Examining Heterogeneity of Patient Outcomes in a Randomized Controlled Trial for Binge-Eating Disorder Testing...

Although trials have documented the overall effectiveness of cognitive-behavioral therapy (CBT) and lisdexamfetamine (LDX) for binge-eating disorder (BED), the nature and extent of individual patient variability in outcomes have not been examined. This secondary analysis of a controlled trial examined heterogeneity of outcomes with CBT and LDX, alone and combined, for BED.

One hundred and forty-one patients with BED with co-occurring obesity were randomized to CBT, LDX, or combined CBT+LDX 3-month treatments. Changes in binge-eating frequency, eating-disorder psychopathology, weight, and depression were repeatedly assessed. Outcomes were dichotomized as increased or decreased/no change, and differences between treatments were explored. Corset plots were used to examine changes in outcomes at the patient level.

In CBT, 94.4% (N = 34) patients reported decreased binge-eating frequency and 75.0% (N = 24) decreased eating-disorder psychopathology. In LDX, 90.5% (N = 38) reported decreased binge-eating frequency and 89.7% (N = 35) decreased eating-disorder psychopathology. In CBT+LDX, 100% (N = 44) reported improvements in binge eating and eating-disorder psychopathology. Patients not prescribed LDX had significantly fewer decreases in weight: in CBT, 55.6% (N = 20) had weight loss, compared to 92.9% (N = 39) in LDX and 81.3% (N = 4) in CBT+LDX. No differences in decreased depression scores were observed across treatments (80.0% (N = 28) in CBT; 89.2% (N = 33) in LDX; 86.1% (N = 38) in CBT+LDX).

Frequency of individual cases with increases in binge-eating, eating-disorder psychopathology, and depression were low in CBT and LDX treatments, and particularly so for the combined CBT+LDX approach. These participant-level findings add important clinical context regarding the significant overall improvements associated with CBT, LDX, and CBT+LDX for BED.

Clinicaltrials.gov registration: NCT03924193 (Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment).