Showing papers on "Randomized controlled trial published in 1989"
TL;DR: The effect of psychosocial intervention on time of survival of 86 patients with metastatic breast cancer was studied prospectively and survival plots indicated that divergence in survival began at 20 months after entry, or 8 months after intervention ended.
2,248 citations
TL;DR: There was limited evidence of the specific effectiveness of interpersonal psychotherapy and none for cognitive behavior therapy, but Superior recovery rates were found for both interpersonal Psychotherapy and imipramine plusclinical management, as compared with placebo plus clinical management.
Abstract: • We investigated the effectiveness of two brief psychotherapies, interpersonal psychotherapy and cognitive behavior therapy, for the treatment of outpatients with major depressive disorder diagnosed by Research Diagnostic Criteria. Two hundred fifty patients were randomly assigned to one of four 16-week treatment conditions: interpersonal psychotherapy, cognitive behavior therapy, imipramine hydrochloride plus clinical management (as a standard reference treatment), and placebo plus clinical management. Patients in all treatments showed signifi-cant reduction in depressive symptoms and improvement in functioning over the course of treatment. There was a consistent ordering of treatments at termination, with imipramine plus clinical management generally doing best, placebo plus clinical management worst, and the two psychotherapies in between but generally closer to imipramine plus clinical management. In analyses carried out on the total samples without regard to initial severity of illness (the primary analyses), there was no evidence of greater effectiveness of one of the psychotherapies as compared with the other and no evidence that either of the psychotherapies was significantly less effective than the standard reference treatment, imipramine plus clinical management. Comparing each of the psychotherapies with the placebo plus clinical management condition, there was limited evidence of the specific effectiveness of interpersonal psychotherapy and none for cognitive behavior therapy. Superior recovery rates were found for both interpersonal psychotherapy and imipramine plus clinical management, as compared with placebo plus clinical management. On mean scores, however, there were few significant differences in effectiveness among the four treatments in the primary analyses. Secondary analyses, in which patients were dichotomized on intial level of severity of depressive symptoms and impairment of functioning, helped to explain the relative lack of significant findings in the primary analyses. Significant differences among treatments were present only for the subgroup of patients who were more severely depressed and functionally impaired; here, there was some evidence of the effectiveness of interpersonal psychotherapy with these patients and strong evidence of the effectiveness of imipramine plus clinical management. In contrast, there were no significant differences among treatments, including placebo plus clinical management, for the less severely depressed and functionally impaired patients.
2,171 citations
TL;DR: In this article, the authors evaluated the efficacy of interferon alfa therapy for chronic hepatitis C (non-A, non-B hepatitis) and found that it is a common and often progressive viral liver disease.
Abstract: Chronic hepatitis C (non-A, non-B hepatitis) is a common and often progressive viral liver disease. To assess the efficacy of therapy with the antiviral agent interferon alfa, we randomly ...
1,567 citations
TL;DR: The observed 20% reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfarction throughout at least 3 years and a reduction in sudden death during the 1st year after infarction and possibly for 2-3 years.
Abstract: Of 22 randomized trials of rehabilitation with exercise after myocardial infarction (MI), one trial had results that achieved conventional statistical significance. To determine whether or not these studies, in the aggregate, show a significant benefit of rehabilitation after myocardial infarction, we performed an overview of all randomized trials, involving 4,554 patients; we evaluated total and cardiovascular mortality, sudden death, and fatal and nonfatal reinfarction. For each endpoint, we calculated an odds ratio (OR) and 95% confidence interval (95% CI) for the trials combined. After an average of 3 years of follow-up, the ORs were significantly lower in the rehabilitation than in the comparison group: specifically, total mortality (OR = 0.80 [0.66, 0.96]), cardiovascular mortality (OR = 0.78 [0.63, 0.96]), and fatal reinfarction (OR = 0.75 [0.59, 0.95]). The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year (OR = 0.63 [0.41, 0.97]). The data were compatible with a benefit at 2 (OR = 0.76 [0.54, 1.06]) and 3 years (OR = 0.92 [0.69, 1.23]), but these findings were not statistically significant. For nonfatal reinfarction, there were no significant differences between the two groups after 1 (OR = 1.09 [0.76, 1.57]), 2 (OR = 1.10 [0.82, 1.47]), or 3 years (OR = 1.09 [0.88, 1.34]) of follow-up. The observed 20% reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfarction throughout at least 3 years and a reduction in sudden death during the 1st year after infarction and possibly for 2-3 years. With respect to the independent effects of the physical exercise component of cardiac rehabilitation, the relatively small number of "exercise only" trials, combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion. To do so would require a randomized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview.
1,375 citations
TL;DR: Any evaluation of an innovation may include both bias and the true efficacy of the new therapy, therefore any evaluation of a new therapy may consider making adjustments for the average bias associated with a study design.
Abstract: We analysed the results of 221 comparisons of an innovation with a standard treatment in surgery published in six leading surgery journals in 1983 to relate features of study design to the magnitude of gain. For each comparison we measured the gain attributed to the innovation over the standard therapy by the Mann—Whitney statistic and the difference in proportion of treatment successes. For primary treatments (aimed at curing or ameliorating a patient's principal disease), an average gain of 0.56 was produced by 20 randomized controlled trials. This was less than the 0.62 average for four non-randomized controlled trials, 0.63 for 19 externally controlled trials, and 0.57 for 73 record reviews (0.50 represents a toss-up between innovation and standard). For secondary therapies (used to prevent or treat complications of therapy), the average gain was 0.53 for 61 randomized controlled trials, 0.58 for eleven non-randomized controlled trials, 0.54 for eight externally controlled trials, and 0.55 for 18 record reviews. Readers of studies evaluating new treatments, particularly for primary treatments, may consider adjustment of the gain according to the study type.
506 citations
TL;DR: Counselling by health visitors is valuable in managing non-psychotic postnatal depression.
Abstract: OBJECTIVE--To determine whether counselling by health visitors is helpful in managing postnatal depression. DESIGN--Controlled, random order trial. SETTING--Health centres in Edinburgh and Livingston. PATIENTS--Sixty women identified as depressed by screening at six weeks post partum and by psychiatric interview at about 13 weeks post partum. Five women did not wish to participate, and a further five did not complete the trial. Age, social and obstetric factors, and diagnosis were similar in women who completed the trial and those who withdrew. INTERVENTION--Eight weekly counselling visits by health visitors who had been given a short training in counselling for postnatal depression. END POINT--Reduction of depression. MEASUREMENTS and main results--Standardised psychiatric interviews and a 10 point self report scale were used to identify depression before and after intervention. The psychiatrist was not told to which group women were allocated. After three months 18 (69%) of the 26 women in the treatment group had fully recovered compared with nine (38%) of the 24 in the control group. The difference between the groups was thus 32% (95% confidence interval 5 to 58). CONCLUSIONS--Counselling by health visitors is valuable in managing non-psychotic postnatal depression.
497 citations
TL;DR: In this paper, a randomized, double-blind, placebo-controlled multicenter trial was conducted to determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis.
