Randomized trial of lifestyle modification and pharmacotherapy for obesity.
BACKGROUND
Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits.


METHODS
In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen.


RESULTS
At one year, subjects who received combined therapy lost a mean (+/-SD) of 12.1+/-9.8 kg, whereas those receiving sibutramine alone lost 5.0+/-7.4 kg, those treated by lifestyle modification alone lost 6.7+/-7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5+/-8.0 kg (P<0.001). Those in the combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently (18.1+/-9.8 kg vs. 7.7+/-7.5 kg, P=0.04).


CONCLUSIONS
The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone. The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.
Wadden
Thomas A
TA
University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. wadden@mail.med.upenn.edu
Berkowitz
Robert I
RI
Womble
Leslie G
LG
Sarwer
David B
DB
Phelan
Suzanne
S
Cato
Robert K
RK
Hesson
Louise A
LA
Osei
Suzette Y
SY
Kaplan
Rosalind
R
Stunkard
Albert J
AJ
D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases; D003131:Combined Modality Therapy; D003376:Counseling; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D015444:Exercise; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D011615:Psychotherapy, Group; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; D017367:Selective Serotonin Reuptake Inhibitors; C058254:sibutramine