scholarly journals Gastrointestinal Tolerance and Protein Absorption Markers with a New Peptide Enteral Formula Compared to a Standard Intact Protein Enteral Formula in Critically Ill Patients

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2362
Author(s):  
Ione de Brito-Ashurst ◽  
Marianne Klebach ◽  
Eleni Tsompanaki ◽  
Sundeep Kaul ◽  
Peter van Horssen ◽  
...  
Keyword(s):  
Tube Feeding ◽  
Intact Protein ◽  
Gastric Residual Volume ◽  
Double Blind ◽  
Urinary Markers ◽  
Protein Absorption ◽  
Gastrointestinal Tolerance ◽  
Enteral Formula ◽  
To Receive ◽  
Blind Manner

The aim of this exploratory study was to investigate gastrointestinal tolerance and protein absorption markers with a new enteral peptide formula (PF) compared to an isocaloric enteral intact protein standard formula (SF) containing the same amount of protein in ICU patients. Patients admitted to a cardio-thoracic intensive care unit expected to receive tube feeding for ≥5 days were randomized to receive either PF (1.5 kcal/mL) or SF in a double-blind manner for ≤14 days. Twenty-six patients were randomized (13 SF and 13 PF) and 23 (12 SF and 11 PF) completed at least 5 days of product administration. There were no statistically significant differences between the feeds during the first 5 days of intervention for diarrhea (SF:3 (23%); PF:5 (39%), p = 0.388), vomiting (SF:1 (8%); PF:2 (15%), p = 0.549), constipation (SF:7 (54%), PF:3 (23%), p = 0.115), and high gastric residual volume (>500 mL: SF:1 (8%); PF: 2 (15%), p = 0.535). There were no differences in plasma amino acids or urinary markers of protein absorption and metabolism. In conclusion, no major differences were found in tolerability and protein absorption markers between the standard intact protein formula and the peptide formula.

Effect of Creatine Supplementation and a Lacto-Ovo-Vegetarian Diet on Muscle Creatine Concentration

2002 ◽  
Vol 12 (3) ◽  
pp. 336-348 ◽  
Author(s):  
Judith M. Lukaszuk ◽  
Robert J. Robertson ◽  
Judith E. Arch ◽  
Geoffrey E. Moore ◽  
Kenneth M. Yaw ◽  
...  
Keyword(s):  
Creatine Supplementation ◽  
Vegetarian Diet ◽  
Creatine Monohydrate ◽  
Double Blind ◽  
Healthy Men ◽  
Total Creatine ◽  
Muscle Creatine ◽  
To Receive ◽  
Blind Manner ◽  
Omnivorous Diet

The purpose of this investigation was to examine the effects of preceding oral creatine monohydrate with a lacto-ovo-vegetarian diet on muscle creatine concentration. Thirty-two healthy men, who regularly consumed an omnivorous diet, were randomly assigned to consume a weight maintaining, lacto-ovo-vegetarian (LOV; n = 16) or omnivorous (Omni; n = 16) diet for 26 days. In addition to their assigned diet, on day 22 of the study, subjects were assigned in a double-blind manner to receive either creatine monohydrate (CM; 0.3 g · kg · d−1 + 20 g Polycose) or an equivalent dose of placebo (PL) for 5 days. There were no significant differences between the LOV and Omni groups at baseline with respect to age, height, and weight. The results demonstrated that consuming a LOV diet for 21 days was an effective procedure to decrease muscle creatine concentration (p < .01) in individuals who normally consume meat and fish in their diet. However, muscle total creatine (TCr) following creatine supplementation did not differ statistically between LOV and Omni diet groups (148.6 ± 4.5 vs. 141.7 ± 4.5 mmol · kg−1 d.m.).

Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.

1994 ◽  
Vol 12 (12) ◽  
pp. 2630-2633 ◽  
Author(s):  
R L Foote ◽  
C L Loprinzi ◽  
A R Frank ◽  
J R O'Fallon ◽  
S Gulavita ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Oral Cavity ◽  
Strong Evidence ◽  
Clinical Situation ◽  
Receive Radiation Therapy ◽  
Double Blind ◽  
Radiation Induced ◽  
Taste Alteration ◽  
To Receive ◽  
Blind Manner

PURPOSE To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis. PATIENTS AND METHODS Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity. RESULTS Twenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm. CONCLUSION In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.

Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis.

