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Results for “randomized crossover trial”

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PubMed1996

Propofol at conscious sedation doses produces mild analgesia to cold pressor-induced pain in healthy volunteers.

STUDY OBJECTIVE: To determine whether subanesthetic doses of propofol have analgesic effects in healthy volunteers. DESIGN: Prospective, double-blind, placebo-controlled, randomized, crossover trial. SETTING: Human psychomotor performance laboratory within our anesthesia and critical care department. SUBJECTS: 12, non-drug abusing volunteers, aged 22 to 38 years. INTERVENTIONS: Five drug conditions were used in which a loading injection was followed by a 20-minute infusion period: placebo [saline (Intralipid)] injection, Intralipid infusion; propofol 0.125 mg/kg injection, propofol 12.5 mcg/kg/min infusion; propofol 0.25 mg/kg injection, propofol 25 mcg/kg/min infusion; propofol 0.5 mg/kg injection, propofol 50 mcg/kg/min infusion; fentanyl 1.4 mcg/kg injection (positive control), Intralipid infusion. Five minutes into the infusion period and 115 minutes after the infusion period was terminated, subjects immersed their forearms in ice-cold water for three minutes while pain assessments were recorded. MEASUREMENTS AND MAIN RESULTS: Propofol at the two higher doses during part of the first immersion produced a significant reduction (p < 0.05) in pain intensity and bothersomeness ratings. However, relative to fentanyl, the analgesia was mild. Propofol did not affect any ratings on the 15-item short-form McGill Pain Questionnaire, whereas fentanyl reduced 10 of the ratings. CONCLUSION: Our laboratory results are consistent with the commonly accepted clinical practice of supplementing propofol with an opioid in conscious sedation procedures to provide a satisfactory level of pain relief.

Adult↗

PubMed1996

Effects of shrimp consumption on plasma lipoproteins.

Shrimp is very low in total fat, yet it has a high cholesterol content. Although shrimp is a popular food in the American diet, many people avoid it because of its high cholesterol content. The objective of this study was to test the effect of the addition of cholesterol from shrimp to a low-fat baseline diet as well as to compare the effect of an equal amount of dietary cholesterol derived from shrimp or egg on the plasma lipoprotein pattern of normolipidemic subjects. In a randomized crossover trial, a diet containing 300 g shrimp/d, which supplied 590 mg dietary cholesterol/d, significantly increased low-density-lipoprotein (LDL) cholesterol by 7.1% (P = 0.014) and high-density-lipoprotein (HDL) cholesterol by 12.1% (P = 0.0001) when compared with a baseline diet matched for fat content but containing only 107 mg cholesterol/d. However, because the percentage increase in LDL cholesterol was less than for HDL cholesterol, the shrimp diet did not worsen the ratio of total cholesterol to HDL cholesterol or the ratio of LDL to HDL cholesterol. Moreover, shrimp consumption decreased triacylglycerol (triglyceride) concentrations by 13% (P = 0.004). The diet containing two large eggs per day with 581 mg dietary cholesterol/d also raised LDL- and HDL-cholesterol concentrations compared with baseline, but the percentage increase in LDL cholesterol (10.2%, P = 0.0001) was more than for HDL cholesterol (7.6%, P = 0.004) and there was a trend toward worse lipoprotein ratios. In a comparison of the two high-cholesterol diets, the shrimp diet produced significantly lower ratios of total to HDL cholesterol and lower ratios of LDL to HDL cholesterol than the egg diet as well as lower triacylglycerol concentrations. We conclude that moderate shrimp consumption in normolipidemic subjects will not adversely affect the overall lipoprotein profile and can be included in "heart healthy" nutritional guidelines.

Adult↗

PubMed1995

Early versus late partial sleep deprivation in patients with premenstrual dysphoric disorder and normal comparison subjects.

