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dc.creatorShikora, SA
dc.creatorWolfe, BM
dc.creatorApovian, CM
dc.creatorAnvari, M
dc.creatorSarwer, DB
dc.creatorGibbons, RD
dc.creatorIkramuddin, S
dc.creatorMiller, CJ
dc.creatorKnudson, MB
dc.creatorTweden, KS
dc.creatorSarr, MG
dc.creatorBillington, CJ
dc.date.accessioned2021-01-29T22:19:49Z
dc.date.available2021-01-29T22:19:49Z
dc.date.issued2015-01-01
dc.identifier.issn2090-0708
dc.identifier.issn2090-0716
dc.identifier.doihttp://dx.doi.org/10.34944/dspace/5233
dc.identifier.other26246907 (pubmed)
dc.identifier.urihttp://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.extent1-8
dc.language.isoen
dc.relation.haspartJournal of Obesity
dc.relation.isreferencedbyHindawi Limited
dc.rightsCC BY
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/
dc.subjectAbdominal Pain
dc.subjectBody Mass Index
dc.subjectDouble-Blind Method
dc.subjectDyspepsia
dc.subjectElectrodes
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHeartburn
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectNerve Block
dc.subjectObesity, Morbid
dc.subjectRisk Assessment
dc.subjectTreatment Outcome
dc.subjectUnited States
dc.subjectVagus Nerve
dc.subjectWeight Loss
dc.titleSustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial
dc.typeArticle
dc.type.genreJournal Article
dc.relation.doi10.1155/2015/365604
dc.ada.noteFor Americans with Disabilities Act (ADA) accommodation, including help with reading this content, please contact scholarshare@temple.edu
dc.creator.orcidSarwer, David B|0000-0003-1033-5528
dc.date.updated2021-01-29T22:19:46Z
refterms.dateFOA2021-01-29T22:19:50Z


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