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Results for “randomized crossover trial”

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PubMed1996

The short-term effect of dietary pectin on plasma levels and renal excretion of dehydroepiandrosterone sulfate.

Studies specifically investigating the effects of single dietary components on plasma levels of dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS) are rare. Especially no data is available with regard to specific dietary fibers. Therefore, the impact of pectin (a representative fiber that affects the enterohepatic recirculation of bile acids) was studied in a randomized crossover trial consisting of three diet periods characterized by the same food supply and daily doses of 0 g, 15 g or 30 g pectin. Blood and 24-h-urine samples were collected at the end of each 4-day diet period from 6 healthy male volunteers. Plasma levels of DHEA, cortisol and the major binding protein of DHEAS albumin remained unchanged with the varying pectin supplements. Also, no changes were observed for several urinary analytes including urinary DHEAS. However, effects of pectin intake (30, 15 versus 0 g/d) were seen for plasma DHEAS (9.3 +/- 2.8, 9.2 +/- 2.6, 8.0 +/- 3.1 mumol/L, p < 0.01) and total plasma cholesterol (4.4 +/- 0.7, 4.5 +/- 0.7, 4.7 +/- 0.8 mmol/L, p = 0.1). Obviously, the altered intake of fiber in the form of pectin affects plasma concentrations of DHEAS and cholesterol in an opposite direction. The reason for this is not known but a dietetically induced modulation of the binding properties of plasma albumin for DHEAS appears possible. Our findings suggest that the target tissue-available, not protein-bound fraction of circulating DHEAS (as reflected by the renal DHEAS output) is not necessarily altered when total plasma concentrations of DHEAS vary.

Adult↗

PubMed2002

Moderate intakes of intact soy protein rich in isoflavones compared with ethanol-extracted soy protein increase HDL but do not influence transforming growth factor beta(1) concentrations and hemostatic risk factors for coronary heart disease in healthy subjects.

BACKGROUND: Soybeans contain estrogenic isoflavones that may influence plasma concentrations of transforming growth factor beta(1) (TGF-beta(1)) and plasma lipid and hemostatic risk factors for coronary heart disease. OBJECTIVE: We compared the effects of moderate intakes of soy protein containing intact phytoestrogens (high-isoflavone diet) and soy protein from which most of the phytoestrogens had been extracted (low-isoflavone diet) on active TGF-beta(1) concentrations and plasma lipid and hemostatic risk factors for coronary heart disease. DESIGN: A randomized crossover trial was conducted in 22 young, healthy, normolipidemic subjects (5 men and 17 women) who consumed diets providing 56 or 2 mg isoflavones/d for 17 d each with a 25-d washout period between treatments. Fasting blood samples were obtained on days 13 and 14 of each treatment to measure plasma isoflavone, lipid, fibrinogen, and active TGF-beta(1) concentrations and factor VII coagulant and plasminogen activator inhibitor type 1 activities. RESULTS: Plasma isoflavone concentrations were 100-999 times greater after the high-isoflavone diet than after the low-isoflavone diet (P < 0.05). Plasma HDL-cholesterol and apolipoprotein A-I concentrations were 4% (95% CI: 1%, 8%) and 6% (95% CI: 3%, 10%) higher, respectively, after the high-isoflavone diet than after the low-isoflavone diet (P < 0.01 for both). CONCLUSION: Compared with soy protein from which most of the phytoestrogens have been extracted, soy protein with intact phytoestrogens increases HDL-cholesterol and apolipoprotein A-I concentrations but does not influence LDL-cholesterol, TGF-beta(1), or fibrinogen concentrations; factor VII coagulant activity; or plasminogen activator inhibitor type 1 activity in normolipidemic, healthy subjects.

Adult↗

PubMed2000

Opioid treatment of painful chronic pancreatitis.