Abstract: Study objective To determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis. Design Randomized, double-blind, placebo-controlled multicenter trial. Setting Four university teaching hospitals. Patients We enrolled 66 patients with alcoholic hepatitis and either spontaneous hepatic encephalopathy or a discriminant function value greater than 32, calculated using the formula: 4.6 (prothrombin time - control time) + serum bilirubin [in mumol/L]/17.1. Fifty-nine patients (89%) completed the study. Two patients withdrew from the trial. The other 64 patients were hospitalized for the duration of the trial; however, treatment was discontinued in 5 patients because of potential drug toxicity. Interventions Patients were randomly assigned to receive either methylprednisolone (32 mg) or placebo within 7 days of admission. Treatment was given for 28 days. The doses were then tapered over 2 weeks and discontinued. Measurements and main results The endpoint of the study was death. Of the 31 recipients of placebo, 11 (35%) died within 28 days of randomization compared with 2 (6%) of the 35 patients given methylprednisolone (P = 0.006). The 95% CI for the difference in mortality was 12% to 70%. In the patients with spontaneous hepatic encephalopathy at entry, 9 of 19 recipients of placebo died (47%) compared with 1 (7%) of the 14 patients given methylprednisolone (P = 0.02). The 95% CI for the difference in mortality was 14% to 66%. The Cox proportional hazards regression model showed the advantage of methylprednisolone over placebo after adjustment for other potentially important prognostic variables (P = 0.004). Conclusions Methylprednisolone therapy decreases short-term mortality in patients with severe alcoholic hepatitis manifested either by spontaneous hepatic encephalopathy or a markedly elevated discriminant function value.
456 citations
TL;DR: Thirty-nine newborn infants with severe persistent pulmonary hypertension and respiratory failure who met criteria for 85% likelihood of dying were enrolled in a randomized trial in which extracorporeal membrane oxygenation (ECMO) therapy was compared with conventional medical therapy (CMT).
Abstract: Thirty-nine newborn infants with severe persistent pulmonary hypertension and respiratory failure who met criteria for 85% likelihood of dying were enrolled in a randomized trial in which extracorporeal membrane oxygenation (ECMO) therapy was compared with conventional medical therapy (CMT). In phase I, 4 of 10 babies in the CMT group died and 9 of 9 babies in the ECMO group survived. Randomization was halted after the fourth CMT death, as planned before initiating the study, and the next 20 babies were treated with ECMO (phase II). Of the 20, 19 survived. All three treatment groups (CMT and ECMO in phase I and ECMO, phase II) were comparable in severity of illness and mechanical ventilator support. The overall survival of ECMO-treated infants was 97% (28 of 29) compared with 60% (6 of 10) in the CMT group (P less than .05).
451 citations
TL;DR: Within 3 weeks of definitive surgery, 571 adult patients with histologically confirmed, supratentorial malignant gliomas were randomly assigned to receive one of three chemotherapy regimens: BCNU (1,3-bis(2-chloroethyl)-1-nitrosourea) alone,BCNU plus hydroxyurea alternating with procarbazine plus VM-26 (epipodophyllotoxin).
Abstract: Within 3 weeks of definitive surgery, 571 adult patients with histologically confirmed, supratentorial malignant gliomas were randomly assigned to receive one of three chemotherapy regimens: BCNU (1,3-bis(2-chloroethyl)-1-nitrosourea) alone, alternating courses (every 8 weeks) of BCNU and procarbazine, or BCNU plus hydroxyurea alternating with procarbazine plus VM-26 (epipodophyllotoxin). Patients accrued in 1980 and 1981 were to receive 6020 rads of whole-brain radiotherapy concurrent with the first course of chemotherapy. Patients accrued in 1982 and 1983 were randomly assigned to receive either whole-brain irradiation as above, or 4300 rads of whole-brain radiotherapy plus 1720 rads coned down to to the tumor volume. The data were analyzed for the total randomized population and separately for the 510 patients, termed the "Valid Study Group (VSG)," who met protocol eligibility specifications (including central pathology review), 80% of whom had glioblastoma multiforme. The median survival times from time of randomization for the three chemotherapy groups of the VSG ranged from 11.3 to 13.8 months, and 29% to 37% of the patients survived for 18 months (life-table estimate); the differences between these groups were not statistically significant. Survival differences between the radiotherapy groups were small and not statistically significant. It is concluded that, for malignant glioma, giving part of the radiotherapy by coned-down boost is as effective as full whole-brain irradiation, and that multiple-drug chemotherapy as outlined in this protocol conferred no significant survival advantage over BCNU alone.
