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Results for “randomized crossover trial”

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PubMed1995

Lack of effectiveness of magnesium in chronic stable asthma. A prospective, randomized, double-blind, placebo-controlled, crossover trial in normal subjects and in patients with chronic stable asthma.

BACKGROUND: Magnesium sulfate has been helpful in the treatment of acute exacerbations of asthma. We hypothesized that magnesium would also be an effective bronchodilator in patients with chronic stable asthma. METHODS: We performed a prospective, randomized, double-blind, placebo-controlled, crossover trial in 15 patients with chronic, stable asthma and 10 nonasthmatics. On study day 1, spirometry and albuterol challenge were used to confirm the presence of asthma according to American Thoracic Society criteria. On study day 2, subjects received intravenous magnesium sulfate (2 g) or placebo (saline). On study day 3, subjects were crossed over to receive the other drug. Spirometry was performed before, during, and after drug or placebo administration. Circulating ionized magnesium concentrations were determined before and after intravenous magnesium or placebo administration. RESULTS: Magnesium infusion caused no statistically significant changes in forced expiratory volume in 1 second (mean +/- SEM, 1.92 +/- 0.13 L before, 1.98 +/- 0.12 L during, and 2.01 +/- 0.14 L after magnesium administration), forced vital capacity (mean +/- SEM, 3.44 +/- 0.25 L before, 3.60 +/- 0.26 L during, and 3.59 +/- 0.25 L after magnesium administration), or maximum forced expiratory flow rate (mean +/- SEM, 5.42 +/- 0.44 L/second before, 5.46 +/- 0.46 L/second during, and 5.57 +/- 0.49 L/second after magnesium administration). Placebo caused no changes in these three physiologic variables. CONCLUSION: Magnesium is not effective as a bronchodilator in chronic, stable asthmatics or in normal non-asthmatic adults.

Adult↗
PubMed2002

Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized, double-blind, sham-controlled crossover trial.

To evaluate immediate effects of two different modes of acupuncture on motion-related pain and cervical spine mobility in chronic neck pain patients compared to a sham procedure. Thirty-six patients with chronic neck pain and limited cervical spine mobility participated in a prospective, randomized, double-blind, sham-controlled crossover trial. Every patient was treated once with needle acupuncture at distant points, dry needling (DN) of local myofascial trigger points and sham laser acupuncture (Sham). Outcome measures were motion-related pain intensity (visual analogue scale, 0-100 mm) and range of motion (ROM). In addition, patients scored changes of general complaints using an 11-point verbal rating scale. Patients were assessed immediately before and after each treatment by an independent (blinded) investigator. Multivariate analysis was used to assess the effects of true acupuncture and needle site independently. For motion-related pain, use of acupuncture at non-local points reduced pain scores by about a third (11.2 mm; 95% CI 5.7, 16.7; P = 0.00006) compared to DN and sham. DN led to an estimated reduction in pain of 1.0 mm (95% CI -4.5, 6.5; P = 0.7). Use of DN slightly improved ROM by 1.7 degrees (95% CI 0.2, 3.2; P = 0.032) with use of non-local points improving ROM by an additional 1.9 degrees (95% CI 0.3, 3.4; P = 0.016). For patient assessment of change, non-local acupuncture was significantly superior both to Sham (1.7 points; 95% CI 1.0, 2.5; P = 0.0001) and DN (1.5 points; 95% CI 0.4, 2.6; P = 0.008) but there was no difference between DN and Sham (0.1 point; 95% CI -1.0, 1.2; P = 0.8). Acupuncture is superior to Sham in improving motion-related pain and ROM following a single session of treatment in chronic neck pain patients. Acupuncture at distant points improves ROM more than DN; DN was ineffective for motion-related pain.

Acupuncture Analgesia↗
PubMed2001

Fatigue in progressive multiple sclerosis: results of a randomized, double-blind, placebo-controlled, crossover trial of oral 4-aminopyridine.