OBJECTIVE: The aim of this study was to compare the clinical effects of early-night and late-night partial sleep deprivation in patients with premenstrual dysphoric disorder and normal comparison subjects. METHOD: In the premenstrual phase of two menstrual cycles, 23 subjects with DSM-IV premenstrual dysphoric disorder and 18 normal comparison subjects underwent a randomized crossover trial of 1) early-night sleep deprivation, in which subjects slept from 3:00 a.m. to 7:00 a.m., followed by a night of recovery sleep (11:00 p.m. to 7:00 a.m.), and 2) late-night sleep deprivation, in which subjects slept from 9:00 p.m. to 1:00 a.m., followed by a night of recovery sleep. RESULTS: For the subjects with premenstrual dysphoric disorder, in both partial sleep deprivation conditions the Hamilton and Beck depression ratings were significantly lower after recovery sleep than at baseline. Ratings on the day after early or late partial sleep deprivation tended to be lower than at baseline but were not statistically different. The normal comparison subjects showed no clinically important mood changes. A factor analytic approach used with the Hamilton depression scores showed that depressive retardation symptoms were the most responsive to sleep deprivation in the premenstrual dysphoric disorder subjects. CONCLUSIONS: These results are consistent with the reported efficacy of sleep deprivation for major depressive disorder. However, the premenstrual dysphoric disorder subjects improved after the recovery sleep rather than directly after partial sleep deprivation. That late-night sleep deprivation did not have greater benefit than did the hypothesized sham treatment, early-night sleep deprivation, also suggests that placebo effects cannot be ruled out.

Adult↗

PubMed1984

Influence of intravenous Mg++ solutions on renal excretion of potassium, sodium, calcium, chloride, intraleukocytic potassium and peripheral vascular resistance: a metabolic and hemodynamic study in normal volunteers.

In an open randomized crossover trial 8 healthy male volunteers received an intravenous infusion of potassium chloride, potassium/magnesium chloride, potassium-(D,L)-aspartate, and potassium/magnesium-(D,L)-aspartate. Equimolar amounts of potassium (27.75 mmol) and magnesium (13.9 mmol) were given in a 500-ml volume during 24 h. During two 9-day periods subjects were maintained on a constant diet with a daily intake of 80 mmol potassium and 60 mmol magnesium. Infusions were administered on day 5 and 7 of each period. Serum and urine electrolyte concentrations as well as intraleukocyte potassium were measured before, during, and after the tests; cardiac output and systemic vascular resistance were determined by impedance cardiography. Potassium and magnesium containing solutions did not influence renal elimination of potassium, and also the circadian rhythm of potassium excretion did not show any change. The elimination of sodium, calcium, potassium, and chloride rose significantly over the corresponding control values during magnesium infusions, but not when potassium salts were given. The increase of calcium excretion after Mg++ is most probably due to suppression of parathyroid hormone. Intraleukocyte potassium was not affected significantly by the various infusions, indicating that intracellular compartments are completely filled. There was no evidence that the anion (D,L-aspartate or chloride) had a significant effect on all measured variables. Mean arterial blood pressure and peripheral vascular resistance were not altered significantly during the infusions.

Adult↗

PubMed2003

The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers.

UNLABELLED: We compared the central nervous system (CNS) and cardiovascular effects of levobupivacaine and ropivacaine when given IV to healthy male volunteers (n = 14) in a double-blinded, randomized, crossover trial. Subjects received levobupivacaine 0.5% or ropivacaine 0.5% after a test infusion with lidocaine to become familiar with the early signs of CNS effects (e.g., tinnitus, circumoral paresthesia, hypesthesia). The development of CNS symptoms was assessed at 1-min intervals and study drug administration was terminated when the first CNS symptoms were recognized. Thereafter, symptoms were recorded at 1-min intervals until symptom resolution. Hemodynamic variables were assessed by transthoracic electrical bioimpedance. Continuous 12-lead electrocardiogram monitoring was also performed. There was no significant difference between levobupivacaine and ropivacaine for: the mean time to the first onset of CNS symptoms (P = 0.870), mean total volume of study drug administered at the onset of the first CNS symptom (P = 0.595), stroke index (P = 0.678), cardiac index (P = 0.488), acceleration index (P = 0.697), PR interval (P = 0.213), QRS duration (P = 0.637), QT interval (P = 0.724), QTc interval (P = 0.737), and heart rate (P = 0.267). Overall, fewer CNS symptoms were reported for levobupivacaine than ropivacaine (218 versus 277). This study found that levobupivacaine and ropivacaine produce similar CNS and cardiovascular effects when infused IV at equal concentrations, milligram doses, and infusion rates. IMPLICATIONS: This study compared directly, for the first time, the toxicity of levobupivacaine and ropivacaine in healthy volunteers. Levobupivacaine and ropivacaine produced similar central nervous system and cardiovascular effects when infused IV at equal concentrations, milligram doses, and infusion rates.

