Heparin and Infusion Phlebitis: A Prospective Study

1992 ◽  
Vol 26 (10) ◽  
pp. 1211-1214 ◽  
Author(s):  
Jose A. Nieto-Rodriguez ◽  
M.A. Garcìa-Martìn ◽  
M.D. Barreda-Hernandez ◽  
M.J. Hervàs ◽  
O. Cano-Real
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Venous Catheter ◽  
Final Concentration ◽  
Percent Confidence Interval ◽  
Heparin Group ◽  
Double Blind ◽  
Heparin Sodium ◽  
The Difference ◽  
Infusion Fluids

OBJECTIVE: To determine whether heparin sodium, when added to fluids infused through a peripheral catheter, reduces some local catheter-related problems (i.e., phlebitis, catheter obstruction, and extravasation of fluid) and extends the catheter's useful life. DESIGN: Prospective, double-blind, placebo-controlled. SETTING: Internal medicine ward of a general hospital with 400 beds. PATIENTS: Eighty-one consecutive acute collaborating patients who had a venous catheter in the forearm, inserted by nurses with more than one year of professional experience. INTERVENTION: Heparin sodium 1000 units/mL or NaCl 0.9% was added to compatible infusion fluids just before they were given to the patients. The final concentration of heparin was 1 unit/mL. MEASUREMENTS: Length of time until catheters were removed and reasons for their removal. RESULTS: The heparin group had a lower rate of local catheter-related problems than the placebo group (34.3 vs. 61.5 percent, respectively, p<0.05; 95 percent confidence interval for the difference 4.3 to 50.1 percent). The catheter's mean life in the heparin group was longer than that of the placebo group (98.9 ± 55.2 vs. 66.2 ± 47.2 h, respectively, p<0.05; 95 percent confidence interval for the difference 9.15 to 56.25 h). This effect was mainly attributable to prevention of noninflammatory catheter-related problems (e.g., obstruction, extravasation) and to a delay in the appearance of phlebitis. CONCLUSIONS: Heparin sodium, when added to infusion fluids to a final concentration of 1 unit/mL, diminishes local intravenous catheter-related problems and extends the catheter's life.

A Double-Blind Trial of Bradilan (Tetranicotinoylfructose) in Perniosis in General Practice

1974 ◽  
Vol 2 (1) ◽  
pp. 56-58 ◽  
Author(s):  
F de S Donnan
Keyword(s):  
General Practice ◽  
Placebo Group ◽  
Comparative Study ◽  
Effective Treatment ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
The Difference

An initial double-blind cross-over study and a subsequent double-blind comparative study against placebo tablets has shown Bradilan (tetranicotinoylfructose) to be an effective treatment of chilblains. The difference between the active and placebo group was highly significant statistically with p < ·001

Effect of KATP channel blocker glibenclamide on levcromakalim-induced headache

Cephalalgia ◽  
2020 ◽  
Vol 40 (10) ◽  
pp. 1045-1054 ◽  
Author(s):  
Mohammad Al-Mahdi Al-Karagholi ◽  
Hashmat Ghanizada ◽  
Lili Kokoti ◽  
Joachim S Paulsen ◽  
Jakob Møller Hansen ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Potassium Channel ◽  
Healthy Volunteers ◽  
Channel Blocker ◽  
Area Under The Curve ◽  
Mean Difference ◽  
Double Blind ◽  
Headache Intensity ◽  
Primary Endpoints ◽  
The Difference

Introduction Administration of ATP-sensitive potassium channel opener levcromakalim triggers headache in healthy volunteers and migraine attacks in migraine patients. Here, we investigated the effect of ATP-sensitive potassium channel blocker glibenclamide on levcromakalim-induced headache in healthy volunteers. Methods In a randomized, double-blind, placebo-controlled, three-way cross-over study, 15 healthy volunteers aged 18–40 years were randomly allocated to receive glibenclamide and levcromakalim (day 1), glibenclamide and placebo (day 2), and placebo and placebo (day 3) on three different days separated by at least 1 week. The primary endpoints were the difference in incidence of headache and the difference in area under the curve for headache intensity scores (0–12 hours) between the days. Results Fifteen healthy volunteers completed the 3 days of the study. More participants (12/15, 80%) developed headache on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day (5/15, 33%) ( p = 0.01; mean difference 47%; 95% confidence interval 18–75%) and compared to the placebo-placebo day (1/15, 7%) ( p = 0.001; mean difference 73%; 95% confidence interval 48–99%). We found no difference in headache incidence between glibenclamide-placebo day and placebo-placebo day ( p = 0.12; mean difference 27%; 95% confidence interval 1.3–52%). The area under the curve for headache intensity was significantly larger on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day ( p = 0.003); and compared to the placebo-placebo day ( p = 0.001). We found no difference in the area under the curve between the glibenclamide-placebo day compared to the placebo-placebo day ( p = 0.07). The median time to onset for headache after levcromakalim infusion with glibenclamide pretreatment was delayed (180 min) compared to levcromakalim without pretreatment (30 min) from a previously published study. Conclusion Glibenclamide administration did not cause headache, and glibenclamide pretreatment did not prevent levcromakalim-induced headache. However, glibenclamide delayed the onset of levcromakalim-induced headache. More selective blockers are needed to further elucidate the role of the ATP-sensitive potassium channel in headache initiation. Trial Registration: ClinicalTrials.gov NCT03886922.

Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 40 (7) ◽  
pp. 665-674
Author(s):  
Man Amanat ◽  
Mansoureh Togha ◽  
Elmira Agah ◽  
Mahtab Ramezani ◽  
Ali Reza Tavasoli ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Effects ◽  
Confidence Interval ◽  
Children And Adolescents ◽  
Sodium Valproate ◽  
Medical Center ◽  
Controlled Trial ◽  
Migraine Prophylaxis ◽  
Double Blind ◽  
Double Blind Placebo

Background Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents. Methods We carried out a randomized double-blind placebo-controlled trial in the Children’s Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents. Results A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: −8.0; 95% confidence interval (CI): −9.3 to −6.6), sodium valproate (difference: −8.3; 95% confidence interval: −9.3 to −7.2), and placebo (difference: −4.4; 95% confidence interval: −5.4 to −3.4) arms. The decrease was statistically greater in cinnarizine (difference: −3.6; 95% confidence interval: −5.5 to −1.6) and sodium valproate (difference: −3.9; 95% confidence interval: −5.8 to −1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: −4.6; 95% confidence interval: −5.2 to −4.0; sodium valproate: −4.0; 95% confidence interval: −4.8 to −3.3; placebo: −2.6; 95% confidence interval: −3.4 to −1.8). The decrease was statistically greater in cinnarizine (difference: −2.0; 95% confidence interval: −3.2 to −0.8) and sodium valproate (difference: −1.5; 95% confidence interval: −2.7 to −0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation. Conclusion Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Do androgens enhance the response to antithymocyte globulin in patients with aplastic anemia? A prospective randomized trial

Blood ◽  
1985 ◽  
Vol 66 (1) ◽  
pp. 184-188 ◽  
Author(s):  
RE Champlin ◽  
WG Ho ◽  
SA Feig ◽  
DJ Winston ◽  
C Lenarsky ◽  
...  
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Aplastic Anemia ◽  
Antithymocyte Globulin ◽  
Response Rates ◽  
Severe Aplastic Anemia ◽  
Actuarial Survival ◽  
The Difference ◽  
To Receive ◽  
Historical Controls

We analyzed the effect of antithymocyte globulin (ATG) with or without androgens in 121 patients with aplastic anemia. Fifty-three patients with moderate to severe aplastic anemia were prospectively randomized to receive ATG with or without oral androgens. Eleven of 26 patients (42%) receiving ATG plus androgen responded, including three complete and eight partial responses. Twelve of 27 patients (44%) receiving ATG plus placebo responded, including five complete and seven partial responses. The difference in response rates was not significant (P greater than .9). Survival was also comparable in the two groups; for patients with severe aplastic anemia, actuarial survival at two years was 55% +/- 24% (95% confidence interval) in patients receiving ATG plus androgen compared with 50% +/- 24% in the ATG plus placebo group (P = .65). Furthermore, results in both groups were indistinguishable from those obtained in 68 historical controls receiving ATG without androgens. These data indicate that androgens are not required in order to respond to antithymocyte globulin and the addition of androgens, as used in this trial, did not significantly improve response rates to ATG treatment.

scholarly journals Do androgens enhance the response to antithymocyte globulin in patients with aplastic anemia? A prospective randomized trial

Blood ◽  
1985 ◽  
Vol 66 (1) ◽  
pp. 184-188 ◽  
Author(s):  
RE Champlin ◽  
WG Ho ◽  
SA Feig ◽  
DJ Winston ◽  
C Lenarsky ◽  
...  
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Aplastic Anemia ◽  
Antithymocyte Globulin ◽  
Response Rates ◽  
Severe Aplastic Anemia ◽  
Actuarial Survival ◽  
The Difference ◽  
To Receive ◽  
Historical Controls

