SI group, however, were ...

Psychological treatment for atypical non-cardiac chest pain: a controlled evaluation.

Abstract: Thirty-one patients with atypical non-cardiac chest pain which had persisted despite negative medical investigation were treated in a controlled trial of cognitive-behavioural therapy. The average duration of pain was 4.7 years. Patients were randomized to either immediate treatment or as a control to assessment only. Treatment involved teaching patients how to anticipate and control symptoms, and modification of inappropriate health beliefs. The average number of sessions given was 7.2. There were significant reductions in chest pain. limitations and disruption of daily life, autonomic symptoms, distress and psychological morbidity in the treated group as compared with the control group who were unchanged. The assessment-only group were treated subsequently and showed comparable changes. Improvements were fully maintained by both treated groups at four- to six-months follow-up.

A randomized trial of family caregiver support in the home management of dementia.

Abstract: A randomized trial of family caregiver support for the home management of older people suffering from moderate to severe progressive irreversible dementia was conducted in an urban center in southern Ontario. Thirty caregivers were allocated to receive the experimental intervention consisting of: caregiver-focused health care, education about dementia and caregiving, assistance with problem solving, regularly scheduled in-home respite, and a self-help family caregiver support group. Thirty control subjects received conventional community nursing care. Before completion of the intervention, 18 (30%) were withdrawn, almost equally from each group. The most frequent reason was long-term institutionalization of the demented relative (n = 10). At baseline, caregivers in both groups were suffering from above-average levels of depression and anxiety. After the six-month intervention period, we found neither experimental nor control group improved in these areas. However, the experimental group showed a clinically important improvement in quality of life, experienced a slightly longer mean time to long-term institutionalization, found the caregiver role less problematic, and had greater satisfaction with nursing care than the control group.

Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain

Abstract: Therapeutic trials often attempt to "blind" patient and investigator to the true nature of treatments received, reducing the influences of conscious or subconscious prejudices. In drug trials, this is accomplished with placebo tablets, but blinding in trials of physical treatments is more problematic. This issue arose in a clinical trial of transcutaneous electrical nerve stimulation (TENS) for patients with chronic low back pain. Several study design features were incorporated to promote blinding: use of sham TENS units visually identical with real units, exclusion of potential subjects with previous TENS experience, avoidance of a crossover design and use of identical visit frequency, instructions and modifications in electrode placement. Subjects were asked not to discuss treatments with the clinicians who performed outcome assessments. Both patients and clinicians were asked to guess actual treatment assignments at the trial's end. Every patient in the true TENS group believed the unit was functioning properly, but the degree of certainty varied. In the sham TENS group, 84% also believed they had functioning units, but their certainty was significantly less than in the active treatment group. Differences in patient perceptions did not affect compliance, as the two groups had similar dropout rates, appointment compliance, days of TENS use and daily duration of TENS use. Clinicians guessed treatments correctly 61% of the time (as opposed to 50% expected by chance), again suggesting partial success in blinding. These efforts at blinding may partly explain the negative trial results for TENS efficacy. We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner.(ABSTRACT TRUNCATED AT 250 WORDS)

A double-blind, placebo-controlled trial of fluoxetine plus behavior modification in the treatment of obese binge-eaters and non-binge-eaters.

Abstract: To determine whether fluoxetine is effective in the long-term treatment of obesity and whether it is particularly useful in the treatment of obese binge-eaters, the authors randomly assigned 45 obese subjects (22 with binge-eating problems and 23 without binge-eating) to fluoxetine (60 mg/day) or placebo in a 52-week double-blind trial. The 21 subjects who completed the trial made 13 clinic visits and were taught basic behavior modification strategies. Patients treated with fluoxetine plus behavior modification lost significantly more weight than those treated with placebo plus behavior modification. However, the drug did not appear to have a differential benefit for binge-eaters.

A possible preventive effect of low-dose fish oil on early delivery and pre-eclampsia: indications from a 50-year-old controlled trial.

Abstract: A preventive effect of dietary marine n-3 fatty acids on early delivery and toxaemia has recently been hypothesized. In only one published controlled trial fish oil has been given to pregnant women, namely in that conducted during 1938-9 in London by the People's League of Health with a dietary supplement containing vitamins, minerals, and halibut liver oil. Although it was of high quality and its findings are hitherto unexplained, neglect and misinterpretation of the trial seem to occur commonly in reviews. Of the 5644 women who were enrolled the 622 withdrawals were independent of treatment. Alternate allocation to treatment was used, producing two groups that were well balanced as to age and parity. The supplement was given from about week 20. The control group did not receive any supplement. Reductions of 20.4% (95% confidence interval 9-30%, P = 0.00083) and 31.5% (95% confidence interval 11-47%, P = 0.0047) were seen in odds of delivering before 40 weeks of gestation and pre-eclampsia respectively. No significant effects were seen on perinatal mortality, average birth weight, deliveries after 40 weeks, hypertension in the absence of oedema and proteinuria, duration of labour, sepsis or breast-feeding occurrence. Later controlled trials with vitamins or minerals given in the same amounts as in this trial have largely failed to show convincing effects as seen here. A controlled trial assessing the isolated effects of fish oil in pregnancy is warranted.