BACKGROUND: Abdominal pain is the dominant symptom in 50-75% of patients with chronic pancreatitis, often requiring opioid analgesics. Fentanyl, a potent synthetic opioid, can be administered percutaneously at a constant dose and is claimed to have fewer systemic side effects. AIM: To evaluate transdermal fentanyl plaster versus sustained release morphine tablets as analgesic treatment of painful chronic pancreatitis. METHODS: In an open randomized crossover trial, 18 patients were included. The treatment period was 4 wk for each drug. All patients had immediate-release morphine tablets as rescue medication. RESULTS: The dosage of transdermal fentanyl had to be increased on average 50% over that indicated by the manufacturer. When this was done and rescue medication was secured, no difference between the two drugs in primary endpoint or patient preference was observed. There was also no difference in the secondary endpoints, pain control, and quality of life. However, skin side effects, mostly mild, occurred in 44% of the patients during treatment with transdermal fentanyl, and the mean daily dose of immediate release morphine was significantly higher during the transdermal fentanyl period than during the sustained-release morphine period (30.7 mg vs. 14.7 mg [p < 0.01]). CONCLUSION: When given in an appropriate dose, transdermal fentanyl might be useful for treatment of some patients with painful chronic pancreatitis, e.g., when tablet ingestion is difficult. However, the dosage often has to be increased above that recommended by the manufacturer. The need of rescue morphine is considerable and skin side effects often occur. Transdermal fentanyl is, therefore, not the ideal first-choice analgesic in patients with painful chronic pancreatitis.

Administration, Cutaneous↗

PubMed1996

Effect of ramipril on blood pressure and protein excretion rate in normotensive nondiabetic patients with proteinuria.

Angiotensin-converting enzyme inhibitors reduce proteinuria in both normotensive and hypertensive patients with proteinuric renal disease. However, the mechanism of the antiproteinuric effect has not been clarified. We performed a prospective, double-blind, placebo-controlled, randomized crossover trial to test the hypothesis that the antiproteinuric effect of ramipril was due to an improvement in glomerular permselectivity independent of blood pressure and glomerular filtration rate. The effect of low-dose (1.25 mg/d) and high-dose (5 mg/d) ramipril was assessed in 15 normotensive nondiabetic patients with proteinuria (> 150 mg/d). The study was divided into four 12-week periods: placebo, high- or low-dose ramipril, crossover to low- or high-dose ramipril, and placebo. Blood pressure, glomerular filtration rate, renal plasma flow rate, urinary protein excretion rate, and plasma angiotensin II levels were measured at the end of each period. Mean arterial pressure, urine protein to creatinine ratio, and albumin excretion rate decreased significantly during low- and high-dose ramipril. Glomerular filtration rate and renal plasma flow rate were not changed significantly. Plasma angiotensin II levels decreased with both low- and high-dose ramipril. There were no episodes of hypotension and only one subject developed cough during ramipril that did not require discontinuation of the study drug. In conclusion, administration of ramipril in both low and high doses lowered blood pressure and reduced proteinuria in this cohort of normotensive patients with a variety of proteinuric renal diseases. The antiproteinuric effect of ramipril is probably mediated by a reduction in glomerular capillary pressure.

Adolescent↗

PubMed2000

Greater quinidine-induced QTc interval prolongation in women.

BACKGROUND: Prolongation of the electrocardiographic QT interval by drugs is associated with the occurrence of a potentially lethal form of polymorphic ventricular tachycardia termed torsades de pointes. Women are at greater risk than men for development of this adverse event when taking drugs that prolong the QT interval. To determine whether this may be the result of gender-specific differences in the effect of quinidine on cardiac repolarization, we compared the degree of quinidine-induced QT interval lengthening in healthy young men and women. METHODS: Twelve women and 12 men received a single intravenous dose of quinidine (4 mg/kg) or placebo in a single-blind, randomized crossover trial. Total plasma and protein-free concentrations of quinidine and 3-hydroxyquinidine were measured in serum. QT intervals were determined and corrected for differences in heart rate with use of the method of Bazett (QTc = QT/RR1/2). RESULTS: As expected, the mean QTc interval at baseline was longer for women than for men (mean +/- SD; 407 +/- 7 versus 395 +/- 9 ms, P < .05). The slope of the relationship between change in the QTc interval (delta QTc) from baseline to the serum concentration of quinidine was 44% greater for women than for men (mean +/- SE; 42.2 +/- 3.4 versus 29.3 +/- 2.6 ms/microg per mL, P < .001). These results were not influenced by analysis of 3-hydroxyquinidine, free concentrations of quinidine and 3-hydroxyquinidine, or the JT interval. CONCLUSIONS: Quinidine causes greater QT prolongation in women than in men at equivalent serum concentrations. This difference may contribute to the greater incidence of drug-induced torsades de pointes observed in women taking quinidine and has implications for other cardiac and noncardiac drugs that prolong the QTc interval. Adjustment of dosages based on body size alone are unlikely to substantially reduce the increased risk of torsades de pointes in women.

