Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial
dc.creator | Shikora, SA | |
dc.creator | Wolfe, BM | |
dc.creator | Apovian, CM | |
dc.creator | Anvari, M | |
dc.creator | Sarwer, DB | |
dc.creator | Gibbons, RD | |
dc.creator | Ikramuddin, S | |
dc.creator | Miller, CJ | |
dc.creator | Knudson, MB | |
dc.creator | Tweden, KS | |
dc.creator | Sarr, MG | |
dc.creator | Billington, CJ | |
dc.date.accessioned | 2021-01-29T22:19:49Z | |
dc.date.available | 2021-01-29T22:19:49Z | |
dc.date.issued | 2015-01-01 | |
dc.identifier.issn | 2090-0708 | |
dc.identifier.issn | 2090-0716 | |
dc.identifier.doi | http://dx.doi.org/10.34944/dspace/5233 | |
dc.identifier.other | 26246907 (pubmed) | |
dc.identifier.uri | http://hdl.handle.net/20.500.12613/5251 | |
dc.description.abstract | © 2015 Scott A. Shikora et al. 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. | |
dc.format.extent | 1-8 | |
dc.language.iso | en | |
dc.relation.haspart | Journal of Obesity | |
dc.relation.isreferencedby | Hindawi Limited | |
dc.rights | CC BY | |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/ | |
dc.subject | Abdominal Pain | |
dc.subject | Body Mass Index | |
dc.subject | Double-Blind Method | |
dc.subject | Dyspepsia | |
dc.subject | Electrodes | |
dc.subject | Female | |
dc.subject | Follow-Up Studies | |
dc.subject | Heartburn | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Nerve Block | |
dc.subject | Obesity, Morbid | |
dc.subject | Risk Assessment | |
dc.subject | Treatment Outcome | |
dc.subject | United States | |
dc.subject | Vagus Nerve | |
dc.subject | Weight Loss | |
dc.title | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial | |
dc.type | Article | |
dc.type.genre | Journal Article | |
dc.relation.doi | 10.1155/2015/365604 | |
dc.ada.note | For Americans with Disabilities Act (ADA) accommodation, including help with reading this content, please contact scholarshare@temple.edu | |
dc.creator.orcid | Sarwer, David B|0000-0003-1033-5528 | |
dc.date.updated | 2021-01-29T22:19:46Z | |
refterms.dateFOA | 2021-01-29T22:19:50Z |