12-month follow-up of fluoxetine and cognitive behavioral therapy for binge eating disorder.

OBJECTIVE: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.

METHOD: 81 overweight patients with BED within a randomized double-blind placebo-controlled acute treatment trial allocated to fluoxetine-only, CBT + fluoxetine, and CBT + placebo were assessed before treatment, during treatment, posttreatment, and 6 and 12 months after completing treatments. Outcome variables comprised remission from binge eating (0 binge-eating episodes for 28 days) and continuous measures of binge-eating frequency, eating disorder psychopathology, depression, and weight.

RESULTS: Intent-to-treat remission rates (missing data coded as nonremission) differed significantly across treatments at posttreatment and at 6- and 12-month follow-ups. At 12-month follow-up remission rates were 3.7% for fluoxetine-only, 26.9% for CBT + fluoxetine, and 35.7% for CBT + placebo. Mixed-effects models of all available continuous data (without imputation) at posttreatment and at 6- and 12-month follow-ups (controlling for baseline scores) revealed the treatments differed on all clinical outcome variables, except for weight, across time. CBT + fluoxetine and CBT + placebo did not differ and both were significantly superior to fluoxetine-only on the majority of clinical outcomes.

CONCLUSIONS: This represents the first report from any randomized placebo-controlled trial for BED that has reported follow-up data after completing a course of medication-only treatment. CBT + placebo was superior to fluoxetine-only, and adding fluoxetine to CBT did not enhance findings compared to adding placebo to CBT. The findings document the longer term effectiveness of CBT, but not fluoxetine, through 12 months after treatment completion.