Adolescent↗

PubMed2004

The effect of back-up rate during non-invasive ventilation in young patients with cystic fibrosis.

OBJECTIVE: The aim of the study was to evaluate the effect of the back-up rate on respiratory effort during non-invasive mechanical ventilation. DESIGN: An in vitro study evaluated the inspiratory trigger in seven domiciliary ventilators. Then, a prospective, randomized, crossover trial compared the effect on respiratory effort of three different back-up rates during pressure support (PS) and assist-control/volume-targeted (AC/VT) ventilation. SETTING: A research unit and a tertiary referral pediatric center. PATIENTS: Ten patients with cystic fibrosis (CF). INTERVENTIONS: During the in vivo study, the back-up rate was progressively increased to the maximum that patients could tolerate (Fmax) and respiratory effort, as judged by pressure/time product of the diaphragm (PTPdi/min), was compared between the two ventilatory modes. RESULTS: Differences were observed between trigger pressure, trigger time delay, trigger pressure/time product and the slope between flow and pressure in the seven ventilators. PS and AC/VT ventilation were associated with a decrease in respiratory effort (PTPdi/min was 518+/-172, 271+/-119 and 291+/-138 cmH(2)O. s(-1). min(-1), for spontaneous breathing, PS and AC/VT ventilation, respectively, p=0.05). During the two modes, increasing the back-up rate to Fmax resulted in a greater reduction in PTPdi/min (p=0.001), which was more pronounced during AC/VT ventilation, due to the automatic adjustment of the inspiratory/expiratory time ratio. CONCLUSIONS: Increasing the back-up rate during PS and AC/VT ventilation decreases respiratory effort in young patients with CF, but this effect was more marked with AC/VT ventilation.

Adolescent↗

PubMed1998

Mid- and long-term similarity of ventricular response to paroxysmal atrial fibrillation: digoxin versus placebo.

The effects of digoxin on ventricular response during atrial fibrillation (AF) and consequent effects on arrhythmic symptoms have still not been fully explained. This study investigated whether the treatment by digoxin contributes to mid- and long-term stabilization of ventricular cycles in patients with paroxysmal AF. A population of 45 patients with paroxysmal AF underwent 24-hour ECG recordings during each arm of a randomized crossover trial comparing digoxin and placebo. This yielded 30 Holter recordings from 22 patients that contained AF episodes lasting in excess of 2 minutes and with acceptably low Holter noise. Each AF episode was divided into nonoverlapping segments of 30 seconds and the distribution of RR intervals in each segment was compared with the distribution of all other AF segments in the same recording using the Kolmogorov-Smirnov test. The percentage of tests that revealed significant differences at levels of P < or = 0.01, and P < or = 0.001 were sorted according to the time between the segments compared. The comparisons of these results were performed between: (a) all recordings on placebo (n = 16) and all recordings on digoxin (n = 14), and (b) between recordings on placebo and on digoxin in 8 patients in whom paired analysis was possible. Adjacent AF segments (distance 0) differed significantly only in < 30% of both recordings on placebo and on digoxin. However, with increasing the distance between segments, the proportion of the significant differences between RR interval distributions increased more with placebo than with digoxin (P < 10(-300), Chi-square test). Paired data revealed larger differences between placebo and digoxin with increasing distance between segments. Thus in patients with paroxysmal AF, digoxin leads to more reproducible patterns of ventricular cycles that may be better tolerated clinically.

