© 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 4/17 Introduction to Magellan’s Adopted Clinical Practice Guideline for the Assessment and Treatment of Patients With Eating Disorders Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. i Table of Contents Purpose of This Document ........................................................................................................................... 1 Additional Recommendations Based on Recent Literature Review ............................................ 2 Executive Summary......................................................................................................................................... 2 Introduction ..................................................................................................................................................... 14 First Ever Eating Disorder Legislation December 2016 ................................................................. 14 Epidemiology ................................................................................................................................................... 14 Feeding and Eating Disorders – Changes in the DSM-5 .................................................................. 17 Anorexia Nervosa ........................................................................................................................................... 18 Bulimia Nervosa ............................................................................................................................................. 28 Binge Eating Disorder .................................................................................................................................. 34 Pica and Rumination Disorder .................................................................................................................. 43 Avoidant/Restrictive Food Intake Disorder ........................................................................................ 44 Obtaining Copies of the APA Guidelines ................................................................................................ 46 Provider Feedback ......................................................................................................................................... 47 References ........................................................................................................................................................ 48 Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 1 Magellan Practice Guideline Task Force Thomas G. Carlton, M.D. Varum Choudhary, M.D., M.A., D.F.A.P.A. Gary M. Henschen, M.D., L.F.A.P.A. Steven Jenkusky, M.D., M.A., F.A.P.A. Pamela E. Kumar, B.S.N. Kathryn Kvederis, M.D., D.F.A.P.A. Louis A. Parrott, M.D., Ph.D. Clifton A. Smith, D.O., M.S., F.A.P.A. Purpose of This Document Magellan Healthcare has adopted the American Psychiatric Association’s (APA) Practice Guideline for the Treatment of Patients With Eating Disorders, Third Edition (2006) and Guideline Watch (August 2012): Practice Guideline for the Treatment of Patients with Eating Disorders, 3rd Edition to serve as an evidence-based framework for practitioners’ clinical decision-making with adult patients who have an eating disorder. The adopted guideline indicates that while APA practice guidelines are for the care of adults, this particular guideline for eating disorders includes recommendations that apply to adolescents, since anorexia nervosa and bulimia nervosa often begin during this period. This guideline makes special notations when recommendations apply exclusively to a certain age group. An extensive literature review suggests that the APA guideline is among the most comprehensive, evidence-based clinical practice guidelines (CPGs) for this disorder, and in general, APA guidelines are widely used. The guideline covers most areas of psychiatric management of patients with eating disorders, from clinical features and epidemiology to numerous aspects of treatment approach and planning. Since the guideline is widely accepted by managed behavioral healthcare organizations (MBHOs), this adoption will minimize the burden on practitioners serving multiple MBHOs. As with all guidelines, these adopted guidelines and Magellan’s introduction augment, but do not replace, sound clinical judgment. As a matter of good practice, clinically sound exceptions to the treatment guidelines should be included in the member’s record. Additionally, this guideline does not supersede Food and Drug Administration (FDA) determinations or other actions regarding withdrawal or approval of specific medications or devices, and their uses. It is the responsibility of the treating clinician to remain current on medication/device alerts and warnings issued by the FDA and other regulatory and professional bodies, and to incorporate such information in treatment decisions. Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 2 Additional Recommendations Based on Recent Literature Review The APA guideline is based on a literature review through 2004, while the APA Guideline Watch is based on information from randomized, controlled trials and meta-analyses published through December 13, 2011. Magellan conducted a further review of the clinical literature on assessment and treatment of eating disorders published through March 2017. We summarize key relevant recommendations from this more recent literature review here. Magellan encourages providers to be familiar with this information, as well as the information discussed in the guideline. Executive Summary (Discussion of changes/new information in this updated guideline) First Ever Eating Disorder Legislation December 2016 A piece of federal legislation, the 21st Century Cures and Mental Health Reform Package, was passed by Congress in December 2016 and is the first ever eating disorder legislation (Eating Disorders Coalition, 2016). The legislation clarifies existing mental health parity law to improve health insurance coverage for eating disorders, and includes plans to better educate health professionals and the general public on early identification of eating disorders. Epidemiology Although eating disorders are not very common in the population as a whole, morbidity is high and eating disorders’ mortality rate is the highest of any psychiatric diagnoses (Green et al., 2016; Claudino et al., 2015). According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the twelve-month prevalence of anorexia nervosa among young females is approximately 0.4%, much more common in females than in males, with a female to male ratio of 10:1 (APA, 2013). The prevalence of subthreshold anorexia nervosa is estimated to be 1.5% and 0.1% in adolescent females and males, respectively (Lock et al., 2015). Some studies have suggested that the disorder is less common among persons of African origin (Lock et al., 2015). The twelve-month prevalence of bulimia nervosa (BN) among young females is approximately 1% to 1.5%, also more common in females than in males, with a female to male ratio of 10:1 (APA, 2013). According to Lock et al., diagnosis of BN in children and adolescents is rare, although older patients have indicated that onset began in adolescence (Lock et al., 2015). The twelve-month prevalence of binge eating disorder in adult females and males is 1.6% and 0.8%, respectively, with a far less skewed gender ratio (APA, 2013). Lock et al. reported that this disorder is the most common eating disorder, and that it affects 3.5% of females and 2% of males among adults, with rates in children and adolescents estimated at 2.3% in adolescent females and 0.8% in adolescent males. Lock et al. reported that there are no epidemiological studies available for the diagnosis of avoidant restrictive food intake disorder. In a recent review of literature, Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 3 Mitchison and Mond focused on the prevalence of eating disorders in males, not by conducting a systematic review of epidemiological studies of eating disorders in males due to the “relative infancy of epidemiological studies of eating disorders in males, but by focusing on functional impairment and help-seeking behavior” (Mitchison and Mond, 2015). The Mitchison and Mond study reported that eating disorders are often not included in national mental health surveys due to low population prevalence, and when considered, only anorexia nervosa and/or bulimia nervosa are usually included (Mitchison and Mond, 2015). The majority of eating disorder cases in males are in binge eating disorders. Authors suggest that eating disorders have been, historically, conceptualized as occurring in young females and that “although we are currently in a climate of increased appreciation of eating and body image problems in males, our methods of identification, assessment, classification, and treatment are yet to catch up” (Mitchison and Mond, p. 2). Authors reported studies showing that extreme dietary restriction and purging increased at a faster rate in males between 1998 and 2008 than in females during the same period. They also noted that some authorities have suggested the classification of muscle dysmorphia, currently classified with the Obsessive Compulsive and Related Disorders section of DSM-5, as an eating disorder (seeking muscularity as opposed to seeking thinness), especially as muscle dysmorphia is associated with symptoms of eating disorder. Authors further noted that higher levels of psychopathology, psychosocial impairment, and suicide risk are associated with muscle dysmorphia than in other forms of body dysmorphic disorder. Authors concluded, “The prevalence of binge eating may be nearly as high in males as in females and the prevalence of extreme weight control behavior, such as extreme dietary restriction and purging, may be increasing more rapidly in males than females” (Mitchison and Mond, p. 7). They suggested that future epidemiological studies should include more males and male-relevant variables, and that research should focus on behaviors, rather than on diagnoses. Assessment of Eating Disorders in Children and Adolescents Assessment and diagnosis of feeding and eating disorders in children and adolescents is complex. Although the prevalence of full threshold eating disorders is only approximately 3% among youths, problematic eating behaviors and cognitions, e.g., preoccupation with weight and shape, and loss of control eating, are common in adolescents and children (Walsh et al., 2016). To prevent the onset of full threshold eating disorders, early detection and diagnosis are vital. Measures, e.g., interviews and self-reports, have been developed or adapted from adult measures for this purpose. Walsh et al. recommend assessment of children for diagnostic criteria as well as for subthreshold features. Authors noted that the Eating Disorder Assessment – 5 (EDA-5) is available for assessment of AN, BN, BED, pica, rumination disorder, and ARFID, and that there is a need for research focusing on measurement development to assess diagnostic criteria and categories of eating disorders in children and adolescents (Walsh et al., 2016). Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 4 Anorexia Nervosa (AN) A recent study summarized the results of a scoping review of published literature (between 2010 and 2015) on functional magnetic resonance imaging (fMRI) research in anorexia nervosa that investigated brain activation in patients with the disorder (Fuglset et al., 2016). Authors noted the growing body of evidence indicating “that risk for AN is genetically linked with underlying neural networks sustaining the illness” as in other psychiatric illnesses (Fuglset et al., p. 1). This scoping review of 49 studies addresses broader topics than a systematic review, which is limited to “the best available research on a specific research question” (Fuglset et al., p. 2). These studies involved various paradigms, e.g., body-related stimuli, neuropsychological tests, food-related stimuli, reward, emotions, taste, pain stimulation, social cognition, compulsivity, and self-identify, and collectivity found altered neural activity across the brain in regions related to the fronto-striato and the limbic circuits. Authors remarked on how the studies demonstrated that altered neural activity was present even in individuals who had recovered from AN, and that scarring effects in the brain may persist. They suggested follow-up studies including long-term recovered individuals, as well as studies investigating how viewing images of bodies that are of various sizes and weight may affect neural activity. Other future studies suggested by authors include those investigating whether neural alterations, common in AN, are also seen in other mental disorders. A recent study analyzed data obtained from diagnostic interviews, investigator-rated interviews, health surveys, and questionnaires collecting demographic data and clinical history of participants (n=355) with anorexia nervosa who were enrolled in two academic medical center eating disorder programs (Wildes et al., 2016). The data from the assessments, completed within about two weeks of admission to inpatient or partial hospital, were analyzed to characterize population heterogeneity in the severity and chronicity of AN to develop a definition of severe and enduring anorexia nervosa (SE-AN) psychopathology. Authors noted that this is the “first effort to utilize empirical methods to characterize associations among putative indicators of severity and chronicity in eating disorders, with the goal of developing an evidence-based definition of SE-AN” (Wildes et al., p. 6). The analysis found that illness duration and number of hospitalizations vary continuously among individuals with AN, and do not distinguish SE-AN. Instead, they documented that impairment in quality-of-life differentiates severity profiles in AN. Authors reported a past study (Touyz, 2013) emphasizing quality-of-life as a primary clinical outcome of treatment for SE-AN. In summary, they concluded that a holistic approach to the assessment of severity and chronicity in eating disorders is important, highlighting the importance of quality of life (Wildes et al., 2016). A recent study examined the impact of parental expressed emotion (EE) on adolescent treatment outcome among families, including adolescents (n=121), primarily females aged 12-18, participating in a larger treatment study for adolescent AN comparing two forms of treatment: family-based therapy (FBT) and individual adolescent-focused therapy (AFT) (Rienecke et al., 2016). In the recent study, assessment at baseline, end of treatment, and 6- and 12-month follow-ups occurred. Families completed the Standardized Clinical Family Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 5 Interview (SCFI) at baseline, and the Family Assessment Device (FAD), a self-report measure of family functioning, at baseline and at end of treatment. Data analysis included an examination of the relationships between EE and self-reported family functioning. The study found that no main effects of maternal or paternal hostility, emotional over- involvement, positive remarks or warmth on improvement in expected body weight or eating disorder psychopathology, although paternal criticism predicted significantly less improvement in eating disorder psychopathology at end of treatment. For adolescents whose mothers expressed any hostility, however, AFT was associated with greater gains in expected body weight compared with FBT. At the end of treatment, family functioning was better for families whose mother expressed no hostility. Authors suggested that although parental EE did not positively affect weight gain, it may “influence eating-related cognitions for adolescents with AN, and impact family functioning” (Rienecke et al., p. 11). They suggested future studies to explore effective modification of EE in treatment. A recent study randomized adolescents (n=45) aged 12–18 with AN to standard family- based therapy (FBT) or to FBT with a novel three-session adaptive intervention, i.e., intensive parental coaching (IPC) (Lock et al., 2015). IPT seeks to enhance parental self- efficacy related to re-feeding skills in children who are poor early responders to FBT by providing in vivo coaching. It adds three additional sessions that re-invigorate the family “to make definitive behavioral changes to support weight restoration (Lock et al., p. 5). Authors noted that when adolescents with AN who are treated with FBT do not gain 2.3 kg by the fourth week of treatment, they have a 40-50% lower chance of recovery and greater risk of developing enduring AN than those who gain weight. Not powered to compare treatment effects between the randomized groups, researchers compared weight gain during treatment of early poor responders to a sample of adolescents treated within another randomized controlled trial who did have early response to FBT, but did not receive the intensive parental coaching. Results of this study showed