417 citations
TL;DR: A six- to eight-week double-blind placebo-controlled trial of the potent and selective serotonin reuptake inhibitor fluvoxamine was conducted in 42 patients with primary obsessive-compulsive disorder, lending partial support to the serotonin hypothesis of OCD.
Abstract: • A six- to eight-week double-blind placebo-controlled trial of the potent and selective serotonin reuptake inhibitor fluvoxamine was conducted in 42 patients with primary obsessive-compulsive disorder (OCD). Approximately one half of the patients also had symptoms of major depression. Fluvoxamine was significantly better than placebo on all measures of obsessive-compulsive symptoms. Nine of 21 patients were responders ("much improved") with fluvoxamine compared with no responders with placebo, and fluvoxamine was effective in patients with OCD both with and without secondary depression. Response of OCD was not correlated with severity of baseline depression. These data lend partial support to the serotonin hypothesis of OCD. However, since a number of patients failed to respond to fluvoxamine, the role of other neurochemical systems in this disorder needs to be explored.
355 citations
TL;DR: It is concluded that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids.
Abstract: We randomly assigned 71 patients with active chronic Crohn's disease who were resistant to or intolerant of corticosteroids to treatment with oral cyclosporine (5 to 7.5 mg per kilogram of body weight per day) or placebo for three months. Disease activity was assessed on a clinical grading scale without knowledge of the treatment given. At the end of the treatment period, 22 of the 37 cyclosporine-treated patients (59 percent) had improvement, as compared with 11 of the 34 placebo-treated patients (32 percent) (P = 0.032). During cyclosporine treatment, there was significant improvement in plasma orosomucoid levels (P = 0.0025) and the Crohn's Disease Activity Index (P = 0.00012). The effect of treatment became evident after two weeks. In the subsequent three months, during which the patients were gradually withdrawn from treatment, the improvement continued in 14 of the 37 patients (38 percent) in the cyclosporine group and in 5 of the 34 (15 percent) in the placebo group (P = 0.034). No serious adverse events were observed. We conclude that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids.
TL;DR: Cancers detected by screening were at a less advanced pathological stage, but it is too early to show any effect of screening on mortality from colorectal cancer.
TL;DR: This study is to the authors' knowledge the only randomized trial to investigate effectiveness of chemotherapy in the treatment of high-grade astrocytoma in children and found that treatment with chemotherapy prolonged survival and event-free survival.
Abstract: Fifty-eight patients with high-grade astrocytoma were treated by members of the Childrens Cancer Study Group in a prospective randomized trial designed to study the effectiveness of chemotherapy as an adjuvant to standard surgical treatment and radiotherapy. Following surgical therapy, patients were assigned randomly to radiotherapy with or without chemotherapy consisting of chloroethyl-cyclohexyl nitrosourea, vincristine, and prednisone. Treatment with chemotherapy prolonged survival and event-free survival. Five-year event-free survival was 46% for patients in the radiotherapy and chemotherapy group, and 18% for patients in the radiotherapy-alone group. Five-year survival was similarly improved. The differences in outcome due to treatment were statistically significant after correcting for imbalances in important prognostic factors (event-free survival, p = 0.026; survival, p = 0.067). The presence of mitoses or necrosis in the tumor specimen was associated with poorer outcome. Patients whose initial surgery was limited to biopsy, and patients with basal ganglia lesions, also had significantly worse outcome. Chemotherapy administered at the time of recurrence in a small number of patients did not produce any long-term survivors. This study is to our knowledge the only randomized trial to investigate effectiveness of chemotherapy in the treatment of high-grade astrocytoma in children.
TL;DR: It is concluded that heparin administered subcutaneously in a dosage of 12,500 unitsevery 12 hours to patients with acute anterior transmural myocardial infarction is more effective than a lower dosage (5000 units every 12 hours) in preventing left ventricular mural thrombosis.
