title: Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.
abstract: OBJECTIVE
  Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity.
  
  
  OBJECTIVE
  To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment.
  
  
  METHODS
  A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013.
  
  
  METHODS
  One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education.
  
  
  METHODS
  The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%.
  
  
  RESULTS
  In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity.
  
  
  CONCLUSIONS
  Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01327976.
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis.
authors.forename: Sayeed
authors.initials: S
authors.lastname: Ikramuddin
authors.affiliation: University of Minnesota, Minneapolis; Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.
authors.forename: Robin P
authors.initials: RP
authors.lastname: Blackstone
authors.affiliation: Institute of Weight Control, Sydney, Australia.
authors.forename: Anthony
authors.initials: A
authors.lastname: Brancatisano
authors.affiliation: Adelaide Bariatric Centre, Adelaide, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Toouli
authors.affiliation: Department of Surgery, Tufts Medical Center, Boston, Massachusetts.
authors.forename: Sajani N
authors.initials: SN
authors.lastname: Shah
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Wolfe
authors.affiliation: Scripps Clinic, San Diego, California.
authors.forename: Ken
authors.initials: K
authors.lastname: Fujioka
authors.affiliation: Division of General Surgery, Virginia Commonwealth University, Richmond.
authors.forename: James W
authors.initials: JW
authors.lastname: Maher
authors.affiliation: University of Minnesota, Minneapolis; Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.
authors.forename: James
authors.initials: J
authors.lastname: Swain
authors.affiliation: Department of Gastroenterologic and General Surgery, Mayo Clinic Rochester, Rochester, Minnesota.
authors.forename: Florencia G
authors.initials: FG
authors.lastname: Que
authors.affiliation: Division of General Surgery, Stanford University School of Medicine, Stanford, California.
authors.forename: John M
authors.initials: JM
authors.lastname: Morton
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Leslie
authors.affiliation: Institute of Weight Control, Sydney, Australia.
authors.forename: Roy
authors.initials: R
authors.lastname: Brancatisano
authors.affiliation: Adelaide Bariatric Centre, Adelaide, Australia.
authors.forename: Lilian
authors.initials: L
authors.lastname: Kow
authors.affiliation: Department of Surgery, University of Michigan and Ann Arbor VA Hospital.
authors.forename: Robert W
authors.initials: RW
authors.lastname: O'Rourke
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland.
authors.forename: Clifford
authors.initials: C
authors.lastname: Deveney
authors.affiliation: Scripps Clinic, San Diego, California.
authors.forename: Mark
authors.initials: M
authors.lastname: Takata
authors.affiliation: North American Science Associates, Minneapolis, Minnesota.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Miller
authors.affiliation: EnteroMedics Inc, St Paul, Minnesota.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Knudson
authors.affiliation: EnteroMedics Inc, St Paul, Minnesota.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Tweden
authors.affiliation: EnteroMedics Inc, St Paul, Minnesota14Division of General and Gastrointestinal Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Shikora
authors.affiliation: Department of Gastroenterologic and General Surgery, Mayo Clinic Rochester, Rochester, Minnesota.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Sarr
authors.affiliation: Division of Endocrinology and Diabetes, Minneapolis VA Medical Center and University of Minnesota, Minneapolis.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D004311:Double-Blind Method; D004415:Dyspepsia / Q000209:etiology; D004566:Electrodes; D005260:Female; D006356:Heartburn / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009407:Nerve Block / Q000009:adverse effects / Q000379:methods*; D009767:Obesity, Morbid / Q000628:therapy*; D014630:Vagus Nerve / Q000503:physiopathology; D015431:Weight Loss