Showing papers on "Randomized controlled trial published in 1980"

Clomipramine treatment of obsessive-compulsive disorder. I. A controlled clinical trial.

Abstract: The effect of clomipramine hydrochloride in severe obsessive-compulsive disorder (OCD) was compared with that of nortriptyline hydrochloride and placebo in a five-week randomized, double-blind trial. Clomipramine, but not nortriptyline, was superior to placebo in interview-based ratings of severity of OCD. The effect was not clear-cut until after five weeks of treatment. When clomipramine was given openly to 22 patients after the end of the controlled trial, half of the patients responded to the drug. The response could not be predicted from severity or duration of illness, sex or age of the patient, or presence or absence of secondary depressive symptoms. The amelioration with clomipramine was not sustained if the drug was withdrawn.

Why data bases should not replace randomized clinical trials.

Abstract: Advances in computer technology have made it possible to store large amounts of observational data concerning treatment of patients for medical disorders. It has been suggested that these data banks might replace randomized clinical trials as a means of evaluating the efficacy of therapies. A review of the methodological problems likely to arise in analyzing such data for the purpose of comparing treatments suggests that sound inferences would not generally be possible because of difficulties with bias in treatment assignment, nonstandard definitions, definitions changing in time, specification of groups to be compared, missing data, and multiple comparisons.

Management of acute stroke in the elderly: follow-up of a controlled trial.

Abstract: Follow-up of a controlled trial of the management of acute stroke in the elderly showed that the improvement in functional outcome at the time of discharge from hospital that had been achieved through establishing a stroke unit had disappeared by one year. Factors that might have contributed to this included overprotection by the families of patients who had been treated in the stroke unit, who were not permitted to carry out activities of daily living in which they were independent, and the early discharge from medical units of patients whose full rehabilitation potential had not been realised. Prolonging the benefits of short-term gains in functional outcome through the intervention of a stroke unit requires that all the links in the chain of stroke rehabilitation are maintained, including the proper orientation of patients9 families before discharge from hospital.

A randomized trial of combined modality therapy of childhood non-Hodgkin's lymphoma.

Abstract: From 1975 to 1978, 69 children with non-Hodgkin's lymphoma were staged and treated in a randomized protocol to determine the contribution of involved-field radiotherapy (IF-RT) to an effective drug regimen in Stages III-IV and the efficacy of prophylactic treatment of the central nervous system with cranial irradiation and intrathecal methotrexate in Stages II-IV. Induction therapy for Stages I-II was vincristine, prednisone, cyclophosphamide and IF-RT (3000–3500 rad). Stages III-IV received the same three drugs plus adriamycin, and were randomized to receive or not receive IF-RT. The complete remission rate was 88%. After randomization to receive CNS prophylaxis or not, all children received oral mercaptopurine and methotrexate for 18 months. The two-year actuarial estimate of disease-free survival for all responders is 55% and is significantly influenced by stage. (Ninety percent disease-free survival for Stages I-II, versus 38.8% for III-IV, P <.05). We observed no benefit but added toxicity from IF-RT in Stages III-IV. Efforts at CNS prophylaxis in high-risk children are warranted, since only 1 of 18 children randomized to receive prophylaxis developed CNS disease as the site of first relapse, whereas 4 of 16 receiving no prophylaxis did so. Cancer 45:630-637, 1980.

Management of acute stroke in the elderly: preliminary results of a controlled trial.

Abstract: A randomised controlled trial compared the management of elderly patients with acute stroke in a stroke unit and medical units. A significantly higher proportion of patients discharged from the stroke unit (78 of the 155 admitted) were assessed as independent compared with patients discharged from medical units (49 of the 152 admitted). The intensive use of treatment that might have been implied by creating a stroke unit did not occur, although almost all the patients admitted to the unit received occupational therapy while only 47% of the patients admitted to medical units received occupational therapy. The delay before starting treatment was significantly shorter in the stroke unit. Results of this trial show that the stroke unit improved the natural history of stroke by increasing the proportion of patients who were returned to functional independence.

Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease.