Previous studies suggest that aminopyridine may play a role in the symptomatic treatment of fatigue in multiple sclerosis. Although the mechanism underlying the beneficial effect on fatigue remains unclear, it has been proposed that aminopyridines may help to improve conduction in demyelinated central pathways, implicating both axonal and synaptic mechanisms. The objective of the present study is to determine whether 4-AP decreases daily-living fatigue in progressive multiple sclerosis. The effect of 4-AP on other neurophysiological and neuropsychological parameters was also considered. A 'double-blind', randomized, 'placebo-controlled', crossover trial was conducted on 54 patients with progressive multiple sclerosis. All patients received treatment with placebo and 32 mg per day of 4-AP, each for 6 months. The main outcome measure was the Fatigue Severity Scale. Secondary measures were EDSS, cognitive functions and neurophysiological parameters. Forty-nine patients (91%) completed the study. Changes in fatigue scores, EDSS and cognitive functions were not significantly different between 4-AP and placebo. However, when patients treated with 4-AP were divided into two groups according to the serum level of 4-AP, a significant effect on fatigue compared with placebo was observed in the 'high level' (>30 ng/ml) group (P=0.05). Synchronization of motor evoked potentials improved during 4-AP with respect to placebo (P=0.019) and this correlated positively with fatigue reduction (P=0.010). No relevant side effects were observed.

4-Aminopyridine↗
PubMed1993

An evaluation of the effect of gonadotropin-releasing hormone analogs and medroxyprogesterone acetate on uterine leiomyomata volume by magnetic resonance imaging: a prospective, randomized, double blind, placebo-controlled, crossover trial.

The purpose of this study was to prospectively compare the effectiveness of administering medroxyprogesterone acetate (MPA; 20 mg/day) in either the first (protocol A) or last (protocol B) 12-week period along with a 6-month course of the GnRH analog (GnRH-a; leuprolide acetate; 1 mg/day, sc) on uterine and leiomyomata volumes and hormone (estradiol, LH, and FSH) and serum lipid (total cholesterol, triglycerides, and high and low density lipoprotein) levels. Sixteen women were randomized into protocol A or B, received either MPA or placebo along with GnRH-a, respectively, and were then crossed over at 12 weeks to placebo or MPA, respectively, for the final 12-week interval of GnRH-a therapy. Total, myoma, and nonmyoma uterine volumes were determined by magnetic resonance imaging, and serum studies were performed at the beginning of the study and at 12 and 24 weeks. In both protocols, LH and estradiol levels declined by 80-90% (P < 0.03) and 55-72% (P < 0.02) of the baseline, respectively, at 12 weeks and remained at this level at 24 weeks. There were no significant changes in the other laboratory tests between protocols or longitudinally over time. Total uterine volume decreased to 73% of the baseline at 12 weeks in protocol B (P < 0.04), but did not change in protocol A. After crossover at 12 weeks, the total uterine volume of women in protocol A decreased to 74% of the baseline (P < 0.02) at 24 weeks. Between-protocol comparisons demonstrated a greater decline in total uterine volume in protocol B than A at 12 weeks, but after cross-over, MPA addition was associated with a significant increase in total uterine volume (protocol B) compared to a decrease in protocol A at 24 weeks (P < 0.005). In contrast, although myoma volume declined in both protocols, no significant changes in myoma volume were detected within or between groups over the treatment period. Nonmyoma volume changes in protocols A and B roughly paralleled total uterine volume changes, with MPA coadministration showing a correlation with a reversal in the GnRH-a-associated decrease in nonmyomatous tissue volume.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed2003

Effects of long and short hemodialysis on endothelial function: a short-term study.

BACKGROUND: Endothelial dysfunction is common in end-stage renal disease and may contribute to the development of both hypertension and atherosclerosis. Long-slow hemodialysis (HD) has been associated with superior blood pressure control and fewer cardiovascular complications. We hypothesized that long dialysis times would improve endothelial function compared with shorter dialysis times. METHOD: Eight long-term hemodialysis patients, not on antihypertensive drugs and with no evidence of vascular disease, were studied in a three-way randomized crossover-controlled trial. Each received, for one week and in randomized sequence, four hours of HD (SD), eight hours of HD, and eight hours of HD using a smaller dialyzer and slower blood pump. The same post-dialysis target weights were used with each treatment. On the third day of each treatment endothelium-dependent (flow mediated) and independent glyceryl trinitrate (GTN) induced vasodilation were measured by forearm strain-gauge plethysmography, and von Willebrand (vW) antigen, plasma homocysteine (tHcy) and neurohormones were measured pre- and post-dialysis. RESULTS: Despite achieving target post-dialysis weights with all treatments, pre-dialysis weight tended higher on SD. Endothelial dependent vasodilation increased after all HD treatments but did not differ between them. Adrenomedullin, N-terminal brain natriuretic peptide and vW antigen increased similarly across all HD whereas atrial and C-type natriuretic peptide, and endothelin-1 decreased across dialysis and were higher with SD. Pre-dialysis plasma tHcy concentrations were 13% higher during SD treatment. CONCLUSION: Hemodialysis improved endothelial-dependent vasodilation but the effect was similar with all three HD treatments. Improved endothelial function might result in part from altered local hormone production (endothelin-1 and adrenomedullin). These data suggest that increasing dialysis time is unlikely, in the short-term, to significantly improve endothelial function in patients with end-stage renal disease, but longer term studies are needed.

Adrenomedullin↗
PubMedDate not supplied

Validation of a single-patient drug trial methodology for personalized management of gastroesophageal reflux disease.

BACKGROUND: Single-patient trials (SPTs) are randomized, often multiple-crossover trials where patients serve as their own control to determine their appropriate treatment. Historically, SPTs have been individually customized, requiring significant time and cost for execution. The patient.s progress is tracked and evaluated in a blinded, multiple-crossover design comparing different therapies. Standardized, cost-efficient SPTs could help avoid (a) inappropriate extrapolation of the average-group outcomes from parallel, clinical trials to community-practice patients and (b) wasteful prescribing of high-cost drugs. Aggregate SPT results can also provide new data on appropriate drug prescribing in subpopulations. OBJECTIVE: To validate a standardized, commercially useful SPT method for comparing drugs/doses in patients with gastroesophageal reflux disease (GERD) requiring maintenance therapy. METHODS: A double-blind, single-dummy, randomized, 3 paired-period (28 days per period, 14 days per leg), multiple-crossover, SPT comparing omeprazole 20 mg daily and ranitidine hydrochloride (ranitidine) 150 mg twice daily was employed for 32 patients with GERD taking acid-suppressing medications chronically. Endpoints to determine effectiveness were selected from a recently approved new-drug application. Heartburn, regurgitation, difficulty swallowing, epigastric pain, and nausea were evaluated daily. Use of rescue medications was also measured. Quality of life was measured weekly by the patient.s global evaluation. Observations for days 1 to 4 were excluded by using aggregate database sensitivity analyses to define appropriate surrogate washout periods. Frequently reported adverse events found in labeling for acid-suppressing drugs were directly solicited and compared between treatments. Unsolicited events were recorded. Patients completed a test-kit-acceptability questionnaire. RESULTS: Fourteen of 27 evaluable SPTs (52%) showed significant superiority for omeprazole over ranitidine and 7 of 27 (26%) for ranitidine over omeprazole. Four of 27 (15%) showed parity performance. Neither agent could be recommended in 2 of 27 (7%) of SPTs due to significant adverse events experienced with both drugs. For those patients taking proton pump inhibitors (PPIs) prior to enrollment, the estimated step-down substitution rate from omeprazole to ranitidine, combined with the drug therapy discontinuation rate, was 40% (90% confidence interval: 22% to 68%). The majority of patients rated the test kits as appropriate and desirable. CONCLUSION: Omeprazole was the appropriate treatment in only 52% of these chronic users of acid-suppressing drugs. Eleven of 27 trials (41%) indicated that ranitidine was the preferred treatment. The SPT method proved acceptable to patients, feasible to administer, and reproducible. It can statistically discriminate effectiveness and adverse events and serve as a useful, prognostic tool in community practice by determining the least costly, evidence-based, appropriate treatment.

Clinical Trial↗
PubMed2006

Speed of injection influences efficacy of inferior alveolar nerve blocks: a double-blind randomized controlled trial in volunteers.