Adult↗

PubMed1995

Chronic angiotensin-converting enzyme inhibition may improve sodium excretion in cardiac transplant hypertension.

Cyclosporine-associated hypertension (CAH) may be mediated in part by sodium and volume retention. To investigate this issue, we studied the effects of a calcium antagonist, nitrendipine (NIT, 10-20 mg b.i.d.), and a converting enzyme inhibitor, lisinopril (LIS, 10-20 mg o.d.), on blood pressure (office BP, 24 hr ambulatory BP), excretion of an acute sodium load (200 mmol/2 hr i.v.), glomerular filtration rate (insulin clearance), cumulative dopamine excretion, plasma atrial natriuretic peptide (ANP), and endothelin excretion in 8 patients with CAH after cardiac transplantation in a double-blind, randomized, crossover trial for 6 weeks. Five patients received a diuretic during the trial at a constant dose. Office diastolic BP (DBP) decreased significantly with LIS from 97 +/- 6 to 87 +/- 9 mmHg and with NIT from 96 +/- 7 to 92 +/- 12 mmHg. Ambulatory 24 hr DBP decreased significantly from 96 +/- 7 mmHg to 86 +/- 10 mmHg (LIS) and to 84 +/- 11 mmHg (NIT). Ambulatory DBP during the day was lowered significantly from 98 +/- 11 mmHg to 87 +/- 10 mmHg (LIS) and to 88 +/- 9 mmHg (NIT) and during the night from 95 +/- 9 mmHg to 86 +/- 8 mmHg (LIS) and to 79 +/- 7 mmHg (NIT). Cumulative sodium excretion 6 hr after an acute sodium load increased to 52 +/- 39 mmol (placebo), 96 +/- 44 mmol (LIS, P < 0.05 vs. placebo), and 71 +/- 34 mmol (NIT). Glomerular filtration rate, cumulative dopamine excretion, ANP, and endothelin excretion did not differ between either treatment group. We conclude, that: (1) both drugs were similar in lowering office BP and during the day, but NIT tended to be more effective during the night; and (2) cumulative sodium excretion during LIS was significantly increased compared with placebo. There was a similar trend during NIT also. Therefore, it is possible that chronic angiotensin-converting enzyme inhibition and possibly calcium antagonists might improve the sodium-retaining state in CAH independent of differences in blood pressure, ANP, dopamine, or renal function.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed2001

Alternative voice after laryngectomy using a sound-producing voice prosthesis.

OBJECTIVE: To improve the voice quality of female laryngectomees and/or laryngectomees with a hypotonic pharyngoesophageal (PE) segment by means of a pneumatic artificial source of voice incorporated in a regular tracheoesophageal (TE) shunt valve. STUDY DESIGN: Experimental, randomized, crossover trial. METHODS: The new sound source consists of a single silicone lip, which performs an oscillatory movement driven by expired pulmonary air flowing along the outward-striking lip through the TE shunt valve. A prototype of this pneumatic sound source is evaluated in vitro and in six laryngectomees. In vivo evaluation includes speech rate, maximal phonation time, perceptual voice evaluation of read-aloud prose by an expert listener, speech intelligibility measurements with 12 listeners, and self-assessment by the patients. Moreover, extensive acoustical and aerodynamic in vivo registrations are performed using a newly developed data acquisition system. RESULTS: The current prototype seems beneficial in female laryngectomees with a hypotonic PE segment only. For them the sound-producing voice prosthesis improves voice quality and increases the average pitch of voice, without decreasing intelligibility or necessitating other pressure and airflow rates than regular TE shunt speech. Pitch regulation of this prosthetic voice is possible, yet limited. CONCLUSIONS: The mechanism is feasible and does not result in unacceptable airflow resistance. For this new mechanism of alaryngeal voice to become an established technique for postlaryngectomy voice restoration, a voice suitably pitched for male laryngectomees has to be generated and a large part of the melodic and dynamic range of the sound source has to be attainable within physiological airflow rates.

Aged↗

PubMed2001

Differential patterns of inhibin secretion in response to gonadotrophin stimulation in normal men.

