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Results for “randomized crossover trial”

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At least 703 records · Page 39Linked to original sources
PubMed1991

Effect of maintenance digoxin therapy on aerobic performance and exercise left ventricular function in mild to moderate heart failure due to coronary artery disease: a randomized, placebo-controlled, crossover trial.

Despite 200 years of use, the ability of digitalis glycosides to improve exercise capacity in patients with congestive heart failure remains controversial, partly because of imprecise end points and suboptimal study design. Therefore, this question was examined in 10 ambulatory patients (8 men and 2 women) aged 46 to 70 years (mean 57.8) in sinus rhythm with mild to moderate chronic stable congestive heart failure due to coronary artery disease and systolic left ventricular dysfunction (ejection fraction 32 +/- 12). All underwent maximal treadmill exercise with respiratory gas analysis and upright cycle ergometry with gated radionuclide angiography after 4 weeks of digoxin or placebo therapy, administered in a randomized double-blind crossover protocol. Neither treadmill exercise duration (7.7 +/- 2.3 versus 7.3 +/- 2.7 min) nor peak oxygen consumption (18.7 +/- 3.7 versus 18.4 +/- 5.4 ml/kg per min) differed between digoxin and placebo regimens. However, the change in peak oxygen consumption induced by digoxin was inversely related to the peak oxygen consumption during placebo therapy (r = -0.64, p less than 0.05). At maximal treadmill effort, heart rate (138 +/- 16 versus 141 +/- 21 beats/min), oxygen pulse (10.3 +/- 2.1 versus 9.9 +/- 2.2 ml/beat), ventilation (40.3 +/- 10.6 versus 42.0 +/- 10.8 liters/min) and ventilatory equivalent (29.4 +/- 4.8 versus 31.5 +/- 6.8) did not differ between digoxin and placebo treatment, although systolic blood pressure was higher during digoxin therapy (163.0 +/- 23.1 versus 153.2 +/- 25.3 mm Hg, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed2003

A randomized placebo-controlled crossover trial with phytoestrogens in treatment of menopause in breast cancer patients.

OBJECTIVE: Phytoestrogens are popular in treatment of menopause, although scientific evidence is insufficient as to their efficacy. We studied the effects of daily use of isoflavonoids on climacteric symptoms and quality of life in patients with a history of breast cancer. METHODS: Sixty-two postmenopausal symptomatic women were randomized to use either phytoestrogen (tablets containing 114 mg of isoflavonoids) or a placebo for 3 months; the treatment regimens were reversed after a 2-month washout period. Fifty-six women completed the study. Menopausal symptoms were recorded on the Kupperman index and the visual analogue scale, and working capacity and mood changes were assessed via validated questionnaires. In addition, we followed the levels of phytoestrogens, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and sex hormone-binding globulin. Liver enzymes and creatinine were also assessed at each visit. RESULTS: The phytoestrogen regimen raised the circulating levels of phytoestrogens (daidzein, genistein, equol) 19- to 106-fold. The Kupperman index was reduced by 4.2 +/- 9.6 (mean +/- standard deviation) (15.5%) during phytoestrogen use and similarly by 4.0 +/- 8.1 (14.7%) during placebo use (P nonsignificant). The quality of life parameters (working capacity, mood changes) were unaffected by phytoestrogen. In addition, the phytoestrogen regimen caused no changes in FSH, LH, estradiol, or sex hormone-binding globulin. Phytoestrogen treatment was well tolerated and caused no changes in liver enzymes, creatinine, body mass index, or blood pressure. Of the 56 women, 25 (44.6%) preferred the phytoestrogen regimen, 15 preferred the placebo (26.8%), and 16 (28.6%) reported no preference (nonsignificant). CONCLUSION: Pure isoflavonoids did not alleviate subjective menopausal symptoms in breast cancer patients.

Breast Neoplasms↗
PubMed1992

Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial.

We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.

Administration, Oral↗
PubMed2004

Evaluation of additional amine fluoride/stannous fluoride-containing mouthrinse during supportive therapy in patients with generalized aggressive periodontitis. A randomized, crossover, double-blind, controlled trial.

