Showing papers on "Randomized controlled trial published in 1969"
Journal Article•
558 citations
TL;DR: There was a significant reduction in the area of retina involved by hard exudation in the treated group and the improvement in retinal exudates was not associated with any significant improvement in visual acuity.
Abstract: A double blind controlled trial has been made of clofibrate in the treatment of diabetic retinopathy. Fifty-six patients completed one year in the trial and form the basis for this paper. At the end of one year there was a significant reduction in the area of retina involved by hard exudation in the treated group. There were no significant effects on other retinal lesions. The improvement in retinal exudates was not associated with any significant improvement in visual acuity.
89 citations
Journal Article•
TL;DR: A double-blind controlled trial of the effect of large doses of methylprednisolone showed no significant differences between treated and placebo groups either at discharge from the hospital or 1 to 4 years later.
Abstract: Adrenal cortical steroids have been advocated as adjuncts to the treatment of severe bacterial infection, including meningitis. A double-blind controlled trial of the effect of large doses of methylprednisolone showed no significant differences between treated and placebo groups either at discharge from the hospital or 1 to 4 years later. There was a surprisingly large number (31%) of survivors who showed sequelae-mostly subtle perceptual motor problems.Methylprednisolone does not offer benefit to the usual patient with bacterial meningitis.
75 citations
TL;DR: There was no significant difference in the incidence of diarrhœa one year after operation, but a higher proportion of negative insulin tests was found in patients treated by the selective operation.
53 citations
TL;DR: An assessment of the prevalence of urinary tract infection in the general population is an important step towards determining their importance in this context.
Abstract: Infections of the urinary tract are among the most frequent of all infections, especially in women (Kass, 1956). Most studies of the prevalence of symptoms referable to the urinary tract have been based on patients consulting their practitioners. However, such symptoms do not always lead to a woman attending a doctor. There do not appear to be any published estimates of the prevalence of urinary tract symptoms in representative samples of the general population in this country. Urinary tract infections are of importance in themselves as a troublesome cause of discomfort and sometimes of ill-health. They may also progress to chronic pyelonephritis and hence be aetiologically related to the morbidity and mortality of chronic renal failure and hypertension. At present there is considerable controversy as to how often acute urinary tract infections do lead to renal damage and how often renal failure is an end result of acute urinary tract infections. An assessment of the prevalence of urinary tract infection in the general population is an important step towards determining their importance in this context.
35 citations
TL;DR: It is generally agreed today that the advent of the controlled clinical trial has been one of the most notable advances in modern medical practice.
Abstract: IT is generally agreed today that the advent of the controlled clinical trial has been one of the most notable advances in modern medical practice. The type of trial that has evolved over the past 25 years is recognized as an essential part of the clinical evaluation of remedies.1 There is increasing interest in evaluating the effects of surgical operations, as well as drugs, by the method of a controlled trial. It has become apparent that the only way to separate the effects of most types of therapy from those of patient selection is by a study in which patients . . .
20 citations
TL;DR: The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible and positive impact in promoting the calorie intake and some subscales of anorexia.
Abstract: Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.
15 citations
TL;DR: If indomethacin is as effective as phenylbutazone in rheumatic disorders, the safety factor clearly represents an important advantage and a trial to compare the two preparations with each other and with a placebo has been conducted.
Abstract: The introduction of new therapeutic agents if often followed by a period of initial enthusiasm, succeeded by one of caution, and then after clinical trial and experience, drugs find their rightful place in medical treatment. Since its introduction in 1962, indomethacin has acquired an established place in the treatment of acute gout (Emmerson, 1967). It also seems to be effective in ankylosing spondylitis (Hart and Boardman, 1965) and a controlled short-term trial showed benefit in osteoarthrosis of the hip (Wanka and Dixon, 1964). In rheumatoid arthritis reports have varied from enthusiastic (Kelly, 1964) to \"no advantage over aspirin\" (Pinals and Frank, 1967) and \"no advantage over placebo\" (Co-operating Clinics, 1967). There is other evidence that it is comparable to phenylbutazone (Hart and Boardman, 1965). The toxic effects of the latter preparation are well known and several fatal reactions have been encountered, but although side-effects are quite common with indomethacin, it is in general a safe drug. If, therefore, indomethacin is as effective as phenylbutazone in rheumatic disorders, the safety factor clearly represents an important advantage. To resolve the conflicting views, a trial to compare the two preparations with each other and with a placebo has been conducted, carefully designed to overcome the difficulties inherent in such an investigation.