Inhibin B is produced by the testis, and its constituent alpha and beta B subunits have been localized immunohistochemically to Leydig as well as Sertoli cells in both rodent and human testes. Whether Leydig cells contribute to circulating inhibin B concentrations, however, is uncertain. We have investigated this by selectively stimulating Leydig and Sertoli cells with hCG and FSH, respectively. The study was a randomized crossover trial, investigating responses to 225 IU recombinant FSH or 3000 IU hCG administered s/c 4-6 weeks apart. Ten normal men were recruited to participate. Blood was taken twice before treatment and after 8, 24, 48, 72 and 96 h. Serum was assayed for FSH, LH and testosterone by radioimmunoassay (RIA); inhibin B and pro-alpha C inhibin forms by ELISA. Administration of hCG, but not FSH, caused a rapid increase in blood testosterone levels, which reached a maximum after 72 h (22.2 +/- 2.7-50.1 +/- 4.5 nmol/L, p < 0.001). Inhibin B concentrations in blood were unchanged following either treatment. Conversely, pro-alpha C concentrations increased following both treatments. FSH administration resulted in a gradual increase in pro-alpha C concentrations (369 +/- 18 pg/mL pre-treatment to 453 +/- 33 pg/mL after 96 h, p=0.013). Administration of hCG resulted in a more rapid response, with pro-alpha C concentrations rising from 384 +/- 23 pg/mL pre-treatment to a peak at 48 h of 535 +/- 45 pg/mL (p=0.007). This response was more rapid than that of testosterone. These results demonstrate that adult human Leydig, as well as Sertoli, cells secrete inhibin alpha subunit in response to gonadotrophin stimulation but provide no evidence for the secretion of inhibin B from Leydig cells. The lack of change in inhibin B secretion in response to FSH suggests that more prolonged or intense stimulation of Sertoli cells may be required for secretion of the dimeric form.

Adult↗

PubMed2001

A comparison of the effect of loperamide in oral or suppository form vs placebo in patients with ileo-anal pouches.

OBJECTIVE: The effect of the anti-diarrhoeal drug, loperamide hydrochloride, on bowel function in patients with an ileo-anal pouch was studied by means of a blinded, three-tailed, case-controlled and randomized crossover trial, using a daily dose of 12 mg in either oral (4 mg t.d.s.) or suppository (6 mg b.d.) form. PATIENTS AND METHODS: Daily stool frequency was recorded in a diary and an objective measure of pouch motor function was obtained at the end of each treatment phase. Ten subjects (seven males, three females) aged 23-50 years (median 38 years) were studied 9-48 months (median 27 months) after ileostomy closure. Eight pouches had been constructed for ulcerative colitis and two for familial adenomatous polyposis (9J, 1W). RESULTS: Mean daily stool frequency during the oral loperamide phase was lower than during both the placebo (P=0.05) and suppository (P < 0.02) phases. Stool frequency did not differ significantly between placebo and suppository phases. There was a strong inverse correlation between mean daily stool frequency and pouch capacity (r=-0.82 after both oral and suppository phases). Large isolated pouch contractions were evident in five of eight subjects studied; suppression was observed in two of the five after oral loperamide and in three of the five after loperamide suppositories. Rhythmic pouch contractions were seen in four subjects and suppression was evident after loperamide suppositories (but not after oral loperamide) in three. A daily oral dose of 12 mg loperamide significantly lowered stool frequency in pouch patients and modified some aspects of pouch contraction. Loperamide suppositories produced more prominent suppression of pouch contractions but did not lower stool frequency. CONCLUSION: This suggests that the beneficial effect of oral loperamide is primarily due to its action on intestine proximal to the pouch itself.

Clinical Trial↗

PubMedDate not supplied

Compared to glibenclamide, repaglinide treatment results in a more rapid fall in glucose level and beta-cell secretion after glucose stimulation.

