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Results for “randomized crossover trial”

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At least 343 records · Page 19Linked to original sources

Piroxicam in primary dysmenorrhea.

Ninety-two patients with primary dysmenorrhea were included in a double-blind randomized crossover trial to study the efficacy of piroxicam on menstrual pain and associated symptoms, with placebo as control. Ninety patients completed the 4-month study period. Piroxicam afforded a highly significant relief from menstrual pain and reduced the need for the supplementary analgesic paracetamol. Piroxicam also had a significant effect on associated symptoms. The drug was well tolerated, with only a few side effects of a mild nature reported and with no difference between the piroxicam and placebo groups in this respect.

Adolescent↗

A prospective comparison study between a butterfly needle and a Teflon cannula for subcutaneous narcotic administration.

To evaluate the hypothesis that subcutaneous sites initiated with the Teflon cannula would have longer durations and be more comfortable for the patient than the butterfly needle, we performed a prospective randomized crossover trial to compare the 25-gauge butterfly needle to a Teflon cannula with a 26-gauge introducer needle and a 24-gauge cannula. The analysis of 20 patients showed that duration of the subcutaneous site was significantly longer with the Teflon cannula. Both patients and nurses preferred the Teflon cannula because it did not need to be changed as frequently. There was no difference reported in the level of comfort.

Aged↗

Night-time indomethacin in rheumatoid arthritis.

Indomethacin is commonly prescribed at night to relieve morning stiffness in patients with rheumatoid arthritis. Pharmacokinetic and pharmacodynamic interactions are frequently described with non-steroidal anti-inflammatory drugs, and the rationale of using more than one of these agents at the same time is questionable. A randomized crossover trial was carried out in 14 patients to compare the effects of 100 mg indomethacin at night with those of placebo when added to a baseline regimen of stabilized salicylate therapy with a slow-release preparation. Each treatment was given for 2 weeks. The results suggest that the addition of indomethacin produced no significant benefit in terms of reduction in the duration of morning stiffness or on the overall daily pain score.

Arthritis, Rheumatoid↗

Effect of food on the bioavailability of 100-mg dilantin Kapseals.

The authors examined the effect of food on the bioavailability of Dilantin Kapseals in a nonblinded, single 100-mg dose, randomized, crossover trial. Drug was administered after an 8-hour fast and after a high-fat meal. Differences in mean dietary state values were +6% for maximum concentrations (C(max)) and -2% for area under the curve. Associated 90% CI were within US Food and Drug Administration criteria, confirming the absence of a food effect. Thus, patients may take 100-mg Dilantin Kapseals without regard to meals.

Adult↗

Absence of an interaction between iron and mycophenolate mofetil absorption.

AIM: To determine whether concomitant iron affects the absorption of mycophenolate mofetil. METHODS: An open-label, single centre, randomized, crossover trial was conducted in 16 healthy males. Fasting subjects received mycophenolate mofetil alone (treatment A) or co-administered with iron (treatment B). RESULTS: The mycophenolic acid AUC(0,24 h) for treatments A and B were 42.5 +/- 10.5 and 44.7 +/- 12.4 microg ml(-1) h, respectively. anova modelling showed the relative bioavailability of mycophenolate mofetil to be similar for the two treatments (90% confidence interval 0.92, 1.19). CONCLUSIONS: There was no interaction between mycophenolate mofetil and iron supplements administered concomitantly to healthy fasting subjects.

Adult↗

Clonazepam treatment of tardive dyskinesia: a practical GABAmimetic strategy.

Because of the efficacy of specific gamma-aminobutyric acid (GABA) agonists in tardive dyskinesia, the authors tested the benzodiazepine clonazepam in a 12-week, double-blind, placebo-controlled, randomized crossover trial in 19 chronically ill patients with tardive dyskinesia who were being treated with neuroleptics. They found a 35% decrease in dyskinesia ratings with clonazepam treatment. The six patients with predominantly dystonic symptoms showed greater benefit than the 13 patients with predominantly choreoathetoid dyskinesias. Tolerance developed to the antidyskinetic effect of clonazepam in the five patients whose long-term use of the drug was followed, but a 2-week clonazepam-free period recaptured its antidyskinetic effect.

Adult↗

A treatment for the acute migraine attack.

