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Biomedical subjects

C Sampaio

Publications and source records attributed to C Sampaio.

At least 37 records · Page 2Linked to original sources

Effect of ropinirole on sleep onset: a randomized, placebo-controlled study in healthy volunteers.

Somnolence and "sleep attacks" have been reported as an adverse effect of several antiparkinsonian drugs. The authors document, in a placebo-controlled, randomized, double-blind, crossover study performed in 20 healthy volunteers, using the Multiple System Latency Test (MSLT) as primary outcome, that ropinirole reduces time to sleep onset in humans. Ropinirole therapy was not associated with daytime episodes of rapid eyes movement (REM) sleep.

Cross-Over Studies↗

[Influence of placebo effect on planning and analysis of clinical trials].

Placebos, seen as any pharmacological procedure without a specific effect, have been widely used in medical practice. In the fifties, when clinical trial development started, placebos assume a new dimension, as fundamental tools in clinical trial design. The aim of this review was to evaluate and describe methodological aspects related to placebo use in clinical trials. Despite the importance attributed to placebos, particularly to maintain blinding, it is not always easy to simulate an active procedure. On the other hand, the ethical aspects of placebo utilization in some clinical and experimental circumstances are becoming more and more complex. These two aspects are commented. It is emphasized that the use of a placebo, by itself, may influence the results of a clinical study. We analyze the factors that determine the placebo effect but also how placebos and the placebo effect affect final results.

Clinical Trials as Topic↗

[Cardiac effects of acute poisoning with tricyclic antidepressants: systematic review of the literature. Part I].

Tricyclic antidepressant overdose is a frequent diagnosis in the emergency room. It is responsible for a significant percentage of hospital admissions for observation and treatment. This is due to its cardiac (as well as neurologic) toxicity, and the difficulty in predicting its clinical gravity. The authors present the paper with two objectives in mind: 1) information about a common and significant cardiological emergency; 2) presentation of the methodology concerning systematic reviews of the literature. In this first (of four) articles, the epidemiology tricyclic antidepressant overdose is presented. In the remaining three papers we will present its clinical presentation, diagnosis, treatment, prognosis and prevention. Note: this is the first of a series of four articles on the cardiac toxicity of tricyclic antidepressant overdose; the next three articles will be presented in the July, August and September issues of the RPC.

Acute Disease↗

[Cardiac effects of acute poisoning with tricyclic antidepressants: systematic review of the literature -- Part III].

Tricyclic antidepressant overdose is a frequent diagnosis in the emergency room. It is responsible for a significant percentage of hospital admissions for observation and treatment. This is due to its cardiac (as well as neurologic) toxicity, and the difficulty in predicting its clinical gravity. The authors present this paper with two objectives in mind: 1) information about a common and significant cardiological emergency; 2) presentation of the methodology concerning systematic reviews of the literature. In this third (of four) articles, the prognosis of tryciclic antidepressant overdose is presented (in the two previous articles--published in previous issues of the Revista--we discussed the epidemiological aspects as well as the clinical presentation and the diagnosis). In the remaining paper we will present its management, and prevention. Note: this is the third of a series of four articles on the cardiac toxicity of tricyclic antidepressant overdose; the final article will be presented in the October issue of the Revista.

Algorithms↗

[Cardiac effects of acute poisoning with tricyclic antidepressants: systematic review of the literature -- Part IV].

Tricyclic antidepressant overdose is a frequent diagnosis in the emergency room. It is responsible for a significant percentage of hospital admissions for observation and treatment. This is due to its cardiac (as well as neurologic) toxicity, and the difficulty in predicting its clinical gravity. The authors present this paper with two objectives in mind: 1) information about a common and significant cardiological emergency; 2) presentation of the methodology concerning systematic reviews of the literature. In this fourth article (the last in a series), we present the prevention and management of tricyclic antidepressant overdose (in the three previous articles--published in previous issues of the Revista--we discussed the epidemiological aspects as well as the clinical presentation and the diagnosis, and the prognosis). Note: this is the fourth and last article on the cardiac toxicity of tricyclic antidepressant overdose.

Acute Disease↗

[Numbers needed for treatment and their respective confidence intervals: useful tools to assess clinical significance and uncertainty associated with medical interventions].

This is a narrative review of a concept--number needed to treat (NNT). The proprieties of NNTs are described. Furthermore NNTs as important tools for medical decision are discussed. In particular, conditions that make calculus and the interpretation of NNTs somewhat more complex are commented. Namely, we consider situations where the results are not primarily binary or are expressed as "time to event" or come from a meta-analysis. The inconsistencies that might occur when NNTs are calculated from meta-analysis are discussed in some detail. Definitions for parameters derived from NNTs, as numbers needed to harm (NNH), unqualified success (NNTUS) and unmitigated failure (NNHUF) are given. Finally the usefulness of NNTs and absolute risk reductions to communicate risk to individual patients are considered. It is concluded that despite NNTs being powerful tools for medical decision, in the case of communicating risks to the individual patient absolute risks might be preferable.