BACKGROUND: The more rapid onset of action and the shorter half-life of repaglinide may reduce the post-load glucose excursion and limit sustained insulin secretion compared to sulphonylurea (SU) derivatives. METHODS: We studied 12 patients with type 2 diabetes (age 62 +/- 2 years, BMI 28.3 +/- 1.3 kg m(-2), HbA1c 6.7 +/- 0.2%) on SU monotherapy at submaximal dose. Patients were treated for 3 weeks with repaglinide or glibenclamide in a randomized, crossover trial. At the end of each treatment period, patients underwent a 60-min hyperglycaemic clamp (glucose 12 mmol L(-1)) followed by 4-h observation (60-300 min) with frequent blood sampling for determination of glucose, insulin, proinsulin and C-peptide levels. Before the clamp (5 min for repaglinide, 30 min for glibenclamide), patients ingested their usual morning drug dose. RESULTS: After the end of the hyperglycaemic clamp, mean plasma glucose fell to a level of 5 mmol L(-1) after approximately 150 min with repaglinide, and after approximately 190 min with glibenclamide. While initially quite similar, in the period from 240 to 300 min, insulin, proinsulin and C-peptide levels were lower during repaglinide treatment (insulin 133 +/- 20 vs 153 +/- 25 pmol L(-1) (P < 0.05), proinsulin 14 +/- 3 vs 19 +/- 4 pmol L(-1) (P = 0.06) and C-peptide 0.81 +/- 0.19 vs 1.14 +/- 0.18 nmol L(-1) (P = 0.05) for repaglinide vs glibenclamide, respectively). CONCLUSIONS: Following glucose stimulation, plasma glucose levels, and insulin concentration decrease more rapidly after repaglinide treatment than after glibenclamide. Proinsulin and C-peptide secretion tended to fall more rapidly as well. These findings are consistent with a more rapid onset and shorter duration of beta-cell stimulation associated with repaglinide.

Blood Glucose↗

PubMed2004

Decreased tumor necrosis factor-induced adhesion of human monocytes to endothelial cells after moderate alcohol consumption.

BACKGROUND: Moderate alcohol consumption protects against ischemic heart disease, possibly through an antiinflammatory effect. However, little is known about the mechanisms by which alcohol may interfere in the development of atherosclerosis. OBJECTIVE: We analyzed the effects of 2 alcoholic beverages with high (red wine) or low (gin) polyphenolic content on human monocyte adhesion to an endothelial cell line (Ea.hy926). DESIGN: This was a randomized, crossover trial with 8 healthy men. After a washout period, the subjects received 30 g ethanol/d as red wine or gin for 28 d. Before and after each intervention, a dietary survey and laboratory analysis were performed. Adhesion of human monocytes to endothelial cells was measured in basal and stimulated [by tumor necrosis factor alpha (TNF-alpha)] conditions. Adhesion molecules involved in monocyte-endothelium interactions were determined on the cell surface. RESULTS: The mean expression of very late activation antigen 4 on monocytes significantly decreased after red wine intake [by 18% (95% CI: 33%, 3%); P = 0.022]. Monocyte adhesion significantly increased after TNF-alpha stimulation of endothelial cells. This increase, however, was 39% less (95% CI: 48%, 35%; P = 0.049) after gin intake than after the respective washout period and was nearly abolished by red wine intake [96% less than after the respective washout period (95% CI: 142%, 76%); P < 0.001]. The reduction after red wine intake was significantly different from that after gin intake (P = 0.014). CONCLUSIONS: TNF-alpha-induced adhesion of monocytes to endothelial cells was virtually abolished after red wine consumption but was only partially reduced after gin consumption. This effect may be due to the down-regulation of adhesion molecules on the monocyte surface.

Adult↗

PubMed2001

Acceptability of the Reality female condom and a latex prototype.