no differences in most clinical outcomes, rates of attrition, and suitability between the randomized groups, but found that full weight restoration by end of treatment in the group of poor early responders who received IPC was similar to that of those who had responded early. Researchers suggested, “Using IPC for poor early responders significantly improves weight recovery rates to levels comparable to those who respond early” (Lock et al., p. 2). Grave et al. provided an update on recent developments in cognitive behavioral therapy (CBT) for AN in a recent study (Grave et al., 2016). They discussed a “specific” form of CBT, CBT-Enhanced (CBT-E), adapted to focus on eating disorder psychopathology instead of on the diagnosis of eating disorders. Authors reported results of studies investigating the effect of CBT-E in both adults and adolescents with AN. Data from various studies indicated the viability of CBT-E, suggesting that in adolescents, it “seems to be a potential alternative to family-based treatment (FBT)” (Grave et al., 2016, p. 3). Authors reported that 40% and 60% of adults and adolescents, respectively, treated with CBT-E reached and maintained a normal weight range, and in 50% and 80% of adults and adolescents, respectively, the decrease was accompanied by a decrease in eating disorder psychopathology. Authors noted the need for studies comparing the efficacy of CBT-E and FBT in the treatment of adolescents with AN. Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 6 A pilot randomized controlled trial examined the use of D-cycloserine facilitated exposure therapy to increase weight gain in participants diagnosed with anorexia and experiencing anxiety during mealtimes (Levinson et al., 2015). Participants (n=36) from a community eating disorder treatment center with a mean age of 25.44 were randomized to receive exposure therapy plus D-cycloserine or plus placebo. All participants completed psychoeducation and four group exposure sessions, including mealtime exposures across two weeks, led by a cognitive behavioral therapist. They were reminded to experience any anxiety they felt (e.g., not perform anxiety-reducing behaviors such as tearing food). Participants received either 250 mg of D-cycloserine prior to the first three sessions of exposure therapy or placebo. Study results showed that participants in the D-cycloserine group had a greater increase in body mass index (BMI) at the end of the sessions than the participants in the control group. At one-month follow-up, BMI continued to increase for those in the D-cycloserine group whereas it decreased in the placebo group. Researchers suggested that “D-cycloserine increases positive learning during exposure sessions by disruption of the connection between fear and eating, which may then generalize to similar meals complete outside of the exposure sessions” (Levinson et al., p. 7). Researchers in a new observational study, which utilized a retrospective chart review of patients (n=87) with restrictive eating disorders hospitalized with medical complications of malnutrition, evaluated the safety of a higher calorie nutritional rehabilitation protocol (NRP) than the lower levels recommended by guidelines of the APA and the Academy of Nutrition and Dietetics (Maginot et al., 2017). The guidelines use a more conservative approach to prevent refeeding syndrome and resulting low serum electrolyte levels. Patients began oral nutritional rehabilitation upon admission based on recent dietary history, with initial caloric levels ranging from 1500 to 1800 kcal/day; it was lower (1200 kcal/day) for patients with past extreme dietary restriction. To achieve an overall goal of 1- 2 kg of weight gain per week, the daily caloric intake was titrated, increased in increments of 300 kcal/day in the absence of expected body weight (EBW) gain for two days and when a patient had cardiac complications even while meeting weight restoration goals. Patients received three meals (orally) per day and up to three snacks per day in a group setting. Nutrition provided by nasogastic or nasojejunal tubes occurred if a patient had difficulty eating or drinking by mouth, and intravenous fluids provided nutrition in dehydrated patients unable to tolerate oral fluid replacements. Results found that electrolyte abnormalities in this sample were associated more with a lower % EBW on admission than the initial calorie level or rate of increase in caloric intake during treatment. Researchers reported that their data “suggested that with every 1% decrease in % EBW on admission, the odds of hypophosphatemia increased by 6%. However, among the subset of severely malnourished patients presenting at <75% EBW, starting at a higher calorie diet was not associated with a higher risk of hypophosphatemia, hypomagnesemia, or hypokalemia” (Maginot et al., p. 8). Magellan continues to consider an increased caloric inpatient refeeding protocol investigational for the treatment of AN and has determined that large, randomized, controlled, multi-site trials are necessary to address questions of safety and efficacy for refeeding protocols that are more aggressive than those Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 7 recommended by professional association consensus guidelines (Magellan Health, 2012). A recent article discussed anorexia nervosa as a biologically based severe and enduring brain disorder with little to no effective treatments for adults with the disorder (Hill et al., 2016). They described shifting the focus from family and social influences to internal influences integrating genetic and neurobiological contributions. Authors reported genetic studies indicating the role of