14 citations
TL;DR: It is concluded that physicians' judgments of efficacy and side effects are valid to the extent of permitting the demonstration of differences between hypnotic drugs and the placebo, under the conditions of a randomized, double-blind trial.
Abstract: A controlled trial comparing three hynotic drugs— chloral betaine, 750 mg; diphenhydramine hydrochloride, 50 mg; pentobarbital, 100 mg—and a placebo was introduced into a comprehensive drug surveillance program. The standard methods of data collection employed in the program were applied to the trial. These methods employ judgments made by the attending physicians on the efficacy and side effects of drugs. The greater efficacy of hypnotics was evident in the data. There was also some evidence of a higher frequency of side effects among patients who received hypnotic drugs. The efficacy of the placebo was greater among women than among men while the hypnotic drugs were equally effective among both sexes. It is concluded that physicians' judgments of efficacy and side effects are valid to the extent of permitting the demonstration of differences between hypnotic drugs and the placebo, under the conditions of a randomized, double-blind trial.
12 citations
TL;DR: Animal studies indicate the prevention and remission of experimental atheroma in rats and dogs and in rabbits under controlled conditions as well as successful veterinary use and it was felt that a controlled trial in human cerebral athersoma would be of benefit.
Abstract: From Powick Hospital, Worcester, England. &dquo;Strokes&dquo; due to cerebrovascular disease account for nearly one-fifth of all present deaths, compared with 9 per cent of all deaths in 1935,~ and the mortality and morbidity continue to rise. The etiology of atheroma is in dispute, but it has been suggested that ischemia of the middle zone of the arterial walls caused by intimal thickening leads to loss of oxidative enzymes, with consequent accumulation of cholesterol and other fats in the inner zone of the arterial ~=a11.2 Abnormally low values of various enzymes, principally dehydrogenases, have been found in atheromatous artery walls,3 whereas the activity of aldolase is apparently decreased in sclerotic parts of the aortic wall and increased in normal parts of the same aorta.4 Diminution of adenosine triphosphatase activity is said to precede the development of any observable anatomic change.5 There have therefore been several attempts to treat atheroma with various enzymes including j3glueuronidase,&dquo; cytochrome c7 and hepatic catalases as well as with such substances as nicotinic acid,9 metal ionsl° and estrogens, which may well act enzymatically.ll The subject is well reviewed by Kask.11 The enzyme preparation used here has been reported to be successful in atheroma by many authors, some listed here.~2-2o Although these trials were uncontrolled, large numbers (e.g., Forster21 had 2187) of patients were used and often objective criteria of improvement, e.g., skin reddening time, 22 the elasticity coefficient of vascular walls23 and pulse wave velocity.l2 Cerebral atheroma patients may do particularly well.19, 24, 25 Animal studies indicate the prevention and remission of experimental atheroma in rats and dogs26 and in rabbits27 under controlled conditions as well as successful veterinary use28 and we felt that a controlled trial in human cerebral atheroma would be of
12 citations
01 Nov 1969
TL;DR: The controlled clinical triad is designed not to discover new drug effects, but to verify those effects, about which prior knowledge exists adequate for formulating exact null hypotheses, which always meet this requirement.
Abstract: The controlled clinical triad is designed not to discover new drug effects, but to verify those effects, about which prior knowledge exists adequate for formulating exact null hypotheses. Therapeutic effects always meet this requirement. The question of a drug's clinical toxicity is essentially vague and open-ended and, therefore, ineligible for being fully answered by controlled trial. It can examine only those adverse drug effects which are predicted or anticipated, which occur with a certain frequency compatible with a practical trial size, and which do not pose ethical restrictions to human experimentation. Most toxic drug effects must be assessed empirically, i. e., by incompletely controlled observation or survey of events as they happen during ordinary drug use. This does not mean arbitrary collection of isolated data, but requires purposeful, systematic and coordinated procedures. Observational evidence is circumstantial and disputable from a strictly scientific viewpoint. Nevertheless, if observational data satisfy certain criteria, they contribute to decisions which are reasonable and practically useful by minimizing the risks for patients from adverse drug effects.
Journal Article•
TL;DR: The meta-analysis results should be interpreted with caution due to limited effective data, but because of high cost-effectiveness, ischemia preconditioning could not be denied completely.
