Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial

Background/objectives. vagal block therapy (vbloc) is effective for moderate to severe obesity at one year. subjects/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. © 2015 scott a. shikora et al.