Abstract: We performed a double-blind randomized trial comparing high doses of subcutaneous heparin (12,500 units every 12 hours) with low doses (5000 units every 12 hours) for 10 days in the prevention of left ventricular mural thrombosis in 221 patients with acute anterior myocardial infarction. Left ventricular mural thrombosis was observed by two-dimensional echocardiography on the 10th day after infarction in 10 of 95 patients (11 percent) in the high-dose group and in 28 of 88 patients (32 percent) in the low-dose group (P = 0.0004). One patient in the high-dose group and four in the low-dose group had nonhemorrhagic strokes (P = 0.17). One patient in the low-dose group had a fatal pulmonary embolism. There was no difference in the frequency of hemorrhagic complications, which occurred in six patients in the high-dose group and four in the low-dose group. The mean (±SEM) plasma heparin concentration was 0.18±0.017 U per milliliter in the high-dose group and 0.01 ±0.005 U per milliliter in the low-dos...
TL;DR: Calcitriol is not an effective treatment for established postmenopausal osteoporosis, but renal function was not worse than in the placebo group.
Abstract: Study Objective: To determine if calcitriol is an effective treatment in postmenopausal osteoporosis. Design: Double-blind, randomized clinical trial of 2 years' duration. Setting: Univers...
TL;DR: Systemic corticosteroid treatment prevents the exacerbations of Graves' ophthalmopathy that occur after radioiodine therapy in a substantial proportion of patients with hyperthyroidism who have some degree of ocular involvement before treatment.
Abstract: We studied the effects of radioiodine treatment of hyperthyroidism due to Graves' disease on Graves' ophthalmopathy and the possible protective role of corticosteroids. Between June 1985 and June 1988, 26 patients were randomly assigned to treatment with radioiodine alone (group 1) and 26 to treatment with this agent and concomitant administration of systemic prednisone for four months (group 2). The initial dose of prednisone was 0.4 to 0.5 mg per kilogram of body weight for one month; the drug was gradually withdrawn over the next three months. All patients were evaluated at 3-month intervals for 18 months after they underwent radioiodine therapy. Ocular changes were assessed with the ophthalmopathy index; patients with moderate-to-severe changes (scores greater than or equal to 4) were excluded from the study. Before treatment, 10 patients in group 1 and 5 in group 2 had no evidence of ophthalmopathy: in none of them did ocular symptoms appear after radioiodine therapy. Among the patients in group 1 with an initial ophthalmopathy index greater than or equal to 1, ocular disease worsened in 56 percent (mostly involving soft-tissue changes and extraocular-muscle function) and did not change in 44 percent. In contrast, ophthalmopathy improved in 52 percent and did not change in 48 percent of group 2. The mean ophthalmopathy index increased from 1.5 to 3.0 in group 1 (P less than 0.005) and decreased from 2.2 to 1.3 in group 2 (P less than 0.05). We conclude that systemic corticosteroid treatment prevents the exacerbations of Graves' ophthalmopathy that occur after radioiodine therapy in a substantial proportion of patients with hyperthyroidism who have some degree of ocular involvement before treatment.
TL;DR: It is concluded that dietary protein restriction is effective in slowing the rate of progression of chronic renal failure.
Abstract: Dietary protein intake may be an important determinant of the rate of decline in renal function in patients with chronic renal insufficiency. We conducted a prospective, randomized study of the efficacy of protein restriction in slowing the rate of progression of renal impairment. The study lasted 18 months and included 64 patients with serum creatinine concentrations ranging from 350 to 1000 μmol per liter. The patients were randomly assigned to follow either a regular diet or an isocaloric protein-restricted diet (0.4 g of protein per kilogram of body weight per day). Blood-pressure levels and the balance between calcium and phosphate were similar in the two groups. End-stage renal failure developed in 9 of the 33 patients (27 percent) who followed the regular diet during the study, as compared with 2 of the 31 patients (6 percent) who followed the protein-restricted diet (P<0.05). The mean (±SE) glomerular filtration rate, as measured by the clearance of 51Cr bound to EDTA, fell from 0.25±0.03...
