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Results for “randomized crossover trial”

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PubMed2006

Does celecoxib potentiate the anticoagulant effect of warfarin? A randomized, double-blind, controlled trial.

BACKGROUND: The management of patients who are receiving warfarin therapy and have musculoskeletal problems that require treatment with a nonsteroidal antiinflammatory drug (NSAID) is problematic because NSAID use may increase the risk for bleeding. Cyclooxygenase-2 selective NSAIDs such as celecoxib may be less likely to promote gastrointestinal bleeding; however, there are concerns that they could potentiate the anticoagulation effect of warfarin. OBJECTIVE: To determine whether celecoxib potentiates the anticoagulant effect of warfarin, as measured by the international normalized ratio (INR). METHODS: We performed a randomized, controlled, crossover trial to assess the effect on INR of celecoxib versus codeine (control treatment) in 15 patients who were receiving warfarin therapy and required analgesic treatment for osteoarthritis. During Phase 1 of the study, patients were randomly allocated to receive celecoxib 200 mg/day or codeine phosphate 7-15 mg 3-4 times daily for 5 weeks. During Phase 2 of the study, patients stopped the first study medication and started the other study medication; there was no drug-free interval between phases. Weekly INR testing was performed during the 10 week study period. Adopting the intent-to-treat principle, we used generalized estimating equations to analyze the data. RESULTS: There was no significant difference in the mean INR values during each 5 week treatment period when patients received either celecoxib or codeine. There was, therefore, insufficient evidence to reject the hypothesis that these 2 treatments had an equal effect on the INR (mean difference [95% CI] 0.10 [-0.04 to 0.24]; p = 0.16) based on mean imputation. This finding was confirmed after we repeated the analysis with multiple imputations (mean difference [95% CI] 0.093 [-0.16 to 0.35]; p = 0.47). CONCLUSIONS: Our results suggest that treatment with celecoxib does not potentiate the INR when taken with warfarin. Larger randomized trials are warranted to address the effects of coadministered warfarin and celecoxib on clinical outcomes.

Aged↗

PubMed1990

Tacrine (tetrahydroaminoacridine; THA) and lecithin in senile dementia of the Alzheimer type: a multicentre trial. Groupe Français d'Etude de la Tetrahydroaminoacridine.

OBJECTIVE: To see whether combined treatment with oral tacrine (tetrahydroaminoacridine; THA) and lecithin improves the symptoms of patients with Alzheimer's disease. DESIGN: Multicentre double blind, placebo controlled, random order crossover trial with individual determination of maximum tolerated dosage and four month follow up. SETTING: Outpatient departments at six university neurological centres. PATIENTS: 67 Outpatients (24 men, 43 women) aged 53-81 (mean 66 (SD 7.3)) selected according to the following criteria: probable Alzheimer's disease as defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association; absence of mood disorder; mini mental state score lower than 26; availability of a close relative able to complete questionnaires; and informed consent of the patient or his or her closest relative, or both. INTERVENTIONS: Mean of 114 mg tacrine or placebo daily plus 1200 mg lecithin daily given in three divided doses for one four week active treatment period and one four week control period without washout at crossover. MAIN OUTCOME MEASURES: Cognitive state as assessed by Folstein's mini mental state rating scale, behavioural state as assessed by the Stockton geriatric rating scale, and overall state as assessed with a visual analogue scale rated by both the relative and the physician. RESULTS: Compared with placebo tacrine did not improve either the mini mental state score (mean 14.9 (SD 7.3) v 14.8 (7.3)) or the Stockton geriatric score (28.2 (15.7) v 28.7 (17.8)), but a slight and statistically significant improvement occurred in the physician's score on the visual analogue scale (6.3 (10.2) v 11.6 (17.9)). Seven patients dropped out. Six patients were excluded because of acute hepatitis and one withdrew for personal reasons not related to treatment. Two other patients developed acute hepatitis at the end of the eight week crossover trial and another during the follow up study. Twenty patients complained of gastrointestinal side effects. CONCLUSIONS: Neither short term nor long term treatment with oral tacrine at dosages lower than 125 mg/day improves the symptoms of Alzheimer's disease. Moreover, these dosages may induce hepatitis (nine of 67 patients in this series).