1997 ◽  
Vol 15 (3) ◽  
pp. 1239-1243 ◽  
Author(s):  
W L McGinnis ◽  
C L Loprinzi ◽  
S J Buskirk ◽  
J A Sloan ◽  
R G Drummond ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Oral Solution ◽  
Study Medication ◽  
Double Blind ◽  
Thoracic Radiation ◽  
Gastrointestinal Side Effects ◽  
Radiation Induced ◽  
To Receive ◽  
Blind Manner

PURPOSE To determine whether a sucralfate oral solution can prevent/alleviate radiation-induced esophagitis. PATIENTS AND METHODS Patients included on this clinical trial were beginning thoracic radiation therapy to the mediastinum. Following stratification, they were randomized, in a double-blind manner, to receive a sucralfate solution or an identical-appearing placebo solution. Esophagitis was measured by physicians who used standard criteria and also by patients who used short questionnaires completed weekly during the course of the trial. RESULTS A total of 97 assessable patients were entered onto this clinical trial. During the first 2 weeks of the study, two placebo patients (4%) stopped their study medication, compared with 20 sucralfate patients (40%). This was related to substantially increased incidences of gastrointestinal toxicity (58% of sucralfate patients v 14% of placebo patients; P > .0001). There was no substantial benefit from the sucralfate in terms of esophagitis scores. CONCLUSION This oral sucralfate solution does not appear to inhibit radiation-induced esophagitis and is associated with disagreeable gastrointestinal side effects in this patient population.

Acute and long-term effects of once-daily oral bromocriptine and a new long-acting non-ergot dopamine agonist, quinagolide, in the treatment of hyperprolactinemia: A double-blind study

1991 ◽  
Vol 125 (4) ◽  
pp. 385-391 ◽  
Author(s):  
J. A. Verhelst ◽  
A. L. Froud ◽  
R. Touzel ◽  
J. A. H. Wass ◽  
G. M. Besser ◽  
...  
Keyword(s):  
Dopamine Agonist ◽  
Adverse Reactions ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Once Daily ◽  
Long Acting ◽  
To Receive ◽  
Blind Manner

Abstract. Quinagolide (CV 205-502, Sandoz), an octahydrobenzo (g) quinoline, is a new non-ergot dopamine agonist which has specific D2 receptor activity and a long half-life, making it suitable for once-daily treatment. Recent uncontrolled reports have suggested that quinagolide may be successfully used for the clinical management of hyperprolactinemia with fewer adverse reactions than bromocriptine. This study is the first to compare quinagolide in a double-blind manner with bromocriptine, given only once-daily instead of the usual multidose regimen. In the first phase we compared, in 7 hyperprolactinemic patients, the effects over 24 h of a single oral dose of 0.05 mg quinagolide with 2.5 mg bromocriptine. Compared with placebo, both bromocriptine and quinagolide showed potent PRL-inhibiting and GH-releasing effects, with comparable effects at 24 h; no significant changes were observed in TSH, LH, FSH or cortisol. Twelve hyperprolactinemic patients were then randomized to receive either once-daily bromocriptine or quinagolide in incremental doses for a period of six months. Both drugs were found to be equally effective, and no differences were seen either in adverse reactions or PRL levels during repeated diurnal sampling. We therefore conclude that quinagolide and bromocriptine are therapeutically equivalent in long-term use, and both are equally effective when given once a day. However, some patients intolerant of bromocriptine may respond better to quinagolide, and vice versa.

scholarly journals A novel infusible botanically-derived drug, PG2, for cancer-related fatigue: A phase II double-blind, randomized placebo-controlled study

2012 ◽  
Vol 35 (1) ◽  
pp. 1 ◽  
Author(s):  
Hong-Wen Chen ◽  
I-Hsin Lin ◽  
Yu-Jen Chen ◽  
Kao-Hwa Chang ◽  
Meng-Hao Wu ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Treatment Cycle ◽  
Response Rate ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Open Label ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
To Receive ◽  
Blind Manner

Purpose: This study investigated the efficacy of the botanical-derived drug, PG2, a partially purified extract of Astragalus membranaceus, as a complementary and palliative medicine for managing cancer-related fatigue (CRF). Methods: Patients with advanced cancer and moderate to severe CRF were randomized to receive either PG2 or a placebo (normal saline, NS) in the first treatment cycle (four weeks) in a double-blind manner; thereafter, on the next cycle (four weeks), all patients received open-label treatment with PG2. Results: PG2 significantly improved CRF in the NS-primed group. In the first four week cycle, PG2 administration resulted in a greater fatigue-improvement response rate than seen with NS alone. In addition, approximately 82% of patients who reported an improvement of fatigue symptoms following the first cycle of PG2 experienced sustained benefits after administration of the second treatment cycle. Among patients treated with PG2 who did not report an improvement in symptoms throughout the first treatment cycle, approximately 71% showed significant improvement after the second treatment cycle. No major or irreversible toxicities were observed with PG2 treatment. Conclusion: PG2 might be an effective and safe treatment for relieving CRF among advanced cancer patients.

