title: MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After poseSMvs. Medical Therapy.
abstract: PoseSMis an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.
  
  
  
  Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.
  
  
  
  From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.
  
  
  
  In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.
  
  
  
  clinicaltrials.gov identifier # NCT01843231.
authors.affiliation: Bariatric Medical Unit, Wehrle Diakonissen Private Clinic, Salzburg, Austria. karl@miller.co.at.
authors.forename: Karl
authors.initials: K
authors.lastname: Miller
authors.affiliation: Unidad de Endoscopia, Centro Médico Teknon, Barcelona, Catalonia, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Turró
authors.affiliation: Department of General Surgery, Bariatric and Gastrointestinal Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.
authors.forename: J W
authors.initials: JW
authors.lastname: Greve
authors.affiliation: Department of General Surgery, Bariatric and Gastrointestinal Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.
authors.forename: C M
authors.initials: CM
authors.lastname: Bakker
authors.affiliation: Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA.
authors.forename: J N
authors.initials: JN
authors.lastname: Buchwald
authors.affiliation: Unidad de Endoscopia, Centro Médico Teknon, Barcelona, Catalonia, Spain.
authors.forename: J C
authors.initials: JC
authors.lastname: Espinós
mesh_terms: D000328:Adult; D050110:Bariatric Surgery / Q000379:methods*; D001521:Behavior Therapy; D003131:Combined Modality Therapy; D003376:Counseling; D004038:Diet, Reducing; D004724:Endoscopy; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery* / Q000628:therapy; D012527:Satiation / Q000502:physiology*; D016896:Treatment Outcome; D015431:Weight Loss; D061217:Weight Reduction Programs / Q000379:methods*; D055815:Young Adult
keywords: Bariatric; Endoscopic; Satiety; Weight loss; pose