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Background: Cognitive behavioral therapy (CBT) has efficacy for binge eating disorder (BED) but not obesity. No controlled studies have tested whether adding obesity medication to CBT facilitates weight loss. We performed a randomized, placebo-controlled study of orlistat administered with guided self-help CBT (CBTgsh). Methods: Fifty obese BED patients were randomly assigned to 12-week treatments of either orlistat plus CBTgsh (120 mg three times a day [t.i.d.]) or placebo plus CBTgsh and were followed in double-blind fashion for 3 months after treatment. Results: Seventy-eight percent of patients completed treatments without differential dropout between orlistat+CBTgsh and placebo+CBTgsh. Intent-to-treat remission rates (zero binges for past 28 days on Eating Disorder Examination Interview) were significantly higher for orlistat+CBTgsh than placebo+CBTgsh (64% versus 36%) at posttreatment but not at 3-month follow-up (52% in both). Intent-to-treat rates for achieving 5% weight loss were significantly higher for orlistat+CBTgsh than placebo+CBTgsh at posttreatment (36% versus 8%) and 3-month follow-up (32% versus 8%). Significant and comparable improvements in eating disorder psychopathology and psychological distress occurred in both treatments. Conclusions: The addition of orlistat to CBTgsh was associated with greater weight loss than the addition of placebo to CBTgsh. Clinical improvements were generally maintained at 3-month follow-up after treatment discontinuation. [Copyright &y& Elsevier]

Background: Cognitive behavioral therapy (CBT) and certain medications have been shown to be effective for binge eating disorder (BED), but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of CBT and fluoxetine alone and in combination for BED. Methods: 108 patients were randomized to one of four 16-week individual treatments: fluoxetine (60 mg/day), placebo, CBT plus fluoxetine (60 mg/day) or CBT plus placebo. Medications were provided in double-blind fashion. Results: Of the 108 patients, 86 (80%) completed treatments. Remission rates (zero binges for 28 days) for completers were: 29% (fluoxetine), 30% (placebo), 55% (CBT+fluoxetine), and 73% (CBT+placebo). Intent-to-treat (ITT) remission rates were: 22% (fluoxetine), 26% (placebo), 50% (CBT+fluoxetine), and 61% (CBT+placebo). Completer and ITT analyses on remission and dimensional measures of binge eating, cognitive features, and psychological distress produced consistent findings. Fluoxetine was not superior to placebo, CBT+fluoxetine and CBT+placebo did not differ, and both CBT conditions were superior to fluoxetine and to placebo. Weight loss was modest, did not differ across treatments, but was associated with binge eating remission. Conclusions: CBT, but not fluoxetine, demonstrated efficacy for the behavioral and psychological features of BED, but not obesity. [Copyright &y& Elsevier]