Double-blind evaluation of chemonucleolysis for herniated lumbar discs

1978 ◽  
Vol 49 (6) ◽  
pp. 816-827 ◽  
Author(s):  
Albert N. Martins ◽  
Archimedes Ramirez ◽  
James Johnston ◽  
P. Robert Schwetschenau
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conservative Management ◽  
Double Blind Study ◽  
Double Blind ◽  
Content Type ◽  
Treatment Groups ◽  
Small Clinical Trial ◽  
The Difference ◽  
Fine Print

✓ 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.

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 ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Water Soluble ◽  
Striking Difference ◽  
Double Blind Study ◽  
Double Blind ◽  
Content Type ◽  
Nonionic Contrast Medium ◽  
Double Blind Clinical Trial ◽  
Clinical Accuracy ◽  
Fine Print

✓ 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.

Antibiotic prophylaxis during prolonged clean neurosurgery

1990 ◽  
Vol 73 (3) ◽  
pp. 383-386 ◽  
Author(s):  
Michel Djindjian ◽  
Elisabeth Lepresle ◽  
Jean-Bernard Homs
Keyword(s):  
Antibiotic Prophylaxis ◽  
Final Analysis ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Content Type ◽  
The Difference ◽  
Fine Print

✓ 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.

No effect of enoxaparin on outcome of aneurysmal subarachnoid hemorrhage: a randomized, double-blind, placebo-controlled clinical trial

2003 ◽  
Vol 99 (6) ◽  
pp. 953-959 ◽  
Author(s):  
Jari Siironen ◽  
Seppo Juvela ◽  
Joona Varis ◽  
Matti Porras ◽  
Kristiina Poussa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Molecular Weight ◽  
Subarachnoid Hemorrhage ◽  
Low Molecular Weight Heparin ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Intracranial Bleeding ◽  
Low Molecular Weight ◽  
Double Blind ◽  
Content Type ◽  
Fine Print

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.

A Comparative Clinical Trial of Diflunisal and Ibuprofen in the Control of Pain in Osteoarthritis

1979 ◽  
Vol 7 (4) ◽  
pp. 272-276 ◽  
Author(s):  
J G M Keet
Keyword(s):  
Clinical Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Treatment Groups ◽  
Ambulatory Patients ◽  
Efficacy Parameters ◽  
Osteoarthritis Of Hip

A randomized double-blind study in ambulatory patients with osteoarthritis of hip and/or knee was conducted, comparing the efficacy and safety of diflunisal 500 mg daily with ibuprofen 1200 mg daily, over a period of 8 weeks. Thirty-five patients participated in the study. The results revealed no significant differences between the treatment groups with regard to the efficacy parameters.

scholarly journals Randomized, Double-Blind, Multicenter Safety and Efficacy Study of Rifalazil Compared with Azithromycin for Treatment of Uncomplicated Genital Chlamydia trachomatis Infection in Women

2014 ◽  
Vol 58 (7) ◽  
pp. 4014-4019 ◽  
Author(s):  
William M. Geisler ◽  
Maria Luz G. Pascual ◽  
Judy Mathew ◽  
William D. Koltun ◽  
Franklin Morgan ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Lower Limit ◽  
Double Blind Study ◽  
Cure Rate ◽  
Double Blind ◽  
Content Type ◽  
Chlamydia Trachomatis Infection ◽  
The Difference ◽  
Number Of Treatment ◽  
Treatment Emergent Adverse Event

ABSTRACTA randomized, double-blind study comparing single-dose chlamydia therapies of oral rifalazil (25 mg) and azithromycin (1 g) was conducted in 82 women with uncomplicated genitalChlamydia trachomatisinfection. The microbiologic cure rate ofC. trachomatiswith rifalazil (n= 33) was 84.8% at the visit on day 22 to 26 (test-of-cure visit), versus 92.1% with azithromycin (n= 38), and the number of treatment failures in each group was 5 and 3, respectively. The difference in cure rate was −7.3%, with a lower limit of the 95% confidence interval (95% CI) of −22.5, and thus, noninferiority was not established at the prespecified margin (lower limit of CI of −15%). The overall treatment-emergent adverse event (TEAE) and treatment-related TEAE rates were lower in the rifalazil group (68% and 55%) than in the azithromycin group (71% and 62%), respectively. Subjects classified as treatment failures at day 22 to 26 had a lower mean plasma concentration of rifalazil at the visit on day 8 to 12 than those classified as treatment cures, but this difference was not significant; however, the levels were similar for both groups at the visit on day 22 to 26. A single 25-mg dose of rifalazil was well tolerated and eradicatedC. trachomatisin most of these women with uncomplicated genitalC. trachomatisinfection. (The study was registered at clinicaltrials.gov under registration no. NCT01631201).