heredity (50-80%) in the risk of developing the disorder and imaging studies revealing, “common temperament and personality traits related to neural circuit function, which are heavily implicated in the development and maintenance of the disorder” (Hill et al., p. 3). Authors proposed a new anorexia nervosa model reflecting temperament and alterations in brain circuitry to inform and help guide treatment interventions. Heritable traits identified include harm avoidance, perfectionism, anxiety and inhibition. The treatment approach authors discussed includes both neurobiological research findings and family-based approaches for adults, e.g., CBT or CBT-Enhanced. This new five-day intervention for adults with AN “treats to the trait” by addressing the heritable traits identified above, via “experiential, neurobiologically based activities and playful clinical tools” (Hill et al., p. 8). “It is a neurobiologically informed, interactive, family- based treatment that draws upon the specific etiological traits characterizing anorexia nervosa” (Hill et al., p. 5). Preliminary results of NEW FED TR (Neurobiological research findings Enhanced With Family/Friends of those with Eating Disorders) have shown that adults with AN who received the treatment improved their understanding of the illness, “while better conceptualizing how to respond to their traits and manage their symptoms” (Hill et al., p. 1). Bulimia Nervosa (BN) Thompson-Brenner et al. have discussed an association between outcomes for patients with BN and two co-occurring problems: mood intolerance and interpersonal problems (Thompson-Brenner, et al., 2016). In a randomized study, patients (n=50) with BN and borderline personality disorder, and current or recent mood or anxiety disorders, were assigned to receive either broad or focused protocols of enhanced CBT (Thompson- Brenner, et al., 2016). Broad CBT (CBT-Eb) includes modules addressing co-occurring problems that interfere with treatment response, while focused CBT (CBT-Ef) includes interventions related to concerns with weight and shape. Analysis of data from this study found substantial improvement in both eating disorder symptoms and associated psychopathology across the entire sample. Remission from objective binge eating and purging at termination occurred at the rate of 42% of those who began treatment and 53% of those who completed treatment, with no significant differences between groups. Results were similar for remission from objective binge eating and purging at follow-up: 41.2% of all participants reported remission from binge eating and purging at follow-up, again with no significant differences between groups. However, multivariate analyses suggested that CBT-Ef was associated with better eating disorder outcomes at both termination and follow-up when compared to CBT-Eb. “Analyses indicated that severity of affective and interpersonal problems moderated treatment condition response” (Thompson-Brenner et Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 8 al., p. 46). They further suggested, “higher treatment effect associated with focused treatment was especially strong in patients with lower levels of affective and interpersonal problems at baseline, while those patients with more severe affective and interpersonal problems at baseline showed relatively favorable response to broad treatment.” Researchers concluded that this research supports CBT-E for patients with both BN and complex comorbidity and that CBT-Eb “appears to be more efficacious for patients with more severe BPD symptoms” (Thompson-Brenner et al., p. 36). Cognitive-behavioral therapy continues to be regarded as a first-line treatment for BN, as it has been “proven superior to wait list, placebo, medication, and other forms of psychotherapy, with the exception in interpersonal psychotherapy, which was found to be equally effective, but slower in achieving positive effects” (Watson et al., 2016, p. 1). Nonetheless, Thompson-Brenner has reported results of first generation of studies of CBT for BN showing that 40-60% of patients receiving CBT in clinical trials did not achieve remission from BN (Thompson-Brenner et al., 2016). In a recent randomized control, researchers sought to determine whether internet-based CBT (CBT4BN) would increase engagement and decrease dropout compared with face-to-face CBT (CBTF2F) in the treatment of BN (Watson et al., 2016). Researchers examined significant predictors and moderators in analysis of data from a multicenter randomized control trial of CBT4BN and CBTF2F including participants (n=191) 19+ years (98% female). In that trial, trained therapists conducted assessments at baseline, weekly during treatment, mid-treatment, post-treatment, and at 3-, 6-, and 12-month follow-ups. CBT4BN included communication via online chat groups including patients, therapist and group members in a chat room open for 90-minute periods without video or audio. Weekly homework worksheets and performance of daily self-monitoring via the website were required of the participants. The CBTF2F group met the therapist and group members in person and completed weekly homework worksheets and self-monitoring using hard copy. Study found that risk of failure to engage was associated with higher body mass index and a perception of less likely to succeed, while dropout was associated with novelty-seeking, previous CBT experience, less education, and assignment to a non-preferred treatment group. Unlike the expected result of the researchers, the study found that CBT4BN did not decrease failure to engage or dropout compared with CBTF2F. Researchers suggested the need for studies “evaluating clinical strategies to enhance