OBJECTIVES: The objective of the present randomized controlled trial was to evaluate the efficacy of a mouthrinse containing a combination of AmF/SnF2 in controlling supragingival plaque accumulation and gingival inflammation during a 12-week period in patients affected by generalized aggressive periodontitis (GAP). METHODS: Eighteen subjects, six males and 12 females, mean age: 32.2 years, were evaluated. One-half of the patients was either prescribed an AmF/SnF2-containing mouthrinse (test mouthrinse) or a control mouthrinse in addition to mechanical plaque control for 12 weeks. After a 2-week wash-out period, the patients received the alternative mouthrinse. Before and after treatment plaque index (PlI), gingival index (GI), angulated bleeding index (AngBI), tooth stain (GMSI), and tongue stain were recorded. RESULTS: Test mouthrinse resulted in a statistically significant decrease in PlI (p = 0.029) and GI (p = 0.017). After treatment, PlI was significantly lower in test compared to control mouthrinse (p = 0.027). GMSI significantly increased post-treatment for both mouthrinse regimens (p < 0.001), a significantly higher score being observed for the test compared to control mouthrinse (p = 0.002). CONCLUSIONS: The 12-week use of a AmF/SnF2-containing mouthrinse as an adjunct to conventional mechanical oral hygiene procedures in GAP patients was effective in controlling the amount of supragingival plaque deposits.

Adult↗
PubMed1999

Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep Apnea/Hypopnea syndrome.

The minimal disease severity at which patients with the sleep apnea/hypopnea syndrome (SAHS) gain benefit from treatment is not well characterized, although a pilot study of continuous positive airway pressure (CPAP) therapy showed daytime improvements in patients with 5 to 15 apneas + hypopneas per hour slept (AHI). We have thus performed a second, larger, randomized, placebo- controlled study in a prospective series of 34 patients (13 female) with mild SAHS (AHI 5 to 15) and daytime sleepiness. Patients spent 4 wk on CPAP treatment and 4 wk on an oral placebo, with randomization of treatment order, and daytime assessments on the last day of each treatment. Effective CPAP use averaged 2.8 +/- 2.1 h (mean +/- SD) per night. Compared with placebo, CPAP improved symptom score (p < 0.01), subjective (Epworth; p < 0.01) but not objective (maintenance of wakefulness test; p > 0.2) sleepiness, performances on 2 of 7 cognitive tasks (p < 0.02), depression score (p < 0.01), and five subscales of the SF-36 health/functional status questionnaire (p </= 0.03). Fourteen of 34 patients preferred CPAP. In 14 patients with AHI in the range 5 to 10, symptoms, cognitive function, psychological well-being and quality of life were improved. These results confirm benefits for daytime function after CPAP treatment for mild SAHS, but highlight unacceptability of CPAP in many such patients.

Adult↗
PubMed2003

A randomized, double-blind crossover trial of paracetamol 1000 mg four times daily vs ibuprofen 600 mg: effect on swelling and other postoperative events after third molar surgery.

AIMS: To evaluate the effect of a 3-day regimen of ibuprofen 600 mg x 4 on acute postoperative swelling and pain and other inflammatory events after third molar surgery compared with a traditional regimen of paracetamol 1000 mg x 4. METHODS: A controlled, randomized, double-blind, cross-over study where 36 patients (26 females, 10 males) with mean age 23 (range 19-27) years acted as their own controls. All patients were subjected to surgical removal of bilateral third molars. After one operation the patients received tablets of ibuprofen 600 mg x 4 for 3 days. After the other operation they received an identical regimen of paracetamol 1000 mg tablets. Swelling was objectively measured (mm) with a standardized face bow and the patients scored their pain intensity (PI) on a 100-mm visual analogue scale. RESULTS: There was no statistically significant difference between paracetamol and ibuprofen treatment with respect to effect on acute postoperative swelling. Swelling after paracetamol on the third postoperative day was 1.8% less than that after ibuprofen. Mean (95% CI) difference between treatments was -0.3 (-4.7, 4.1) mm. On the sixth postoperative day swelling after ibuprofen was 2.3% less than that after paracetamol. Mean (95% CI) between treatments was 0.2 (-2.4, 2.8) mm. There was no statistically significant difference in pain intensity between the paracetamol and the ibuprofen regimen on the day of surgery. The mean (95% CI) difference between the treatments for summed pain intensity on the day of surgery (SUMPI 3.5-11) was 3.31 (-47.7, 54.3) mm. Two patients developed fibrinolysis of the blood clot (dry socket) after receiving ibuprofen while none did this after paracetamol treatment. There was no noticeable difference between treatments with respect to appearance of haematomas/ecchymoses or adverse effects which all were classified as mild to moderate. CONCLUSIONS: A 3-day regimen of ibuprofen 600 mg x 4 daily does not offer any clinical advantages compared with a traditional paracetamol regimen 1000 mg x 4 daily with respect to alleviation of acute postoperative swelling and pain after third molar surgery.

Acetaminophen↗
PubMed2003

Impact of bedtime snack composition on prevention of nocturnal hypoglycemia in adults with type 1 diabetes undergoing intensive insulin management using lispro insulin before meals: a randomized, placebo-controlled, crossover trial.

OBJECTIVE: To determine the impact of four bedtime (HS) snack compositions on nocturnal glycemic control, including frequency of hypoglycemia (<4 mmol/l) and morning hyperglycemia (>10 mmol/l), in adults with type 1 diabetes using lispro insulin before meals and NPH insulin at bedtime. RESEARCH DESIGN AND METHODS: Substitutions of 15 g carbohydrate (one starch exchange) for an equivalent amount of uncooked cornstarch or pure protein were compared to a standard snack (control: two starch + one protein exchange) and to no snack (placebo) in 15 adults using a randomized, cross-over design. All snacks were equivalent in kcal, fat, and total available glucose. An intravenous facilitated hourly blood glucose sampling during the night (11:00 P.M. to 7:00 A.M.). RESULTS: The glycemic level at bedtime (<7, 7-10, and >10 mmol/l) mediated the effects observed. A total of 14 hypoglycemic episodes, in 60% of patients, and 23 morning hyperglycemic episodes occurred over 50 nights. Most hypoglycemic episodes (10 of 14, 71%) occurred with no snack compared to any snack (P < 0.001) and at HS levels of <7 mmol/l (P = 0.05). The standard and protein snacks resulted in no nocturnal hypoglycemia at all HS glucose levels (P < 0.001). Only HS glucose >10 mmol/l was protective against hypoglycemia, even in the absence of a snack (P = 0.05); 46% of morning hyperglycemic episodes were associated (r = 0.37, P = 0.07) with this HS glucose level. CONCLUSIONS: The need for and composition of an HS snack depends on the HS glucose such that no snack is necessary at levels >10 mmol/l. At levels between 7 and 10 mmol/l, any snack is advised, and at <7 mmol/l, a standard or protein snack is recommended.

Adult↗
PubMed1999

Supine bicycle versus post-treadmill exercise echocardiography in the detection of myocardial ischemia: a randomized single-blind crossover trial.

OBJECTIVES: We sought to determine the comparative accuracy of supine bicycle exercise echocardiography (SBE) and posttreadmill exercise echocardiography (TME) in detecting myocardial ischemia in patients with known or suspected coronary artery disease (CAD). BACKGROUND: Supine bicycle echocardiography and TME have been used for evaluation of CAD. However, the comparative accuracy of these modalities in the detection of ischemia in the same patients is not known. METHODS: Seventy-four patients (age 59 +/- 9 years [mean +/- SD]) referred for evaluation of coronary disease underwent SBE (starting at 25 to 50 W with 25-W increment every 3 min) and post-TME (Bruce protocol) in a random sequence. Digitized images at baseline and maximal exercise were interpreted in a random and blinded fashion. RESULTS: Maximal heart rate was higher during TME, whereas systolic blood pressure was higher during SBE, resulting in a similar double product. At quantitative angiography (n = 67), 57 patients had coronary stenosis (>50%). During SBE, ischemia was detected in 47 patients compared with 38 patients by TME (p < 0.001). Wall motion score index at maximal exercise was higher with SBE than with TME (1.48 +/- 0.51 vs. 1.38 +/- 0.43; p < 0.001). The extent of myocardial ischemia (number of ischemic segments) was higher during SBE compared with TME (3.3 +/- 3.4 vs. 2.3 +/- 2.9 segments; p = 0.004), whereas severity of abnormal wall motion was similar. The sensitivity of SBE and TME for CAD was 82% and 75% with a specificity of 80% and 90%, respectively. Image quality was similar with both techniques. Patients and sonographers favored SBE over TME. CONCLUSIONS: During SBE and TME exercise, patients achieve a similar double product. During SBE, however, the detection of ischemia is more frequent and more extensive which, along with patient and sonographer preference, makes supine bicycle exercise a valuable stress echocardiographic modality.

Adult↗
PubMed1987

Comparison of propafenone and disopyramide in the treatment of ventricular premature complexes: a randomized double blind crossover placebo controlled trial.

