Showing papers on "Randomized controlled trial published in 1978"

The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials.

Abstract: Seventy-one "negative" randomized control trials were re-examined to determine if the investigators had studied large enough samples to give a high probability (greater than 0.90) of detecting a 25 per cent and 50 per cent therapeutic improvement in the response. Sixty-seven of the trials had a greater than 10 per cent risk of missing a true 25 per cent therapeutic improvement, and with the same risk, 50 of the trials could have missed a 50 per cent improvement. Estimates of 90 per cent confidence intervals for the true improvement in each trial showed that in 57 of these "negative" trials, a potential 25 per cent improvement was possible, and 34 of the trials showed a potential 50 per cent improvement. Many of the therapies labeled as "no different from control" in trials using inadequate samples have not received a fair test. Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials.

A randomized comparative trial of adriamycin versus methotrexate in combination drug therapy.

Abstract: A prospective randomized trial was conducted comparing the clinical response of 78 previously untreated patients with advanced metastatic breast cancer to a combination of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) or to a combination of cyclophosphamide, adriamycin, and 5-fluorouracil (CAF) Sixty-two percent of the patients receiving CMF responded to treatment compared to an 82% response rate for the patients receiving CAF Although within acceptable limits, hematologic and GI toxicity was greater with CAF There was no significant difference in the duration of response to the two regimens Therefore, the therapeutic difference between the two therapies is a higher initial response rate to the adriamycin containing regimen

Behavior therapy, supportive psychotherapy, imipramine, and phobias.

Abstract: • In a controlled outcome study of phobias, 111 adult patients (69% women, 31% men) received a course of 26 weekly treatment sessions consisting of (1) behavior therapy and imipramine hydrochloride (2) behavior therapy and placebo, or (3) supportive psychotherapy and imipramine. Patients were classified as agoraphobic, mixed phobic, or simple phobic. The great majority of patients in all groups showed moderate to marked global improvement (70% to 86%, depending on rater). In agoraphobics and mixed phobics (both groups experiencing spontaneous panic attacks), imipramine was significantly superior to placebo. There was no difference between behavior therapy and supportive therapy, both resulting in high improvement rates (76% to 100%, depending on rater). In simple phobic patients, there was a high rate of improvement with all treatment regimens (72% to 93%, depending on rater), with no significant difference between imipramine and placebo or between behavior therapy and supportive therapy. Of 88 moderately to markedly improved patients followed up for one year after completing treatment, 83% maintained their gains and 17% relapsed. No patients showed symptom substitution. Eighteen percent of the patients receiving imipramine hydrochloride showed marked stimulant side effects on from 5 to 75 mg/day.

Effect of propranolol and phentolamine on myocardial necrosis after subarachnoid haemorrhage.

Abstract: A study was set up to assess the effect on the clinical course of subarachnoid haemorrhage (SAH) of giving propranolol 80 mg eight-hourly plus phentolamine 20 mg three-hourly by mouth for three weeks. Out of the 90 patients studied, 14 died. Two of the deaths occurred in an open pilot study of 10 patients, the remaining 12 deaths occurring in patients in a randomised double-blind placebo-controlled study. Postmortem examination was carried out on 12 of the patients, six of whom had been receiving placebo and six propranolol plus phentolamine. Necrotic myocardial lesions were present in the hearts of all six patients (age range 30-59 years) who died while taking placebo (all had had abnormal electrocardiograms (ECGs). In contrast, no necrotic lesions were found in the hearts of the six patients (age range 28-59) who died while receiving the drugs (all had previously had normal ECGs). We conclude that the necrotic myocardial lesions were induced by catecholamines and that propranolol had a cardioprotective effect. While death from a further haemorrhage in cases of SAH is not affected by propranolol and phentolamine, propranolol may have a beneficial effect in other potentially lethal stresses.

Chemotherapy studies in primary liver cancer: a prospective randomized clinical trial.