Abstract We analyzed the effect of antithymocyte globulin (ATG) with or without androgens in 121 patients with aplastic anemia. Fifty-three patients with moderate to severe aplastic anemia were prospectively randomized to receive ATG with or without oral androgens. Eleven of 26 patients (42%) receiving ATG plus androgen responded, including three complete and eight partial responses. Twelve of 27 patients (44%) receiving ATG plus placebo responded, including five complete and seven partial responses. The difference in response rates was not significant (P greater than .9). Survival was also comparable in the two groups; for patients with severe aplastic anemia, actuarial survival at two years was 55% +/- 24% (95% confidence interval) in patients receiving ATG plus androgen compared with 50% +/- 24% in the ATG plus placebo group (P = .65). Furthermore, results in both groups were indistinguishable from those obtained in 68 historical controls receiving ATG without androgens. These data indicate that androgens are not required in order to respond to antithymocyte globulin and the addition of androgens, as used in this trial, did not significantly improve response rates to ATG treatment.

scholarly journals A prospective randomised controlled study of the use of ranitidine in patients with gastric cancer

Gut ◽  
1998 ◽  
Vol 42 (1) ◽  
pp. 17-19 ◽  
Author(s):  
J N Primrose ◽  
G V Miller ◽  
S R Preston ◽  
J Gokhale ◽  
N S Ambrose ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Placebo Group ◽  
Median Survival ◽  
Palliative Resection ◽  
Controlled Study ◽  
Double Blind ◽  
Randomised Controlled Study ◽  
Tumour Group ◽  
The Difference ◽  
Randomised Controlled

Background—Does the use of the histamine H2 receptor antagonist ranitidine improve the outcome of patients with gastric cancer?Patients—A total of 222 patients with gastric cancer who had received radical or palliative resection or who were deemed inoperable at presentation.Setting—Hospitals within Yorkshire, the participating clinicians being members of the Yorkshire GI Tumour Group.Methods—A multicentre prospective randomised double blind trial comparing ranitidine 150 mg twice daily with placebo twice daily was undertaken. The principal outcome measures were survival and survival excluding those who died within 30 days of operation.Results—The median survival (95% confidence intervals) was 331 (232 to 393) days for patients in the ranitidine group compared with 187 (143 to 269) for those in the placebo group. The difference in survival was not statistically significant (p = 0.225). When patients who died within 30 days of operation were excluded (21 in the placebo group, 15 in the ranitidine group), the difference in survival remained not significant (p = 0.358). No subgroup could be identified who significantly benefited from treatment, but for patients with stage VIa cancer the median survival was 134 days with placebo compared with 313 days with ranitidine (p = 0.073).Conclusion—This study does not show significant benefit from the use of ranitidine for gastric cancer but further larger studies may be indicated.

scholarly journals Efficacy and safety of oral tolvaptan in patients undergoing hemodialysis: a Phase 2, double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hiroaki Ogata ◽  
Naoko Shimofurutani ◽  
Tadashi Okada ◽  
Hisashi Nagamoto ◽  
Tadao Akizawa
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Urine Volume ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Fluid Removal ◽  
Interdialytic Weight Gain ◽  
The Mean ◽  
Total Fluid

Abstract Background Loop diuretics are used to manage fluid retention in patients with end-stage kidney disease undergoing hemodialysis (HD). This randomized, double-blind, placebo-controlled, Phase 2 trial evaluated the efficacy and safety of tolvaptan, a vasopressin V2 receptor antagonist, in Japanese HD patients. Methods A total of 124 patients (24-h urine volume ≥500 mL) on thrice-weekly HD were randomized to receive oral tolvaptan 15 mg/day (n = 40), tolvaptan 30 mg/day (n = 40) or placebo (n = 44) for 24 weeks. Efficacy endpoints were change from baseline in 24-h urine volume, total fluid removal by HD per week and interdialytic weight gain (IDWG). Safety was assessed via the incidence of treatment-emergent adverse events (TEAEs). Results At treatment end, the difference (95% confidence interval) from the placebo group in the mean change from baseline in 24-h urine volume was significant in the tolvaptan 15 mg {429.1 mL [95% confidence interval (CI) 231.0, 627.2]; P &lt; 0.0001} and 30 mg [371.6 mL (95% CI 144.1, 599.2); P = 0.0017] groups. The mean changes from baseline in total fluid removal by HD and IDWG were not significantly different in the tolvaptan groups versus the placebo group. Although the proportion of patients with TEAEs was lower in the placebo group (77.3%) than in the tolvaptan groups (92.3%), tolvaptan was safe and well-tolerated during the study period. Conclusions Tolvaptan significantly sustained diuretic action for 24 weeks in HD patients but did not reduce total fluid removal by HD per week and IDWG to the same extent.

