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.

Pharmacological Modulation of Cutaneous Reactivity to Histamine: A Double-Blind Acute Comparative Study between Cetirizine, Terfenadine and Astemizole

1989 ◽  
Vol 17 (1) ◽  
pp. 24-27 ◽  
Author(s):  
L. Ghys ◽  
J.-P. Rihoux
Keyword(s):  
Comparative Study ◽  
Healthy Volunteers ◽  
Inhibitory Effect ◽  
Blind Study ◽  
Double Blind Study ◽  
Single Administration ◽  
Double Blind ◽  
Pharmacological Modulation ◽  
The Difference ◽  
Cutaneous Reactivity

In a double-blind study performed in 81 healthy volunteers, 10 mg cetirizine and 60 mg terfenadine given orally in a single administration significantly inhibited skin reactivity to histamine. Astemizole (10 mg) was completely ineffective. The inhibitory effect of cetirizine was potent and regular whereas 6/28 (21%) volunteers did not respond to terfenadine. The difference observed beween cetirizine and terfenadine might be due to differences in the metabolism of the two drugs after administration: terfenadine is rapidly and extensively metabolized whereas cetirizine is directly active without the need for biotransformation and, indeed is poorly metabolized.

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.

Effectiveness and Tolerance of the Hypericum Extract LI 160 Compared to Maprotiline: A Multicenter Double-Blind Study

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 24-28 ◽  
Author(s):  
G. Harrer ◽  
W.-D. Hübner ◽  
H. Podzuweit
Keyword(s):  
Depression Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Mean Values ◽  
Mouth Dryness ◽  
Treatment Groups ◽  
Icd 10 ◽  
Hypericum Extract

A randomized, double-blind study examining the effectiveness and tolerance of a standardized hypericum preparation when compared to maprotiline was performed in a group of 102 patients with depression, in accordance with ICD-10, F 32.1. The study was conducted in the offices of neurology and psychiatry specialists. The patients received, over a period of 4 weeks, either 3 x 300 mg of the hypericum extract or 3 x 25 mg maprotiline pills of identical appearance. Effectiveness was determined using the Hamilton Depression Scale (HAMD), the Depression Scale according to von Zerssen (D-S), and the Clinical Global Impression Scale (CGI). The total score of the HAMD scale dropped during the 4 weeks of therapy in both treatment groups by about 50%. The mean values of the D-S scale and the CGI scale showed similar results, and after 4 weeks of therapy, no significant differences in either treatment group were noticed. The onset of the effects occurred up to the second week of treatment, but were observed earlier with maprotiline than with the hypericum extract. On the other hand, maprotiline treatment resulted in more cases of tiredness, mouth dryness, and heart complaints.

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.

Comparison of Diflorasone Diacetate and Betamethasone Dipropionate Ointment in the Treatment of Psoriasis

1982 ◽  
Vol 10 (1) ◽  
pp. 22-27 ◽  
Author(s):  
Eugene Leibsohn
Keyword(s):  
Betamethasone Dipropionate ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Clinical Evaluations ◽  
Lesion Severity

In this double-blind study, 100 patients with mild, moderate, or severe thick lesion psoriasis, characterized as acute, subacute, or chronic, were treated with either diflorasone diacetate ointment 0.05% or betamethasone dipropionate ointment 0.05% twice a day for 3 weeks. Clinical evaluations were based on overall improvement and improvement in signs or symptoms of erythema, oedema, lichenification, induration, scaliness, excoriations, pruritus, and soreness. Results showed that both medications were effective and when patients were categorized according to initial lesion severity, no statistically significant differences existed between treatment groups.

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]

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.

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.

Diphenylpyraline (Lergobine®) in the Treatment of Patients Suffering from Allergic and Vasomotor Rhinitis

1977 ◽  
Vol 5 (1) ◽  
pp. 37-41 ◽  
Author(s):  
Heikki Puhakka ◽  
Torsti Rantanen ◽  
Erkki Virolainen
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Vasomotor Rhinitis ◽  
Double Blind ◽  
The Difference

In a double-blind study, diphenylpyraline (Lergobine®) was given to 63 patients whose main symptoms were stuffiness of the nose, increased secretion of mucus, snuffling, sneezing and redness of the eyes. Fifty-seven patients were given placebo for identical symptoms. Diphenylpyraline was found to have a better effect on all the symptoms than placebo. The difference was statistically significant in respect of the discharge of mucus and redness of the eyes, and when the total symptoms were considered as a whole. In atopic patients the better effect of diphenylpyraline was highly significant.

Prevention and Therapy of Serous Otitis Media by Oral Decongestant: A Double-Blind Study in Pediatric Practice

PEDIATRICS ◽  
1978 ◽  
Vol 61 (5) ◽  
pp. 679-684 ◽  
Author(s):  
Ardis L. Olson ◽  
Suzanne W. Klein ◽  
Evan Charney ◽  
James B. MacWhinney ◽  
Thomas K. McInerny ◽  
...  
Keyword(s):  
Otitis Media ◽  
Clinical Evaluation ◽  
Acute Otitis Media ◽  
Blind Study ◽  
Double Blind Study ◽  
Pediatric Practice ◽  
Double Blind ◽  
Treatment Groups ◽  
Serous Otitis Media ◽  
Prevention And Therapy

We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no significant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM.

Sign in / Sign up

Export Citation Format

Share Document