Abstract: A simulated randomized clinical trial in coronary artery disease was conducted to illustrate the need for clinical judgment and modern statistical methods in assessing therapeutic claims in studies of complex diseases. Clinicians should be aware of problems that occur when a patient sample is subdivided and treatment effects are assessed within multiple prognostic categories. In this example, 1073 consecutive, medically treated coronary artery disease patients from the Duke University data bank were randomized into two groups. The groups were reasonably comparable and, as expected, there was no overall difference in survival. In a subgroup of 397 patients characterized by three-vessel disease and an abnormal left ventricular contraction, however, survival of group 1 patients was significantly different from that of group 2 patients. Multivariable adjustment procedures revealed that the difference resulted from the combined effect of small imbalances in the distribution of several prognostic factors. Another subgroup was identified in which a significant survival difference was not explained by multivariable methods. These are not unlikely examples in trials of a complex disease. Clinicians must exercise careful judgment in attributing such results to an efficacious therapy, as they may be due to chance or to inadequate baseline comparability of the groups.

Homoeopathic therapy in rheumatoid arthritis: evaluation by double-blind clinical therapeutic trial.

Abstract: Twenty-three patients with rheumatoid arthritis on orthodox first-line anti-inflammatory treatment plus homeopathy were compared wtih a similar group of twenty-three patients on orthodox first-line treatment plus an inert preparation. There was a significant improvement in subjective pain, articular index, stiffness and grip strength in those patients receiving homoeopathic remedies whereas there was no significant change in the patients who received placebo. Two physicians were involved in prescribing for the patients and there were no significant differences in the results which they obtained. No side effects were observed with the homoeopathic remedies.

Randomised trial comparing propranolol with atenolol in immediate treatment of suspected myocardial infarction.

Abstract: The value of beta-blockade for suspected acute myocardial infarction was assessed by determining the six-week and one-year mortality rates in patients started on propranolol, atenolol, or placebo immediately on entry to a coronary care unit. A total of 388 patients entered this double-blind, randomised study, and when analysed on the basis of the initial, intention-to-treat categories there was no significant difference between the three groups in respect of the mortality rate at one year. There was, however, a high withdrawal rate from the trial; the reasons for this illustrate problems of physician compliance and interpretation of data, which are common to all early-entry trials of haemodynamically active agents in acute myocardial infarction.

Controlled trial of supervised exercise training in chronic bronchitis.

Abstract: In a controlled trial of exercise retraining in patients with severe chronic bronchitis, 33 subjects were followed for a mean period of 10.3 months. The exercise programme was supervised once a week, and daily training comprised a 12-minute walk and simple stair climbing exercises. The subjects in the exercise group showed a highly significant improvement in their walking distance, attaining a maximum increase of 24% after eight to 12 months. There was also considerable subjective improvement. The control group did not improve. No significant changes in cardiorespiratory function or muscle strength were seen. Simple exercise rehabilitation is of benefit to patients with disabling obstructive lung disease.

Statistical considerations for pilot studies

Abstract: A pilot study is a non randomized clinical trial that is conducted to decide whether a new treatment should be tested in a large controlled trial. The statistical considerations for this type of study are presented. Criteria for deciding whether a treatment deserves further testing are specified and the required sample size is computed.

Research diagnostic criteria subtypes of depression. Their role as predictors of differential response to psychotherapy and drug treatment.

Abstract: • We studied the usefulness of the research diagnostic criteria subtypes in the prediction of response to amitriptyline and short-term interpersonal psychotherapy (IPT) in a 16-week, controlled, randomized clinical trial with 81 ambulatory depressed patients. Both patients with a situational depression and patients with an endogenous depression responded to combined treatment; those with an endogenous depression did not respond to IPT alone, whereas those with a situational depression responded to IPT or tricyclic medication alone. It may not be necessary to offer both treatments to the situationally depressed patients. However, situational and endogenous are not mutually exclusive diagnoses, and it would be of clinical interest to obtain a longer group of patients with both diagnoses for further study.

The acupuncture treatment of low back pain: a randomized controlled study.