Abstract: One hundred and sixty-eight patients with unresectable primary liver cancer were prospectively studied by members of the Eastern Cooperative Oncology Group. These patients were randomized to receive treatment with oral 5-Fluorouracil (5-Fu), oral 5-Fu plus Streptozotocin, oral 5-Fu plus MethylCCNU or Adriamycin. The single agent treatments (oral 5-Fu and Adriamycin) were associated with less gastrointestinal toxicity than were the oral 5-Fu treatment combinations. A total of 15 partial responses were reported. Adriamycin appears to be the most active agent and responsible for 9 of the 15 responses. No response was seen in any of the 48 patients randomized to oral 5-Fu alone. The survival associated with oral 5-Fu alone was significantly shorter than the survival time associated with the remaining 3 treatment programs among both North American and South African patients. A multivariate model of survival was formulated. Covariates of prognostic significance were treatment, initial performance status and sex. South African black patients had a shorter survival time than North American black patients. Excluding oral 5-Fu from consideration, prognostic variables appeared to dominate any differences between the remaining treatments under study. Cancer 42:2149–2156, 1978.

Conjoint marital therapy: a controlled outcome study.

Abstract: Forty-two couples with marital problems were randomly allocated to conjoint therapy of (i) a directive, (ii) an interpretative or (iii) a supportive (control) type. Self and independent assessment at the end of treatment showed the directive significantly superior to the control procedure on several measures. This superiority was maintained to 18 months' follow-up, when the interpretative procedure also showed some superiority over the control.

Acute cholecystitis treated by early and delayed surgery. A controlled clinical trial

Abstract: 100 patients with acute cholecystitis (AC) diagnosed by clinical, laboratory, and roentgenological examinations were randomly divided into 2 groups; early surgery (ES), operated within 7 days after the onset of acute symptoms, and delayed (DS), operated 2--3 months after the acute episode. Patients with elevated serum bilirubin and/or amylase were included in the trial. Two patients died during conservative treatment, and in 4 cases medical treatment was interrupted because of peritonitis, and in 3 cases because of increasing jaundice. Recurrence of AC was found in 24% of the patients in the DS group. There was no mortality in the ES group, but 2 patients died postoperatively in the DS group. Wound infection developed in 3 patients in the ES, and in 8 patients in the DS group. Retained stones remained in 3 cases of the DS and in 1 case of the ES group. The operative procedures were easier to perform in the ES group than in the DS, as estimated by the duration of operation. The operation time was 76.7 +/- 4.6 min (mean p S.E.) in the ES and 98.0 +/- 7.3 min in the DS group. There was a statistically significant difference between the 2 groups (p less than 0.01). The results suggest that early surgery in the treatment of acute cholecystitis is recommended. The complications of failed medical treatment can be avoided by early operation without added risk of mortality or complications.

A randomised controlled trial of the effect on middle-aged men of advice to stop smoking.

Abstract: A randomised controlled trial of smoking cessation is reported in 1445 male smokers aged 40-59 at high risk of cardiorespiratory disease. The 714 men in the intervention group were recalled for a series of personal interviews with a doctor. After one year, 51% of the intervention group reported that they were not smoking any cigarettes, and most of the others reported a reduction. Compared with the "normal care" group, the men in the intervention group showed a decline in the prevalence of sputum production and dyspnoea; ventilatory function did not improve but its rate of decline was significantly slowed. There were no evident effects on blood pressure levels, nor on electrocardiographic findings over three years, nor on sickness absence over one year. Mortality follow-up has continued for an average of 7.9 years; 98 (13.7%) of the intervention group have died, compared with 94 (12.9%) of the "normal care" group. The 95% confidence limits on mortality range from 2.63% in favour of intervention to 4.37% in favour of normal care. The power of the trial has been reduced by smoking cessation in the "normal care" group. It is concluded that smoking cessation in these middle-aged men improved the symptoms and progress of chronic bronchitis; but the reversibility of the risk of cigarettes to the smoker's life may have been overestimated in observational studies.

Anaesthetic techniques for surgical correction of fractured neck of femur. A comparative study of spinal and general anaesthesia in the elderly.

