This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (130)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in JAMA  Topic Collections  • Pediatrics  • Adolescent Medicine  • Obesity  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

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.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLES

Health-Related Quality of Life of Severely Obese Children and Adolescents
, , and
JAMA. ;289():1813-1819.
FULL TEXT  

Treatment of Pediatric and Adolescent Obesity
and
JAMA. ;289():1851-1853.
FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Prevention and Treatment of Pediatric Obesity: An Endocrine Society Clinical Practice Guideline Based on Expert Opinion
August et al.
J. Clin. Endocrinol. Metab. 2008;93:4576-4599.
ABSTRACT | FULL TEXT  

Insulin resistance and obesity in childhood
Chiarelli and Marcovecchio
Eur J Endocrinol 2008;159:S67-S74.
ABSTRACT | FULL TEXT  

Treatment Modalities of Obesity: What fits whom?
Hainer et al.
Diabetes Care 2008;31:S269-S277.
ABSTRACT | FULL TEXT  

Expert Committee Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity: Summary Report
Barlow and and the Expert Committee
Pediatrics 2007;120:S164-S192.
ABSTRACT | FULL TEXT  

Recommendations for Treatment of Child and Adolescent Overweight and Obesity
Spear et al.
Pediatrics 2007;120:S254-S288.
ABSTRACT | FULL TEXT  

Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes
Danielsson et al.
J. Clin. Endocrinol. Metab. 2007;92:4101-4106.
ABSTRACT | FULL TEXT  

Review: Obesity and cardiometabolic syndrome in children
Velasquez-Mieyer et al.
Ther Adv Cardiovasc Dis 2007;1:61-81.
ABSTRACT  

State of the Art Review: Long-term Pharmacotherapy for Overweight and Obesity: A Review of Sibutramine, Orlistat, and Rimonabant
Dunican et al.
AMERICAN JOURNAL OF LIFESTYLE MEDICINE 2007;1:367-388.
ABSTRACT  

Pharmacotherapeutic Options for Overweight Adolescents
Dunican et al.
The Annals of Pharmacotherapy 2007;41:1445-1455.
ABSTRACT | FULL TEXT  

Cardiovascular Effects of Sibutramine in the Treatment of Obese Adolescents: Results of a Randomized, Double-Blind, Placebo-Controlled Study
Daniels et al.
Pediatrics 2007;120:e147-e157.
ABSTRACT | FULL TEXT  

Pharmacological Treatment of the Overweight Patient
Bray and Greenway
Pharmacol. Rev. 2007;59:151-184.
FULL TEXT  

The Effect of Sibutramine on Energy Expenditure and Body Composition in Obese Adolescents
Van Mil et al.
J. Clin. Endocrinol. Metab. 2007;92:1409-1414.
ABSTRACT | FULL TEXT  

Pharmacotherapy of Childhood Obesity: An evidence-based, conceptual approach
Freemark
Diabetes Care 2007;30:395-402.
FULL TEXT  

Exercise Therapy as a Treatment for Psychopathologic Conditions in Obese and Morbidly Obese Adolescents: A Randomized, Controlled Trial
Daley et al.
Pediatrics 2006;118:2126-2134.
ABSTRACT | FULL TEXT  

Weight-Loss Drugs Appropriate for Some Morbidly Obese Teens
Beckley
DOC News 2006;3:9-9.
FULL TEXT  

Effects of Sibutramine Treatment in Obese Adolescents: A Randomized Trial
Berkowitz et al.
ANN INTERN MED 2006;145:81-90.
ABSTRACT | FULL TEXT  

The regulation of appetite
Druce and Bloom
Arch. Dis. Child. 2006;91:183-187.
ABSTRACT | FULL TEXT  

Where to Begin With the Extremely Obese Child
DOC News 2005;2:5-5.
FULL TEXT  

A two year family based behaviour treatment for obese children
Jiang et al.
Arch. Dis. Child. 2005;90:1235-1238.
ABSTRACT | FULL TEXT  

Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity
Wadden et al.
NEJM 2005;353:2111-2120.
ABSTRACT | FULL TEXT  

Current and Future Treatment of Metabolic Syndrome and Type 2 Diabetes in Children and Adolescents
Mallare et al.
Diabetes Spectr. 2005;18:220-228.
ABSTRACT | FULL TEXT  

Screening and Interventions for Overweight in Children and Adolescents: Recommendation Statement
US Preventive Services Task Force
Pediatrics 2005;116:205-209.
ABSTRACT | FULL TEXT  

Screening and Interventions for Childhood Overweight: A Summary of Evidence for the US Preventive Services Task Force
Whitlock et al.
Pediatrics 2005;116:e125-e144.
ABSTRACT | FULL TEXT  

Effect of Orlistat on Weight and Body Composition in Obese Adolescents: A Randomized Controlled Trial
Chanoine et al.
JAMA 2005;293:2873-2883.
ABSTRACT | FULL TEXT  

Pharmacotherapy for Adolescent Obesity: A Weighty Issue
Joffe
JAMA 2005;293:2932-2934.
FULL TEXT  

Overweight Children and Adolescents
Dietz and Robinson
NEJM 2005;352:2100-2109.
FULL TEXT  

Overweight in Children and Adolescents: Pathophysiology, Consequences, Prevention, and Treatment
Daniels et al.
Circulation 2005;111:1999-2012.
ABSTRACT | FULL TEXT  

An Integrative Review of Interventions for Adolescent Weight Loss
Stuart et al.
The Journal of School Nursing 2005;21:77-85.
ABSTRACT | FULL TEXT  

Treatment of Obese Adolescents with Sibutramine: A Randomized, Double-Blind, Controlled Study
Godoy-Matos et al.
J. Clin. Endocrinol. Metab. 2005;90:1460-1465.
ABSTRACT | FULL TEXT  

Childhood Obesity
Speiser et al.
J. Clin. Endocrinol. Metab. 2005;90:1871-1887.
ABSTRACT | FULL TEXT  

Dietary supplements for body-weight reduction: a systematic review
Pittler and Ernst
Am. J. Clin. Nutr. 2004;79:529-536.
ABSTRACT | FULL TEXT  

Development of Novel Medications for Use in the Treatment of Obesity in Children Will Be Directed by Delineating Controls of Energy Homeostasis
Sherman and Zlotkin
Arch Pediatr Adolesc Med 2003;157:721-721.
FULL TEXT  

Treating Obesity: New Directions
JWatch Psychiatry 2003;2003:2-2.
FULL TEXT  

Treatment of Pediatric and Adolescent Obesity
Yanovski and Yanovski
JAMA 2003;289:1851-1853.
FULL TEXT