TL;DR: It is concluded that involvement of families utilizing school based resources is feasible and effective and there was evidence that behavior change persisted one year beyond the completion of the intervention program.
Abstract: The effectiveness of a family-based cardiovascular disease risk reduction intervention was evaluated in two ethnic groups. Participants were 206 healthy, volunteer low-to-middle-income Mexican-American and non-Hispanic white (Anglo-American) families (623 individuals), each with a fifth or a sixth-grade child. Families were recruited through elementary schools. Half of the families were randomized to a year-long educational intervention designed to decrease the whole family's intake of high salt, high fat foods, and to increase their regular physical activity. Eighty-nine percent of the enrolled families were measured at the 24-month follow-up. Both Mexican- and Anglo-American families in the experimental groups gained significantly more knowledge of the skills required to change dietary and exercise habits than did those in the control groups. Experimental families in both ethnic groups reported improved eating habits on a food frequency index. Anglo families reported lower total fat and sodium intake. There were no significant group differences in reported physical activity or in tested cardiovascular fitness levels. Significant differences for Anglo-American experimental vs. control adult subjects were found for LDL cholesterol. Significant intervention-control differences ranging from 2.2 to 3.4 mmHg systolic and/or diastolic blood pressure were found in all subgroups. Direct observation of diet and physical activity behaviors in a structured environment suggested generalization of behavior changes. There was evidence that behavior change persisted one year beyond the completion of the intervention program. It is concluded that involvement of families utilizing school based resources is feasible and effective. Future studies should focus on the most cost-effective methods of family involvement, and the potential for additive effects when family strategies are combined with other school health education programs.
TL;DR: Melatonin can alleviate jet lag and tiredness after long haul flights and was more severe on the return (westward) than the outward (eastward) journey.
Abstract: OBJECTIVE: To determine whether doses of the pineal hormone melatonin alleviate jet lag. DESIGN: Double blind, placebo controlled crossover trial. SETTING: Long haul return flights from Auckland, New Zealand, to London and back. SUBJECTS: Twenty volunteers with experience of transcontinental flights (eight women and 12 men aged 28 to 68). INTERVENTIONS: Melatonin (or placebo) 5 mg three days before flight, during flight, and once a day for three days after arrival. END POINT: Symptoms of jet lag. MEASUREMENTS AND MAIN RESULTS: Visual analogue scale for feelings of jet lag and tiredness; profile of moods states questionnaire for vigour-activity and fatigue-inertia; and retrospective ratings 10 days after arrival of sleep pattern, energy, and daytime tiredness. Feelings of jet lag were less for subjects taking melatonin (mean score 2.15 v 3.4); these subjects took fewer days than the placebo group to establish a normal sleep pattern (2.85 v 4.15), to not feel tired during the day (3.0 v 4.6), and to reach normal energy levels (3.25 v 4.7). Results for fatigue-inertia and vigour-activity were similar. For all subjects jet lag was more severe on the return (westward) than the outward (eastward) journey. CONCLUSIONS: Melatonin can alleviate jet lag and tiredness after long haul flights.
TL;DR: The relapse and readmission rates of schizophrenic patients who participated in a controlled trial of a nine-month behavioural family intervention trial based on the EE status of their relatives are presented at two years.
Abstract: The relapse and readmission rates of schizophrenic patients who participated in a controlled trial of a nine-month behavioural family intervention trial based on the EE status of their relatives are presented at two years. The patients who received the behavioural family intervention had lower rates of relapse and readmission than patients from high-EE homes who had received a short educational programme or routine treatment. The relapse rate of the behavioural family intervention group (33%) was the same as that of the low-EE group (33%), and significantly lower than that of the non-intervention high-EE group (59%).
TL;DR: The results indicate that the cancer screening reminders strategy was the most effective in promoting the performance of routine cancer screening tests.