Abstract: Fifty-five patients presenting with fractured neck of femur were randomly allocated to either a standard general anaesthetic or spinal block in the lateral position combined with light sedation. The comparability of the two groups was established. There was little difference in the intra-operative course of postoperative morbidity in the two groups. There was a statistically significant difference in post-operative mortality between two groups, the general anaesthetic group showing a much higher mortality than the spinal group.

A controlled trial of cervical manipulation of migraine.

Abstract: The efficacy of cervical manipulation for migraine was evaluated. In a six-month trial, 85 volunteers suffering from migraine were randomly allocated to three treatment groups. One group received cervical manipulation performed by a medical practitioner or by a physiotherapist, another received cervical manipulation performed by a chiropractor, while the control group received mobilization performed by a medical practitioner or by a physiotherapist. For the whole sample, migraine symptoms were significantly reduced. No difference in outcome was found between those who received cervical manipulation, performed by chiropractor or orthodox therapist, and those who received the control treatment. Chiropractic treatment was no more effective than the other two treatments in reducing frequency, duration or induced disability of migraine attacks, but chiropractic patients did report a greater reduction in pain associated with their attacks.

Prophylactic diazepam or phenobarbitone in febrile convulsions: a prospective, controlled study.

Abstract: After their first episode of febrile convulsions, 195 previously healthy children, aged 6--30 months, were given either diazepam or phenobarbitone for a year. Each child was assigned at random to one of the two medications: children admitted on even days were given a suppository containing 5 mg diazepam every 8 hours when the rectal temperature was greater than or equal to 38.5 degree C. Children admitted on odd days were given treatment with phenobarbitone, 3.5 +/- 1 mg/kg per day. 156 children completed treatment and outpatient control for a year, 83 in the diazepam and 73 in the phenobarbitone group. The rate of recurrence was independent of the prophylactic and 15--16 % of the children in both groups had new febrile convulsions within a year. The recurrence rate after 6 months was also similar, 11% in the diazepam group and 9% in the phenobarbitone group. New convulsions were of similar duration and severity in both groups. In both groups 6% of all febrile episodes led to new convulsions. Long-term treatment with phenobarbitone thus offered no advantage over intermittent diazepam.

Comparison of intravenous and nebulised salbutamol in initial treatment of severe asthma.

Abstract: 1 Aherne, G, Transactions of the Ophthalmological Societies of the UK, 1974, 94, 938. 2 Kitchin, F D, and Ellsworth, R M, Journal of Medical Genetics, 1974, 11, 244. 3 Chan, H, and Pratt, C B, J'ournal of the National Cancer Institute, 1977, 58, 205. 4 Gordon, H, Birth Defects Original Article Series, 1974, 10, No 10. 5 Doll, R, Muir, C, and Waterhouse, J, Cancer Incidence in Five Continents, vol 2. Berlin, Springer-Verlag, 1970.

Controlled trial of mobilisation and manipulation for patients with low back pain in general practice.

Abstract: Ninety-four patients with non-specific lumbar pain who were seen by their general practitioners took part in a double-blind controlled trial to compare mobilisation and manipulation with placebo physiotherapy. Immediately after treatment most patients showed improvements in the various features studied, but for several features improvement was more common in the treated group than the controls. At three months the condition of most patients was still improved but the differences between the two groups had largely disappeared. At one year the groups were identical. Prognostic presenting features were sought, but only a shorter history correlated with clinical improvement. This study indicates the high rate of spontaneous resolution of low back pain. A course of mobilisation and manipulation may hasten improvement but does not affect the long-term prognosis.

Beta-blockers and plasma triglycerides.

