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Berkowitz RI, Wadden TA, Tershakovec AM, Cronquist JL. Behavior Therapy and Sibutramine for the Treatment of Adolescent Obesity: A Randomized Controlled Trial. JAMA. 2003;289(14):1805–1812. doi:10.1001/jama.289.14.1805
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.
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
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.
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