Adult↗

PubMed2002

Anthropometric data and acetylsalicylic acid pharmacokinetics.

The relationship between anthropometric data and pharmacokinetic characteristics of acetylsalicylic acid (ASA) after administration of a single oral dose of 500 mg ASA, an oral and intravenous dose of 500 mg D,L-lysine-mono-acetylsalicylate (Lys-ASA) and an oral dose of 1,000 mg Lys-ASA were evaluated. Individual data from an open, randomized crossover trial in 13 healthy volunteers (age 18-50 years, 6 female, 7 male, height 158-189 cm, weight 45-118 kg) were re-analyzed using a non-compartmental approach. The influence of body weight, height, body surface area and age on pharmacokinetic characteristics (Cmax, Tmax, AUClast, MRTlast, t 1/2, Cl, Vd) was assessed using the multiple regression method and pairwise multiple correlations were calculated. Multiple regression analysis showed significant multiple correlation coefficients of approximately 0.86 for Cmax (500 mg Lys-ASA i.v., 1,000 mg Lys-ASA per os and 500 mg ASA per os), Cl and AUClast (1,000 mg Lys-ASA per os). Standardized regression values (beta) reflected a major contribution for height, weight and body surface area, but age was not a relevant factor. Pairwise comparisons confirmed negative correlations between anthropometric characteristics and Cmax, AUClast and MRTlast and positive correlations between anthropometric data, Cl and Vd. In conclusion, apart from Tmax and t 1/2, all pharmacokinetic characteristics were influenced by body weight, height and body surface area. Whereas repeated administration of high doses in patients with low body weights may give rise to toxic effects, acute single dose administration would not lead to significant under-dosing in tall or stout patients.

Adult↗

PubMed1983

Long-term responses to nifedipine in patients with coronary spasm who have an initial favorable response.

Twenty-six patients with angina and coronary spasm participated in a randomized crossover trial comparing nifedipine with isosorbide dinitrate. Eighteen patients had a short-term beneficial response to nifedipine, and 14 of these were followed up for an average period of 9.4 months. During follow-up study, nifedipine was the primary therapy in these 14 patients, but other drugs were added when clinically necessary to control angina. There was an overall 86% beneficial response rate (greater than 50% decrease in angina frequency). However, 2 patients had a large increase (greater than 10 times) and 4 patients had a slight increase (transient) in angina frequency over the long term compared with the short-term response. The other 8 patients had a similar angina frequency compared with the short-term response. Of the 12 patients with a good response (transient slight increase or no change), 8 (67%) required additional drug therapy to maintain angina control. Nifedipine was discontinued in 2, and the dose was decreased in 3 of the 14 patients because of adverse effects. Three patients had a marked increase in angina at 9, 14, and 3 months, requiring hospitalization; 1 patient had coronary bypass for symptom control. Thus, patients with coronary spasm selected because of a favorable short-term response to nifedipine were effectively treated over the long term with nifedipine; however, additional therapy was often needed to control symptoms. Adverse effects were common, but simple reduction of nifedipine dose usually diminished the unwanted effects of the drug.

Angina Pectoris↗

PubMed2004

Doppler evaluation of the descending aorta in patients with hypertrophic cardiomyopathy: potential for assessing the functional significance of outflow tract gradients and for optimizing pacemaker function.

UNLABELLED: We evaluated whether analysis of aortic flow could be useful for determining the functional significance of left ventricular outflow gradients and for optimizing pacing therapy in patients with hypertrophic cardiomyopathy (HOCM). METHODS: Doppler echocardiography was performed in 32 patients with HOCM. Eleven patients with pacemakers (PPM) also underwent treadmill and quality-of-life (QOL) testing in a randomized crossover trial (1 month of backup pacing (AAI at 30 beats per minute), 1 month with an atrioventricular interval (AVI) of 30 ms (DDD30), and 1 month with an "optimized" AVI (DDDop) that maximized the descending aortic Doppler velocity time integral. RESULTS: Patients with HOCM displayed a notch in the aortic Doppler flow profile. The location of the notch in systole corresponded with the development of the peak left ventricular outflow gradient. Aortic flow after the notch was variable ranging from 6-48% of the total flow. In patients with pacemakers, improved response to pacing was noted in those patients that developed the notch early in systole and had subsequent attenuation of aortic flow. Optimizing the AVI was associated with improved exercise tolerance (AAI: 4.6 +/- 2.3 min., DDD30: 5.5 +/- 2.2 min., and DDDop: 7.7 +/- 2.5 min.; p < 0.05) and improved QOL. CONCLUSIONS: Patients with HOCM have a notch in their aortic Doppler flow profile. The location of the notch correlates with the development of the peak left ventricular outflow gradient and flow after the notch is variable. Patients with an early notch and attenuated flow after the notch appear to have the greatest response to pacing therapy.

