European neurology
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Comparative Study
Gender differences in coping with tension-type headaches.
To study gender differences of coping with illness strategies in tension-type headaches. ⋯ We conclude that pessimistic coping with illness strategies are more frequent in female episodic and chronic TTH sufferers. We would like to recommend special psychologic intervention in particular to female chronic TTH sufferers which would offer counseling in developing active coping skills.
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All trials require a principal investigator to take the lead role and act as main contact amongst the various groups of participants. His role ranges from assistance in protocol design; through selection of investigators, monitoring of study conduct and responding to Safety Committee recommendations; to involvement in study reporting and in maintaining access to the data set after the conclusion of the trial. This article describes the role of the principal investigator and Steering Committee in more detail and discusses the issues that arise out of the organisational requirements of modern clinical trials and the potential tensions between the various participating groups.
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The responsibility for reports about drug trials in medical journals should lie with the clinicians in the steering committee, not with the industrial sponsor. Examples of undue influence of sponsors on the conduct and analysis are the choice of surrogate outcome events, changes in the protocol during the trial, discontinuation of the study, post hoc analyses and suppression of publication. Since this essay was written, the International Committee of Medical Journal Editors ("Vancouver Group") has issued the condition that authors of submitted manuscripts should guarantee their independence in data analysis and reporting. ⋯ Institutional Review Boards should routinely take the matter of independence into account. Also, European guidelines should be rewritten to reflect these fundamental issues rather than a multitude of details. In fact not sponsors or physicians but patients and the general public are the true owners of trial data.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Crossover comparison of efficacy and preference for rizatriptan 10 mg versus ergotamine/caffeine in migraine.
Rizatriptan is a selective 5-HT(1B/1D) receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This randomized double- blind crossover outpatient study assessed the preference for 1 rizatriptan 10 mg tablet to 2 ergotamine 1 mg/caffeine 100 mg tablets in 439 patients treating a single migraine attack with each therapy. Of patients expressing a preference (89.1%), more than twice as many preferred rizatriptan to ergotamine/caffeine (69.9 vs. 30.1%, p < or = 0.001). ⋯ Recurrence rates were 31.4% with rizatriptan and 15.3% with ergotamine/caffeine. Both active treatments were well tolerated. The most common adverse events (incidence > or = 5% in one group) after rizatriptan and ergotamine/caffeine, respectively, were dizziness (6.7 and 5.3%), nausea (4.2 and 8.5%) and somnolence (5.5 and 2.3%).
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A reliable and reproducible method for precisely predicting the neurological outcome of patients with hypoxic-ischemic encephalopathy after cardiac arrest is urgently needed in neurological intensive care units. We prospectively investigated the predictive power of serum concentrations of neuron-specific enolase (NSE) and protein S-100B (S-100B) measured on days 1, 2, 3 and 7 as well as somatosensory-evoked potentials (SEPs) recorded within 48 h and on day 7 after cardiopulmonary resuscitation (CPR) in 27 patients (14 females, 13 males; mean age 61.3 +/- 17.3 years) with hypoxic-ischemic encephalopathy. ⋯ Additional use of S-100B on day 2 did not increase sensitivity, but this could be markedly increased by combining NSE and S-100B on days 1, 3 and 7. SEPs showing bilateral loss of cortical responses identified patients who did not regain consciousness with a specificity of 100%.