Abstract: Background: During the on-pump coronary artery bypass grafts surgery, ischemia/reperfusion injury would happen. Ischemia preconditioning could increase the tolerance against subsequent ischemia and reduce the ischemia/reperfusion injury. However the clinical outcomes of the available trials were different. Methods: We searched the Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 3, 2013), the Medline/PubMed and CNKI in March 2013. RevMan 5.1.6 and GRADEprofiler 3.6 were used for statistical analysis and evidence quality assessment. Heterogeneity was evaluated with significance set at P ≤ 0.10. Results: Eighteen randomized controlled trials were included. There were no differences on in-hospital mortality, postoperative myocardial infarction morbidity between ischemia preconditioning and control groups. The heterogeneity of creatine kinase-MB level 24 hours after surgery was obvious. The differences of 72 hours area under the curve of cardiac troponin T (mean differences of -14.50, 95% confidence interval of -21.71 to -7.28) and troponin I (mean differences -181.79, 95% confidence interval of -270.07 to -93.52) after surgery were observed. Conclusions: All the 18 trails, the positive and the negative results were equal. The meta-analysis results should be interpreted with caution due to limited effective data. Because of high cost-effectiveness, ischemia preconditioning could not be denied completely. Large-scale randomized studies are needed, with the operation procedures and included criteria being more specific.
31 Dec 1969
TL;DR: Positive evidence for the efficacy of Korean red ginseng on reducing blood pressure in patients with pre-hypertension and hypertension in acute and long-term is provided.
Abstract: BACKGROUND: Evidence of ginseng for reducing blood pressure (BP) in hypertensive patients is controversial. This systematic review updated the previous reviews and evidence for it. METHODS: Ten databases were searched from their inception through October 2016, without language restriction. Randomized clinical trials (RCTs) were included if any types of ginseng were tested as the sole treatment or as an adjunct to other treatments for pre-hypertension or hypertension. The risk of bias (ROB) was assessed with Cochrane ROB tools by two independent reviewers. RESULTS: We found 528 potentially relevant articles, of which 9 RCTs met our inclusion criteria. Two studies reported positive effects of Korean red ginseng (KRG) on acute reduction of systolic BP (SBP: n=54, mean differences (MD), -6.52; P=0.0002; I2=0%) and diastolic BP DBP: MD, -5.21; P=0.0001; I2=0%), while two other trials failed to do so with north American ginseng (NAG) in both SBP and DBP. Five RCTs assessed the long-term effects of ginseng (KRG or NAG) on SBP and DBP. Two studies showed positive effects of KRG on reducing SBP and DBP compared with placebo (SBP: n = 183, MD, -2.92, P=0.04; I2 = 0%; DBP: MD, -3.19, P=0.008; I2 = 0%). CONCLUSION: This systematic review provides positive evidence for the efficacy of KRG on reducing blood pressure in patients with pre-hypertension and hypertension in acute and long-term. Future RCTs appear to be warranted.
Journal Article•
TL;DR: Slow injection is important, since cardiac arrest can occur with rapid injection, and if given slowly only minimal quantities of acetylcholine are carried back to heart and lungs, and no bradycardia or bronchospasm of any severity occurs.
Abstract: I have given doses up to 400 mg. at a time (100 mg. in 1 ml.), but there appears to be no advantage in using more than 100 mg. at a time. I use this routinely now, mixed with some 6 ml. of 1% lignocaine. Injections may be given daily or less often. There is probably no advantage in giving more than one injection daily. Pain down the leg at the time of injection is considerable but not intolerable, and is lessened by giving the injection slowly. If given slowly only minimal quantities of acetylcholine are carried back to heart and lungs, and no bradycardia or bronchospasm of any severity occurs. Slow injection is important, since cardiac arrest can occur with rapid injection. It is, of course, vital to avoid injection of acetylcholine into the femoral vein, and to be certain that the artery has been entered it is advisable to use a syringe with a freely moving plunger so that the blood from the artery enters readily. A disposable syringe has a plunger which is too stiff in its movement to be forced outward by arterial pressure, and this type of syringe is unsuitable. I use a 21 S.W.G. 1 needle. It is presumed that acetylcholine is beneficial through improving the collateral circulation in the affected limb. This may be in part due to vasodilator effect, but in view of the apparent permanence of improvement it might be conjectured that some local or spinal vasoconstrictor reflexes, possibly arising in the diseased main vessel, are inhibited and removed and 'do not recur. No ill effects have been observed from this therapy, and it is hoped that others may see fit to give it a trial. It is, of course, a matter of common sense to 'vary the point at which the artery is punctured.-I am, etc.,