To determine the efficacy of the newer antiarrhythmic drug propafenone and to compare it to disopyramide, sixteen patients--11 men and 5 women--participated in a randomized double-blind crossover placebo-controlled trial using 150 mg quid of propafenone or disopyramide. Twenty-four hour ECG's were performed at the end of the placebo period and each 2 weeks of drug therapy. Droupouts (2) because of adverse effects were not included in analysis. On placebo there were 485 +/- 535 (mean +/- SD) ventricular premature complexes (VPC's)/hour. Propafenone significantly (p = 0.010) reduced VPC's to a slightly smaller amount 182 +/- 298/hour. There was no significant difference between propafenone and disopyramide in suppressing VPC's, however, analysis of the circadian rhythm of VPC's showed a greater reduction in VPC's from 1600 to 2400 hour after propafenone compared to disopyramide using this dose regimen. Using a criterion of efficacy of greater than 80% reduction in VPC's, 8/14 patients had a good suppression with propafenone, 3 patients responded only to propafenone, 4 patients only to disopyramide, 5 patients to both and 2 patients to neither. Using a criterion of efficacy of greater than 65% reduction in VPC's 11/14 patients had good suppression with propafenone or disopyramide, 3 patients responded only to propafenone and 4 patients only to disopyramide. Side effects were more common with disopyramide. Two patients dropped out after disopyramide because of gastrointestinal symptoms. Side effects were found in 11/14 remaining patients on disopyramide, but in 6/14 on propafenone.(ABSTRACT TRUNCATED AT 250 WORDS)

Arrhythmias, Cardiac↗
PubMed2005

Effects of single and long-term administration of wheat albumin on blood glucose control: randomized controlled clinical trials.

OBJECTIVE: To examine the effects of single and long-term administration of wheat albumin (WA) on blood glucose levels and blood glucose control, respectively. DESIGN: Randomly arranged crossover trial for single administration in healthy subjects and double-blinded randomized controlled trial for long-term administration (3 months) in diabetic patients. In vitro alpha-amylase inhibitory activity of WA was also determined. SETTING: Central Research Laboratories of Nisshin Flour Milling Co. Ltd. (Saitama, Japan) for single administration and Aiwa Clinic (Saitama, Japan) for long-term administration. SUBJECTS: A total of 12 healthy adult male volunteers for the single administration and 24 type II outpatient diabetics with mild hyperglycemia for the long-term administration. INTERVENTIONS: Subjects took soups containing 0, 0.25, 0.5, and 1.0 g WA before test meals for single administration, and patients took soups with or without 0.5 g WA before every meal for the long-term (3 months) administration. RESULTS: In vitro alpha-amylase inhibitory activity of WA was 150 times that of wheat flour. In the single administration experiment, WA suppressed peak postprandial blood glucose levels in a dose-dependent manner: 31, 47, and 50% reduction after 0.25, 0.5, and 1.0 g administrations, respectively. In the long-term administration, 0.5 g of WA did not affect fasting blood glucose levels, whereas it reduced hemoglobin A1c levels. No significant adverse effects such as hypoglycemia or gastrointestinal disturbances were observed in the two experiments. CONCLUSION: In the treatment of type II diabetic patients, WA might be a useful functional food, which, with diet and exercise, could help to improve blood glucose control without any critical adverse effects.

Administration, Oral↗
PubMed2007

Comparison of inhibitory effects of irbesartan and atorvastatin treatment on the renin angiotensin system (RAS) in veins: a randomized double-blind crossover trial in healthy subjects.

Experimental studies point to an interplay between hypercholesterolemia and hypertension, acting through the renin angiotensin system. In a crossover study design with 8 healthy subjects, the authors tested the hypothesis that statin treatment exerts renin angiotensin system-modulating effects in veins by down-regulation of AT1-receptors, resulting in reduced Angiotensin II (Ang II)-induced venoconstriction and by increasing the pleiotropic Ang II-metabolite Ang-(1-7). Irbesartan was used as positive control. Ang II-induced venoconstriction was 49% +/- 9% before and 64% +/- 10% after 30 days of atorvastatin treatment compared to 50% +/- 8% before and 15% +/- 9% after irbesartan (P = .004). Plasma angiotensin levels significantly increased only after irbesartan treatment (Ang II: 35 +/- 4 vs 329 +/- 101 pg/mL [P = .02]; Ang-(1-7): 10 +/- 3 vs 35 +/- 6 pg/mL [P = .01]) compared to atorvastatin treatment (Ang II: 26 +/- 5 vs 31 +/- 4 pg/mL [P = ns]; Ang-(1-7): 9 +/- 2 vs 11 +/- 3 pg/mL [P = ns]). The data indicate that atorvastatin does not inhibit Ang II-induced venoconstriction in vivo and point toward a supportive role of Ang-(1-7) in contributing to the antihypertensive and beneficial vascular effects of irbesartan.