Abstract: • To determine effective methods of promoting routine cancer screening, we randomly assigned 62 internal medicine residents to receive cancer screening reminders (computer-generated lists of overdue tests at patients' visits), audit with feedback (monthly seminars about screening, with feedback about their performance rates), or no intervention (controls) Half of the residents in each group also were randomized to receive patient education (patients received literature and notices of overdue tests) We reviewed a sample of each physician's medical records to assess performance of seven tests during 9-month periods before and after initiating the interventions Cancer screening reminders increased performance of six of seven tests; audit with feedback, four of seven tests; and patient education, one of two targeted breast cancer screening tests The results indicate that the cancer screening reminders strategy was the most effective in promoting the performance of routine cancer screening tests (Arch intern Med 1989;149:1866-1872)
TL;DR: In this paper, the effects of endurance or resistance exercise training on maximal O2 consumption (VO2max) and the cardiovascular responses to exercise of 70- to 79-yr-old men and women were determined.
Abstract: This study determined the effects of endurance or resistance exercise training on maximal O2 consumption (VO2max) and the cardiovascular responses to exercise of 70- to 79-yr-old men and women. Hea...
TL;DR: Results indicate that even a moderate reduction in risk factors for hypertension among hypertension-prone individuals contributes to the primary prevention of the disease.
Abstract: A 5-year trial involving 201 men and women with high-normal blood pressure at baseline demonstrated the ability to reduce the incidence of hypertension in participants randomized to nutritional-hygienic intervention compared with a control group. The incidence of hypertension was 8.8% among 102 intervention group participants vs 19.2% among 99 control group members. The odds ratio for the incidence of hypertension in the control group was 2.4. Mean trial blood pressure also was lower in the intervention compared with the control group ( -1.2 and -1.9 mm Hg, respectively, for diastolic blood pressure at work-site and office visits and -1.3 and - 2.0 mm Hg, respectively, for systolic blood pressure at the two sites). Net weight loss in the intervention group averaged 2.7 kg during the trial; sodium intake was reduced by 25% and reported alcohol intake decreased by 30%. The majority of intervention participants also reported an increase in physical activity. Effect on blood pressure was related particularly to degree of weight loss. Results indicate that even a moderate reduction in risk factors for hypertension among hypertension-prone individuals contributes to the primary prevention of the disease. ( JAMA . 1989;262:1801-1807)
TL;DR: In this paper, meta-analytic methods were applied to review clinical trials published in English that have assessed the efficacy of parenteral nutrition for cirrhotic patients with acute hepatic encephalopathy.
TL;DR: Lidocaine administered to monitored patients during the prehospital phase of AMI will not reduce mortality by a clinically important amount and lidocaineadministered in the hospital phase of monitored, uncomplicated AMI may increase mortality among recipients with proved AMI.
Abstract: • Although lidocaine prophylaxis reduces the incidence of ventricular fibrillation during acute myocardial infarction (AMI), randomized control trials (RCTs) have not demonstrated any significant mortality effect of this therapy. We conducted a meta-analysis of 14 RCTs of lidocaine prophylaxis during AMI to detect any mortality effect. Six prehospital- and eight hospital-phase RCTs that randomized totals of 7656 and 1407 patients, respectively, were selected and reviewed in a blinded fashion. Mortality data were evaluated according to therapy type, reporting interval, and patient category. The prehospital-phase RCTs showed no meaningful mortality effect (risk difference, 0.0184; 95% confidence interval, −0.048 to +0.012). The hospital-phase RCTs showed a statistically significant increase in mortality during the treatment period for lidocaine recipients (risk difference, 0.029; 95% confidence interval, +0.004 to +0.055). These results confirm that lidocaine administered to monitored patients during the prehospital phase of AMI will not reduce mortality by a clinically important amount and suggest that lidocaine administered in the hospital phase of monitored, uncomplicated AMI may increase mortality among recipients with proved AMI. ( Arch Intern Med. 1989;149:2694-2698)
TL;DR: In a randomized prospective trial of radiotherapy in 29 patients no differences could be detected in daily subjective pain scores for one month or monthly objective scores for six months in the palliative treatment of bone metastasis.