Adult↗

PubMed2003

Oral L-arginine improves endothelial function in healthy individuals older than 70 years.

Ageing is associated with progressive endothelial dysfunction in normal humans. Flow-mediated dilation (FMD) of the brachial artery is impaired in elderly individuals with cardiovascular disease and vascular nitric oxide (NO) bioavailability is reduced. We investigated whether oral L-arginine, the substrate for NO synthesis, can improve impaired FMD in healthy very old people. In a prospective, double-blind, randomized crossover trial, 12 healthy old subjects (age 73.8 +/- 2.7 years) took L-arginine (8 g p.o. two times daily) or placebo for 14 days each, separated by a wash-out period of 14 days. FMD was determined by high-resolution ultrasound in the brachial artery during reactive hyperaemia. Baseline artery diameter was 3.88 +/- 0.18 mm. L-Arginine significantly improved FMD (to 5.7 +/- 1.2%, p < 0.0001), whereas placebo had no effect (-0.25 +/- 0.7%; n.s.). After L-arginine, plasma levels of L-arginine increased significantly (114.9 +/- 11.6 versus 57.4 +/- 5.0 micromol/l), but placebo had no effect. As NO synthesis can be antagonized by its endogenous inhibitor asymmetric dimethyl L-arginine (ADMA), we determined ADMA plasma concentrations, which were elevated at baseline in comparison to healthy middle-aged individuals (3.9 +/- 0.2 versus 1.0 +/- 0.1 micromol/l; p < 0.0001). ADMA remained unchanged during treatment, but L-arginine supplementation normalized the L-arginine/ADMA ratio (p < 0.05). We conclude that in healthy very old age endothelial function is impaired and may be improved by oral L-arginine supplementation, probably due to normalization of the L-arginine/ADMA ratio.

Administration, Oral↗

PubMed2003

A comparison of dual dialyzers in parallel and series to improve urea clearance in large hemodialysis patients.

BACKGROUND: Dialysis adequacy targets frequently are difficult to achieve in large hemodialysis patients. Dual dialyzers can be used to improve clearance. It is unknown whether series or parallel configurations are superior. METHODS: Eighteen large hemodialysis patients (mean weight, 92.4 kg) were enrolled in a randomized, crossover trial to directly compare dual dialyzers in parallel and series configurations. Treatment times, blood flow rates, and dialysate flow rates were kept constant. RESULTS: Compared with a single dialyzer, parallel dual dialyzers increased the single-pool Kt/V (spKt/V) from 1.25 +/- 0.22 to 1.43 +/- 0.29 (P < 0.003). Series dual dialyzers improved urea clearance measured by spKt/V (spKt/V(urea)) to 1.46 +/- 0.26 (P < 0.0003 compared with a single dialyzer). Kt/V and urea reduction ratio of dual dialyzers in parallel were not significantly different from those of dual dialyzers in series. Half the subjects failed to meet the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative recommended adequacy target for spKt/V(urea) of 1.2 or less using a single dialyzer. With the use of dual dialyzers, 83% of subjects achieved this adequacy target. Serum levels of a middle molecule, beta2-microglobulin, were reduced 34% after 2 months of dual-dialyzer therapy. Cost analysis estimates annual net savings of 1,260 dollars with dual-dialyzer therapy, primarily from projected savings in inpatient expenses. CONCLUSION: In large hemodialysis patients, our study shows that dual dialyzers in parallel and series are equally effective at improving urea clearance without prolonging dialysis treatment times.

Adult↗

PubMed1990

Alinidine in chronic stable angina: the effect on diastolic perfusion time.