A compound analgesic/anti-emetic formulation was significantly effective in reducing the severity of acute attacks of migraine, in a double-blind, randomized, crossover trial of 34 patients referred to a migraine clinic. The preparation contained paracetamol (acetaminophen) 500 mg, codeine phosphate 8 mg, buclizine hydrochloride 6.25 mg and dioctyl sodium sulphosuccinate 10 mg. The dosage was two tablets taken as early as possible in the acute attack. No specific factors could be identified which influenced response to treatment. Patients with a long history of migraine (more than 10 years) responded as well as those with a recent onset of the condition.

Acetaminophen↗

Dual-chamber pacing in hypertrophic cardiomyopathy.

This review focuses on recent developments in the field of pacing in hypertrophic cardiomyopathy (HCM). Regarding mechanisms of action, recent data indicates that pacing acts by inducing dysynchronous left ventricular activation, thus reducing contractility and increasing end-systolic volume. Following several positive uncontrolled studies, three randomized crossover trials, with a total of approximately 140 patients, have now confirmed that gradients are on average halved with pacing but the reduction in symptoms has been modest and maximum exercise capacity has not been improved. These studies have identified a placebo effect from pacemaker implantation in HCM and have questioned the efficacy of pacing as a symptomatic therapy for HCM. There is probably a subgroup of patients with HCM who respond to permanent dual-chamber pacing but their precise identification is not yet clear. Permanent pacing should continue to be considered as one option in the management of the patient with drug refractory, symptomatic obstructive HCM.

Cardiac Pacing, Artificial↗

Effect of milk on absorption of norfloxacin in healthy volunteers.

The authors studied the effect of milk on the bioavailability of norfloxacin in six healthy male volunteers in a randomized crossover trial. After an overnight fast, 200 mg of norfloxacin was given with 200 mL of water or milk. Area under the curve (AUC) of norfloxacin with milk was significantly (P < 0.01) smaller than that with water. The mean peak serum concentration was decreased to 60% after oral administration of norfloxacin with milk (P < 0.01). The apparent volume of distribution at central compartment (Vc/f) value of norfloxacin was significantly (P < 0.05) increased with milk. Milk exhibits a clinically significant effect on norfloxacin absorption.

Adult↗

Effect of theophylline and salbutamol on hepatic drug metabolism.

Fifteen otherwise healthy asthmatics with reversible airway obstruction were treated with salbutamol (8 mg slow release twice daily) and theophylline (300 mg twice daily). Each drug was administered for 4 weeks in a double-blind randomized crossover trial. Irrespective of which drug was given first, salbutamol increased antipyrine clearance significantly by a factor of 1.10 and 1.15 after 2 and 4 weeks of treatment, respectively. Theophylline did not change antipyrine clearance. There was no correlation between the extent of change in antipyrine clearance during either of the drug treatments and alterations in lung function as assessed by changes in peak flow, forced vital capacity and forced expiratory volume in first second.

Adult↗

Electroencephalogram--entropy and acupuncture.

Computer-based measuring of the level of sedation and hypnosis is difficult and has proven to be challenging. The electroencephalogram (EEG) has been proposed as a potential method. Response entropy (RE) and state entropy (SE) are multifactor, dimensionless parameters of a new technology of EEG monitoring, and we investigated them for the first time in acupuncture research within this study. Both parameters have been alleged to reflect changes in the clinical state of sedation. Two different acupuncture schemes were tested in a randomized crossover trial with nine healthy volunteers (mean age +/- sd, 28.8 +/- 3.6 yr; 25-36 yr). Applying and stimulating acupuncture needles or performing laserneedle acupuncture at special sedation points decreased RE and SE significantly (P < or = 0.01; paired t-test) compared with the reference interval before acupuncture. In contrast, acupuncture of points for increasing "Qi-energy" did not decrease parameters of entropy. Specific acupuncture schemes produce specific, reproducible, and quantifiable effects on entropy parameters in the EEG. Therefore, entropy measurements during acupuncture seem to be worthy of further evaluation with a larger series of subjects.

Acupuncture Points↗

[The pharmacokinetics of dihydroergocristine in free-will subjects after oral administration of three formulations].

This paper reports the pharmacokinetics of three dihydroergocristine (DHEC, CAS 17479-19-5) oral formulations in six volunteers. In a randomized crossover trial the volunteers received 6 mg of the drug (1 tablet of 6 mg; 3 ml of drops containing 2 mg/ml; 1 single-dose bottle containing 6 mg); radioimmunoassay was used for the determination of the unchanged drug plasma levels. DHEC shows a plasma profile according to a 3-compartment pharmacokinetic model with a long half-life and high distribution volume. The analysis of AUC0-infinity, Cmax, tmax, and other pharmacokinetic parameters shows that the three formulations investigated are practically bioequivalent.

