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 o...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Obesity |
| Online Access: | http://dx.doi.org/10.1155/2015/365604 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Scott A. Shikora |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-198d9b1a2ab5403b9a5f30294fb42ba6 |
| institution | Kabale University |
| issn | 2090-0708 2090-0716 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Obesity |
| spelling | doaj-art-198d9b1a2ab5403b9a5f30294fb42ba62025-02-03T01:11:11ZengWileyJournal of Obesity2090-07082090-07162015-01-01201510.1155/2015/365604365604Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge TrialScott A. Shikora0Bruce M. Wolfe1Caroline M. Apovian2Mehran Anvari3David B. Sarwer4Robert D. Gibbons5Sayeed Ikramuddin6Christopher J. Miller7Mark B. Knudson8Katherine S. Tweden9Michael G. Sarr10Charles J. Billington11Division of General and Gastrointestinal Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USADepartment of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USADepartment of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USADepartment of Surgery, McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, CanadaDepartments of Psychiatry and Surgery, Perelman School of Medicine, Hospital of the University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, USADepartments of Medicine and Public Health Sciences, University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USADepartment of Surgery, University of Minnesota, University of Minnesota Medical Center, 420 Delaware Street SE, Minneapolis, MN 55455, USA3D Communications LLC, 8386 Six Forks Road, Raleigh, NC 27615, USAEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USAEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USADepartment of Gastroenterologic and General Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USADivision of Endocrinology and Diabetes, University of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans Drive, Minneapolis, MN 55417, USABackground/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.http://dx.doi.org/10.1155/2015/365604 |
| spellingShingle | 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 Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial Journal of Obesity |
| title | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial |
| title_full | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial |
| title_fullStr | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial |
| title_full_unstemmed | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial |
| title_short | Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial |
| title_sort | sustained weight loss with vagal nerve blockade but not with sham 18 month results of the recharge trial |
| url | http://dx.doi.org/10.1155/2015/365604 |
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