Aged↗

PubMed2006

Serum prostate-specific antigen but not testosterone levels decrease in a randomized soy intervention among men.

BACKGROUND: Low prostate cancer incidence and high soy intake in Asian countries suggest a possible protective effect of soy foods against prostate cancer. The goal of this pilot study was to evaluate the feasibility of a randomized, crossover soy trial among men and to investigate the effects of daily soy intake on serum prostate-specific antigen (PSA) and testosterone levels. METHODS: We randomized 24 men to a high or a low soy diet for 3 months. After a 1-month washout period, the men crossed over to the other treatment. During the high soy diet, the men consumed two daily soy servings; during the low soy diet, they maintained their usual diet. During the entire study each man donated four blood samples and five overnight urine samples. Dietary compliance was assessed by soy calendars, 24-h dietary recalls, and urinary isoflavone excretion measured by high-pressure liquid chromatography with photodiode array detection. Blood samples were analyzed for serum testosterone and PSA by radioimmunoassay. When necessary, variables were log transformed. Two sample t-tests compared the two groups before each study period. Mixed models incorporating the repeated measurements were used to evaluate the effect of the soy diet on urinary isoflavone excretion and serum analytes. RESULTS: Twenty-three men aged 58.7+/-7.2 years completed the study. The compliance with the study regimen was high according to self-reported soy food intake and urinary isoflavone excretion. No significant between-group and within-group differences were detected. During the high soy diet, dietary isoflavone intake and urinary isoflavone excretion increased significantly as compared to the low soy diet. A 14% decline in serum PSA levels (P=0.10), but no change in testosterone (P=0.70), was observed during the high soy diet in contrast to the low soy diet. CONCLUSION: The high adherence as shown by three measures of compliance in this pilot trial demonstrated the feasibility of an intervention based on soy foods among free-living men.

Biomarkers, Tumor↗

PubMed1982

Randomized double-blind placebo controlled crossover trial documenting oral lorcainide efficacy in suppression of symptomatic ventricular tachyarrhythmias.

Lorcainide, a new antiarrhythmic drug, was given to 10 patients with frequent (greater than 1/min) premature ventricular contractions (PVCs) on a baseline 24-hour Holter monitor. Each patient received lorcainide, 100 mg twice daily, and an identical placebo, in a randomized double-blind crossover trial, with 1 week in each treatment period. Before the trial and at the end of each period, routine laboratory, clinical evaluation, 12-lead ECG's, and 24-hour ambulatory ECG recordings were performed. Trough drug plasma concentration measurements were done at the end of each treatment period. All patients had reduction in PVCs, comparing drug to placebo, averaging 82.3 +/- 19.7% (mean +/- SD, p less than 0.01 by Wilcoxin ranked sum), and there was also significant decrease in the number of ventricular pairs and runs. Levels of the major metabolite, norlorcainide, ranged from 34 to 254 ng/ml (mean 160 ng/ml) and exceeded those for lorcainide, range 6 to 169 ng/ml (mean 79 ng/ml). Prolongation of PR, QRS, and QTc intervals was evident during drug therapy, as was decrease in heart rate, but these changes were minimal. The major adverse effect noted was sleep disturbance, which was often initially severe, but improved during the week of therapy.

Administration, Oral↗

PubMed2000

Effect of the alpha-glucosidase inhibitor acarbose on control of glycemia in dogs with naturally acquired diabetes mellitus.

OBJECTIVE: To evaluate effect of acarbose on control of glycemia in dogs with diabetes mellitus. DESIGN: Prospective randomized crossover controlled trial. ANIMALS: 5 dogs with naturally acquired diabetes mellitus. PROCEDURE: Dogs were treated with acarbose and placebo for 2 months each: in 1 of 2 randomly assigned treatment sequences. Dogs that weighed < or = 10 kg (22 lb; n = 3) or > 10 kg (2) were given 25 or 50 mg of acarbose, respectively, at each meal for 2 weeks, then 50 or 100 mg of acarbose, respectively, at each meal for 6 weeks, with a 1-month interval between treatments. Caloric intake, type of insulin, and frequency of insulin administration were kept constant, and insulin dosage was adjusted as needed to maintain control of glycemia. Serum glucose concentrations, blood glycosylated hemoglobin concentration, and serum fructosamine concentration were determined. RESULTS: Significant differences in mean body weight and daily insulin dosage among dogs treated with acarbose and placebo were not found. Mean preprandial serum glucose concentration, 8-hour mean serum glucose concentration, and blood glycosylated hemoglobin concentration were significantly lower in dogs treated with insulin and acarbose, compared with insulin and placebo. Semisoft to watery feces developed in 3 dogs treated with acarbose. CONCLUSIONS AND CLINICAL RELEVANCE: Acarbose may be useful as an adjunctive treatment in diabetic dogs in which cause for poor glycemic control cannot be identified, and insulin treatment alone is ineffective.