Abstract: The acupuncture treatment situation was beneficial to the majority of people with low back pain. This was shown by the use of short-term controls and long-term controls, although the latter were not intended in the study design. After acupuncture, there was a 51% pain reduction in the average pain score in the Immediate Treatment Group. The short-term controls, the Delayed Treatment Group, had no reduction whatsoever in their pain scores at the comparable followup period. Later, the Delayed Treatment Group bere also treated by acupuncturists, and reported 62% less pain. When these two treatment groups were compared at 40 weeks with long-term controls (Inadequate Treatment Group), the Inadequate Treatment Group still had the same pain scores, on the average, as when they enrolled in the study. Both treatment groups, on the average, had 30% lower pain scores. Furthermore, 58% of the treatment groups felt that they were definitely improved at 40 weeks, while only 11% of the Inadequate Treatment Group felt definitely improved at 40 weeks.

Heart disease prevention project: a randomised controlled trial in industry.

Abstract: Twenty-four factories or other occupational groups, employing 18 210 men aged 40 to 59, were formed into matched pairs. One of each pair was allocated randomly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors. Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations, stopping or reducing cigarette smoking, regular exercies for the sedentary and reduced energy intake for the overweight, and hypertension was treated. The programme was delivered mainly through existing occupational medical services, helped by a small central staff. Personal consultations were largely confined to men with a high risk of developing coronary heart disease. Changes in risk factors were assessed by regular standardised examinations of random samples of men. The spread of information by general propaganda proved easy, but a change in habits seemed to require personal contact. Small but significant reductions occurred, mainly in the high-risk group, but these were not sustained when pressure was relaxed.

Cimetidine treatment for the prevention of recurrence of duodenal ulcer: an international collaborative study.

Abstract: Comparison of cimetidine and placebo in the prevention of recurrence of ulceration was carried out in the study of 696 patients with recently healed duodenal ulcers. Treatment with cimetidine 400 mg at bedtime or twice daily for up to 12 months very significantly reduced recurrence of symptomatic ulceration. Asymtomatic ulceration occurred in treated and untreated patients but was found significantly less often in cimetidine-treated patients. There were no serious untoward effects of cimetidine treatment. Only 3 patients (0.8%) were withdrawn for possible drug-related reasons. Evidence from other studies suggests that the natural history of duodenal ulcer remains unaltered when cimetidine treatment is stopped after one year. Investigations have been planned to study the efficacy and safety of longer periods of treatment.

Early intervention for infants with Down syndrome: a controlled trial.

Abstract: The mental development of 37 infants with Down syndrome, allocated either to an experimental or control group, was assessed over a six-month period by an independent evaluator. The experimental group participated in biweekly therapy sessions designed to stimulate normal development while the control group received no intervention. The Griffiths Mental Developmental Scales were used to assess changes in the developmental status in the two groups, which were shown to be equal initially on a variety of variables. No statistically significant differences in mental development between the experimental and control groups were found. The early intervention regimen investigated in this study was not efficacious in altering the pattern of mental development in those Down syndrome infants participating in the program.

The competing objectives of randomized trials.

Abstract: The intervention trial of greatest benefit to patients satisfies three objectives: validity (its results are true), generalizability (its results are widely applicable), and efficiency (the trial i...

A randomized study of split-course radiotherapy of lung cancer: Long term results☆

Abstract: A randomized clinical trial was performed from 1964 to 1967 to compare the results of split-course treatment with those of continuous daily fractionated treatment. No difference in survival was apparent between the two treatment regimens. Furthermore, no difference was evident in disease free survival between the groups. No significant difference was found for epidermoid carcinoma, small cell carcinoma, anaplastic carcinoma and unclassified carcinoma. In the patients with localized diasease the survival results were somewhat better in the split-course group for 6 months and 1 year, but not later. The continuously treated responders did slightly better than the split-course treated responders. It is evident that end results are achievable with split-course treatment which are similar to those with continuous treatment. Split-course treatment has the advantage of better tolerance and less marked or milder side effects.