The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo

1982 ◽  
Vol 12 (4) ◽  
pp. 741-751 ◽  
Author(s):  
Joan Thomson ◽  
H. Rankin ◽  
G. W. Ashcroft ◽  
Celia M. Yates ◽  
Judith K. McQueen ◽  
...  
Keyword(s):  
Depression Scale ◽  
Double Blind Study ◽  
Global Rating ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Plasma Tryptophan ◽  
Treatment Of Depression ◽  
Biochemical Profiles ◽  
The Difference

SynopsisOne hundred and fifteen patients from 5 general practices participated in a 12-week, double-blind study comparing L-tryptophan, amitriptyline, L-tryptophan–amitriptyline combination and placebo in the treatment of depression. Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo. Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups. Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active tratment groups, but this difference was not significant. Plasma amitriptyline and nortriptyline levels were similar in the difference was not significant. Plasma amitriptyline and nortriptyline and biochemical profiles did not alter significantly in any group, but mean heart rate was significantly increased in patients receiving amitriptyline. There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms.

Evaluation of daily breakthrough chemotherapy-induced nausea and vomiting (CINV) rates in a phase III study of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 120-120 ◽  
Author(s):  
Eric Roeland ◽  
Gary Binder ◽  
Joseph Ma ◽  
Corinna Lanzarotti ◽  
Li Zhang
Keyword(s):  
Statistical Significance ◽  
Secondary Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Double Blind Study ◽  
Close Monitoring ◽  
Double Blind ◽  
Treatment Groups ◽  
The Difference ◽  
Delayed Phase

120 Background: Antiemetic trials typically evaluate CINV control during acute (Day 1), delayed (Days 2-5), and overall (Days 1-5) phases post-chemotherapy; the daily course of events is often unstudied in the delayed phase. In a head-to-head study evaluating NK1RA-containing regimens, a single dose of NEPA, an oral fixed combination of the NK1RA netupitant and 5-HT3RA palonosetron, was non-inferior to a 3-day regimen of APR and GRAN for overall complete response (no emesis/no rescue use) rates (74% NEPA vs 72% APR/GRAN) in 828 patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). This secondary analysis explores daily rates of breakthrough CINV in this study. Methods: This was a double-blind study in chemotherapy-naïve patients with solid tumors. Daily rates of breakthrough CINV, defined as the % of patients with emesis and/or rescue use were calculated with differences between treatment groups evaluated by the Cochran-Mantel-Haenszel method stratified by sex. Results: While daily rates of patients with breakthrough CINV remained stable between 13%-15.1% for APR/GRAN, they declined from 15.5% to 8% over the 5 days for NEPA, with the difference between groups reaching statistical significance on Day 5 (Table). Percent of total patient days with CINV events were 11.7% [NEPA] and 14.0% [APR/GRAN]. The % of patients with ≥ 3 days of breakthrough CINV were 8.5% and 12.3%, respectively. Conclusions: In this study evaluating guideline-recommended antiemetic regimens for HEC, CINV was prevented in most patients during the overall phase yet breakthrough CINV on individual days differed between treatment groups. APR/GRAN showed a relatively constant rate over time, while NEPA rates decreased and patients had fewer total days with breakthrough. This suggests the need for close monitoring of CINV events during the delayed phase. [Table: see text]

Salsalate in the Treatment of Rheumatoid Árthritis: A Double-Blind Clinical and Gastroscopic Trial versus Piroxicam. I – Clinical Trial

1989 ◽  
Vol 17 (4) ◽  
pp. 316-319 ◽  
Author(s):  
F. Montrone ◽  
I. Caruso ◽  
M. Cazzola ◽  
G. Bianchi Porro
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Treatment Period ◽  
Controlled Study ◽  
Evening Meal ◽  
Double Blind ◽  
Treatment Groups ◽  
End Of Treatment ◽  
The Difference ◽  
Equal Efficacy

A double-blind, double-dummy controlled study to compare the clinical efficacy and gastric tolerability of salsalate and piroxicam in the treatment of rheumatoid arthritis was performed. Twenty-three patients were treated with 1.5 g salsalate twice daily and 20 with 20 mg piroxicam (taken after the evening meal) for a period of 4 weeks. Patients were submitted to gastroscopy at the start and end of treatment; only patients who presented a normal baseline gastroscopy were admitted to the trial. At the end of the planned treatment period, a statistically significant improvement of all clinical variables was observed in both treatment groups, the difference between the two drugs not being statistically significant. Seven (37%) patients treated with salsalate complained of tinnitus. The results show that salsalate and piroxicam have equal efficacy in relieving the symptoms of arthritis.