Abstract: strains of Bordetella pertussis.2 One of the liquidmedium vaccines (coded V15) was made at the Lister Institute; the other liquid-medium vaccine was coded V14 and the solid-medium vaccine V12. In this field trial the Lister vaccine, V15, performed consistently better than V14, V12 being intermediate in efficacy. In laboratory tests V 15 was significantly more potent than both V14 and V12. But having made this point I should not think of using it to suggest that any one method of manufacture is \"better\" than any other; another trial with different batches of vaccine would possibly give somewhat different results. (4) Telephone calls to these laboratories following the appearance of Dr Griffith's paper and your leading article indicate that the impression has been created among some that pertussis vaccines other than Wellcome's may be less potent or more toxic. Practitioners should be aware that all such vaccines made in Britain have to meet identical statutory specifications and that no batcb of vaccine containing an adsorbed pertussis component may be distributed until a sample has been submitted to the National Institute of Biological Standards and Control for examination before release. (5) On the question of toxicity, the Wellcome method of growing vaccine on medium containing charcoal may indeed absorb out \"bacterial toxins\" (p 811); but the association of these putative toxins with adverse reactions in children is, as I am sure Dr Griffith would agree, a very moot point. In this connection-and in any consideration of reactions to pertussis vaccine-it is important to be clear as to what is meant by \"toxicity.\" B pertussis can induce a remarkable range of responses in small animals; some of them appear to be associated with specific components of the organism, but none has as yet been unequivocally linked with reactions in children, which fall into two main groups: first, the sort of local inflammatory response, with or without transient fever and malaise, that can be caused by any bacterial vaccine, including the diphtheria and tetanus toxoids contained in the triple preparation; and second, the more serious reactions such as collapse, persistent screaming, convulsions, and encephalopathy. There is evidence3 that toxicity tests in animals are of some use in predicting the liability of a given batch of vaccine to induce reactions in the first category; but-for the moment begging the question of a cause-and-effect relationship between pertussis vaccine and central nervous system (CNS) reactions-there is at present simply no evidence that the reactions in the second category are determined by the strains of B pertussis used, method of manufacture, or performance in any laboratory test. The comparative rarity of these serious reactions bedevils any attempt to relate them to such variables in pertussis vaccine-if indeed such a relationship exists; in addition to the possibility, referred to by Dr Griffith, that some reactions may be purely coincidental, susceptibility to convulsions or other CNS complications could be determined by factors pertaining to a particular child rather than to a particular vaccine. Again, such reactions might not be specific to pertussis; were it customary to inject large numbers of infants with vaccines made from other Gram-negative organisms such as cholera or typhoid, might not similar accidents occur from time to time ?4

The National Exercise and Heart Disease Project

Abstract: The National Exercise and Heart Disease Project (NEHDP) was funded by the Rehabilitation Services Administration (RSA) of the Department of Health, Education and Welfare, to determine the effects of regular physical activity on the rehabilitation, morbidity and mortality of patients with healed myocardial infarctions. Planning and development lasted from June 1972 through September 1974. Since 1974, 932 subjects were referred for evaluation. At randomization, 651 subjects were assigned to exercise treatment (323) or control (328) groups. Those who qualified for randomization had to complete an initial evaluation, attend 14 of 18 consecutively scheduled, low-level physical activity sessions during a period of 6 weeks, and complete a second evaluation. This prerandomization phase was accompanied by significant alterations in work capacity, heart rate levels at rest and during three levels of physical stress, systolic blood pressure reductions during stress but not at rest, and by changes in the level of anxiety and depression. The subjects will be followed for a minimum of 2 years at regular intervals to determine if regularly performed physical activity is beneficial to the rehabilitation of myocardial infarction survivors.

Is There a Real Treatment for Stroke? Clinical and Statistical Comparison of Different Treatments in 300 Patients

Abstract: In the absence of universally accepted criteria for the medical treatment of stroke, we made a rigorously randomized comparative study of different treatments in 300 patients. One group of patients received only a general supportive treatment designed to ensure adequate supplies of water, electrolytes and calories, plus whatever was needed to prevent infection and correct extant associated pathology. Three other groups of patients were treated in the same way but were also given, respectively, one of the following medications: Hydergine (Sandoz) (a mixture of three ergot alkaloids), dexamethasone, and mannitol. No statistically significant difference emerged among any of the treatment groups and the reference group in terms of objective therapeutic results. The authors concluded that, at least with the dosage used in this study, none of the treatments proved more useful than conventional supportive therapy in the first 10 days after a stroke.