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A Randomized Controlled Trial

Robert I. Berkowitz, MD; Thomas A. Wadden, PhD; Andrew M. Tershakovec, MD; Joanna L. Cronquist, BA

JAMA. 2003;289:1805-1812.

Context  Adolescent obesity is becoming a national public health problem. Weight-loss medications including sibutramine facilitate weight control in adults and could be used with obese adolescents in combination with behavior therapy (BT).

Objective  To examine whether increased weight loss in obese adolescents is induced when sibutramine is added to a family-based, behavioral weight control program.

Design, Setting, and Participants  Randomized, double-blind, placebo-controlled trial consisting of 82 adolescents aged 13 to 17 years with a body mass index (BMI) of 32 to 44 conducted from March 1999 to August 2002 at a university-based clinic for 6 months, followed by open-label treatment during months 7 to 12.

Interventions  For the first 6 months, participants received either BT and sibutramine or BT and placebo. From months 7 to 12, all participants received sibutramine in open-label treatment.

Main Outcome Measures  Percentage change in BMI; systolic and diastolic blood pressure and pulse; and hunger.

Results  In intention-to-treat analysis at month 6, participants in the BT and sibutramine group lost a mean (SD) of 7.8 kg (6.3 kg) and had an 8.5% (6.8%) reduction in BMI, which was significantly more than weight loss of 3.2 kg (6.1 kg) and reduction in BMI of 4.0% (5.4%) in the BT and placebo group. Significantly greater reductions in hunger (P = .002) also were reported by participants who received BT and sibutramine. From months 7 to 12, adolescents initially treated with sibutramine gained 0.8 kg (10.5 kg) with continued use of the medication, whereas those who switched from placebo to sibutramine lost an additional 1.3 kg (5.4 kg). Medication dose was reduced (n = 23) or discontinued (n = 10) to manage increases in blood pressure, pulse rate, or other symptoms.

Conclusions  The addition of sibutramine to a comprehensive behavioral program induced significantly more weight loss than did BT and placebo. Until more extensive safety and efficacy data are available, medications for weight loss should be used only on an experimental basis in adolescents and children.

Author Affiliations: Department of Psychiatry, Weight and Eating Disorders Program, University of Pennsylvania School of Medicine, Philadelphia (Drs Berkowitz and Wadden, and Ms Cronquist); and Departments of Psychiatry (Dr Berkowitz) and Pediatrics (Dr Tershakovec), The Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia.

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