This randomized double-blind crossover trial investigated the efficacy and discomfort associated with slow (60 seconds) and rapid (15 seconds) inferior alveolar nerve blocks (IANB) using 2.0 ml of 2% lidocaine with 1:80,000 epinephrine in securing mandibular first molar, premolar and lateral incisor pulp anesthesia in 38 healthy adult volunteers. Episodes of maximal stimulation (80 microA) without sensation on electronic pulp testing were recorded. Injection discomfort was self-recorded by volunteers on 100 mm visual analogue scales. Data were analyzed by McNemar, Friedman, Wilcoxon Signed Ranks, and paired t tests. Slow IANB produced more episodes of no response to maximal pulp stimulation than rapid IANB in molars (220 episodes versus 159, p < 0.001), premolars (253 episodes versus 216, p = 0.003) and lateral incisors (119 episodes versus 99, p = 0.049). Slow IANB was more comfortable than rapid IANB (p = 0.021).

Adult↗
PubMed2002

A randomized double-blinded placebo-controlled crossover trial of nebulized taurolidine in adult cystic fibrosis patients infected with Burkholderia cepacia.

Burkholderia cepacia is an aggressive pathogen that colonizes cystic fibrosis (CF) patients, causing greatly increased morbidity and mortality. It is resistant to most antibiotics, but sensitive in vitro to a novel agent, taurolidine. This has not previously been used against B. cepacia, nor given in nebulized form. We assessed the effect of nebulized taurolidine on United Kingdom epidemic (ET12) B. cepacia infection in 20 adult CF patients attending our regional adult cystic fibrosis outpatient clinic using a prospective, randomized, double-blinded placebo-controlled crossover trial. Nebulized taurolidine (4 mL 2% solution) or saline (4 mL 0.9% solution) was given twice daily. Each arm lasted 4 weeks, with a 2-week intervening washout period. Sputum B. cepacia colony counts (primary outcome measure), spirometry, and symptoms (secondary outcome measures) were assessed. Eighteen patients completed the study. There was no change in B. cepacia colony counts or spirometry, nor symptom scores. We conclude that, although taurolidine is well tolerated in nebulized form, in this study it had no in vivo anti-B. cepacia activity.

Adolescent↗
PubMed2005

Topiramate add-on in treatment-resistant schizophrenia: a randomized, double-blind, placebo-controlled, crossover trial.

OBJECTIVE: We tested the hypothesis that topiramate is more effective than placebo in reducing symptoms in patients with treatment-resistant schizophrenia when combined with ongoing antipsychotic medication. METHOD: Twenty-six hospitalized treatment-resistant patients with chronic DSM-IV-diagnosed schizophrenia participated in a randomized, double-blind, placebo-controlled trial in which 300 mg/day of topiramate was gradually added to their ongoing treatment (clozapine, olanzapine, risperidone, or quetiapine) over two 12-week crossover treatment periods. Data were collected from April 2003 to November 2003. RESULTS: In intention-to-treat analysis, topiramate was more effective than placebo in reducing Positive and Negative Syndrome Scale general psychopathologic symptoms (effect size = 0.7, p = .021), whereas no significant improvement was observed in positive or negative symptoms. CONCLUSION: Glutamate antagonist topiramate may be an effective adjuvant treatment in reducing general psychopathologic symptoms in patients with schizophrenia resistant to treatment with second-generation antipsychotics.

Adult↗
PubMed1999

A randomized, controlled trial of bright light therapy for agitated behaviors in dementia patients residing in long-term care.

BACKGROUND: Agitated behaviors are common in dementia patients residing in chronic care settings. Their occurrence may be associated with lack of adequate exposure to sunlight and with circadian rhythm disturbances. OBJECTIVE: Prior research has suggested that bright light therapy (BLT) may reduce agitated behaviors in dementia patients. The aim of this study was to test the efficacy of BLT in a randomized, controlled, crossover clinical trial. METHOD: Fifteen patients with dementia and agitated behaviors residing in a chronic care facility were randomized in a crossover design to morning BLT for 1 hour per day or to a control condition with dim light exposure. Patients were treated in either condition for 4 weeks, followed by 1 week on no treatment, prior to being crossed over to the other condition. RESULTS: Eight out of 15 patients completed the entire study. The rest completed at least 2 weeks of study. Patients randomized to the BLT condition exhibited a statistically significant improvement in nocturnal sleep from a mean of 6.4 hours/night to 8.1 hours/night 4 weeks later (p<0.05). The sleep of patients in the control condition did not improve significantly. There were no other significant differences between baseline and follow-up, nor between BLT and control treated patients on the other outcome measures, which included the Behavioral Pathology in Alzheimer Disease scale (Behave-AD) and the Cornell Scale for Depression in Dementia. CONCLUSION: Patients with dementia in chronic care who exhibit agitated behaviors sleep more hours at night when administered morning BLT. However, BLT does not lead to improvements in agitated behaviors in institutionalized patients with dementia with non-disturbed sleep-wake cycles.