Failure of the competitive N-methyl-d-aspartate antagonist Selfotel (CGS 19755) in the treatment of severe head injury: results of two Phase III clinical trials

1999 ◽  
Vol 91 (5) ◽  
pp. 737-743 ◽  
Author(s):  
Gabrielle F. Morris ◽  
Ross Bullock ◽  
Sharon Bowers Marshall ◽  
Anthony Marmarou ◽  
Andrew Maas ◽  
...  
Keyword(s):  
Head Injury ◽  
Demographic Data ◽  
Phase Iii ◽  
Double Blind ◽  
Content Type ◽  
Treatment Groups ◽  
Severity Of Injury ◽  
Significant Difference ◽  
Cgs 19755 ◽  
Fine Print

Object. Excessive activity of excitatory amino acids released after head trauma has been demonstrated to contribute to progressive injury in animal models and human studies. Several pharmacological agents that act as antagonists to the glutamate receptor have shown promise in limiting this progression. The efficacy of the N-methyl-d-aspartate receptor antagonist Selfotel (CGS 19755) was evaluated in two parallel studies of severely head injured patients, defined as patients with postresuscitation Glasgow Coma Scale scores of 4 to 8.Methods. A total of 693 patients were prospectively enrolled in two multicenter double-blind studies. Comparison between the treatment groups showed no significant difference with regard to demographic data, previous incidence of hypotension, and severity of injury. As the study progressed, the Safety and Monitoring Committee became concerned about possible increased deaths and serious brain-related adverse events in the treatment arm of the two head injury trials, as well as deaths in the two stroke trials being monitored concurrently. The Selfotel trials were stopped prematurely because of this concern and because an interim efficacy analysis indicated that the likelihood of demonstrating success with the agent if the studies had been completed was almost nil.Conclusions. Subsequently, more complete data analysis revealed no statistically significant difference in mortality rates in all cases between the two treatment groups in the head injury trials. In this report the authors examine the studies in detail and discuss the potential application of the data to future trial designs.

scholarly journals Ertapenem Once a Day Versus Piperacillin–Tazobactam Every 6 Hours for Treatment of Acute Pelvic Infections: A Prospective, Multicenter, Randomized, Double-Blind Study

2003 ◽  
Vol 11 (1) ◽  
pp. 27-37 ◽  
Author(s):  
Subir Roy ◽  
Iliana Higareda ◽  
Edith Angel-Muller ◽  
Mahmoud Ismail ◽  
Caren Hague ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Primary Efficacy ◽  
Pelvic Infection ◽  
Double Blind ◽  
Treatment Groups ◽  
Duration Of Therapy ◽  
The Difference ◽  
Cure Rates ◽  
Post Therapy

Objective:To compare ertapenem therapy with piperacillin–tazobactam therapy for the management of acute pelvic infections.Methods:In a multicenter, double-blind study, 412 women with acute pelvic infection were assigned to one of two strata, namely obstetric/postpartum infection or gynecologic/postoperative infection, and were then randomized to ertapenem, 1 g once a day, or piperacillin–tazobactam, 3.375 g every 6 hours, both administered intravenously.Results:In total, 163 patients in the ertapenem group and 153 patients in the piperacillin–tazobactam group were clinically evaluable. The median duration of therapy was 4.0 days in both treatment groups. The most common single pathogen wasEscherichia coli. At the primary efficacy endpoint 2–4 weeks post therapy, 93.9% of patients who received ertapenem and 91.5% of those who received piperacillin–tazobactam were cured (95% confidence interval for the difference, adjusting for strata, –4% to 8.8%), indicating that cure rates for both treatment groups were equivalent. Cure rates for both treatment groups were also similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both groups.Conclusions:In this study, ertapenem was as effective as piperacillin–tazobactam for the treatment of acute pelvic infection, was generally well tolerated, and had an overall safety profile similar to that of piperacillin–tazobactam.

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