Adult↗
PubMed1983

The antihypertensive effect of verapamil on twice and thrice daily dose regimens. A randomized, double-blind, crossover trial.

The antihypertensive effect of verapamil 200 mg b.i.d. was compared with that of verapamil 120 mg t.i.d. in a double-blind crossover study of eight out-patients with essential hypertension. The mean supine blood pressure measured before the morning dose was 150/87 mm Hg in patients treated with verapamil 200 mg b.i.d. and 151/87 mm Hg in those treated with verapamil 120 mg t.i.d. The recently reported prolonged half-life and accumulation of verapamil during steady-state conditions explains the lasting antihypertensive effect with the twice-daily dose regimen. Such a twice daily dose regimen is presumed to be more convenient to the patients and thus improve their compliance.

Adult↗
PubMed2004

L-carnitine and creatine in Friedreich's ataxia. A randomized, placebo-controlled crossover trial.

Impaired oxidative phosphorylation is a crucial factor in the pathogenesis of Friedreich's ataxia (FA). L-carnitine and creatine are natural compounds that can enhance cellular energy transduction. We performed a placebo-controlled triple-phase crossover trial of L-carnitine (3 g/d) and creatine (6.75 g/d) in 16 patients with genetically confirmed FA. Primary outcome measures were mitochondrial ATP production measured as phosphocreatine recovery by 31Phosphorus magnetic resonance spectroscopy, neurological deficits assessed by the international co-operative ataxia rating scale and cardiac hypertrophy in echocardiography. After 4 months on L-carnitine phosphocreatine recovery was improved compared to baseline (p<0.03, t-test) but comparison to placebo and creatine effects did not reach significance (p=0.06, F-test). Ataxia rating scale and echocardiographic parameters remained unchanged. Creatine had no effect in FA patients. L-carnitine is a promising substance for the treatment of FA patients, and larger trials are warranted.

Adenosine Triphosphate↗
PubMed2001

AAIR versus DDDR pacing in the bradycardia tachycardia syndrome: a prospective, randomized, double-blind, crossover trial.

In 19 patients paced and medicated for bradycardia tachycardia syndrome (BTS), AAIR and DDDR pacing were compared with regard to quality of life (QoL), atrial tachyarrhythmia (AFib), exercise tolerance, and left ventricular (LV)function. Patients had a PQ interval < or = 240 ms during sinus rhythm, no second or third degree AV block, no bundle branch block, or bifascicular block. In DDDR mode, AV delay was optimized using the aortic time velocity integral. After 3 months, QoL was assessed by questionnaires, patients were investigated by 24-hour Holter, cardiopulmonary exercise testing (CPX) was performed, and LV function was determined by echocardiography. QoL was similar in all dimensions, except dizziness, showing a significantly lower prevalence in AAIR mode. The incidence of AFib was 12 episodes in 2 patients with AAIR versus 22 episodes in 7 patients with DDDR pacing (P = 0.072). In AAIR mode, 164 events of second and third degree AV block were detected in 7 patients (37%) with pauses between 1 and 4 seconds. During CPX, exercise duration and work load were higher in AAIR than in DDDR mode (423+/-127 vs 402+/-102 s and 103+/-31 vs 96+/-27 Watt, P < 0.05). Oxygen consumption (VO2), was similar in both modes. During echocardiography, only deceleration of early diastolic flow velocity and early diastolic closure rate of the anterior mitral valve leaflet were higher in DDD than in AAI pacing (5.16+/-1.35 vs 3.56+/-0.95 m/s2 and 69.2+/-23 vs 54.1+/-26 mm/s, P < 0.05). As preferred pacing mode, 11 patients chose DDDR, 8 patients chose AAIR. Hence, AAIR and DDDR pacing seem to be equally effective in BTS patients. In view of a considerable rate of high degree AV block during AAIR pacing, DDDR mode should be preferred for safety reasons.

Aged↗
PubMed2000

Randomized, placebo-controlled, crossover trial of low-dose oral methotrexate in children with extended oligoarticular or systemic arthritis.

