Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial.

Background: Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-trauma focused treatment that may offer an alternative treatment for PTSD. Methods: This paper describes the study protocol for IMPACT, an assessor-blinded randomized controlled trial that examines the non-inferiority of UP relative to PE for participants who meet DSM-5 criteria for current PTSD. One hundred and twenty adult participants with PTSD will be randomized to receive either 10 × 90-min sessions of UP or PE with a trained provider. The primary outcome is severity of PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at post-treatment. Discussion: While evidence-based treatments are available for PTSD, high levels of treatment dropout and non-response require new approaches to be tested. The UP is based on emotion regulation theory and is effective in treating anxiety and depressive disorders, however, there has been limited application to PTSD. This is the first rigorous study comparing UP to PE in a non-inferiority randomized controlled trial and may help improve clinical outcomes for those with PTSD. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry, Trial ID (ACTRN12619000543189).

Low risk of significant echocardiographic valvulopathy in patients treated with anorectic drugs.

BACKGROUND: Phentermine--fenfluramine and dexfenfluramine use for weight loss has been previously associated with increased prevalence of valvular heart disease. This association was initially based on small numbers of patients, limited data on dose and duration of drug therapy, and no correlation with matched controls. METHODS: Our investigation involved 343 obese subjects enrolled in a prospective, strict weight loss, research protocol from September 1994 to September 1997. All subjects underwent transthoracic echocardiography for significant valvular lesions within a mean of 121 days from the manufacturer's announcement of the voluntary withdrawal of fenfluramine and dexfenfluramine from the market. All echocardiograms were interpreted by 2 independent readers. RESULTS: The study population included 281 females and 62 males with a mean age of 46.7+/-9.1 years and mean initial body mass index of 40.1+/-8.1 kg/m(2). Using the Food and Drug Administration's criteria, only 21 subjects (6.1%) had significant valvular lesions. Aortic regurgitation was detected in 18 subjects, mitral regurgitation in 3 subjects, and both aortic and mitral regurgitation in 1 subject; no one had severe regurgitation. Significant valvular disease did not correlate with age, gender, initial/ending body mass index, the drug dose, duration of drug therapy, or serotonin reuptake inhibitors. CONCLUSIONS: Anorexigen therapy is associated with a low prevalence of significant valvular regurgitation. Late valvular abnormalities from drug treatment await long term prospective studies.

Safety and efficacy of an accelerated dobutamine stress echocardiography protocol in the evaluation of coronary artery disease.

Although dobutamine requires up to 10 minutes to achieve steady state, dobutamine stress echocardiography is routinely performed using stepwise increments at 3-minute intervals. Consequently, the full effect of any infusion rate is not attained before the dobutamine dose is advanced to the next level. This study sought to test the safety and efficiency of high-dose continuous dobutamine infusion. One hundred consecutive patients underwent an accelerated protocol using a constant infusion of 50 microg/kg/min. In the absence of a stress echocardiographic end point (>/=85% of maximal predicted heart rate, new wall motion abnormalities, hypotension, arrhythmia, or intolerable symptoms), dobutamine infusion was discontinued at 10 minutes. Hemodynamic responses and adverse effect profile were compared with 100 patients who underwent a standard stepwise dobutamine stress protocol. Peak heart rate (140 +/- 16 vs 140 +/- 19 beats/min, p = 0.95) and systolic blood pressure (169 +/- 32 vs 162 +/- 31 mm Hg, p = 0.08) were similar in both protocols. Accelerated dobutamine administration produced a rapid increase in heart rate (12.5 +/- 6.2 vs 5.7 +/- 2.6 beats/min, p <0.001), and a substantial reduction in test duration (6.4 +/- 2.4 vs 12.9 +/- 3.0 minutes, p <0.001). The mean weight-adjusted cumulative dobutamine dose was lower in the accelerated protocol group (320 +/- 111 vs 353 +/- 133 microg/kg, p = 0.016). No significant differences were noted between the 2 groups with respect to various side effects. These data demonstrate that a high-dose, single-stage dobutamine echocardiographic stress protocol is a feasible, well-tolerated alternative to standard dobutamine stress echocardiography, and results in a substantial reduction in test time while maintaining a low complication rate.

MRI and echocardiography: how do they compare in adults?

TTE with color flow imaging remains the most appropriate initial method for imaging CHD in adults. In many patients with minor abnormalities, this will be the only imaging required. For complicated intracardiac anomalies not well shown by TTE, TEE or MRI are usually adequate with the choice of technique being dependent on the availability of appropriate equipment and expertise. For great vessel abnormalities, further evaluation with MRI and MRA is most appropriate. In patients suspected of having significant systemic or pulmonary venous abnormalities or abnormalities of the aortic arch, MRI and MRA should be regarded as the definitive imaging technique. MRI and MRA are robust methods for evaluating intracardiac disease and can provide accurate information on cardiac chamber anatomy relationships, valvar lesions, and shunts. However, in most patients, this information is provided more rapidly and cost effectively by color Doppler echocardiography.