Prospective double-blind placebo-controlled randomized trial on the use of ranitidine in preventing postoperative gastroduodenal complications in high-risk neurosurgical patients

1995 ◽  
Vol 82 (3) ◽  
pp. 413-417 ◽  
Author(s):  
Kwan-Hon Chan ◽  
Edward C. S. Lai ◽  
Henry Tuen ◽  
John H. K. Ngan ◽  
Francis Mok ◽  
...  
Keyword(s):  
High Risk ◽  
Multivariate Logistic Regression Analysis ◽  
Multivariate Logistic Regression ◽  
Double Blind ◽  
Cerebral Disease ◽  
Content Type ◽  
Neurosurgical Patients ◽  
To Receive ◽  
Blind Manner ◽  
Fine Print

✓ To determine the efficacy of ranitidine in preventing clinically acute overt gastroduodenal (GD) complications (bleeding and/or perforation) after neurosurgery, 101 patients with nontraumatic cerebral disease considered at high risk of developing postoperative GD complications were randomized in a standard double-blind manner to receive either ranitidine (50 mg every 6 hours) or placebo medication preoperatively. Postoperative serial GD endoscopy was used to document the occurrence of complications: an overt symptomatic complication was defined as bleeding requiring blood transfusion and/or surgery. Fifty-two patients received ranitidine and 49 received a placebo preoperatively; 30 developed overt GD bleeding; nine of these received ranitidine and 21 received a placebo. Ranitidine significantly reduced the incidence of bleeding (p < 0.05). Multivariate logistic regression analysis revealed three factors of independent significance in predicting overt GD bleeding: use of a placebo drug, a gastric pH of less than 4, and a high daily volume of gastric output. The authors conclude that ranitidine is useful in preventing postoperative GD complications in high-risk neurosurgical patients.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

The Antiaggressive Action of Combined Haloperidol-Propranolol Treatment in Schizophrenia

2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  
Keyword(s):  
Rating Scales ◽  
Double Blind ◽  
Propranolol Group ◽  
Schizophrenic Patients ◽  
Propranolol Treatment ◽  
Simultaneous Decrease ◽  
The Mean ◽  
Haloperidol Treatment ◽  
To Receive ◽  
Drug Free

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

scholarly journals Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Laurent Papazian ◽  
◽  
Samir Jaber ◽  
Sami Hraiech ◽  
Karine Baumstarck ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Invasive Mechanical Ventilation ◽  
Double Blind ◽  
Intravenous Ganciclovir ◽  
Subdistribution Hazard ◽  
Mechanically Ventilated ◽  
Cytomegalovirus Reactivation ◽  
Secondary Outcomes ◽  
To Receive ◽  
Cmv Reactivation

Abstract Background The effect of cytomegalovirus (CMV) reactivation on the length of mechanical ventilation and mortality in immunocompetent ICU patients requiring invasive mechanical ventilation remains controversial. The main objective of this study was to determine whether preemptive intravenous ganciclovir increases the number of ventilator-free days in patients with CMV blood reactivation. Methods This double-blind, placebo-controlled, randomized clinical trial involved 19 ICUs in France. Seventy-six adults ≥ 18 years old who had been mechanically ventilated for at least 96 h, expected to remain on mechanical ventilation for ≥ 48 h, and exhibited reactivation of CMV in blood were enrolled between February 5th, 2014, and January 23rd, 2019. Participants were randomized to receive ganciclovir 5 mg/kg bid for 14 days (n = 39) or a matching placebo (n = 37). Results The primary endpoint was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included day 60 mortality. The trial was stopped for futility based on the results of an interim analysis by the DSMB. The subdistribution hazard ratio for being alive and weaned from mechanical ventilation at day 60 for patients receiving ganciclovir (N = 39) compared with control patients (N = 37) was 1.14 (95% CI from 0.63 to 2.06; P = 0.66). The median [IQR] numbers of ventilator-free days for ganciclovir-treated patients and controls were 10 [0–51] and 0 [0–43] days, respectively (P = 0.46). Mortality at day 60 was 41% in patients in the ganciclovir group and 43% in the placebo group (P = .845). Creatinine levels and blood cells counts did not differ significantly between the two groups. Conclusions In patients mechanically ventilated for ≥ 96 h with CMV reactivation in blood, preemptive ganciclovir did not improve the outcome.

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