The present study has been performed to assess the effects of alinidine on diastolic duration during exercise in chronic coronary artery disease. Twelve male patients with stable effort angina and without previous myocardial infarction were studied. They received alinidine or placebo in a double-blind randomized crossover trial for 3 days after a wash-out period of 4 days. Alinidine was administered at a dosage of 30 mg 3 times a day. At the end of each treatment the patients underwent upright bicycle exercise. Left ventricular time intervals were obtained by means of carotid thermistor plethysmography. Diastolic duration was calculated by subtracting the electromechanical systole from the R-R interval and expressed as a percentage of the cardiac cycle (%D). Alinidine increased both total exercise duration from 246.7 +/- 120.7 to 346.6 +/- 114.1 s (p less than 0.05) and time to 0.1-mV ST segment depression from 98.3 +/- 53 to 187.2 +/- 105 s (p less than 0.05). Similarly the drug induced a reduction of the rate-pressure product and of the extent of ischemic ST segment depression during exercise. %D was increased by alinidine both at rest and during exercise. A direct linear regression between R-R and %D was found after both alinidine and placebo treatments either at rest or during exercise. Nevertheless, no difference was observed between both slopes and intercepts. Therefore, since the relationship between R-R interval and %D was unaffected by alinidine, it was possible to hypothesize that the changes in diastolic duration were due only to the bradycardic action of the drug.

Angina Pectoris↗

PubMed2006

Phytosterols mixed with medium-chain triglycerides and high-oleic canola oil decrease plasma lipids in overweight men.

Phytosterols (PSs) have been recently added to various mediums. Nevertheless, matrices with functional properties, such as medium-chain triglycerides (MCTs), should be precisely examined for supplementary advantages. The objective of this study was to identify the existence of combined biological actions of a functional oil enriched in PSs within MCTs and high-oleic canola (HOC), relative to a control (olive oil), in overweight, hyperlipidemic men using a rigorously controlled dietary intervention. Twenty-three overweight, hyperlipidemic men consumed both types of oil in a randomized, crossover trial for 6 weeks each. Fasted plasma samples were collected on the first and last 2 days of each study period. Body weight decreased -1.22 +/- 0.35 kg (P = .0019) and -1.68 +/- 0.47 kg (P = .0016) after the 6-week study period in the olive oil and functional oil groups, respectively. The end points for total cholesterol and low-density lipoprotein cholesterol (LDL-C) in the functional oil group (P = .0006) were lower than in the olive oil group (P = .0002). Total cholesterol values decreased from comparable baseline to end point of 4.71 +/- 0.16 mmol/L (P < .0001) in the functional oil phase and 5.14 +/- 0.19 mmol/L (P = .0001) in the olive oil phase (P = .0592). In addition, LDL-C demonstrated a similar drop, to an end point of 3.12 +/- 0.16 mmol/L (P < .0001) and 3.54 +/- 0.18 mmol/L (P = .0002), for the functional oil and olive oil groups, respectively, with significant changes (P = .0221). High-density lipoprotein cholesterol levels did not change in either treatment. Triacylglycerol end points decreased in functional oil and olive oil groups (P = .0195 and .0105, respectively) to the same extent from baseline. Results indicate that PSs mixed within an MCT- and HOC-rich matrix lower plasma LDL-C, without significantly changing the high-density lipoprotein cholesterol concentrations, in hyperlipidemic, overweight men, and may therefore decrease the risk of cardiovascular events.

Adolescent↗

PubMed1997

Is the polymerase chain reaction or cure of Helicobacter pylori infection of help in the differential diagnosis of early gastric mucosa-associated lymphatic tissue lymphoma?

PURPOSE: The differential diagnosis of early gastric mucosa-associated lymphatic tissue (MALT) lymphoma based on Helicobacter pylori gastritis may be difficult when lymphoepithelial lesions are not detected. The aim of the present study was to investigate the question whether the polymerase chain reaction (PCR) or cure of H pylori infection may be of help in this respect. PATIENTS AND METHODS: Twenty patients with suspected low-grade gastric MALT lymphomas were treated in a double-blinded, randomized, crossover trial with 2,250 mg of either amoxicillin or placebo, both in combination with omeprazole, for 14 days with the aim to cure H pylori infection. PCR was performed using primers specific for the CDR3 region to detect monoclonal B cells. RESULTS: In five of 20 patients, MALT lymphomas were finally diagnosed. Three of these five patients went into complete remission, while two were referred to surgery. In the 15 patients with gastritis, complete regression was observed in all cases. With respect to PCR, monoclonal bands were detected in all four of the analyzed lymphoma patients before histology showed lymphoma. In addition, monoclonal bands were found in three patients with gastritis. In the patients with gastritis and monoclonal PCR, complete regression took longer as compared with the remaining 12 patients with polyclonal PCR and gastritis (P = .0209). Successful H pylori eradication was associated with earlier diagnosis of the MALT lymphoma (P = .0237). CONCLUSION: CDR3-PCR may be of help in the differential diagnosis of early gastric MALT lymphoma. Furthermore, H pylori eradication may lead to earlier diagnosis.

