title: Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as.
abstract: OBJECTIVE
  This study was a randomized placebo-controlled trial testing the addition of orlistat to behavioral weight loss for obesity in Spanish-speaking-only Latino/as with versus without binge eating disorder (BED) performed at a community mental health center serving educationally- and economically-disadvantaged patients. Latino/as have high rates of obesity but are under-represented in obesity treatment studies and despite comparable-to-or-higher rates of BED than Whites, Latino/as are under-represented in BED treatment studies. BED is associated with obesity but whether it predicts/moderates treatment outcomes remains uncertain. Thus, this study also tested whether BED prospectively predicts/moderates outcomes.
  
  
  METHODS
  Seventy-nine obese Spanish-speaking-only Latino/as with BED (N=40) versus without BED (N=39) at a community mental health center were randomly assigned to four-months of orlistat-plus-BWL or placebo-plus-BWL. BWL was culturally-enhanced modification of Diabetes-Prevention-Program delivered in weekly sessions in Spanish. Orlistat (120 mg tid) and matching-placebo delivered with standard clinical-management. Participants were assessed independently throughout treatment, post-treatment, and six-month follow-up.
  
  
  RESULTS
  78% completed treatments; completion rates did not differ significantly by medication or BED. Intent-to-treat mixed-models analyses revealed significant improvements in binge eating, eating-psychopathology, and depression, and significant--albeit modest--weight-loss. Overall, the addition of orlistat to BWL was not associated with greater improvements; however, BED moderated weight-loss: orlistat-plus-BWL produced significantly greater weight-loss in non-BED group but not in BED. Improvements were maintained through 6-month follow-up; BED significantly predicted/moderated increases in eating concerns and depression following treatment. Within BED-group, binge-eating remission rates were 65% (post-treatment) and 50% (follow-up).
  
  
  CONCLUSIONS
  In this controlled trial performed at community mental health center serving educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with co-morbid psychiatric needs, we observed outcomes for the BWL plus orlistat/placebo medication that approximate or are slightly dampened relative to the literature for efficacy trials with much more restrictive obese and BED samples. In this complex patient group, adding orlistat to BWL produced greater weight-loss than adding placebo among obese patients without BED but not among those with BED. Although 50% of BED patients maintained abstinence from binge-eating following these specific obesity treatments (BWL plus orlistat/placebo), BED was a negative prognostic indicator for some outcome variables.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00516919.
authors: Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA. carlos.grilo@yale.edu
authors: Carlos M
authors: CM
authors: Grilo
authors: Marney A
authors: MA
authors: White
mesh_terms: D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D056912:Binge-Eating Disorder / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D003155:Community Mental Health Centers; D005260:Female; D015438:Health Behavior; D006630:Hispanic or Latino; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D000077403:Orlistat; D011204:Poverty Areas; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat
references: J Consult Clin Psychol. 2005 Dec;73(6):1107-15
references: 16392984
references: Int J Eat Disord. 2011 Jul;44(5):435-9
references: 20635382
references: Obesity (Silver Spring). 2008 Sep;16(9):2024-38
references: 19186327
references: J Psychiatr Pract. 2005 Jul;11(4):221-30
references: 16041232
references: Obes Res. 2005 Oct;13(10):1701-8
references: 16286517
references: Diabetes Care. 2002 Dec;25(12):2165-71
references: 12453955
references: J Consult Clin Psychol. 2012 Apr;80(2):186-95
references: 22201327
references: Am J Clin Nutr. 2011 May;93(5):1163S-7S
references: 21367946
references: Arch Gen Psychiatry. 2010 Jan;67(1):94-101
references: 20048227
references: Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31
references: 19635784
references: Int J Eat Disord. 2004 Jan;35(1):80-5
references: 14705160
references: J Clin Psychiatry. 2004 Nov;65(11):1463-9
references: 15554757
references: JAMA. 2010 Jan 20;303(3):235-41
references: 20071471
references: Psychol Assess. 2003 Dec;15(4):569-77
references: 14692850
references: Obes Rev. 2012 Jun;13(6):483-98
references: 22288431
references: Diabetes Obes Metab. 2003 May;5(3):180-8
references: 12681025
references: Am Psychol. 2007 Apr;62(3):199-216
references: 17469898
references: J Consult Clin Psychol. 2004 Feb;72(1):126-31
references: 14756622
references: Nat Rev Endocrinol. 2010 Oct;6(10):578-88
references: 20680034
references: J Natl Med Assoc. 2009 Jan;101(1):62-70
references: 19245074
references: J Consult Clin Psychol. 2012 Dec;80(6):1108-13
references: 22985205
references: Biol Psychiatry. 2005 May 15;57(10):1193-201
references: 15866560
references: Obesity (Silver Spring). 2008 Jun;16(6):1413-20
references: 18421273
references: Circulation. 2005 Mar 15;111(10):e134-9
references: 15769755
references: J Consult Clin Psychol. 2001 Apr;69(2):317-22
references: 11393608
references: J Consult Clin Psychol. 2011 Oct;79(5):675-85
references: 21859185
references: Annu Rev Clin Psychol. 2008;4:305-24
references: 18370619
references: Psychother Psychosom. 2001 Nov-Dec;70(6):298-306
references: 11598429
references: Eur Eat Disord Rev. 2009 Mar;17(2):101-8
references: 18683898
references: Int J Eat Disord. 2009 Apr;42(3):228-34
references: 18951458
references: Am J Prev Med. 2009 Apr;36(4):341-50
references: 19285199
references: Obesity (Silver Spring). 2009 Apr;17(4):713-22
references: 19180071
references: BMC Psychiatry. 2008 Sep 15;8:77
references: 18793398
references: Eat Weight Disord. 2007 Jun;12(2):54-60
references: 17615489
references: Ethn Dis. 2007 Spring;17(2):397-402
references: 17682376
references: JAMA. 1999 Jan 20;281(3):235-42
references: 9918478
references: Int J Eat Disord. 2007 Nov;40 Suppl:S15-21
references: 17584870
references: Biol Psychiatry. 2007 Feb 1;61(3):348-58
references: 16815322
references: Int J Eat Disord. 2011 Jul;44(5):412-20
references: 20665700
references: J Psychiatr Pract. 2005 Jul;11(4):231-40
references: 16041233
references: Obes Res. 2005 Jun;13(6):1077-88
references: 15976151
references: Psychol Bull. 2005 May;131(3):412-7, discussion 427-33
references: 15869337
references: Behav Res Ther. 2009 Nov;47(11):902-9
references: 19664756