Journal Article•
Journal Article•
TL;DR: The use of steroids in the treatment of hospitalized children with croup is supported and, in the absence of a randomized clinical trial of sufficient size, the most reliable estimate of the impact of steroid therapy on the morbidity associated with croups is provided.
Abstract: The use of adrenocorticoids to reduce the morbidity associated with laryngotracheitis (croup) remains controversial despite ten published reports of randomized trials involving 1,286 patients. To determine whether, viewed in aggregate, these studies demonstrate a significant benefit of steroid treatment for this disorder, a meta-analysis of the nine methodologically satisfactory trials was performed. Clinical improvement 12 and 24 hours posttreatment and incidence of endotracheal intubation were evaluated. For each end point, an estimate of the overall effect was obtained by calculating a typical odds ratio and 95% confidence interval. This analysis indicates that the use of steroids in children hospitalized with croup is associated with a significantly increased proportion of patients showing clinical improvement 12 hours (odds ratio = 2.25, 95% confidence interval = 1.66, 3.06) and 24 hours (odds ratio = 3.19, 95% confidence interval = 1.70, 5.99) posttreatment and a significantly reduced incidence of endotracheal intubation (odds ratio = 0.21, 95% confidence interval = 0.05, 0.84). Higher initial doses of steroid (greater than or equal to 125 mg of cortisone or greater than or equal to 100 mg of hydrocortisone) were associated with a larger proportion of patients improved 12 hours posttreatment than was seen with lower doses. These results support the use of steroids in the treatment of hospitalized children with croup and, in the absence of a randomized clinical trial of sufficient size, provide the most reliable estimate of the impact of steroid therapy on the morbidity associated with croup. In addition, the results of this meta-analysis may be used to estimate the number of subjects who would be required to conduct a randomized clinical trial of steroids for the treatment of croup.
TL;DR: The most favorable regimen was 5‐FU with low‐dose leucovorin, based upon considerations of therapeutic effectiveness, toxicity, and cost, in the treatment of advanced colorectal cancer.
Abstract: The Mayo Clinic and the North Central Cancer Treatment Group (NCCTG) conducted a randomized clinical trial comparing five different combination chemotherapeutic regimens to single-agent 5-fluorouracil (5-FU), given by intravenous bolus technique (500 mg/m2 for 5 days) as a control, in the treatment of advanced colorectal cancer. This report summarizes the results of treatment in 208 patients who were randomized to 5-FU alone or 5-FU with leucovorin in either a high-dose (200 mg/m2) or a low-dose regimen (20 mg/m2) intravenously for 5 days. Both of the 5-FU with leucovorin regimens were associated with improved survival compared with single-agent 5-FU (P less than 0.03). The interval to tumor progression, measurable tumor response rates, and measures of quality of life (performance status, weight gain, and symptomatic relief) were also improved significantly with the addition of leucovorin. There was no therapeutic advantage associated with the use of high-dose compared with low-dose leucovorin. The dose-limiting toxicity of 5-FU/leucovorin was stomatitis. There was one treatment-related fatality (due to sepsis) among the 138 patient receiving 5-FU/leucovorin (0.7%). The most favorable regimen in this trial was 5-FU with low-dose leucovorin, based upon considerations of therapeutic effectiveness, toxicity, and cost. A national intergroup trial is being coordinated by the National Cancer Institute that will test the efficacy of low-dose leucovorin with 5-FU as one approach to adjuvant therapy after a curative surgical resection in selected patients with Dukes' Stage B2 or C colon cancer.
TL;DR: A geriatric consultation team was unable to alter the degree of functional decline among elderly patients entering an acute-care hospital, and such patients are at risk for further decline during hospitalization.
Abstract: Study Objective:To evaluate the impact of a geriatric consultation team on the functional status of hospitalized elderly patients. Design:Randomized controlled clinical trial. Setting:Univ...