Adult↗

PubMed1997

Skeletal muscle endurance training improves peripheral oxidative capacity, exercise tolerance, and health-related quality of life in women with chronic congestive heart failure secondary to either ischemic cardiomyopathy or idiopathic dilated cardiomyopathy.

Despite reported benefits of exercise training in men with chronic congestive heart failure (CHF) and in both men and women with coronary artery disease, the effects of training in women with CHF have not been throughly investigated. Therefore, 16 women (62 +/- 10 years [mean +/- SD]) with stable, moderate, chronic CHF (left ventricular ejection fraction 28 +/- 8%) were studied in a randomized crossover trial with 8 weeks of knee extensor endurance training and 8 weeks of nontraining. The effects of the exercise-based rehabilitation were assessed in skeletal muscle metabolic capacity, exercise tolerance, and quality of life. The compliance rate in training was 98% and no adverse events occurred during the study period. Training increased the activity of citrate synthase (44%, p <0.0001) and lactate dehydrogenase (23%, p <0.002) in the trained muscles, and an improved oxidative capacity in relation to the glycolytic capacity (23%, p <0.002) was found. Peak oxygen uptake (14%, p <0.0005) and peak work rate (43%, p <0.0001) during incremental exercise increased, and blood lactate concentration during standardized submaximal exercise and during the recovery phase decreased (17%, p <0.05). The distance ambulated during 6 minutes (p <0.03), and the overall (p <0.01), physical (p <0.05), and psychosocial (p <0.03) health-related quality of life improved. Because the skeletal muscle endurance training improved peripheral oxidative capacity, exercise tolerance, and the health-related quality of life without any adverse events, this mode of training can be recommended for women with chronic heart failure.

Adult↗

PubMed2002

Is peritoneal dialysis adequate for hypercatabolic acute renal failure in developing countries?

BACKGROUND: Peritoneal dialysis (PD) is a therapeutic option for acute renal failure (ARF) in developing countries, despite concerns about inadequacy. Shorter and more efficient tidal peritoneal dialysis (TPD) was compared with continuous equilibrating peritoneal dialysis (CEPD) therapy in ARF by using their adequacies as accepted standards and analyzing the solute reduction indices (SRI). METHODS: A prospective, randomized crossover trial was performed in patients with mild to moderate hypercatabolic ARF who were assigned to CEPD and TPD therapy after an adequate washout period. Solute clearances (Kt/V, normalized creatinine clearances) were compared to NKF guidelines. Potassium and phosphate clearances, dextrose absorption, protein losses and costs were compared. Kt/V was compared to SRIdialysate, SRIKt/V. RESULTS: Eighty-seven patients with ARF received 236 sessions of dialysis (118 in each treatment). TPD resulted in higher clearances of solutes than CEPD (creatinine and urea clearances in mL/min of 9.94 +/- 2.93, 6.74 +/- 1.63 and 19.85 +/- 1.95, 10.63+/- 2.62, respectively, P=0.001). TPD and CEPD normalized creatinine clearances (L/week/1.73 m2 BSA) and Kt/V values were 68.5 +/- 4.43, 58.85 +/- 2.57 and 2.43 +/- 0.87, 1.80 +/- 0.32, respectively. CEPD did not meet standards of adequacy. TPD resulted in greater potassium and phosphate clearances, less dextrose absorption and was less expensive. CEPD resulted in less protein loss. Kt/V corresponded to SRIdialysate 0.88 +/- 0.12 (P=0.076). CONCLUSION: TPD produced higher solute clearances in less time with greater protein loss. CEPD just fell short to meet the dialysis adequacy standard. However, both TPD and CEPD are reasonable options for mild-moderate hypercatabolic ARF. Kt/V appropriately estimates solute removal in PD.

Acute Kidney Injury↗

PubMed1998

Controlled ovarian hyperstimulation and intrauterine insemination for treating male subfertility: a controlled study.

