Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity: The ReCharge Randomized Clinical Trial
Abstract
IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.
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Two RCTs assessing the effect of vBloc® reported 17% and 24% excess weight loss at 1-year follow-up.
“Two RCTs assessing the effect of vBloc® reported 17% and 24% EWL at 1-year follow-up [144, 145].”
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 [145]
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- Authors
- Ikramuddin, S., Blackstone, R. P., Brancatisano, A., Toouli, J., Shah, S. N., Wolfe, B. M., Fujioka, K., Maher, J. W., Swain, J., Que, F. G., Morton, J. M., Leslie, D. B., Brancatisano, R., Kow, L., O’Rourke, R. W., Deveney, C., Takata, M., Miller, C. J., Knudson, M. B., Tweden, K. S., Shikora, S. A., Sarr, M. G., & Billington, C. J.
- Affiliations
- University of Minnesota (US)
- Circle of Care (AU)
- Adelaide Bariatric Centre, Adelaide, Australia
- Tufts Medical Center (US)
- Oregon Health & Science University (US)
- Scripps Clinic (US)
- Virginia Commonwealth University (US)
- Mayo Clinic (US)
- Stanford Medicine (US)
- University of Michigan (US)
- North American Science Associates, Minneapolis, Minnesota
- ReShape Lifesciences (United States) (US)
- Brigham and Women's Hospital (US)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2014-09-03
- Volume
- 312
- Issue
- 9
- Pages
- 915
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W1988807128
- Cited by
- 214
- References
- 26
- Citations by year
- 2026: 8 · 2025: 11 · 2024: 8 · 2023: 14 · 2022: 11 · 2021: 12 · 2020: 21 · 2019: 23 · 2018: 20 · 2017: 22 · 2016: 38 · 2015: 24 · 2014: 2
- FWCI
- 28.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- 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
- morbid obesity, weight loss, vagus nerve stimulation, neuromodulation, bariatric surgery alternatives, excess weight loss, device safety, serious adverse events, obesity-related comorbidities, body mass index, equipment failure
- MeSH terms
- Adult, Double-Blind Method, Dyspepsia, Electrodes, Female, Heartburn, Humans, Male, Middle Aged, Nerve Block, Obesity, Morbid, Vagus Nerve, Weight Loss, Abdominal Pain
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