retention” in CBT for BN and identifying people at high risk of failure to engage and drop out of treatment” (Watson et al., 2016). Prior studies have suggested that both CBT and FBT are effective in the treatment of adolescent bulimia nervosa. In a recent randomized clinical trial, researchers compared the efficacy of cognitive behavioral therapy adapted for adolescents (CBT-A) and family based treatment (FBT-BN) (Le Grange et al., 2015). Adolescents (n=131) with BN were randomized to CBT-A, FBT-BN, or non-specific treatment (SPT), and outcomes, of which the primary outcome was abstinence from binge eating and purging for 4 weeks prior to assessment, were assessed at baseline, end of 6-month treatment, and 6- and 12-month post-treatment. To promote behavioral change, FBT-BN engaged the adolescent and parents in a more collaborative relationship; the emphasis was more on parental control and management of eating disorder behaviors without emphasis on cognitions related to Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 9 shape and weight. CBT-A, primarily an individual therapy, included emphasis on therapeutic alliance, elicitation of support of treatment from parents, while focusing on changing cognitions concerned with shape and weight. SPT was non-directive in nature and was an exploratory comparison only. Results showed that abstinence rates of binge eating and purging were 39.4% and 19.7% (difference of 19.7%) for FBT-BN and CBT-A, respectively, at end of treatment. At 6-month follow-up, abstinence rates were 44.0% and 25.4% (difference of 18.5%) for FBT-BN and CBT-A, respectively. At 12-month follow-up, the abstinence rate difference between the two treatments was statistically insignificant. The Beck Depression Inventory (BDI) showed individuals receiving FBT-BN had lower BDI scores at end of treatment than the group receiving CBT-A. Lower conflict Family Environment Scale (FES) scores responded better to FBT-BN than to CBT-A, whereas in families with higher FES scores, there was no difference between the two treatments. Researchers concluded that although abstinence occurs more rapidly in FBT-BN and with fewer hospitalizations, both treatments are viable treatment options for adolescents with bulimia nervosa (Le Grange et al., 2015). Authors considered the integration of family-based treatment and dialectical behavior therapy for adolescent bulimia nervosa in an article referencing studies of the treatment of BN (Anderson et al., 2015). Authors discussed how dialectical behavior therapy (DBT) and family-based treatment (FBT), both of which have been applied in the treatment of BN, complement one another and, in a blended treatment approach, “can address the range of symptoms and behaviors typically seen in adolescent BN” (Anderson et al., p. 325). They discussed the complexity of BN etiology, with characteristics of frequent episodes of binge eating/purging, compensatory behaviors, and comorbid complexities. Anderson et al. noted how DBT “does not fully articulate a role for the family in assisting with recovery, and similarly that FBT-BN’s primary focus is on regular eating and not emotional regulation” (Anderson et al., p 327). They suggested that integration of DBT and FBT, two distinct clinical approaches, may provide significant advances in current treatments of adolescent BN and indicated the need of controlled trials of this integrated treatment model. Binge Eating Disorder (BED) A recent study examined the short- and long-term significance of rapid response, during the first weeks of treatment, to cognitive-behavioral guided self-help (CBT-gsh), interpersonal psychotherapy (IPT), and behavioral weight loss (BWL) in the treatment of binge eating disorders (Hilbert et al., 2015). In this randomized clinical study, adults (n=205) with BED were assigned to one of the treatments over a 24-week period consisting of 16 individual, weekly sessions followed by four sessions at two-week intervals. In this study, rapid response was indicated by decreased binge eating (≥70 %) by the fourth week of treatment. Results showed that rapid responders in CBTgsh had 27.3% greater rates of remission from binge eating than non-rapid responders in CBTgsh 5 to 18 months after treatment. In IPT and BWL, rates of remission did not differ significantly by rapid response, although both rapid and non-rapid responders in IPT, and rapid responders in CBTgsh, had greater remission from binge eating than non-rapid responders in CBTgsh and BWL. Remission was also greater in CBTgsh than in BWL. Authors suggested “the results may Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 10 inform a model of evidence-based stepped care to be further investigated” and that “monitoring rapid response may offer the advantage of identifying CBTgsh patients early who are not likely to benefit from this treatment in order to offer an alternative treatment (Hilbert et al., p. 7). The most strongly supported treatments for BED are CBT and IPT, although they do not produce weight loss; BWL produces modest weight loss over the short-term while achieving good outcomes for BED (Grilo, 2017). Grilo discussed the two predictors of treatment outcomes, i.e., presence of overvaluation of body shape and weight, and occurrence of rapid response to treatment. He suggested, “Clinicians should train to provide patients with evidence-supported psychological and behavioral treatments and follow these intervention protocols faithfully to increase the chances of good outcomes” (Grilo, p. 1). A recent study, using data from a large, multicenter randomized controlled trial of outpatient group CBT (gCBT) for adults with BED, sought to identify whether group dynamics