Acarbose↗

PubMed1998

Effect of dietary insoluble fiber on control of glycemia in dogs with naturally acquired diabetes mellitus.

OBJECTIVE: To evaluate the effect of a high insoluble-fiber (HF) diet containing 12% cellulose in dry matter and a low insoluble-fiber (LF) diet on control of glycemia in dogs with naturally acquired insulin-dependent diabetes mellitus. DESIGN: Prospective randomized crossover controlled trial. ANIMALS: 11 dogs with naturally acquired diabetes mellitus. PROCEDURE: Dogs were fed HF and LF diets for 8 months each in 1 of 2 randomly assigned diet sequences. Caloric intake and insulin treatment were adjusted as needed to maintain stable body weight and control of glycemia, respectively. After a 2-month adaptation period, control of glycemia was evaluated every 6 weeks for 6 months. Variables assessed included serum glucose concentration measured during the preprandial state, blood glycosylated hemoglobin concentration, serum glucose concentration measured every 2 hours for 24 hours beginning at the time of the morning insulin injection, 24-hour mean serum glucose concentration, mean serum glucose concentration fluctuation from the 24-hour mean serum glucose concentration, and 24-hour urinary excretion of glucose. RESULTS: Significant differences in mean daily caloric intake, body weight, or daily insulin dosage among dogs fed HF and LF diets were not found. Mean preprandial serum glucose concentration, most postprandial serum glucose concentrations, 24-hour mean serum glucose concentration, and 24-hour urinary excretion of glucose were significantly lower in dogs fed the HF diet, compared with the LF diet. CLINICAL IMPLICATIONS: Results of this study support feeding of commercially available insoluble fiber diets to dogs with naturally acquired diabetes mellitus.

Animals↗

PubMedDate not supplied

Evidence for a direct effect of alcohol consumption on blood pressure in normotensive men. A randomized controlled trial.

A direct pressor effect of alcohol is proposed as the basis for the association between regular alcohol consumption and an increase in blood pressure found in population studies. To examine this further, a randomized controlled crossover trial of the effects of varying alcohol intake on blood pressure in 46 healthy male drinkers was conducted. From an average of 336 ml of ethanol per week, alcohol consumption was reduced by 80% for 6 weeks by drinking a low alcohol content beer alone. This reduction was associated with a significant reduction in systolic and diastolic blood pressure (p less than 0.001 and p less than 0.05 respectively). The mean difference in supine systolic blood pressure during the last 2 weeks of normal or low alcohol intake was 3.8 mm Hg, which correlated significantly with change in alcohol consumption (r = 0.53, p less than 0.001). Reduction of alcohol intake also caused a significant decrease in weight (p less than 0.001). After adjustment for weight change, an independent effect of alcohol on systolic but not diastolic blood pressure was still evident, with a 3.1 mm Hg fall predicted for a decrease in consumption from 350 ml of ethanol equivalent per week to 70 ml per week (p less than 0.01). Systolic blood pressure rose again when normal drinking habits were resumed. These results provide clear evidence for a direct and reversible pressor effect of regular moderate alcohol consumption in normotensive men and suggest that alcohol may play a major role in the genesis of early stages of blood pressure elevation.

Adult↗

PubMed2006

Adequacy of automated peritoneal dialysis with and without manual daytime exchange: A randomized controlled trial.

