Early response to antidepressant treatment in bulimia nervosa

Background. Bulimia nervosa (BN) is a serious psychiatric disorder characterized by frequent episodes of binge eating and inappropriate compensatory behavior. Numerous trials have found that antidepressant medications are efficacious for the treatment of BN. Early response to antidepressant treatment, in the first few weeks after medication is initiated, may provide clinically useful information about an individual's likelihood of ultimately benefitting or not responding to such treatment. The purpose of this study was to examine the relationship between initial and later response to fluoxetine, the only antidepressant medication approved by the US Food and Drug Administration (FDA) for the treatment of BN, with the goal of developing guidelines to aid clinicians in deciding when to alter the course of treatment. Method. Data from the two largest medication trials conducted in BN (n=785) were used. Receiver operating characteristic (ROC) curves were constructed to assess whether symptom change during the first several weeks of treatment was associated with eventual non-response to fluoxetine at the end of the trial. Results. Eventual non-responders to fluoxetine could be reliably identified by the third week of treatment. Conclusions. Patients with BN who fail to report a o60 % decrease in the frequency of binge eating or vomiting at week 3 are unlikely to respond to fluoxetine. As no reliable relationships between pretreatment characteristics and eventual response to pharmacotherapy have been identified for BN, early response is one of the only available indicators to guide clinical management

Clinical and cost-effectiveness of two ways of delivering guided self-help for people with an eating disorder: a multi-arm randomised controlled trial

Objective: Increasing the availability and accessibility of evidence-based treatments for eating disorders is an important goal. This study investigated the effectiveness and cost-effectiveness of guided self-help via face-to-face meetings (fGSH) and a more scalable method, providing support via email (eGSH). Method: A pragmatic, randomised controlled trial was conducted at three sites. Adults with binge-eating disorders were randomised to fGSH, eGSH, or a waiting list condition, each lasting 12 weeks. The primary outcome variable for clinical effectiveness was overall severity of eating psychopathology and, for cost-effectiveness, binge-free days, with explorative analyses using symptom abstinence. Costs were estimated from both a partial societal and healthcare provider perspective. Results: Sixty participants were included in each condition. Both forms of GSH were superior to the control condition in reducing eating psychopathology (IRR = -1.32 [95% CI -1.77, -0.87], p<0.0001; IRR = -1.62 [95% CI -2.25, -1.00], p<0.0001) and binge eating. Attrition was higher in eGSH. Probabilities that fGSH and eGSH were cost-effective compared with WL were 93% (99%) and 51% (79%), respectively, for a willingness to pay of £100 (£150) per additional binge-free day. Discussion: Both forms of GSH were associated with clinical improvement and were likely to be cost-effective compared with a waiting list condition. Provision of support via email is likely to be more convenient for many patients although the risk of non-completion is greater

Symptoms predicting psychosocial impairment in bulimia nervosa

Purpose The current study aimed to determine which particular eating disorder (ED) symptoms and related features, such as BMI and psychological distress, uniquely predict impairment in bulimia nervosa (BN). Methods Two hundred and twenty-two adults with BN completed questionnaires assessing ED symptoms, general psychological distress, and psychosocial impairment. Regression analyses were used to determine predictors which account for variance in impairment. Results Four variables emerged as significant predictors of psychosocial impairment: concerns with eating; concerns with weight and shape; dietary restraint; and general psychological distress. Conclusions Findings support previous work highlighting the importance of weight and shape concerns in determining ED-related impairment. Other ED symptoms, notably dietary restraint and concerns with eating, were also significant predictors as was psychological distress. Results suggest that cognitive aspects of EDs, in addition to psychological distress, may be more important determinants of impairment than behavioural symptoms, such as binge eating or purging

Novel study designs to investigate the placebo response

<p>Abstract</p> <p>Background</p> <p>Investigating the size and mechanisms of the placebo response in clinical trials have relied on experimental procedures that simulate the double-blind randomized placebo-controlled design. However, as the conventional design is thought to elucidate drug rather than placebo actions, different methodological procedures are needed for the placebo response.</p> <p>Methods</p> <p>We reviewed the respective literature for trials designs that may be used to elucidate the size of the placebo response and the mechanisms associated with it.</p> <p>Results</p> <p>In general, this can be done by either manipulation the information provided to the subjects, or by manipulation the timing of the drug applied. Two examples of each strategy are discussed: the "balanced placebo design" (BDP) and the "balanced cross-over design" (BCD) and their variants are based on false information, while the "hidden treatment" (HT) and the ""delayed response test" (DRT) are based on manipulating the time of drug action. Since most such approaches include deception or incomplete information of the subjects they are suitable for patient only with authorized deception.</p> <p>Conclusion</p> <p>Both manipulating the information provided to subjects (BDP, DCD) or manipulating the timing of drug application (HT, DRT) allows overcoming some of the restrictions of conventional drug trials in the assessment of the placebo response, but they are feasible mostly in healthy subjects for ethical reasons.</p