early in treatment resulted in improved BED symptomatology at end of treatment and at follow-up (Pisetsky et al., 2015). Another quest was to determine whether group dynamics were associated with treatment retention and whether “group cohesion may actually be greater in self-help groups than therapist-led groups” (Pisetsky et al., p.76). In the randomized trial, participants (n=190) were randomized to one of these conditions: wait list, self-help treatment group, therapist-assisted treatment group, or therapist-led treatment group. Treatment occurred over 20 weeks with the active treatment groups receiving identical content; only the level of therapist involvement differed. Outcome measures included Group Attitude Scale (GAS); Group Climate Questionnaire – Short Form (GCQ); and Eating Disorder Examination (EDE). Results of the study found stronger engagement at session two associated with lower EDE Global score (greater improvements in global eating disorder psychopathology) at 12 month follow-up and greater reductions in binge eating frequency at 12 month follow-up associated with more positive group attitudes. The results also suggested that adherence to self-monitoring during the entire treatment period was associated with treatment outcomes. Additionally, researchers noted, “This study found participants with BED reported high positive group attitudes and engagement in three delivery methods of gCBT including self-help, therapist-led, and therapist-assisted groups, and that the variables did not differ across delivery methods” (Pisetsky et al., p.78). The evidence base for pharmacotherapy in the treatment of BED remains limited (Reas and Grilo, 2015). A medication, Vyvanse (lisdexamfetamine dimesylate), has won approval for treating moderate to severe BED by the FDA in the treatment of this disorder (FDA, 2015). The FDA approved this drug in 2007 to treat ADHD in patients ages 6 and older (FDA, 2015). The FDA News Release reported results of two clinical studies including adults (n=724) with moderate-to-severe BED. The studies showed that participants taking Vyvanse had decreased number of binge eating days per week and fewer obsessive- compulsive binge eating disorders compared to participants receiving placebo. Serious risks associated with the medication are psychiatric problems and heart complications; it Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 11 may also cause psychotic or manic symptoms. Vyvanse labeling also warns that CNS stimulants have high potential for both abuse and dependence. The FDA has not approved or recommended Vyvanse for weight loss (FDA, 2015). In two multicenter, double-blind, placebo-controlled trials, lisdexamfetamine dimesylate (LDX) was evaluated in terms of both efficacy and safety (McElroy et al., 2016). Participants (n=773) ages 18 to 55 were randomized to dose-optimized LDX (50 or 70 mg/day) dose titration or placebo during the 12-week treatment period. The LDX group showed statistically significant reductions in binge eating days/week, and greater response on outcomes, i.e., global improvement in BED pathology, 4-week cessation of binge eating at endpoint, BED-related obsessive and compulsive psychopathology, relative to placebo. Additionally, a significantly greater percent weight gain was associated with LDX compared to placebo. Researchers cautioned that these studies were limited in that participants were mainly female, white, overweight, and with no current psychiatric comorbidities. These studies were of a short-term nature, precluding extrapolations to long-term efficacy. McElroy et al indicated that although LDS may be an effective pharmacotherapy for BED, further long-term studies are needed (McElroy et al., 2016). In an overview of pharmacotherapy for BED, authors focused on 22 randomized clinical trials that tested pharmacotherapy (antidepressant medications, antiepileptic medications, anti-obesity medications, stimulant medications, and other medications) as monotherapy or combined with psychological-behavioral methods (Reas and Grilo, 2015). The primary outcome measure was binge eating with weight loss (not a core criterion of BED), the secondary outcome measure. Authors noted that although BED is “more prevalent than the two other formal eating disorders combined and is associated strongly with obesity, with heightened risk for psychiatric and medical comorbidities, and functional impairment in the U.S. and worldwide,” limited number of randomized controlled trials have been performed and published for BED (REAS and Grilo, p. 1468). Results of the 22 randomized controlled trials including participants (n=2001) with BED showed that the majority of patients do not achieve abstinence from binge eating. Most of them report little weight loss over the short term. Studies do not report longer-term effects of medications for BED, and authors reported that the little available data shows that relapse occurs following discontinuation. They indicated that improved binge eating outcomes are greater for psychological interventions, e.g., CBT, and combination of medication with CBT/behavioral interventions, compared to pharmacotherapy alone. However, they also noted that the combination of medications with CBT/behavioral interventions do not significantly improve binge-eating outcomes. Specific medications, e.g., topiramate and orlistat) may be associated with modest weight loss. Authors emphasized the need for studies that consider treatment for obesity and view weight control as an ongoing treatment need. In closing, they stated, “For example, four new anti-obesity medications (phentermine/topiramate, lorcaserin, naltrexone/bupropion, and liraglutide) have