title: Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.
abstract: OBJECTIVE
  Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year.
  
  
  METHODS
  The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study.
  
  
  RESULTS
  18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved.
  
  
  CONCLUSIONS
  Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.
authors.affiliation: Division of General and Gastrointestinal Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA ; EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Shikora
authors.affiliation: Department of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Wolfe
authors.affiliation: Department of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Apovian
authors.affiliation: Department of Surgery, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S4L8.
authors.forename: Mehran
authors.initials: M
authors.lastname: Anvari
authors.affiliation: Departments of Psychiatry and Surgery, Perelman School of Medicine, Hospital of the University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Sarwer
authors.affiliation: Departments of Medicine and Public Health Sciences, University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Gibbons
authors.affiliation: Department of Surgery, University of Minnesota, University of Minnesota Medical Center, 420 Delaware Street SE, Minneapolis, MN 55455, USA.
authors.forename: Sayeed
authors.initials: S
authors.lastname: Ikramuddin
authors.affiliation: 3D Communications LLC, 8386 Six Forks Road, Raleigh, NC 27615, USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Miller
authors.affiliation: EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Knudson
authors.affiliation: EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Tweden
authors.affiliation: Department of Gastroenterologic and General Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Sarr
authors.affiliation: Division of Endocrinology and Diabetes, University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans Drive, Minneapolis, MN 55417, USA.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D015992:Body Mass Index; D004311:Double-Blind Method; D004415:Dyspepsia / Q000209:etiology; D004566:Electrodes; D005260:Female; D005500:Follow-Up Studies; D006356:Heartburn / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009407:Nerve Block / Q000009:adverse effects / Q000379:methods*; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014630:Vagus Nerve / Q000503:physiopathology*; D015431:Weight Loss