d-Cycloserine Addition to Exposure Sessions in the Treatment of Patients With Obsessive-Compulsive Disorder

2016 ◽  
Vol 40 ◽  
pp. 38-44 ◽  
Author(s):  
A.S. de Leeuw ◽  
H.J.G.M. van Megen ◽  
R.S. Kahn ◽  
H.G.M. Westenberg
Keyword(s):  
Placebo Group ◽  
Obsessive Compulsive Disorder ◽  
Exposure Therapy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
The Difference ◽  
Exposure Sessions

AbstractBackgroundPreliminary studies have shown that the addition of the partial NMDA-agonist d-cycloserine (DCS) might be promising in enhancing the results of exposure therapy in obsessive-compulsive disorder (OCD). We examined the effect of DCS addition to exposure therapy in a somewhat larger sample of OCD patients with special attention to subgroups, because of the heterogeneity of OCD.MethodsA randomized, double-blind, placebo controlled trial was conducted in 39 patients with OCD. Patients received 6 guided exposure sessions, once a week. One hour before each session 125 mg DCS or placebo was administered.ResultsScores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) declined more in the DCS group than in the placebo group, but the difference did not reach statistical significance (P = 0.076, partial η2 = 0.13). Response percentages also did not differ between the DCS and the placebo group (37% and 15% respectively). In the ‘cleaning/contamination’ subgroup a significant effect was found in favour of DCS (P = 0.033, partial η2 = 0.297).ConclusionsThe results of this study did not support the application of DCS to exposure therapy in OCD. Some specific aspects need further investigation: efficacy of DCS in a larger ‘cleaning/contamination’ (sub-)group, DCS addition only after successful sessions, interaction with antidepressants.

Efficacy and Safety of BMY 21,502 in Alzheimer Disease

1996 ◽  
Vol 30 (12) ◽  
pp. 1376-1380 ◽  
Author(s):  
Rajesh C Shrotriya ◽  
Neal R Cutler ◽  
John J Sramek ◽  
Amy E Veroff ◽  
Denise Y Hironaka
Keyword(s):  
Placebo Group ◽  
Alzheimer Disease ◽  
Disease Assessment ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Nootropic Agent ◽  
Moderate Dementia ◽  
Study Population ◽  
The Difference ◽  
State Examination

OBJECTIVE: To assess the efficacy and safety of BMY 21,502, a nootropic agent, in patients with mild-to-moderate Alzheimer disease. DESIGN AND PARTICIPANTS: Sixty-nine patients with Alzheimer disease (28 men, 41 women, mean age 72 y, range 54–92, mean Mini-Mental State Examination [MMSE] score 23.5) were randomized to receive either BMY 21,502 (n = 34) or placebo (n = 35) for 12 weeks of double-blind treatment followed by a 4-week placebo washout period. SETTING: Outpatient research facility. MEASUREMENTS: Primary efficacy assessments were the Alzheimer's Disease Assessment Scale (ADAS) and the Clinical Global Impressions Scale. The Computerized Neurological Test Battery and MMSE were performed as secondary efficacy measurements. RESULTS: Although overall effects were not statistically significant (p > 0.05), patients taking BMY 21,502 showed a mean change in the ADAS cognitive score of −1.5 points at week 12, compared with −0.5 in patients who received placebo. Patients with moderate dementia (MMSE ≤20) showed a greater change at week 12 with BMY 21,502 (−2.7 points) compared with placebo (+0.3 points), but the difference was not statistically significant. Although BMY 21,502 was well tolerated in general, patients treated with BMY 21,502 experienced higher rates of abnormal liver enzyme concentrations and nausea than did those in the placebo group. There was also a higher rate of discontinuations in the BMY 21,502 group, with 12 of 34 (35%) patients in the BMY 21,502 group discontinuing, compared with 3 of 35 (9%) in the placebo group (p < 0.05). CONCLUSIONS: In this pilot study, BMY 21,502 was not found to be significantly superior to placebo during the treatment period. The compound was generally well tolerated, although 8 of 34 (24%) patients discontinued active drug treatment. Further evaluation of BMY 21,502 in a larger study population may be warranted.

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