Until now, it remains unclear whether the addition of manual daytime exchanges or increasing the nightly dialysate flow is the best strategy to optimize automated peritoneal dialysis (APD) treatment. In this open-label randomized controlled crossover trial, 18 patients with high-average (HA) or low-average (LA) peritoneal transport rates sequentially underwent two different APD regimens for 7 days each, with an intermittent washout period of 7 days. 'Manual exchange' treatment was a conventional APD with low nightly dialysate flow and one manual daytime exchange. 'High-flow' treatment was defined by cycler therapy with high dialysate flow but without manual daytime exchange. Creatinine clearances (8.56+/-1.22 vs 7.87+/-1.04 l/treatment, P = 0.011) and urea nitrogen clearances (12.83+/-1.98 vs 11.68+/-1.06 l/treatment, P = 0.014) were significantly increased during 'high-flow' treatment compared to 'manual exchange' treatment. Sodium removal was significantly lower and glucose absorption was higher with the 'high-flow' regimen. Phosphate clearances, beta2-microglobulin clearances, ultrafiltration, and peritoneal protein loss were not different between the two treatment modalities. Subgroup analysis dependent on peritoneal transport types showed that the effect on clearances was most marked and significant in HA transporters, whereas sodium removal was lowest in LA transporters. We conclude that small solute clearances can be significantly improved and middle molecule clearances maintained in APD patients by increasing the nightly dialysate flow instead of adding a manual daytime exchange. However, the possible benefit of better clearances with higher nightly treatment volumes has to be weighed against increased costs and the possible negative impact of impaired sodium removal, especially in LA transporters.

Adult↗

PubMed2002

A randomized, double-blind, placebo controlled crossover trial of nimodipine in older persons with detrusor instability and urge incontinence.

PURPOSE: We evaluated the efficacy of nimodipine, a dihydropyridine calcium channel blocker that relaxes vascular and nonvascular smooth muscle, for geriatric urge incontinence. MATERIALS AND METHODS: A randomized, double-blind, placebo controlled crossover trial of 30 mg. nimodipine twice daily for 3 weeks in older persons with detrusor instability and chronic urge incontinence was done. A total of 86 participants with a mean age of 73.4 years were randomized. The primary outcome was the number of incontinent episodes, as measured by the self completion of a 5-day voiding record. Secondary outcomes included the impact of urinary incontinence on quality of life measured with a modified incontinence impact questionnaire (mIIQ) and symptoms, as measured by the American Urological Association (AUA) symptom score. RESULTS: A total of 76 (88.4%) participants completed the study. There was no significant difference in the number of incontinent episodes with nimodipine versus placebo, which included a difference of 0.03 incontinent episodes during a 5-day period (p =0.98, 95% confidence interval -2.7 to 2.8). Scores on the mIIQ and the AUA symptom score were not significantly different with nimodipine versus placebo (p = 0.07 and 0.22, respectively). Regardless of initial treatment, participants had improvement with time, that is a period effect, of incontinent episodes (p <0.0001), mIIQ scores (p = 0.0002) and AUA symptom score values (p <0.0001). CONCLUSIONS: Treatment of geriatric urge incontinence with 30 mg. nimodipine twice daily did not result in a significant improvement of incontinent episodes, mIIQ scores or AUA symptom scores.

Aged↗

PubMed1988

Controlled trial of budesonide given by the nebuhaler in preschool children with asthma.

OBJECTIVE: To determine whether the inhaled corticosteroid budesonide, given by a Nebuhaler spacing device, was effective in prophylaxis of asthma in preschool children. DESIGN: Double blind, placebo controlled, random order crossover trial with two week practice run in period. SETTING: Outpatient clinic referrals in secondary referral centre. PATIENTS: 39 children aged 2-6 years selected for the following: able to use Nebuhaler; parents able to complete record card; poorly controlled asthma (defined); not already on systemic or inhaled steroids. Eleven withdrew for various reasons not connected with intolerance to budesonide. Age, sex, other atopies, and symptoms during run in period were similar in the 28 children who completed the trial and in the 11 who withdrew. INTERVENTIONS: Budesonide 200 micrograms or placebo (both one puff) given twice daily during 6-week treatment or control periods, using Nebuhaler after prior training. Three week "washout" at crossover. Compliance monitored by weighing canisters. Patients withdrawn if their acute attacks required treatment with systemic steroids. END POINT: Control of asthma. MEASUREMENTS AND MAIN RESULTS: Peak expiratory flow rate measured twice daily where cooperation allowed. Diary of symptoms and concomitant drug use kept daily. Results showed mean peak flow significantly higher (12% in mornings, 14% in evenings) in second three weeks of intervention compared with control period (95% confidence intervals 6.3-17.3% and 7.2-21.0%). Supplementary bronchodilator drugs reduced by 50% during intervention periods. CONCLUSIONS: Budesonide given by Nebuhaler is effective prophylaxis for preschool children with frequent asthma.