Confidence Intervals↗

Movement Disorders Cochrane Collaborative Review Group.

Evidence-based medicine is the process of systematically finding, appraising, and applying contemporaneous research findings as the basis for clinical decisions. The individual clinician is too busy to perform this long and arduous task across the whole of their specialty, so they must rely on the highest quality reviews available in the literature. The Cochrane Collaboration is an international network of individuals preparing, maintaining, and disseminating systematic reviews of trials of all health care interventions. We examine the work of the Collaboration and the major method it uses to disseminate systematic reviews through the Cochrane Library. The rationale for the Cochrane Movement Disorders Group is discussed, and its management structure outlined.

Databases, Factual↗

DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.

BACKGROUND: Elston and Russell discovered a difference in the biological potency of the English formulation of botulinum toxin type A or BTX-A (Dysport) and the American formulation (Botox). Potency of both is expressed in LD50 mouse units, but because of assay differences, these units are not equivalent. Since the first warning by Quinn and Hallet on the clinical importance of this issue, it has been impossible to reach a consensus on the conversion factor for the potency of these formulations. OBJECTIVE: To test the hypothesis that the conversion factor for the clinical potency of Dysport to Botox is approximately 4:1. DYSBOT is an acronym that results from adding "DYS" from Dysport with "BOT" from Botox. PATIENTS AND METHODS DESIGN: A single-blind, randomized, parallel comparison. A total of 91 patients with blepharospasm or hemifacial spasm were randomized to treatment with Dysport or Botox using a fixed potency ratio of 4:1. Clinical evaluations: The patients were evaluated at baseline (day of the treatment). 1 month after treatment, and whenever the effect was judged to be fading. Objective and functional rating scales were used as quantitative measures of the change in clinical status. Adverse reactions were collected using a systematic questionnaire. RESULTS: Using this ratio between products, both Dysport and Botox groups produced similar clinical efficacy and tolerability. For patients showing a positive response without the need of a booster, the duration of effect was 13.3 +/- 5.9 weeks for the Dysport group and 11.2 +/- 5.8 weeks for the Botox group. Of 48 patients, 11 (23%) needed booster treatment in the Dysport group compared with five (12%) of 43 in Botox group. Adverse events were noted in 24 (50%) of 48 patients in the Dysport group and 20 (47%) of 43 of the Botox-treated group. CONCLUSIONS: Using a 4:1 conversion ratio for Dysport and Botox, similar results were obtained for the two treatments in an appropriately powered study, suggesting that this conversion factor is a good estimate of their comparative clinical potencies.

Aged↗

Botulinum toxin type A for the treatment of arm and hand spasticity in stroke patients.

BACKGROUND: Focal spasticity can be a major drawback in the rehabilitation of stroke patients. Previous studies suggest a beneficial effect for botulinum toxin A (BTX-A) for relief of spasticity. OBJECTIVE: To evaluate the safety and efficacy of BTX-A in the treatment of spasticity in a homogeneous group of stroke patients. METHODS: In this phase III open label trial 19 stroke patients stable for at least six months were enrolled (mean age 53.1 (SD 3.27) years; range 26-72). There were 16 males and 4 females. ASSESSMENTS: Clinical (Ashworth spasticity rating scale, scores for joint mobility, pain and frequency of spasms, Frenchay arm test (FAT)) and subjective (semi-quantitative rating scale filled out by the patient). Only hand and finger flexors were injected. The maximum dosage was 150 U BOTOX (25 U/muscle), the mean dosage was 92.1 +/- 31.6 U BOTOX. RESULTS: Ashworth rating scale and joint mobility scores improved from a median value of 2 at baseline to a median value of 1 one month after treatment, FAT scores also improved from a median value of 0 at baseline to a median value of 1 one month after treatment (Kruskall-Wallis test p < 0.01). Two-thirds of the patients rated their functional improvement as none or mild. CONCLUSIONS: Our study confirmed that BTX-A has an anti-spastic effect but its functional impact needs further evaluation.

Adult↗

A behavioral evaluation of PCE exposure in patients and dry cleaners: a possible relationship between clinical and preclinical effects.