We report on the comparative acceptability of a prototype latex female condom and the polyurethane Reality female condom. We also identified factors associated with acceptability, measured via a composite index with domains related to ease of insertion, noise, and comfort during insertion and use. There were 135 couples in this randomized crossover trial. The average age was 30 years; more than 60% had education beyond high school; 40% were married; and participants were at low risk for sexually transmitted disease and pregnancy (due to the investigational status of the prototype). Participants were asked to use three of each of the study condoms during a 6-week period. Acceptability ratings on 12 items were summed into a composite index for each participant by condom type. The index midpoint (range) for females was 48 (12-84), and it was 32 (8-56) for males, with lower scores indicating higher acceptability (men completed only a subset of the acceptability questions). Both condoms were equally acceptable: Mean scores were 37 and 40 for the women's ranking of the prototype and Reality, respectively (P =.07) and 29 and 30 for men's rankings, respectively (P =.35). Multiple regression models to predict acceptability scores by gender were somewhat uninformative (most R(2) values were less than 0.10). Nevertheless, minority ethnicity (African American or Hispanic vs. white) was associated with higher acceptability by both genders for both condom types. Among women, for both condom types, less education (less than high school compared with high school or beyond) was associated with higher acceptability. Female condom acceptability may not be equally distributed across demographic groups, which is important for health educators to keep in mind when promoting the female condom.

Adolescent↗

PubMed2006

Management of phantom pain with a textile, electromagnetically-acting stump liner: a randomized, double-blind, crossover study.

The treatment of phantom pain is frequently dissatisfying. We wanted to find out whether an electromagnetically shielding stump stocking interwoven with metal (medipro(R)Liner RELAX [medi Bayreuth, Bayreuth, Germany]) could have a positive effect on phantom pain. A double-blind, randomized, crossover trial in a total of 30 leg amputees compared the experimental (=verum) silicon liner (VL) fitted to the amputation stump with a dummy (=placebo) liner (PL). Each liner was worn for two weeks after a two-week baseline period. Daily documentation focused on phantom pain, quality of sleep and improvement of well-being. Twenty-seven of 30 patients completed the 6-week study, and 22 documentations proved valid. On a 0-10 numeric rating scale (NRS), the median pain intensity before treatment was 4, and the median of maximum pain was 6. VL versus PL reduced pain significantly more often (P=0.008), the odds ratio being 5.95. The degree of pain reduction was likewise highly significant (<0.001). Wilcoxon's matched-pairs signed-rank test for the medians of daily maximum pain showed a significant reduction for both PL (P < 0.001) and VL (P <0.001) as compared to baseline, with VL being highly superior again (P < 0.001) versus PL. The experimental device also led to significant amelioration of general well-being (P = 0.037) with an odds ratio of 3.85, and an improvement in the quality of sleep, which was not significantly different than PL (P = 0.223). In this study, the influence of a silicon liner with electromagnetically protecting properties on phantom pain was highly significant. The mechanisms underlying this effect are unclear. Possibilities include reduction of ectopic neuroma activity, shielding from possible electromagnetic weather impulses (sferics), or analgesic effects of changes in the electromagnetic field. PET or fMRI examination with or without a shielding silicon liner might help to elucidate this observation further.

Adult↗

PubMed2001

Uricosuric effect of losartan in patients with renal transplants.

BACKGROUND: The aim of the study was to evaluate the uricosuric effect of the angiotensin II receptor antagonist, losartan, in hypertensive patients with renal transplants who are treated with cyclosporin A (CsA). METHODS: Twenty-six patients with stable renal function and hypertension, 16 men and 10 women, median age 47 years (range, 25-63 years), were studied in an open randomized crossover trial, comparing a 2-week control period with a 2-week period of once-daily administration of 50 mg of losartan. The main outcome measurements were fractional excretion of uric acid (FE(uric acid)) based on 24-hr urine collections and plasma uric acid. RESULTS: The median FE(uric acid) was 5.7% (range, 2.4-10.4%) in the control period with a median change of +0.84% (range, -1.15% to +2.77%) in the losartan period (P<0.0002). Plasma uric acid was 0.47 mM (0.29-0.69 mM) in the control period with a change of -0.03 mM (-0.10 to 0.06 mM) in the losartan period (P<0.002). Diastolic blood pressure was 87 mmHg (70-97 mmHg) in the control period with a change of -3 mmHg (-13 to +6 mmHg) in the losartan period (P<0.005). There was no difference in systolic blood pressure between the two study periods. Plasma creatinine was 165 microM (102-356 microM) in the control period with a change of +9 microM (-36 to +60 microM) in the losartan period (P<0.01). Plasma potassium was 4.2 mM (3.0-4.7 mM) in the control period with a change of + 0.2 mM (-0.2 to +0.9 mM) in the losartan period (P<0.0005). CONCLUSIONS: Once-daily administration of 50 mg of losartan in hypertensive CsA-treated patients with renal transplants caused a 17% increase in FE(uric acid) and an 8% fall in plasma uric acid.