Asthma↗

PubMedDate not supplied

Benzalkonium chloride and nasal mucociliary clearance: a randomized, placebo-controlled, crossover, double-blind trial.

BACKGROUND: Benzalkonium chloride (BKC) has been considered an innocuous preservative for prescription drugs. METHODS: We performed a double-blind, placebo-controlled, randomized, crossover, single-center trial with a 3-week washout period in 43 healthy volunteers comparing the effect of 3-week use of saline nasal spray containing BKC 0.01% to preservative-free saline t.i.d. on nasal mucociliary clearance rate. Evaluations were done at the beginning and the end of each period by gamma-scintigraphy with technetium99m-labeled strontium. RESULTS: Nasal mucociliary clearance rate was significantly impaired by BKC with a difference of 1.23 mm x min(-1) (p < 0.01) between periods. CONCLUSION: BKC in the concentration used in nasal preparations impaired mucociliary clearance in healthy individuals after 3 weeks of use. Presently, when preservative-free alternatives are available, BKC could be a risk without benefit.

Adolescent↗

PubMed2005

Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial.

PURPOSE: Open, observational studies of intradetrusor injections of botulinum toxin for detrusor overactivity have reported beneficial effects. We tested the efficacy and safety of botulinum toxin B for the treatment of the overactive bladder in a randomized, double-blind, placebo controlled crossover trial. MATERIALS AND METHODS: A total of 20 patients 18 to 80 years old with detrusor overactivity unresponsive to oral antimuscarinic agents participated in the study. They were injected with either placebo (20 ml normal saline) or botulinum toxin B (5,000 IU diluted up to 20 ml) intravesically in a day case setting. After 6 weeks the treatments were crossed over without washout in line with previous findings. The primary outcome was the paired difference in change in average voided volumes. Frequency, incontinence episodes and paired differences in quality of life measured by the King's Health Questionnaire were the secondary outcome measures. RESULTS: The Wilcoxon signed ranks test was used to test the paired difference in change between treatment phases. Little carryover was noted in the second arm placebo and the placebo data from both arms were included in analysis. There were clinically statistically significant paired differences in the change in average voided volume, urinary frequency and episodes of incontinence between active treatment and placebo (average voided volume: 95% CI difference 16, 122; Z2.5; p = 0.012/weekly frequency: 95% CI -21, -1; Z2.1, p=0.033/weekly incontinence: 95% CI -26, -7; Z3.3; p = 0.001). There were similarly significant paired differences in the change in quality of life affecting 5 domains of the King's Health Questionnaire. CONCLUSIONS: This double-blind, placebo controlled, crossover study provides evidence of the efficacy of botulinum toxin B in the treatment of overactive bladder. Autonomic side effects were observed in 4 patients. The short duration of action will presumably limit the use to patients who have experienced tachyphylaxis with botulinum toxin A.

Administration, Intravesical↗

PubMed2003

Effect of chitosan rinsing on reduction of dental plaque formation.

The purpose of the present study was to investigate whether the use of a chitosan mouthrinse could be efficacious in reducing plaque and saliva mutans streptococci level. A randomized crossover clinical trial was performed to evaluate the effect of a rinse with 0.5% chitosan for 14 days on plaque formation and mutans streptococci counts in saliva. Twenty-four subjects were randomly assigned either the chitosan rinse or a placebo rinse in addition to their usual oral hygiene procedures. Following the baseline examination, each subject was given a prophylaxis. They were instructed to rinse with 20 ml of the mouthrinse twice daily for 30 seconds. Plaque scores were measured after a 14-day rinsing period, and mutans streptococci counts in saliva were also determined at the start and the end of the each rinsing period. The procedures were repeated with the alternate rinse after a 14-day washout period. Rinsing with 0.5% chitosan was significantly more effective in plaque reduction using the Quigley & Hein Index (chitosan: 1.44, placebo: 1.62, p < 0.001) and Plaque Severity Index (chitosan: 0.138, placebo: 0.186, p = 0.003). The mutans streptococci count in saliva was less after the chitosan rinsing (chi 2 cal = 13.51, p = 0.035) than placebo rinsing. In conclusion, the chitosan rinsing was effective in reducing plaque formation and counts of salivary mutans streptococci after a 14-day rinsing period. These results would appear to warrant further investigation into the potential value of chitosan as an effective anti-plaque agent for use in oral hygiene products.

