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Episode Frequency (episode + frequency)
Selected AbstractsAre antidepressants safe in the treatment of bipolar depression?ACTA PSYCHIATRICA SCANDINAVICA, Issue 5 2008A critical evaluation of their potential risk to induce switch into mania or cycle acceleration Objective:, To address whether switch of depression into hypomania or mania or cycle acceleration in patients with bipolar disorder is caused by antidepressants or whether this phenomenon is attributable to the natural history of bipolar disorder itself. Method:, A critical review of the literature, pointing at sources of bias that have been previously overlooked. For examining the causation in question, the Bradford,Hill criteria were applied, i.e. specificity of the potential causative agent, strength of effect, consistency in findings, dose,response relation, temporal relation with exposure to agent preceding effect and biological plausibility. Results:, There is a scarcity of randomized studies addressing the question, and the available studies all suffer from various forms of bias. However, there is some evidence suggesting that antidepressants given in addition to a mood stabilizer are not associated with an increased rate of switch when compared with the rate associated with the mood stabilizer alone. Conclusion:, When combined with a mood stabilizer, antidepressants given for acute bipolar depression seemingly do not induce a switch into hypomania or mania. Whether antidepressants may accelerate episode frequency and/or may cause other forms of destabilization in patients with bipolar disorder remain to be properly studied. [source] Distribution of Patients, Paroxysmal Atrial Tachyarrhythmia Episodes: Implications for Detection of Treatment EfficacyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2001WILLIAM F. KAEMMERER Ph.D. Distribution of Paroxysmal Atrial Tachyarrhythmia Episodes.Introduction: Clinical trials of treatments for paroxysmal atrial tachyarrhythmia (pAT) often compare different treatment groups using the time to first episode recurrence. This approach assumes that the time to the first recurrence is representative of all times between successive episodes in a given patient. We subjected this assumption to an empiric test. Methods and Results: Records of pAT onsets from a chronologic series of 134 patients with dual chamber implantable defibrillators were analyzed; 14 had experienced > 10 pAT episodes, which is sufficient for meaningful statistical modeling of the time intervals between episodes. Episodes were independent and randomly distributed in 9 of 14 patients, but a fit of the data to an exponential distribution, required by the stated assumption, was rejected in 13 of 14. In contrast, a Weibull distribution yielded an adequate goodness of fit in 5 of the 9 cases with independent and randomly distributed data. Monte Carlo methods were used to determine the impact of violations of the exponential distribution assumption on clinical trials using time from cardioversion to first episode recurrence as the dependent measure. In a parallel groups design, substantial loss of power occurs with sample sizes < 500 patients per group. In a cross-over design, there is insufficient power to detect a 30% reduction in episode frequency even with 300 patients. Conclusion: Clinical trials that rely on time to first episode recurrence may be considerably less able to detect efficacious treatments than may have been supposed. Analysis of multiple episode onsets recorded over time should be used to avoid this pitfall. [source] Urodynamics, the supine empty bladder stress test, and incontinence severity,,§NEUROUROLOGY AND URODYNAMICS, Issue 7 2010Charles W. Nager Abstract Aims Determine whether urodynamic measures of urethral function [(valsalva leak point pressure (VLPP), maximum urethral closure pressure (MUCP), functional urethral length (FUL)] and the results of the supine empty bladder stress test (SEBST) correlate with each other and with subjective and objective measures of urinary incontinence (UI). Methods Data were collected preoperatively from subjects enrolled in a multicenter surgical trial of mid-urethral slings. Subjective measures included questionnaire scores from the Medical Epidemiological and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Objective measures included a 24-hr pad weight test, incontinence episode frequency on a 3-day voiding diary, and a SEBST. Results Five hundred ninety-seven women enrolled. Three hundred seventy-two women had valid VLPP values; 539 had valid MUCP/FUL values. Subjective measures of severity had weak to moderate correlation with each other (r,=,0.25,0.43) and with objective measures of severity (r,=,,0.06 to 0.45). VLPP and MUCP had moderate correlation with each other (r,=,0.36, ,<,0.001). Urodynamic measures of urethral function had little or no correlation with subjective or objective measures of severity. Subjects with a positive SEBST had more subjective and objective severity measures compared to the negative SEBST group, but they did not have significantly different VLPP and MUCP values. Conclusions VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST. This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity. Neurourol. Urodynam. 29:1306,1311, 2010. © 2010 Wiley-Liss, Inc. [source] Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trialBJU INTERNATIONAL, Issue 3 2004R.J. Millard OBJECTIVES To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. PATIENTS AND METHODS The study included 458 women aged 27,79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF <14 and ,14). Analysis of covariance was used to analyse I-QOL scores. RESULTS The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of ,,14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. CONCLUSIONS These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America. [source] Migraine-Related Vertigo: Diagnostic Criteria and Prophylactic TreatmentTHE LARYNGOSCOPE, Issue 10 2006Arturo Maione MD Abstract Objective/Hypothesis: The objective of this prospective, observational study was to evaluate the efficacy of migraine pharmacologic prophylaxis on a group of vertiginous patients considered affected by migraine-related vertigo on the basis of precise criteria of inclusion. Methods: Fifty-three patients affected by migraine-related vertigo were selected from a cohort of 652 vertiginous patients referred to our Dizziness Unit from March 2001 to June 2005. Inclusion criteria were at least five vertigo attacks occurred in any period of time or dizziness and/or positional vertigo for at least 6 months; migraine, past or present, and/or a family history of migraine and/or motion intolerance; and exclusion of other causes. Patients were submitted to migraine pharmacologic prophylaxis selected on the basis of the characteristics of the patients and of the drug side effects. The efficacy of the treatment was evaluated after 6 months by questionnaire divided into five outcome categories (resolution, substantial control, moderate control, minimal control, no improvement or worsening) and, for the patients with recurrent vertiginous attacks, also reporting the percentage reduction of the attack frequency. Results: Thirty-six patients completed the study and were submitted to analysis of the results: 10 reported complete resolution of symptoms, 15 substantial control, 7 moderate control, one minimum control and 3 no improvement. Thirty-three of them had recurrent vertigo: 19 reported complete disappearance of the attacks, 8 reduction of the frequency >50%, 5 reduction <50%, and one no reduction. Conclusions: Migraine prophylactic treatment shows encouraging results in patients with migraine-related vertigo selected with our criteria of inclusion: 69.3% reported satisfactory control of symptoms (sum of complete resolutions and substantial controls) and 81.8% had at least a 50% reduction of the vertiginous episodes frequency. [source] | ||||||||||