Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham

18-Month Results of the ReCharge Trial

Scott A. Shikora, Bruce M. Wolfe, Caroline M. Apovian, Mehran Anvari, David B. Sarwer, Robert D. Gibbons, Sayeed Ikramuddin, Christopher J. Miller, Mark B. Knudson, Katherine S. Tweden, Michael G. Sarr, Charles J. Billington

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article number365604
JournalJournal of Obesity
Volume2015
DOIs
StatePublished - 2015

Fingerprint

Nerve Block
Weight Loss
Therapeutics
Weights and Measures
Heartburn
Morbid Obesity
Dyspepsia
Abdominal Pain
Counseling
Body Mass Index
Randomized Controlled Trials
Obesity
Equipment and Supplies

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

Shikora, S. A., Wolfe, B. M., Apovian, C. M., Anvari, M., Sarwer, D. B., Gibbons, R. D., ... Billington, C. J. (2015). Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial. Journal of Obesity, 2015, [365604]. https://doi.org/10.1155/2015/365604

Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham : 18-Month Results of the ReCharge Trial. / Shikora, Scott A.; Wolfe, Bruce M.; Apovian, Caroline M.; Anvari, Mehran; Sarwer, David B.; Gibbons, Robert D.; Ikramuddin, Sayeed; Miller, Christopher J.; Knudson, Mark B.; Tweden, Katherine S.; Sarr, Michael G.; Billington, Charles J.

In: Journal of Obesity, Vol. 2015, 365604, 2015.

Research output: Contribution to journalArticle

Shikora, SA, Wolfe, BM, Apovian, CM, Anvari, M, Sarwer, DB, Gibbons, RD, Ikramuddin, S, Miller, CJ, Knudson, MB, Tweden, KS, Sarr, MG & Billington, CJ 2015, 'Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial', Journal of Obesity, vol. 2015, 365604. https://doi.org/10.1155/2015/365604
Shikora, Scott A. ; Wolfe, Bruce M. ; Apovian, Caroline M. ; Anvari, Mehran ; Sarwer, David B. ; Gibbons, Robert D. ; Ikramuddin, Sayeed ; Miller, Christopher J. ; Knudson, Mark B. ; Tweden, Katherine S. ; Sarr, Michael G. ; Billington, Charles J. / Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham : 18-Month Results of the ReCharge Trial. In: Journal of Obesity. 2015 ; Vol. 2015.
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abstract = "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.",
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AU - Wolfe, Bruce M.

AU - Apovian, Caroline M.

AU - Anvari, Mehran

AU - Sarwer, David B.

AU - Gibbons, Robert D.

AU - Ikramuddin, Sayeed

AU - Miller, Christopher J.

AU - Knudson, Mark B.

AU - Tweden, Katherine S.

AU - Sarr, Michael G.

AU - Billington, Charles J.

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N2 - 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.

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