Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial
Open accessAbstract
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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Two-year follow-up suggested sustained weight loss with vBloc®.
“Two-year follow-up suggested sustained weight loss [146, 147].”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [146]
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Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
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- Authors
- Shikora, S. A., Wolfe, B. M., Apovian, C. M., Anvari, M., Sarwer, D. B., Gibbons, R. D., Ikramuddin, S., Miller, C. J., Knudson, M. B., Tweden, K. S., Sarr, M. G., & Billington, C. J.
- Affiliations
- Brigham and Women's Hospital (US)
- Oregon Health & Science University (US)
- Boston University (US)
- McMaster University (CA)
- Hospital of the University of Pennsylvania (US)
- University of Chicago (US)
- University of Minnesota (US)
- 3D Communications LLC, 8386 Six Forks Road, Raleigh, NC 27615, USA
- ReShape Lifesciences (United States) (US)
- Mayo Clinic (US)
- Corresponding author
- Tweden, Katherine S.
- ORCID
- Venue
- Journal of Obesity
- Publisher
- Hindawi Limited
- Published
- 2015
- Volume
- 2015
- Pages
- 1-8
- ISSN
- 2090-0708 (ISSN-L)
- 2090-0716
- PMC
- PMC4515300
- OpenAlex
- W1541214928
- Cited by
- 83
- References
- 11
- Citations by year
- 2026: 1 · 2025: 9 · 2024: 4 · 2023: 5 · 2022: 3 · 2021: 6 · 2020: 12 · 2019: 9 · 2018: 13 · 2017: 6 · 2016: 12 · 2015: 3
- FWCI
- 11.42
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Journal of Obesity (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- TUScholarShare (Temple University) (submittedVersion, cc-by)
- Funders
- Oregon Health and Science University
- Tufts Medical Center
- University of Minnesota
- University of Connecticut
- Virginia Commonwealth University
- Universidad Nacional Autónoma de México
- School of Medicine, Stanford University
- University of Colorado Denver
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- vagus nerve block, obesity, weight loss, weight regain, sham device, excess weight loss, weight management counseling, obesity-related comorbidities, adverse events
- MeSH terms
- Double-Blind Method, Dyspepsia, Electrodes, Female, Follow-Up Studies, Heartburn, Humans, Male, Middle Aged, Nerve Block, Obesity, Morbid, United States, Vagus Nerve, Weight Loss, Abdominal Pain, Body Mass Index, Treatment Outcome, Risk Assessment
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