been recently approved by the FDA for the treatment of obesity but none has been tested for BED” (REAS and Grilo, p. 1468). A summary of findings of a later overview of 11 published randomized controlled trials testing combination treatments for BED follows (Grilo et al., 2016): Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 12 Lack of evidence suggesting an advantage for adding antidepressant medications to either CBT or BWL; Addition of anti-obesity medications to CBT or BWL showed little advantage; certain medications, i.e., orlistat, were associated with significantly greater weight loss than addition of placebo; orlistat may promote weight loss in BED with hypocaloric diets; Topiramate with 21 weeks of CBT resulted in significantly greater binge eating abstinence rates compared to placebo with CBT; topiramate added to CBT was not associated with significantly greater reductions in binge eating frequency, eating disorder pathology, or depression; and BWL may be effective for BED with the advantage of producing weight loss over short to intermediate term. Authors concluded, “The empirical base regarding treatment for BED remains limited” (Grilo et al., 2016). Summary The above sections include brief discussion of the results of several recent studies examining the effectiveness of various treatments for eating disorders. In some cases, evidence is both limited and low quality, suggesting the need for additional large, multicenter randomized controlled trials of commonly used treatments in adolescents and children with eating disorders. The American Academy of Child & Adolescent Psychiatry’s Practice Parameter for the Assessment and Treatment of Children and Adolescents with Eating Disorders provides an evidence-based approach to evaluating and treating eating disorders in children and adolescents (Lock et al., 2015). Although designed for child psychiatrists, the Practice Parameter also provides information useful for other medical and mental health professionals collaborate with child psychiatrists. Recommendations from the Practice Parameter related to all eating disorders follow (Lock et al., 2015): Mental health clinicians screen all children and adolescent patients with eating disorders; Follow a positive screening with a comprehensive diagnostic evaluation (including laboratory tests and imaging studies); Treat severe acute physical signs and medical complications; Consider psychiatric hospitalization, day programs, partial hospitalization programs, and residential programs only when outpatient interventions have been unsuccessful or are unavailable; A multidisciplinary team that is developmentally aware, sensitive, and skilled in the care of children and adolescents with eating disorders treats eating disorder in youth; Magellan Clinical Practice Guideline: Eating Disorders © 2006-2017 Magellan Health, Inc. This document is the proprietary information of Magellan Health, Inc. and its affiliates. 13 Initial treatment of choice for children and adolescents with eating disorders is outpatient psychosocial interventions; and Reserve use of medications, including complementary and alternative medications, for comorbid conditions and refractory cases. Information specifically related to treatment for child and adolescent eating disorders is included in the Practice Parameter for the Assessment and Treatment of Children and Adolescents with Eating Disorders. A summary follows: Family-based treatment (FBT) – Randomized controlled trials have supported efficacy of this treatment for treating AN and trials support usefulness of FBT for BN. Parental management of eating and related behavior continues until adolescent shows improvement (Lock et al., 2015). Adolescent-focused treatment – Randomized controlled trials have shown that adolescent-focused therapy, i.e., individual therapy that targets autonomy and self- efficacy in the context of adolescent development, performs worse than FBT for AN while still effective. It is useful for adolescents when FBT is not feasible (Lock et al., 2015). Cognitive-behavioral therapy (CBT) – In a randomized controlled trial and a case series for adolescents with BN, this individually focused therapy targeting adolescent management of behaviors and distorted cognitions may be appropriate treatment of adolescents with BN (Lock et al., 2015). Interpersonal psychotherapy (IPT) – Randomized controlled trials in adults with BN and binge eating disorders (BED) have shown support for the use of IPT in the treatment of these disorders, and preliminary studies have suggested IPT may be useful for adolescents with BED. IPT may be useful as an alternative to CPT in patients with BN and binge eating disorder. This treatment focuses on changing problematic interpersonal relationships triggering or maintaining symptoms of eating disorders (Lock et al., 2015). Antidepressants – Antidepressants target symptoms of depression, anxiety, and obsessionality in AN and BN; they also treat binge eating and purging in BN. An uncontrolled trial has suggested that antidepressants may be helpful for treating BN; they may also be useful for treating comorbid disorders and as a second-line treatment in adolescent BN (Lock et al., 2015). Atypical Antipsychotics – Atypical antipsychotics treat distortions of body image, fears of weight gain, and anxiety related to AN. Randomized trials and case series have provided insufficient evidence to suggest efficacy for use in treatment of AN. However, they may be useful in the treatment of comorbid conditions. More studies are needed to determine efficacy in treatment of core symptoms of AN (Lock et al., 2015).
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