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Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial
Joint Authors
Shikora, S.
Sarwer, David B.
Apovian, Caroline M.
Anvari, Mehran
Gibbons, Robert D.
Miller, Christopher J.
Sarr, Michael G.
Wolfe, Bruce
Billington, C. J.
Tweden, K. S.
Knudson, M. B.
Ikramuddin, Sayeed
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-07-12
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Shikora, S.& Wolfe, Bruce& Apovian, Caroline M.& Anvari, Mehran& Sarwer, David B.& Gibbons, Robert D.…[et al.]. 2015. Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial. Journal of Obesity،Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1069608
Modern Language Association (MLA)
Shikora, S.…[et al.]. Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial. Journal of Obesity No. 2015 (2015), pp.1-8.
https://search.emarefa.net/detail/BIM-1069608
American Medical Association (AMA)
Shikora, S.& Wolfe, Bruce& Apovian, Caroline M.& Anvari, Mehran& Sarwer, David B.& Gibbons, Robert D.…[et al.]. Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial. Journal of Obesity. 2015. Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1069608
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1069608