Adult↗

PubMed2001

Diets with either beef or plant proteins reduce risk of calcium oxalate precipitation in patients with a history of calcium kidney stones.

OBJECTIVE: To determine the effect of substituting equal amounts of dietary protein as animal protein (beef) for plant protein (legumes, seeds, nuts, and grains) on urinary components associated with calcium oxalate precipitability risk. DESIGN: Randomized crossover trial. SUBJECTS: Twenty-three normocalciuric patients with a history of calcium kidney stones (8 women and 15 men, mean age 50.7+/-14.6 years) with 24-hour urinary calcium < or =10.3 micromol, 24 hour urinary oxalate excretion between 228 and 963 micromol, and a urinary calcium increase of < or =1.0 micromol in 4 hours after a 25 micromol oral calcium load. SETTING: Four-day, free-living adaptation period, followed by 2-day metabolic unit study. INTERVENTION: The study compared consumption of 2 servings of beef (43 g protein for women and 50 g for men) daily with an equal amount of protein from plant foods including legumes, nuts, and grains. MAIN OUTCOME MEASURES: Tiselius risk index (TRI) for calcium oxalate precipitability calculated from urinary calcium, oxalate, magnesium, citrate, and volume. STATISTICAL ANALYSES: Paired t tests. RESULTS: Urinary calcium, oxalate, magnesium, citrate, phosphorus, volume, and TRI did not differ between diets. Urinary sodium and potassium were higher for patients on the plant protein diet. After correcting for variations in urinary sodium and potassium between diets, the difference in urinary calcium remained insignificant. TRI was lower on both beef- and plant-protein diets compared with self-selected prestudy diets for all participants. CONCLUSION/APPLICATIONS: Balanced diets containing moderate amounts of either beef or plant protein are equally effective in reducing calcium oxalate kidney stone risk based on changes in urinary composition.

Adult↗

PubMed1999

Effect of parsley (Petroselinum crispum) intake on urinary apigenin excretion, blood antioxidant enzymes and biomarkers for oxidative stress in human subjects.

Seven men and seven women participated in a randomized crossover trial to study the effect of intake of parsley (Petroselinum crispum), containing high levels of the flavone apigenin, on the urinary excretion of flavones and on biomarkers for oxidative stress. The subjects received a strictly controlled diet low in flavones and other naturally occurring antioxidants during the 2 weeks of intervention. This basic diet was supplemented with parsley providing 3.73-4.49 mg apigenin/MJ in one of the intervention weeks. Urinary excretion of apigenin was 1.59-409.09 micrograms/MJ per 24 h during intervention with parsley and 0-112.27 micrograms/MJ per 24 h on the basic diet (P < 0.05). The fraction of apigenin intake excreted in the urine was 0.58 (SE 0.16)% during parsley intervention. Erythrocyte glutathione reductase (EC 1.6.4.1; GR) and superoxide dismutase (EC 1.15.1.1; SOD) activities increased during intervention with parsley (P < 0.005) as compared with the levels on the basic diet, whereas erythrocyte catalase (EC 1.11.1.6) and glutathione peroxidase (EC 1.11.1.9) activities did not change. No significant changes were observed in plasma protein 2-adipic semialdehyde residues, a biomarker of plasma protein oxidation. In this short-term investigation, an overall decreasing trend in the activity of antioxidant enzymes was observed during the 2-week study. The decreased activity of SOD was strongly correlated at the individual level with an increased oxidative damage to plasma proteins. However, the intervention with parsley seemed, partly, to overcome this decrease and resulted in increased levels of GR and SOD.

Adult↗