Adult↗

PubMed2000

Effect on lipid, complete blood count and blood proteins of a standardized preparation for drawing blood: a randomized controlled trial.

OBJECTIVE: To compare a standardized recommended procedure for drawing blood to measure blood lipid and lipoprotein levels with the procedure commonly used in clinical practice. The aim was to see if hemoconcentration and spuriously elevated lipid levels could be avoided. DESIGN: An open randomized crossover clinical trial. SETTING: The University of Calgary. PATIENTS: Twenty-five patients with dyslipidemia. INTERVENTIONS: Blood drawing using a standardized procedure in which the patient remained seated for 5 minutes before blood collection and tourniquet use was minimized or avoided. MAIN OUTCOME MEASURES: Differences in lipid levels between the usual clinical procedure and the recommended procedure for drawing blood. RESULTS: Prior to drawing blood, laboratories have sat patients for an average of 1.4 minutes (95% CI, 0.9 to 1.9) and used a tourniquet in every patient. In the standardized procedure, patients rested for an average of 5.6 minutes (95% CI 5.0 to 6.2), and a tourniquet was used briefly in only 3 of 23 patients. There were no differences in lipid and lipoprotein values and no clinically significant difference in hemoglobin or albumin levels or in the calculation of hemoconcentration. CONCLUSIONS: Efforts to rest patients and avoid tourniquet use when drawing blood for assessment of lipid levels are unlikely to be useful.

Blood Cell Count↗

PubMed2000

Effects of insoluble and soluble dietary fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus.

OBJECTIVE: To evaluate the effects of diets differing in type and quantity of fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus. DESIGN: Prospective randomized crossover controlled trial. ANIMALS: 7 dogs with well-regulated naturally occurring insulin-dependent diabetes mellitus. PROCEDURE: Dogs were fed 1 of 3 diets for 1 month each in 1 of 6 randomized diet sequences. Diets included a low-fiber diet (LF) and 2 high-fiber diets; 1 contained only insoluble fiber (HIF), and 1 contained soluble fiber in addition to insoluble fiber (HSF). Caloric intake was unchanged throughout the study. Glycemic control was assessed after each feeding trial by measuring serum fructosamine concentration and performing 5 serial measurements of blood glucose concentration every 2 hours after the morning feeding and insulin injection. RESULTS: Significant differences were not detected in body weight, required insulin dosage, or albumin concentration among dogs fed the HIF, HSF, and LF diets. Mean and maximum blood glucose concentrations and area under the blood glucose curve were significantly lower in dogs fed the HIF diet, compared with values in the same dogs fed the HSF or LF diet. Fructosamine concentration was significantly lower in dogs fed the HIF or HSF diet, compared with values in the same dogs fed the LF diet. CONCLUSIONS AND CLINICAL RELEVANCE: In dogs with naturally occurring insulin-dependent diabetes mellitus, a dry, high insoluble-fiber diet may aid in glycemic control.

Animals↗

PubMed2005

A daily glass of red wine: does it affect markers of inflammation?