Administration, Oral↗

Effects of single oral doses of gemifloxacin (320 milligrams) versus trovafloxacin (200 milligrams) on fecal flora in healthy volunteers.

Gemifloxacin and trovafloxacin were administered to 12 volunteers in a randomized crossover trial with a 2-week washout period. Stool samples were collected predose and 1, 2, and 3 days postdose. Both quinolones reduced the number of organisms of the family Enterobacteriaceae and aerobic gram-positive organisms. Escherichia coli reduction was greater with gemifloxacin than with trovafloxacin, with postdose isolation of quinolone-resistant strains for which MICs of trovafloxacin were higher than those of gemifloxacin.

Anti-Infective Agents↗

Treatment of chronic diarrhoea: loperamide versus ispaghula husk and calcium.

Twenty-five patients with chronic diarrhoea were included in an open, randomized crossover trial comparing the effect of loperamide with ispaghula and calcium. Nineteen patients completed both treatments. Before treatment the median number of daily stools was 7 (range, 4-13), stool consistency was loose in all, and urgency was present in 16 out of 19 patients. Both treatments halved stool frequency, but with regard to urgency and stool consistency ispaghula and calcium was significantly better. A combination of ispaghula and calcium seems to be a cheap and effective alternative to conventional treatment of chronic diarrhoea. Moreover, side effects were minimized.

Adult↗

Micro-encapsulated aspirin (Levius) compared with aloxiprin (Palaprin Forte) in the treatment of rheumatoid arthritis.

A randomized crossover trial of micro-encapsulated aspirin (Levius) and aloxiprin (Palaprin Forte) was carried out on thirty-three hospital outpatients with rheumatoid arthritis. Both preparations improved the clincial status of the patients. The difference in response to the two preparations was not significant, except for effect on functional status where the micro-encapsulated aspirin was found to be significantly better at the 5% level. Apart from six complaints of constipation with aloxiprin compared with only one with Levius, the side-effects were similar. The trial has shown that Levius can be conveniently given in divided doses thrice daily without loss of efficacy.

Aged↗

Effect of dietary sodium reduction on red blood cell sodium concentration and sodium-lithium countertransport.

A randomized, crossover trial was carried out on the effect of moderate sodium reduction on red-blood-cell sodium metabolism. The participants were healthy high school students (mean age = 16 years, n = 33). Changes in sodium-lithium countertransport and intracellular sodium concentration were evaluated 24 days after a decrease in dietary sodium from approximately 110 to 40 mEq per day. Dietary sodium restriction had no significant effect on either sodium-lithium countertransport or intracellular sodium concentration.

Adolescent↗

Dopaminergic agonist Ro 8-4650 in Parkinson's disease. II. Patients not treated with dopa.

An isoquinolone derivative Ro 8-4650 (rac-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-7-methoxy-2-methylisoquinoline hydrochloride) with dopaminergic properties was studied in a randomized crossover trial. The group studied comprised 37 patients with idiopathic parkinsonism, not previously treated with levodopa or dopamin agonists. The trial drug was significantly more effectve than placebo, but the clinical improvement, according to the Webster rating scale, was small. No significant difference was observed as regards involuntary movements, but the trial drug led to more frequent minor side effects. It can be concluded that the trial drug, despite its proven effect in Parkinson's disease, has only limited clinical value.

Aged↗

Multicentre comparison of the antihypertensive effect of acebutolol and hydrochlorothiazide in uncomplicated mild-moderate hypertension in the elderly.

To evaluate the efficacy of acebutolol, 400-600 mg/day in elderly hypertensive patients, and to compare it with hydrochlorothiazide 25-50 mg/day, 45 patients with mild-moderate uncomplicated hypertension were treated for 6 weeks in a multicentre, single-blind, randomized, crossover trial. Acebutolol decreased supine systolic blood pressure from 186.5 to 162.7 mmHg and diastolic blood pressure from 107.4 to 92.4 mmHg. Hydrochlorothiazide decreased systolic blood pressure from 185.0 to 166.4 and diastolic blood pressure from 107.2 to 96.4. There was no difference between the effects of acebutolol and hydrochlorothiazide on blood pressure during the trial. Both drugs proved to be safe and effective antihypertensive agents, provided the major contraindications for their use were taken into account. Beta-blockade by acebutolol was highly effective in treating mild-moderate arterial hypertension in the elderly.

Acebutolol↗