Aged↗
PubMed2003

Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for Women in women with and without female sexual arousal disorder.

Zestra for Women is a botanical feminine massage oil formulated to enhance female sexual pleasure and arousal when applied to the vulva. We conducted this randomized, double-blinded, crossover study to evaluate the efficacy and safety of Zestra for Women compared to placebo oil in 10 women with and 10 women without female sexual arousal disorder (FSAD) in conditions of home use in conjunction with sexual activities. Subjects were screened by physical examination, sex therapist interviews, and questionnaires. We randomized qualified subjects to treatment paths and gave them 5 doses of test article and diaries to use at home. At Visit 2, we assessed them by questionnaires and gave them 5 doses of crossover test article and diaries to use at home. At the final visit, we assessed them with questionnaires. We assessed safety by adverse event reports and primary efficacy by responses to a diary question regarding satisfaction with arousal. Secondary efficacy instruments included remaining diary questions, recall-based questionnaires, global assessment questions, and a consumer-testing questionnaire. All 20 subjects completed the study. Three subjects reported single incidences of mild genital burning sensations lasting 5-30 min after use of Zestra for Women. Both normal and FSAD women showed statistically significant improvements, relative to placebo, in level of arousal, level of desire, satisfaction with arousal, genital sensation, ability to have orgasms, and sexual pleasure. Although FSAD women showed greater magnitude of response, the presence of FSAD had no effect on response rates. Zestra for Women was just as effective in women using selective serotonin reuptake inhibitor antidepressants as in women not using antidepressants. Zestra for Women improved sexual function in normal and FSAD women under conditions of home use.

Administration, Topical↗
PubMed2005

Randomized, double-blind, placebo-controlled crossover trial of famotidine in patients with functional dyspepsia.

BACKGROUND: Histamine 2-receptor antagonists were used as a first therapy against functional dyspepsia. However, few clinical studies with famotidine for functional dyspepsia have been reported. AIM: To evaluate the effectiveness of famotidine for functional dyspepsia patients. METHODS: A multicentre, randomized, double-blind, placebo-controlled crossover trail was conducted. Patients diagnosed with functional dyspepsia by the Roma II criteria were included. Subjects were randomized into two groups, and received either famotidine or placebo as the first 4 weeks medication. After a 1-week washout period, they were switched to the other regimen for another 4 weeks. Evaluation was made prior to the start of study, upon completion of the first drug cycle, and the second drug cycle, by Gastrointestinal Symptoms Rating Scale for the seriousness of abdominal symptoms, and by Short Form-36 for the level of quality of life. RESULTS: Nineteen of 21 enrolled patients successfully completed this study. Significant improvement in Gastrointestinal Symptoms Rating Scale scores was observed in abdominal pain (P = 0.007), indigestion and reflux syndrome after famotidine treatment. Also quality of life scores showed significant improvement in body pain, vitality and general health perceptions after famotidine treatment. There was no improvement of symptoms and quality of life scores after administration of placebo. CONCLUSIONS: Famotidine was effective for improving symptoms and quality of life in functional dyspepsia patients.

Adult↗
PubMed2004

Sildenafil increased exercise capacity during hypoxia at low altitudes and at Mount Everest base camp: a randomized, double-blind, placebo-controlled crossover trial.