OBJECTIVE: Juvenile idiopathic arthritis (JIA) can persist through adolescence and adulthood, resulting in significant disability. The use of low-dose oral methotrexate (MTX) for persistent polyarthritis has been shown to be effective by the USA/USSR collaborative study group. However, 2 of the most disabling subgroups of JIA, systemic and extended oligoarthritis, were underrepresented in that study. The present study was therefore conducted to investigate the efficacy of MTX in these 2 subgroups. METHODS: Patients under the age of 16 years who fulfilled the International League of Associations for Rheumatology criteria for systemic or extended oligoarticular arthritis were eligible for this multicenter, double-blind, placebo-controlled crossover trial. Forty-five patients with systemic and 43 with extended oligoarticular arthritis were enrolled. The dosage of MTX or placebo was 15 mg/m2, which could be increased to 20 mg/m2 after 2 months. Core outcome variables were considered as primary measures, giving a final score of "improved" or "not improved." Secondary measures included scores of systemic features and biochemical laboratory measures. Assessment of function was not included since there were no validated functional measures at the start of this trial in 1991. RESULTS: In the extended oligoarticular arthritis group, MTX treatment produced significant improvement in 3 of 5 core variables (erythrocyte sedimentation rate, physician's global assessment of disease activity, and parent's global assessment of disease activity). By the primary improvement criteria, there was significant overall improvement during MTX treatment. In the systemic arthritis group, only 2 of 5 core variables were significantly improved (physician's and parent's global assessment of disease activity). Systemic features were not part of the core variables, but the systemic feature score was not significantly different between MTX and placebo treatment. There was no significant overall improvement in this group during MTX treatment. However, no significant interaction between disease subgroup and treatment effect was demonstrated. When the data from both disease subgroups were combined, there was significant clinical improvement during MTX treatment (P = 0.006). CONCLUSION: MTX 15-20 mg/m2 given orally once a week was found to be an effective treatment for both extended oligoarticular and systemic JIA in this shortterm trial. Long-term efficacy needs to be addressed in future studies.

Adolescent↗
PubMed1984

Efficacy of mexiletine in the medium-term treatment of ventricular arrhythmias. A randomized, double-blind, crossover trial against placebo in ambulatory patients.

A double-blind, crossover study was designed to compare the safety and efficacy of mexiletine with that of placebo in reducing premature ventricular complexes (PVC) in ambulatory patients and to find out the dose which gives a good therapeutic response with a minimal incidence of side-effects. Twenty-six patients, who had on average 427.9 PVCs/hour, were admitted to the study. The doses given were designed to reduce the frequency of PVCs by 50% or more from the baseline value. Two out of the twenty-six patients stopped treatment because of major side-effects. In the remaining twenty-four patients the 3 weeks of treatment with mexiletine significantly reduced the rate of PVCs by comparison with placebo (-63.8% versus +7.5%). In the nineteen responders (per cent reduction of PVCs over 50%) the dose of mexiletine was 600 mg daily (200 mg every 8 hours). In the non-responders plasma levels of mexiletine proved to be in the therapeutic range, not in any way different from responders. The most frequent side-effects were digestive difficulties (fifteen patients taking mexiletine and six taking placebo). These results show that mexiletine is an effective anti-arrhythmic drug in the management of ventricular arrhythmias occurring in ambulatory patients. In the majority of patients mexiletine was found to be effective even at the lowest dose studied of 600 mg/day.

Adult↗
PubMed1994

Thalidomide for the treatment of uremic pruritus: a crossover randomized double-blind trial.

Our observation that thalidomide administration to a dialysis patient with leprosy alleviated his pruritus led us to conduct this short-term study to assess the efficacy of the drug in this regard. From 210 hemodialysis patients, 29 cases of refractory uremic pruritus were entered into the study. Patients were instructed to score their symptoms from 0 to 3, three times a day and assigned to receive thalidomide or placebo at bed time for 7 days. After a washout period of 7 days, drugs were crossed over. Response was defined as a reduction of at least 50% in the pruritus scoring. Eighteen patients finished the study. In the first phase, 55% of patients responded showing a mean reduction in their pruritus scoring of 78% (p < 0.05 vs. placebo); no response to placebo was observed. A similar proportion of patients responded to thalidomide in the second phase with a mean reduction in their pruritus scoring of 81%. In conclusion, thalidomide can be a precious tool in the handling of uremic pruritus unresponsive to available therapy.

Aged↗