A double-blind clinical trial of iopamidol versus metrizamide for lumbosacral myelography

1983 ◽  
Vol 58 (4) ◽  
pp. 531-537 ◽  
Author(s):  
Burton P. Drayer ◽  
Charles Vassallo ◽  
Abraham Sudilovsky ◽  
J. Scott Luther ◽  
Robert H. Wilkins ◽  
...  

✓ A double-blind study was performed to compare metrizamide with the new iodinated water-soluble nonionic contrast medium, iopamidol, for conventional and computerized tomography lumbosacral myelography. Both contrast agents were used in 30 patients, and were equivalent in terms of image quality and clinical accuracy. Headaches and nausea were less severe using iopamidol. The most striking difference was found in adverse neurobehavioral reactions and associated electroencephalographic abnormalities, which were noted in 17% of the metrizamide group but were not seen with the use of iopamidol. Iopamidol appears to be superior to metrizamide for intrathecal applications. An explanation of the differential neurotoxicity is provided.

1978 ◽  
Vol 49 (6) ◽  
pp. 816-827 ◽  
Author(s):  
Albert N. Martins ◽  
Archimedes Ramirez ◽  
James Johnston ◽  
P. Robert Schwetschenau

✓ Sixty-six patients with symptomatic herniated lumbar discs refractory to the usual conservative management were allocated at random into one of two treatment groups according to a double-blind protocol: 31 received chymopapain intradiscally (chemonucleolysis) and 35 received a placebo intradiscally. Symptoms remained significantly improved 1 year or more after injection for 55% of those treated with chymopapain and for 46% of those treated with placebo. The difference is not statistically significant. However, to discard chemonucleolysis on the basis of this one small clinical trial may be premature. Since continuing controversy has re-established a climate in which another double-blind study of chemonucleolysis is ethically feasible and scientifically desirable, we favor additional clinical trials under a tightly controlled protocol to help resolve the issue.


2003 ◽  
Vol 99 (6) ◽  
pp. 953-959 ◽  
Author(s):  
Jari Siironen ◽  
Seppo Juvela ◽  
Joona Varis ◽  
Matti Porras ◽  
Kristiina Poussa ◽  
...  

Object. From the moment an intracranial aneurysm ruptures, cerebral blood flow is impaired, and this impairment mainly determines the outcome in patients who survive after the initial bleeding. The exact mechanism of impairment is unknown, but activation of coagulation and fibrinolysis correlate with clinical condition and outcome after aneurysmal subarachnoid hemorrhage (SAH). The purpose of this study was to determine whether enoxaparin, a low-molecular-weight heparin, which is a well-known anticoagulating agent, has any effect on the outcome of aneurysmal SAH postoperatively. Methods. In this randomized, double-blind, single-center clinical trial, 170 patients (85 per group) with aneurysmal SAH were randomly assigned to receive either enoxaparin (40 mg subcutaneously once daily) or a placebo, starting within 24 hours after occlusion of the aneurysm and continuing for 10 days. Analysis was done on an intention-to-treat basis. Outcome was assessed at 3 months on both the Glasgow Outcome and modified Rankin Scales. Patients were eligible for the study if surgery was performed within 48 hours post-SAH, and no intracerebral hemorrhage was larger than 20 mm in diameter on the first postoperative computerized tomography scan. At 3 months, there were no significant differences in outcome by treatment group. Of the 170 patients, 11 (6%) died, and only 95 (56%) had a good outcome. Principal causes of unfavorable outcome were poor initial condition, delayed cerebral ischemia, and surgical complications. There were four patients with additional intracranial bleeding in the group receiving enoxaparin. The bleeding was not necessarily associated with the treatment itself, nor did it require treatment, and there were no such patients in the placebo group. Conclusions. Enoxaparin seemed to have no effect on the outcome of aneurysmal SAH in patients who had already received routine nimodipine and who had received triple-H therapy when needed. Routine use of low-molecular-weight heparin should be avoided during the early postoperative period in patients with SAH, because this agent seems to increase intracranial bleeding complications slightly, with no beneficial effect on neurological outcome.


2003 ◽  
Vol 17 (4) ◽  
pp. 314-318 ◽  
Author(s):  
Claudio Mendes Pannuti ◽  
Joyce Pereira de Mattos ◽  
Paula Nini Ranoya ◽  
Alberto Martins de Jesus ◽  
Roberto Fraga Moreira Lotufo ◽  
...  

The aim of this randomized, double-blind clinical trial was to evaluate the effect of the Paradontax dentifrice on the reduction of plaque and gingivitis. Subjects were randomly allocated into either the test group (n = 15, Paradontax) or the control group (n = 15, standard dentifrice with fluoride). Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index (PI), and gingivitis was evaluated with the Gingival Index (GI). Subjects were asked to brush their teeth with the allocated dentifrice, three times a day, for 21 days. There was no significant difference between groups in relation to the PI and GI medians, at baseline and at the end of the 21-day period. There was no significant reduction in PI in either the test or control groups. There was a significant decrease in GI in the test group. The authors concluded that there was no difference between the dentifrices in the reduction of plaque and gingivitis.


1990 ◽  
Vol 73 (3) ◽  
pp. 383-386 ◽  
Author(s):  
Michel Djindjian ◽  
Elisabeth Lepresle ◽  
Jean-Bernard Homs

✓ The efficacy of oxacillin as a prophylaxis for infection was analyzed in a 27-month randomized double-blind study of 400 patients who had undergone clean neurosurgical interventions lasting longer than 2 hours. Four neurosurgeons took part in the study and 356 patients were eligible for final analysis. Among the 171 patients treated with oxacillin, there was one case of infection (0.6%), compared to nine (4.9%) of the 185 patients given a placebo. The difference between the two groups was statistically significant (p = 0.0398). This study, together with others (randomized or not), clearly demonstrates the efficacy of antibiotic prophylaxis in prolonged clean neurosurgery.


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