Clinical assessment of external pressure circulatory assistance in acute myocardial infarction: Report of a cooperative clinical trial

Abstract: The clinical effects of early application of external pressure circulatory assistance (EPCA) in acute myocardial infarction were evaluated in a prospective, randomized trial involving 258 patients in 25 institutions. All patients had mild left ventricular failure and received circulatory assistance within the first 24 hours after the onset of symptoms. There were no significant differences between the treatment and control groups, consisting of 142 patients and 116 patients, respectively, with regard to age, sex, race, previous cardiac history, electrocardiographic location of myocardial infarction, Norris prognostic index, admission heart rate, blood pressure and chest roentgenogram, and time from onset of symptoms to hospital admission. There were also no differences between the treatment and control groups with regard to antiarrhythmic, positive inotropic, diuretic and vasodilator therapy. Hospital mortality was significantly decreased, compared with that of control patients, in the group receiving 4 or more hours of external pressure circulatory assistance within the first 24 hours after admission (mortality rate 6.5 percent [7 of 108] in treatment group versus 14.7 percent [17 of 116] in control group, p

The Belgian heart disease prevention project. Modification of the coronary risk profile in an industrial population.

Abstract: The Belgian Heart Disease Prevention Project is a controlled, multifactorial prevention trial involving 19,390 males aged 40-59 years employed by 30 Belgian industries These industries were paired and randomized into a control or intervention unit In each intervention factory, the subjects from the two highest deciles of a coronary risk-score distribution curve were given individual advice twice a year A health education campaign was also organized in each intervention factory In the control group, 10% of randomly chosen subjects had the same baseline examination as the whole of the intervention group After 2 years, high-risk subjects and random samples of the control and intervention group were compared regarding the coronary risk profile by means of a multiple logistic function (MLF) In the intervention high-risk group, the MLF showed a decrease of 20%, and in the control group there was an increment of 125% (p less than 0001) Comparing the random samples an increment of 25% was found in the control group vs a drop of 226 in the intervention group (p less than 0001) The coronary risk profile can be altered in a middle-aged male working population through mass media health education supplemented by face-to-face counseling in high-risk subjects

A randomized trial of levamisole versus placebo as adjuvant therapy in malignant melanoma.

Abstract: We conducted a randomized double-blind trial of levamisole versus placebo as adjuvant therapy for surgical treatment of melanoma. Of 203 patients entered into the study, 104 received levamisole and 99 placebo. The distribution of prognostic variables was similar in both groups, indicating the efficacy of the randomization and the absence of bias. Three end points were analyzed: disease-free interval, time to appearance of visceral metastasis, and survival. There was no statistically significant difference between the groups regarding any of these end points. In patients with Stage I disease, there was a trend in favor of levamisole regarding time to first visceral recurrence and survival (P = 0.07). We conclude that levamisole has no benefit, as compared with placebo, as adjuvant therapy for malignant melanoma.

Diet in pregnancy: a randomized controlled trial of nutritional supplements.

Abstract: 241 reach a wider readership of neuroscientists because of the unwieldy mode of presentation and the high price of each book in the series. Interferon is a popular topic today and a textbook on the subject attracts the eye of the casual and generally uninformed reader. As with all popular entities, especially those with putative curative powers, interferon (or, correctly, the interferons) is surrounded by much myth. In this volume Dr. Yabrow has done little to separate fact from fancy. Interferon and Non-Specific Resistance attempts to review several aspects of the interferon system. First, there is a review of the basic knowledge concerning interferons; the review is incomplete and outdated. Second, the book attempts to advocate the clinical efficacy of interferons; sadly interferons have been disappointing in most recent trials of cancer therapy. (These results were presented in international meetings on interferon-Washington, D.C., in November 1980, and Rotterdam, in April 1981.) Third, the concept of non-specific resistance is defined. This is a series of ideas, most unproven, about the mechanisms of defense against disease. Overall I would not recommend this textbook as a review of the interferon system and I advise the reader to exercise extreme caution in interpreting the data presented, especially the clinical studies. This is a report of a multi-investigator project to study the effects of nutritional supplementation on the outcome of pregnancy. It is an effort to test the hypothesis that the effects of nutritional deprivation can be prevented by dietary supplementa-tion. Some interesting and controversial results have come out of this study, leading to the authors' decision to publish this in monograph form rather than as a series of journal papers. This leads, however, to the disadvantage of not having the original data published in a reviewed journal. From that point of view, therefore, it is of interest that several of the articles were submitted to the journal Pediatrics and reviewed; one article and the review have been published (Pediatrics 65:834-836 and 65:683-697). Contrary to the expectations of the investigators, protein supplementa-tion alone in the nutritionally deprived mothers led to only one positive effect in the