BACKGROUND: Alveolar hypoxia causes pulmonary hypertension and enhanced right ventricular afterload, which may impair exercise tolerance. The phosphodiesterase-5 inhibitor sildenafil has been reported to cause pulmonary vasodilatation. OBJECTIVE: To investigate the effects of sildenafil on exercise capacity under conditions of hypoxic pulmonary hypertension. DESIGN: Randomized, double-blind, placebo-controlled crossover study. SETTING: University Hospital Giessen, Giessen, Germany, and the base camp on Mount Everest. PARTICIPANTS: 14 healthy mountaineers and trekkers. MEASUREMENTS: Systolic pulmonary artery pressure, cardiac output, and peripheral arterial oxygen saturation at rest and during assessment of maximum exercise capacity on cycle ergometry 1) while breathing a hypoxic gas mixture with 10% fraction of inspired oxygen at low altitude (Giessen) and 2) at high altitude (the Mount Everest base camp). INTERVENTION: Oral sildenafil, 50 mg, or placebo. RESULTS: At low altitude, acute hypoxia reduced arterial oxygen saturation to 72.0% (95% CI, 66.5% to 77.5%) at rest and 60.8% (CI, 56.0% to 64.5%) at maximum exercise capacity. Systolic pulmonary artery pressure increased from 30.5 mm Hg (CI, 26.0 to 35.0 mm Hg) at rest to 42.9 mm Hg (CI, 35.6 to 53.5 mm Hg) during exercise in participants taking placebo. Sildenafil, 50 mg, significantly increased arterial oxygen saturation during exercise (P = 0.005) and reduced systolic pulmonary artery pressure at rest (P < 0.001) and during exercise (P = 0.031). Of note, sildenafil increased maximum workload (172.5 W [CI, 147.5 to 200.0 W]) vs. 130.6 W [CI, 108.8 to 150.0 W]); P < 0.001) and maximum cardiac output (P < 0.001) compared with placebo. At high altitude, sildenafil had no effect on arterial oxygen saturation at rest and during exercise compared with placebo. However, sildenafil reduced systolic pulmonary artery pressure at rest (P = 0.003) and during exercise (P = 0.021) and increased maximum workload (P = 0.002) and cardiac output (P = 0.015). At high altitude, sildenafil exacerbated existing headache in 2 participants. LIMITATIONS: The study did not examine the effects of sildenafil on normoxic exercise tolerance. CONCLUSIONS: Sildenafil reduces hypoxic pulmonary hypertension at rest and during exercise while maintaining gas exchange and systemic blood pressure. To the authors' knowledge, sildenafil is the first drug shown to increase exercise capacity during severe hypoxia both at sea level and at high altitude.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed1993

Inhibition of leukotriene D4-induced bronchoconstriction in subjects with asthma: a concentration-effect study of ICI 204,219.

The peptide-leukotriene antagonist, ICI 204,219 [4-(5-cyclopentyloxycarbonylamino-lmethylindol-3-ylmethyl )-3-methoxy-n-o-tolylsulfonyl benzamide], was administered 12 hours before an inhaled leukotriene D4 (LTD4) challenge during a double-blind, placebo-controlled, randomized, two-period crossover trial. Subjects with mild asthma were randomized into five treatment groups (six subjects each) and received single oral doses of placebo and either 5, 10, 20, 40, or 100 mg of ICI 204,219 on day 1 of each treatment period. ICI 204,219 was tolerated well by all subjects. A progressive dose response was observed for doses of ICI 204,219 from 5 mg through 100 mg. Compared with placebo, ICI 204,219 increased the concentration (PC20FEV1) and dose of LTD4 needed to reduce forced expiratory volume in 1 second (FEV1) by 20%. Mean LTD4 PC20FEV1 for groups that received placebo and 10, 40, or 100 mg ICI 204,219 increased by tenfold or more (p < 0.05). An association was found between the plasma concentration and protective effect of ICI 204,219 (p < 0.01). ICI 204,219 is the first leukotriene receptor antagonist for which a relationship has been established between drug plasma levels and its protective effect in subjects with asthma.

Adolescent↗
PubMed1998

Comparison of the effects of cetirizine and ebastine on the skin response to histamine iontophoresis monitored with laser Doppler flowmetry.

