Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study

Obes Surg. 2016 May;26(5):983-9. doi: 10.1007/s11695-016-2143-y.

Abstract

Background: Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity.

Methods: The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40-45 or 35-40 kg/m(2) with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35-40 kg/m(2)) at randomization.

Results: Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep apnea (33%), and type 2 diabetes (8%). The vBloc group achieved a percentage excess weight loss (%EWL) of 33% (11% total weight loss (%TWL)) compared to 19% EWL (6% TWL) with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate.

Conclusions: vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.

Keywords: Active implantable medical device; Bariatric surgery; Laparoscopic surgery; Moderate obesity; Obesity; Randomized controlled trial; Vagal nerve blocking.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Body Mass Index
  • Diabetes Mellitus, Type 2 / complications
  • Double-Blind Method
  • Dyslipidemias / complications
  • Female
  • Humans
  • Hypertension / complications
  • Male
  • Middle Aged
  • Nerve Block / methods*
  • Obesity / complications
  • Obesity / therapy*
  • Treatment Outcome
  • Vagus Nerve*
  • Weight Loss / physiology*