Dissonance-Based Interventions for the Prevention of Eating Disorders: Using Persuasion Principles to Promote Health

The limited efficacy of prior eating disorder (ED) prevention programs led to the development of dissonance-based interventions (DBI) that utilize dissonance-based persuasion principles from social psychology. Although DBIs have been used to change other attitudes and behaviors, only recently have they been applied to ED prevention. This article reviews the theoretical rationale and empirical support for this type of prevention program. Relative to assessment-only controls, DBIs have produced greater reductions in ED risk factors, ED symptoms, future risk for onset of threshold or subthreshold EDs, future risk for obesity onset, and mental health utilization, with some effects persisting through 3-year follow-up. DBIs have also produced significantly stronger effects than alternative interventions for many of these outcomes, though these effects typically fade more quickly. A meta-analysis indicated that the average effects for DBIs were significantly stronger than those for non-DBI ED prevention programs that have been evaluated. DBIs have produced effects when delivered to high-risk samples and unselected samples, as well as in efficacy and effectiveness trials conducted by six independent labs, suggesting that the effects are robust and that DBIs should be considered for the prevention of other problems, such as smoking, substance abuse, HIV, and diabetes care

Are Child and Adolescent Responses to Placebo Higher in Major Depression than in Anxiety Disorders? A Systematic Review of Placebo-Controlled Trials

BACKGROUND: In a previous report, we hypothesized that responses to placebo were high in child and adolescent depression because of specific psychopathological factors associated with youth major depression. The purpose of this study was to compare the placebo response rates in pharmacological trials for major depressive disorder (MDD), obsessive compulsive disorder (OCD) and other anxiety disorders (AD-non-OCD). METHODOLOGY AND PRINCIPAL FINDINGS: We reviewed the literature relevant to the use of psychotropic medication in children and adolescents with internalized disorders, restricting our review to double-blind studies including a placebo arm. Placebo response rates were pooled and compared according to diagnosis (MDD vs. OCD vs. AD-non-OCD), age (adolescent vs. child), and date of publication. From 1972 to 2007, we found 23 trials that evaluated the efficacy of psychotropic medication (mainly non-tricyclic antidepressants) involving youth with MDD, 7 pertaining to youth with OCD, and 10 pertaining to youth with other anxiety disorders (N = 2533 patients in placebo arms). As hypothesized, the placebo response rate was significantly higher in studies on MDD, than in those examining OCD and AD-non-OCD (49.6% [range: 17-90%] vs. 31% [range: 4-41%] vs. 39.6% [range: 9-53], respectively, ANOVA F = 7.1, p = 0.002). Children showed a higher stable placebo response within all three diagnoses than adolescents, though this difference was not significant. Finally, no significant effects were found with respect to the year of publication. CONCLUSION: MDD in children and adolescents appears to be more responsive to placebo than other internalized conditions, which highlights differential psychopathology

Eating Disorder Examination-Questionnaire as a measure of change in patients with bulimia nervosa.

OBJECTIVE: The current study evaluated the agreement between the Eating Disorder Examination and the Eating Disorder Examination-Questionnaire in assessing eating disorder pathology in a sample of women with bulimia nervosa. METHOD: Patients with broadly defined bulimia nervosa were enrolled in a double-blind, placebo-controlled treatment study of fluoxetine, with and without guided self-help. The current study presents information from 50 patients with data from both the EDE and EDE-Q at study entry and treatment termination. RESULTS: The EDE and EDE-Q produced more similar scores for compensatory behaviors (vomiting/laxative use) than complex eating-disordered features (binge eating/importance of shape and weight) at the pretreatment and posttreatment assessments, and for change during the study. DISCUSSION: The EDE and EDE-Q are highly correlated for many of the behavioral and attitudinal features of bulimia nervosa. There is substantial variability in agreement for individual patients, but on average, the EDE and EDE-Q will yield similar assessments of eating disorder symptoms and change in symptoms over time