AIMS: Epidemiological studies have shown that moderate consumption of alcohol is associated with a decreased risk of developing cardiovascular disease, but the causal mechanisms are only partly understood. As inflammation is an important process in the progression of atherosclerosis, we hypothesized that the protective effect of red wine is partly mediated through a reduction in inflammation. METHODS: We conducted a randomized controlled crossover trial to study the effect of red wine on the levels of the inflammatory markers serum C-reactive protein (CRP) and plasma fibrinogen in healthy, non-smoking individuals. The subjects were randomized to drink one glass of red wine (150 ml, 15 g alcohol) every day ('wine period') or to undergo a period of total abstention from alcohol ('abstention period'). After 3 weeks they switched intervention group. Eighty-seven volunteers completed the study (mean age 50 years). RESULTS: Red wine did not reduce CRP levels and only marginally reduced fibrinogen levels compared with a similar period without alcohol. CONCLUSIONS: Consumption of 150 ml of red wine slightly reduced fibrinogen levels but did not reduce CRP levels.

Alcohol Drinking↗

PubMed2005

The effects of low-dose fentanyl on emergence agitation and quality of life in patients with moderate developmental disabilities.

STUDY OBJECTIVE: To analyze whether emergence agitation could be reduced by using a low dosage of fentanyl without causing an increase in postoperative adverse effects and/or affecting the patient's quality of life after discharge. DESIGN: Randomized, controlled crossover trial. SETTING: University medical center. PATIENTS: One hundred ten ASA physical status I and II ambulatory patients with moderate developmental disabilities who received anesthesia for dental care. INTERVENTIONS: During their first visit, patients were randomly treated either with a placebo or a 1- to 1.5-microg/kg dose of fentanyl before inserting a reinforced laryngeal mask airway and treated with the remaining method during their second visit 6 to 12 months later. MEASUREMENTS: Measured variables included anesthetic and emergence period, the occurrence of emergence agitation, and postanesthetic adverse effects such as nausea and vomiting. After discharge, the patient's quality of life was evaluated based on disturbances in daily activity, eating habit, and sleeping behavior. Results were analyzed by Student t test and McNemar test (P < 0.05). MAIN RESULTS: Between the two treatments, there was a significant difference in the frequency of emergence agitation (P = 0.04) but no postoperative adverse effects such as postoperative nausea and vomiting. We also found no significant disturbances in the patient's quality of life according to daily activity, eating habits, or sleeping behavior. CONCLUSION: Emergence agitation may be reduced by using 1 to 1.5 microg/kg of fentanyl during induction while maintaining anesthesia by sevoflurane in patients with moderate developmental disabilities undergoing dental care, without causing an increase in postoperative adverse effects and affecting the patient's life quality after discharge.

Adolescent↗

PubMed1998

Factor VIIa response to a fat-rich meal does not depend on fatty acid composition: a randomized controlled trial.

A fat-rich meal increases activated factor VII (FVIIa), but it is not clear whether this increase depends on the fatty acid composition of the meal. Therefore, we studied the FVIIa response to fat-rich meals with different fatty acid composition in a randomized controlled crossover trial and investigated whether this response is mediated by an increase in serum triglycerides. Elderly women (> 60 years, n=91) received on separate days four different fat-rich breakfasts (50 energy percent [en%] of fat) and a control breakfast (1.5 en% fat; crossover). The fat-rich breakfasts differed in fatty acid composition: one rich in palmitic acid (21.7 g), one in stearic acid (18.6 g), and the other two in linoleic and linolenic acid-one with a ratio 3:1 (12.5/3.9 g) and the other with a ratio of 15:1 (18.8/1.2 g). At 8 AM before the breakfast (fasting) and at 1 and 3 PM, blood samples were taken, in which FVIIa and serum triglycerides were measured. FVIIa response to the fat-rich meals ranged from 11.6 mU/mL (95% confidence interval: 8.3,14.9) on the stearic meal to 15.9 mU/mL (12.0,19.8) on the linoleic/linolenic 15:1 meal at 1 PM and from 14.9 mU/mL (10.6,19.2) to 21.1 mU/mL (16.6,25.6) for the same meals at 3 PM. The responses did not differ between the fat-rich meals. After the control breakfast, FVIIa decreased, with 6.3 mU/mL (3.9,8.7) at 1 PM and 8.7 mU/mL (6.3,11.1) at 3 PM. The triglyceride response was lower after both linoleic/linolenic rich breakfasts compared with the palmitic and stearic breakfast (P<.05) and was not associated with the FVIIa response at any of the blood sampling occasions. The results of this study show that the response of FVIIa to a fat-rich meal is independent of its fatty acid composition and is not mediated by serum triglycerides.

Aged↗