BACKGROUND: The administration of histamine with iontophoresis is an alternative method to skin prick tests or intradermal injections. Skin reactions obtained with this method can be recorded with laser Doppler flowmetry (LDF) and previous studies with this method have shown histamine-induced laser Doppler changes in the wheal area. OBJECTIVE: In order to compare the influence of two H1 receptor antagonists (cetirizine 10 mg vs. ebastine 10 mg) on the skin vascular responses to histamine introduced by iontophoresis, we designed a double-blind, randomized, two-period crossover trial in which 18 volunteers were randomized. METHODS: Before and 2, 5 and 7 h after drug administration, iontophoresis (30 s, 1.4 mA/cm2) of histamine 10% was performed and followed by (1) monitoring of skin vascular responses with LDF at the administration site and at 1 cm from it, and (2) wheal and flare area measurements. RESULTS: 2, 5 and 7 h after intake of the antihistaminic drug, there were significant differences between both drugs. Concerning LDF recordings, we noted at the histamine administration site an increase in perfusion unit (PU) values which is an effect known to be in proportion to the degree of inhibition of wheal reaction, and at 1 cm distal to the histamine administration site, there was a decrease in PU values. These changes were more marked under cetirizine. A greater suppressive effect of cetirizine on the wheal and flare reaction was consistently observed at all time points during the study, demonstrating its superior efficacy. CONCLUSION: We conclude that (1) cetirizine demonstrated a stronger antihistaminic effect compared to ebastine at all time points; (2) iontophoresis appears to be an appropriate method to study specific microvascular changes at the delivery site of histamine and hence to detect the earliest changes occurring at the site of agonist-antagonist competition in the skin.

Adult↗
PubMed2006

The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: a SILHOUETTE trial sub-study.

OBJECTIVE: To determine if simvastatin effectively decreases the elevated levels of triglyceride (TG), TG-rich lipoproteins, and small, dense LDL particles, which are characteristic of diabetic dyslipidemia. RESEARCH DESIGN AND METHODS: We conducted a prespecified analysis from a double-blind, placebo-controlled, randomized, 6-week crossover trial in patients with type 2 diabetes and low HDL-C (< 40 mg/dL). Each patient was randomized to 1 of 6 possible treatment arms; each patient received simvastatin 80 mg, simvastatin 40 mg, and placebo over 3 periods. We used the validated vertical auto profile (VAP) method to directly assess TG-rich lipoproteins and LDL subclasses. We assessed the efficacy of simvastatin to improve the lipoprotein profile in adult men (71%) and women (29%) (n = 151) with stable type 2 diabetes (HbA1C < 9%), LDL-C > 100 mg/dL, HDL-C < 40 mg/dL, and fasting TG level > 150 and < 700 mg/dL (median = 273 mg/dL). MAIN OUTCOME MEASURES: Percentage change from baseline in IDL and VLDL (TG-rich lipoproteins), LDL subclasses, and additional lipoproteins at the end of each 6-week treatment interval; percentage of patients who reached NCEP ATP III non-HDL goal of < 130 mg/dL by the end of each 6-week period. RESULTS: Both simvastatin 80 mg and 40 mg significantly reduced VLDL-C, VLDL3, and IDL, as well as the four LDL subclasses measured with VAP, compared with placebo. Simvastatin 80 mg, compared with simvastatin 40 mg, provided additional efficacy. With simvastatin 80 mg, 77.2% of patients not at their non-HDL-C goal of < 130 mg/dL at study baseline reached goal, compared with 65.7% following simvastatin 40 mg treatment, and 2.2% following placebo. CONCLUSIONS: Treatment with simvastatin effectively reduced the elevated levels of TG-rich lipoproteins and improved LDL composition in patients with type 2 diabetes. A large percentage of these patients attained the NCEP ATP III non-HDL-C goal of < 130 mg/dL, which demonstrates the improvement of the atherogenic profile in these patients.

Aged↗
PubMed1980

Double-blind crossover trial of oral meptazinol, pentazocine and placebo in the treatment of pain in the elderly.

In a randomized, double-blind crossover trial in 30 elderly patients suffering from moderate to severe pain, the analgesic efficacy, tendency to produce mental confusion and side effect profile of meptazinol 100 mg orally were compared with those of pentazocine 25 mg orally were compared with those of pentazocine 25 mg orally and placebo. Both the active drugs produced significantly better analgesia than placebo but meptazinol also provided significantly better pain relief than pentazocine, whilst at the same time causing less mental confusion. Side effects were unremarkable. Meptazinol appears to be a better general purpose oral analgesic in this group of patients than pentazocine.

Aged↗