Long-term deficits in visuospatial function and memory and disturbances in mood have been clinically identified and followed in four patients occupationally exposed to perchloroethylene (PCE). A frontal/limbic hypothesis is offered as the site of pathology. A separate study among 65 dry cleaners was conducted to provide similar evidence of impairment, suggesting a continuum between clinical and preclinical effects. Three exposure zones were identified for the counter clerks, pressers, and operators corresponding to air levels of 11.2, 23.2, and 40.8 ppm. Decrements were found for visual reproductions (14.4%), the number correct (6.7%) and the latency (10%) for pattern memory, and the number correct (3.9%) for pattern recognition. Chronic, life-long deficits appear below 50 ppm and require at least 3 years of exposure. A reexamination of the OSHA standard is recommended and shows that behavioral testing can be used as an early indicator of more serious clinical effects.

Adult↗

The response of "de novo" Parkinson's disease patients to bromocriptine in a "low and slow" regimen is predictive for prognosis.

It is possible that Bromocriptine only determines a complete antiparkinson effect in a subset of P.D. patients that have a good dopaminergic reserve. Our study intent to demonstrate that a good short-term response to Bromocriptine used in a "low and slow" regimen is a marker of long term good prognosis. We studied a series of 36 sequential "de novo" P.D. patients treated with Bromocriptine in a "low and slow" regimen. The principal end-point was the introduction of Levodopa. "Good prognosis" was defined as no need of Levodopa until five years of follow-up. An improvement greater than 33% in the Columbia rating scale, at the 6th month of treatment, was the cut-off point to decide that a patient had a good short term response to Bromocriptine. Nine patients fulfilled the criteria for being good short term responders. Multiple regression analysis showed that this outcome could not be predicted by the clinical characteristics of the patients at admission. The sensitivity and the specificity of the short term response to Bromocriptine to predict a good prognosis were 70% and 90.5% respectively. We conclude that Bromocriptine in monotherapy is an efficient antiparkinson agent in 1/3 of "de novo" P.D. patients and good short term response to Bromocriptine is an acceptable marker for a good prognosis. Therefore it is possible that the response to Bromocriptine is a discriminator for a subset of P.D. patients in the early phases of the disease.

Adult↗

Acute behavioural comparisons of toluene and ethanol in human subjects.

A comparison of toluene and ethanol (EtOH) induced changes in central nervous system (CNS) function and symptoms were evaluated in two studies, and when possible the effects of toluene were expressed in EtOH equivalent units. The toluene concentrations were 0, 75, and 150 ppm, bracketing the American Conference of Governmental Industrial Hygienists threshold limit value (ACGIH TLV) of 100 ppm. The socially relevant EtOH doses were 0.00, 0.33, and 0.66 g EtOH/kg body weight, equivalent to two and four 3.5% 12 ounce beers. Forty two paid college students were used in each study. In the first study, subjects were exposed to toluene and an odour masking agent menthol (0.078 ppm) for seven hours over three days. In the second study EtOH or a placebo was administered at 1530 across three days also in the presence of menthol. Verbal and visual short term memory (Sternberg, digit span, Benton, pattern memory), perception (pattern recognition), psychomotor skill (simple reaction time, continuous performance, symbol-digit, hand-eye coordination, finger tapping, and critical tracking), manual dexterity (one hole), mood (profile on mood scales (POMS), fatigue (fatigue checklist), and verbal ability were evaluated at 0800, 1200, and 1600. Voluntary symptoms and observations of sleep were collected daily. A 3 x 3 latin square design evaluated solvent effects simultaneously controlling for learning and dose sequence. An analysis of variance and test for trend were performed on am-pm differences reflecting an eight hour workday and on pm scores for each solvent, in which subjects were their own control Intersubject variation in absorbance was monitored in breath. A 5 to 10% decrement was considered meaningful if consistent with a linear trend at p less than 0.05. At 150 ppm toluene, losses in performance were 6.0% for digit span, 12.1% for pattern recognition (latency), 5% for pattern memory (number correct), 6.5% for one hole, and 3% for critical tracking. The number of headaches and eye irritation also increased in a dose-response manner. The greatest effect was found for an increasing number of observations of sleep. A range of 2 to 7% decrements suggest the ACGIH TLV of 100 ppm toluene may be a good estimate of the biological threshold supporting a re-evaluation of the TLV. At 0.66 g EtOH/kg body weight symptoms and performance decrements were 6.6% for digit span, 9.2% for pattern recognition, 4.0% for continuous performance, 7.9% for symbol-digit, 16.5% for finger tapping, 6.2% for critical tracking, and 5.2% for the one hole test. The EtOH equivalents at 150 ppm toluene for digit span (0.56g EtOH/kg/body weight), the latency for pattern recognition (0.66 g EtOH kg body weight), and the one hole element "move" (0.37 g EtOH kg body weight) show that the first two measures would be affected at or above the 50 mg% blood alcohol concentration. This concentration is recognised as the lowest alcohol concentration associated with increased numbers of automobile accidents. The results suggest that EtOH may be a useful acute standard to compare the effects of various industrial solvents and support investigating an association between exposure to solvents and increased risk to safety in industry.

Adolescent↗