In this randomized crossover trial we investigated whether the use of controlled ovarian hyperstimulation with low-dose human menopausal gonadotrophin in couples with male subfertility leads to a higher probability of conception when intrauterine insemination (IUI) is applied. We also investigated whether the efficacy of IUI in natural or stimulated cycles was related to the severity of male subfertility. Seventy-four couples completed 308 treatment cycles. Thirteen pregnancies occurred after IUI in a natural cycle (pregnancy rate per completed cycle: 8.4%) and 21 after IUI in a stimulated cycle (pregnancy rate per completed cycle: 13.7%). The difference between the two treatment modalities was not statistically significant. The efficacy of IUI in stimulated cycles was related to the severity of the semen defect. In couples with a total motile sperm count < 10 x 10(6), ovarian stimulation did not improve treatment outcome, while it did in couples with a total motile sperm count > or = 10 x 10(6). Compared with the expected chance of conceiving spontaneously without treatment, both natural and stimulated cycles improved the probability of conception. We conclude that, for the group as a whole, ovarian stimulation did not improve the probability of conception. However, in couples with less severe semen defects, ovarian stimulation did improve the probability of conception.

Adult↗

PubMed1994

Psyllium reduces blood lipids in men and women with hyperlipidemia.

To see if a modest amount of soluble fiber reduced blood lipids in subjects with hyperlipidemia who were on a low-fat diet, 42 subjects (21 men, 21 women) consuming an American Heart Association step 2 diet took two servings of breakfast cereal daily for two 2-week periods in a randomized crossover trial. There were two types of test cereals, each providing 6.7 g psyllium fiber daily, and two types of wheat bran control cereals, matched for available carbohydrate and total fiber. Half the subjects tested each type of cereal, and the results were pooled because the psyllium cereals had similar effects on serum cholesterol levels. Comparing values at the end of 2 weeks, psyllium reduced serum total (6.33 +/- 0.12 mmol/L versus 6.76 +/- 0.12 mmol/L, p < 0.001), low-density lipoprotein (LDL; 4.36 +/- 0.11 mmol/L versus 4.73 +/- 0.12 mmol/L, p < 0.001) and high-density lipoprotein cholesterol levels (HDL; 1.10 +/- 0.05 mmol/L versus 1.14 +/- 0.05 mmol/L, p < 0.05) and the LDL/HDL cholesterol ratio (4.27 +/- 0.20 versus 4.48 +/- 0.22, p < 0.02) with no effect on triglycerides. There was no significant interaction between the effects of treatment and sex for any of the blood lipid variables. Women tended to have greater decreases in total, LDL, and HDL cholesterol levels than men, but the percent decrease in LDL/HDL ratio on psyllium was similar in men, 4.9%, and women, 4.7%. It is concluded that 6.7 g of psyllium fiber daily, with a low-fat diet, reduces serum cholesterol levels in both men and women with hyperlipidemia.

American Heart Association↗

PubMed1988

Felodipine, a new calcium antagonist, modifies exercise-induced asthma.

Recently, calcium antagonists have been reported to have a clinically beneficial effect in patients with asthma. Felodipine is a new calcium antagonist of the dihydropyridine group with a high selectivity for arteriolar smooth muscle; it is under clinical investigation for the treatment of hypertension. In this double-blind, randomized crossover trial in 9 patients, the effect of 10 mg felodipine in oral solution on exercise-induced asthma was compared with a placebo on separate days. The FEV1 was at least 80% of the predicted normal value, with variation between study days of less than 10%. Heart rate, blood pressure, and FEV1 were measured before and at 15 and 30 min after each treatment. The exercise test consisted of steady state running at submaximal work loads for 6 to 8 min and started at 30 min after treatments. FEV1 was measured at 1, 2, 5, 10, 15, and 30 min after the end of exercise. The predrug baseline FEV1 values were comparable on the 2 days of the study, and felodipine had no effect on the resting lung function. The mean percentage fall in FEV1 (SEM) after exercise with placebo was 27.0 (4.5)%, and with felodipine it was 13.5 (3.7)%. The difference between felodipine and placebo was statistically significant. While receiving felodipine, the resting heart rate was increased by 15%, with a tendency to lower systolic and diastolic blood pressures. The heart rate after exercise was higher during felodipine treatment than during placebo treatment. One patient receiving placebo and 7 receiving felodipine noted a transient headache. Two patients receiving felodipine also noticed lightheadedness after exercise.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